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  • 1.
    Al-Windi, Ahmad
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences.
    Elmfeldt, Dag
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences.
    Svärdsudd, Kurt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences.
    Determinants of utilisation in a Swedish municipality2004In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 13, no 2, p. 97-103Article in journal (Refereed)
  • 2.
    Bardage, Carola
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Ekedahl, Anders
    Ring, Lena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Health-Care Professionals' Perspectives on Multi-Dose Dispensed Medicines2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no S1, p. 251-251Article in journal (Other academic)
  • 3. Bergendal, Annica
    et al.
    Adami, Johanna
    Bahmanyar, Shahram
    Hedenmalm, Karin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Pharmacology.
    Larfars, Gerd
    Persson, Ingemar
    Sundstrom, Anders
    Kieler, Helle
    Non-steroidal anti-inflammatory drugs and venous thromboembolism in women2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no 6, p. 658-666Article in journal (Refereed)
    Abstract [en]

    Background Non-steroidal anti-inflammatory drugs (NSAIDs) might increase the risk of venous thromboembolism (VTE), and risks might differ by type of NSAID. Compared with men, women have a higher incidence of VTE at younger age, and they more often use NSAIDs. Objectives To assess risks of VTE in young and middle-aged women in association with use of NSAIDs. Patients/Methods In a nationwide case-control study (Thrombo Embolism Hormone Study) performed in Sweden 2003-2009, we included as cases 1433 women, 18 to 64years of age with a first time VTE. Controls were 1402 randomly selected women, frequency matched by age. Information was obtained by telephone interviews and DNA analyses of blood samples. We calculated adjusted odds ratios (ORs) with 95% confidence intervals (CIs) adjusting for degree of immobilization, chronic disease, smoking, body mass index, use of hormonal contraception, hormone therapy or other NSAIDs. Results Use of NSAIDs was not associated with increased risks of VTE (OR=0.98, 95% CI 0.80-1.19). The OR was 0.88 for propionic acid derivatives (95% CI 0.72-1.10), 1.18 for acetic acid derivatives (95% CI 0.82-1.70) and 1.76 for coxibs (95% CI 0.73-4.27). For users of acetic acid derivatives and coxibs, the ORs increased by cumulative dose. Carriership of the prothrombin gene mutation or factor V Leiden had only minor effects on the results. Conclusions We found no increased risks of VTE in association with use of NSAIDs. Users of high cumulative doses of acetic acid derivatives and coxibs had the highest risks, suggesting a relationship with cyclooxygenase selectivity and dose.

  • 4. Bertulyte, Ilma
    et al.
    Schwan, Sofie
    Schubert, Jessica
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Hallberg, Pär
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical pharmacogenomics and osteoporosis.
    Risk Factors for Carbamazepine Induced Serious Skin Reactions2012In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 21, no SI:3, p. 441-441Article in journal (Other academic)
  • 5.
    Bjerre, Lise M.
    et al.
    Univ Ottawa, Ottawa, ON, Canada;Bruyere Res Inst, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada.
    Ramsay, Timothy
    Univ Ottawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Cahir, Catriona
    Trinity Coll Dublin, Dublin, Ireland.
    Ryan, Cristin
    Royal Coll Surgeons Ireland, Dublin, Ireland.
    Halil, Roland
    Univ Ottawa, Ottawa, ON, Canada.
    Farrell, Barbara
    Univ Ottawa, Ottawa, ON, Canada;Bruyere Res Inst, Ottawa, ON, Canada;Univ Waterloo, Waterloo, ON, Canada.
    Thavorn, Kednapa
    Univ Ottawa, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Catley, Christina
    ICES UOttawa, Ottawa, ON, Canada.
    Hawken, Steven
    Univ Ottawa, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Ducharme, Robin
    ICES UOttawa, Ottawa, ON, Canada.
    Smith, Glenys
    ICES UOttawa, Ottawa, ON, Canada.
    Gillespie, Ulrika
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
    Manuel, Douglas G.
    Univ Ottawa, Ottawa, ON, Canada;Bruyere Res Inst, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Identifying Potentially Inappropriate Prescriptions in Whole Populations: Coding the Beers Criteria for Use with Large, Routinely Collected Population Datasets2017In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 26, p. 203-203Article in journal (Other academic)
  • 6.
    Bjerre, Lise M.
    et al.
    Univ Ottawa, Ottawa, ON, Canada;Bruyere Res Inst, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada.
    Ramsay, Timothy
    Univ Ottawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Cahir, Catriona
    Trinity Coll Dublin, Dublin, Ireland.
    Ryan, Cristin
    Royal Coll Surgeons Ireland, Dublin, Ireland.
    Halil, Roland
    Univ Ottawa, Ottawa, ON, Canada.
    Farrell, Barbara
    Univ Ottawa, Ottawa, ON, Canada;Bruyere Res Inst, Ottawa, ON, Canada;Univ Waterloo, Waterloo, ON, Canada.
    Thavorn, Kednapa
    Univ Ottawa, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Catley, Christina
    ICES UOttawa, Ottawa, ON, Canada.
    Hawken, Steven
    Univ Ottawa, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Ducharme, Robin
    ICES UOttawa, Ottawa, ON, Canada.
    Smith, Glenys
    ICES UOttawa, Ottawa, ON, Canada.
    Gillespie, Ulrika
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
    Manuel, Douglas G.
    Univ Ottawa, Ottawa, ON, Canada;Bruyere Res Inst, Ottawa, ON, Canada;ICES UOttawa, Ottawa, ON, Canada;Ottawa Hosp, Res Inst, Ottawa, ON, Canada.
    Identifying Potentially Inappropriate Prescriptions in Whole Populations: Coding the STOPP-START Criteria for Use with Large, Routinely Collected Population Datasets2017In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 26, p. 203-204Article in journal (Other academic)
  • 7.
    Boden, Robert
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Psychiatry, University Hospital.
    Lundgren, Maria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Pediatrics.
    Brandt, Lena
    Reutfors, Johan
    Andersen, Morten
    Kieler, Helle
    Bipolar Disorder, Mood Stabilizers and Adverse Pregnancy Outcome: A Population Based Cohort Study2012In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 21, no SI:3, p. 31-31Article in journal (Other academic)
  • 8.
    Brenner, Philip
    et al.
    Karolinska Inst, Stockholm, Sweden.
    Brandt, Lena
    Karolinska Inst, Stockholm, Sweden.
    Hägg, David
    Karolinska Inst, Stockholm, Sweden.
    Li, Gang
    Janssen, Global Serv, Titusville, NJ USA.
    DiBernardo, Allitia
    Janssen, Global Serv, Titusville, NJ USA.
    Bodén, Robert
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Psychiatry, University Hospital.
    Reutfors, Johan
    Karolinska Inst, Stockholm, Sweden.
    Substance use disorders are risk factors for treatment resistant depression2018In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 27, no Suppl. 2, p. 153-153, article id 331Article in journal (Other academic)
  • 9.
    Brenner, Philip
    et al.
    Karolinska Inst, Stockholm, Sweden.
    Hagg, David
    Karolinska Inst, Stockholm, Sweden.
    DiBernardo, Allitia
    Janssen, Global Serv, Titusville, NJ USA.
    Li, Gang
    Janssen, Global Serv, Titusville, NJ USA.
    Bodén, Robert
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Psychiatry, University Hospital.
    Brandt, Lena
    Karolinska Inst, Stockholm, Sweden.
    Reutfors, Johan
    Karolinska Inst, Stockholm, Sweden.
    Treatment resistant depression as a risk factor for substance use disorders-A national register-based cohort study2018In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 27, no Suppl. 2, p. 152-152, article id 329Article in journal (Other academic)
  • 10.
    Cars, Thomas
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Lindhagen, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Malmstrom, Rickard E.
    Karolinska Inst, Karolinska Univ Hosp, Dept Med, Div Clin Pharmacol, Stockholm, Sweden.
    Neovius, Martin
    Karolinska Inst, Dept Med, Clin Epidemiol Unit, Stockholm, Sweden.
    Schwieler, Jonas
    Karolinska Inst, Dept Cardiol, Stockholm, Sweden.
    Wettermark, Bjorn
    Karolinska Inst, Dept Med, Ctr Pharmacoepidemiol, Stockholm, Sweden.
    Sundström, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Dronedarone and Hepatic Toxicity?: A Model for Evaluation of Post-Marketing Safety of Drugs in Routine Care2017In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 26, p. 381-382Article in journal (Other academic)
  • 11.
    Cars, Thomas
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Lordal, Mikael
    Wettermark, Bjorn
    Using Administrative Healthcare Data to Study the Treatment of Inflammatory Bowel Disease in the Region of Stockholm, Sweden2014In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 23, no S1, p. 137-137Article in journal (Other academic)
  • 12.
    Cars, Thomas
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Neovius, Martin
    Karolinska Inst, Dept Med, Stockholm, Sweden..
    Lindhagen, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Malmström, Rickard E.
    Karolinska Inst, Dept Med, Stockholm, Sweden..
    Schwieler, Jonas
    Karolinska Inst, Dept Cardiol, Stockholm, Sweden..
    Wettermark, Bjon
    Karolinska Inst, Dept Med, Stockholm, Sweden..
    Sundström, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    An Automatized Model for Sequential Monitoring of Effectiveness of New Drugs Using Dronedarone as Example2016In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 25, p. 504-504Article in journal (Refereed)
  • 13.
    Cars, Thomas
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Wettermark, Björn
    Ekeving, Gunnar
    Vikström, Bo
    Malmström, Rickard
    Gustafsson, Lars L.
    Bergman, Ulf
    Neovius, Martin
    Ringertz, Bo
    Extraction of Electronic Health Record Data in a Hospital Setting: Comparison of Automatic and Semi-Automatic Methods Using Anti-TNF Therapy as Model2012In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 21, no SI:3, p. 175-176Article in journal (Other academic)
  • 14. Cea Soriano, Lucía
    et al.
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Andersson, Susan
    Filonenko, Anna
    García Rodríguez, Luis Alberto
    The continuation rates of long-acting reversible contraceptives in UK general practice using data from The Health Improvement Network2015In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 24, no 1, p. 52-58Article in journal (Refereed)
    Abstract [en]

    PURPOSE: The purpose of this study was to determine the continuation rates of new users of long-acting reversible contraceptive (LARC) methods in the UK, using data from general practice.

    METHODS: We conducted an observational study using a general practitioner (GP) database, The Health Improvement Network (THIN). The methods studied were copper intrauterine devices (Cu-IUDs), levonorgestrel-releasing intrauterine system (LNG-IUS), progestogen-only implants and progestogen-only injections. The study population comprised women in THIN aged 18-44 years during the period 2004-2009 who had been registered with their GP for at least 5 years, with a computerized prescription history of at least 1 year. Using computer algorithms, the database was searched for the Read and Multilex codes for each LARC method. New LARC users were identified and followed until there was a record indicating termination of use or the study period ended.

    RESULTS: The proportion of women who discontinued use during the same year of administration was 7.5% for Cu-IUDs, 10.6% for LNG-IUS, 13.2% for progestogen-only implants and 54.4% for progestogen-only injections. By the end of the study, a higher proportion of Cu-IUD and LNG-IUS users (21.1 and 18.6%, respectively) undertook consecutive use of the same method than progestogen-only implant users (10.7%). Manual review of computerized profiles demonstrated the validity of this approach.

    CONCLUSIONS: In the UK, the continuation rates of LARCs are high, and approximately one fifth of women chose to have a second intrauterine device fitted after expiry of the first device. A validation step demonstrated the reliability of the methodology and computer algorithms used.

  • 15. Cea-Soriano, Lucia
    et al.
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Andersson, Susan
    Filonenko, Anna
    Garcia Rodriguez, Luis Alberto
    Continuation Rates of Long-Acting Reversible Contraceptives: A UK Primary Care Study2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no S1, p. 465-466Article in journal (Other academic)
  • 16.
    Ekstrand, Charlotta
    et al.
    Karolinska Inst, Dept Med, Stockholm, Sweden..
    Linder, Marie
    Karolinska Inst, Dept Med, Stockholm, Sweden..
    Cherif, Honar
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.
    Kieler, Helle
    Karolinska Inst, Dept Med, Stockholm, Sweden..
    Bahmanyar, Shahram
    Karolinska Inst, Dept Med, Stockholm, Sweden..
    Characteristics of Patients at Initiation of Treatment for Primary Chronic Immune Thrombocytopenia2016In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 25, no Suppl. 3, p. 197-197, article id Abstr. 336Article in journal (Refereed)
  • 17.
    Ekstrand, Charlotta
    et al.
    Karolinska Inst, Dept Med Solna, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Linder, Marie
    Karolinska Inst, Dept Med Solna, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Cherif, Honar
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.
    Kieler, Helle
    Karolinska Inst, Dept Med Solna, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Bahmanyar, Shahram
    Karolinska Inst, Dept Med Solna, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Increased Anti-infective Treatments Preceding a Diagnosis of Primary Immune Thrombocytopenia2015In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 24, p. 411-412Article in journal (Other academic)
  • 18.
    Ekstrand, Charlotta
    et al.
    Karolinska Inst, Med, Stockholm, Sweden..
    Linder, Marie
    Karolinska Inst, Med, Stockholm, Sweden..
    Cherif, Honar
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.
    Kieler, Helle
    Karolinska Inst, Med, Stockholm, Sweden..
    Bahmanyar, Shahram
    Karolinska Inst, Med, Stockholm, Sweden..
    Susceptibility to Infection before Diagnosis of Primary Chronic Immune Thrombocytopenia2015In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 24, p. 519-519Article in journal (Other academic)
  • 19.
    Frisk, Pia
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Kälvemark-Sporrong, Sofia
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Wettermark, B.
    Selection bias in pharmacy-based patient surveys2014In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 23, no 2, p. 128-139Article in journal (Refereed)
    Abstract [en]

    PurposeTo evaluate if there is a selection bias in drug utilization surveys on prescription drugs regularly conducted in Swedish pharmacies, to describe the direction of this potential bias and discuss the implications for the results. MethodsAge and gender distributions within patient survey samples from drug utilization surveys conducted during 2006-2010 are compared to the age and gender distribution of all Swedish patients, receiving the same drug or drugs, as given by the Swedish Prescribed Drug Register. The differences between the proportions of patients within the age and gender segments of each pair of survey/register data were calculated. ResultsIn 25 (81%) out of 31 included surveys, patients aged 75 years or older are significantly underrepresented, as they are less likely to visit the pharmacy to collect their prescription drugs themselves and thus disqualify for the interviews. Data on women show similar results as overall survey data, whereas the underrepresentation of the oldest age group among men appears in a lower proportion of the surveys, 67%. The general consequence is a selection towards a healthier survey sample, but the consequences in the individual surveys vary, depending on what drug is being studied. ConclusionPharmacy-based patient surveys provide a convenient data collection method for patient self-reported data, but patients aged 75 years or older are consistently underrepresented. In surveys where this may influence the main research question, data should also be collected with other methods reaching the oldest patients.

  • 20. Gaist, David
    et al.
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    González-Pérez, Antonio
    García-Rodríguez, Luis Alberto
    Incidence of hemorrhagic stroke in the general population: validation of data from The Health Improvement Network2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, no 2, p. 176-182Article in journal (Refereed)
    Abstract [en]

    PURPOSE: The Health Improvement Network (THIN) is a UK healthcare database composed of computerized information from primary care physicians (PCPs). We analyzed the validity of our method for identifying cases of intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH) within THIN and assessed the incidence of these events. METHODS: Patients aged 20-89 years were identified and followed until (i) ICH or SAH was detected, (ii) the patient reached 90 years old (iii) death, or (iv) the end of the study. Computerized patient profiles were reviewed manually; those not discarded became potential cases. A validation study was undertaken in 400 computer-detected cases (333 confirmed as potential cases; 67 discarded). PCPs completed a questionnaire to determine the actual incidence of ICH and SAH among these cases. We also assessed the incidence of ICH and SAH in the total cohort. RESULTS: A total of 4330 patients with a READ code suggesting hemorrhagic stroke were identified. Computerized profiles with free-text comments were reviewed manually to identify 3633 potential cases. Responses to the PCP questionnaire were received for 306 potential cases and 63 discarded cases (92% response rate); 82% of potential cases were confirmed. Finally, we identified 3137 cases of hemorrhagic stroke. Crude incidence was 15 per 100 000 person-years for ICH and 11 per 100 000 person-years for SAH; the overall incidence increased sharply with age. CONCLUSIONS: Computer detection of cases of hemorrhagic stroke in THIN followed by manual review of clinical profiles is a valid method. The incidence of hemorrhagic stroke increases sharply with age.

  • 21. Garcia Rodriguez, Luis
    et al.
    Garbe, Edeltraut
    Bezemer, Irene
    Layton, Deborah
    Suzart-Woischnik, Kiliana
    Brobert, Gunnar
    Alderson, Jesse
    Winchester, Christopher
    Herings, Ron
    Jobski, Kathrin
    Schink, Tania
    Shakir, Saad
    Soriano-Gabarro, Montse
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Development of a Collaborative European Post-Authorization Safety Study (PASS) Program Examining Rivaroxaban Use in Routine Clinical Practice2014In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 23, no S1, p. 459-460Article in journal (Other academic)
  • 22. Garcia-Rodriguez, Luis Alberto
    et al.
    Gonzalez-Perez, Antonio
    Stang, Mary Rose
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology.
    Johansson, Saga
    The safety of rosuvastatin in comparison with other statins in over 25 000 statin users in the Saskatchewan Health Databases2008In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 17, no 10, p. 953-961Article in journal (Refereed)
    Abstract [en]

    Purpose To compare mortality and the incidence of hospitalization for myopathy, rhabdomyolysis, acute renal failure and acute liver injury in patients receiving rosuvastatin and those taking other statins. Methods Patients prescribed a statin that they had not used before were selected from the Saskatchewan Health Databases (SHD) and followed up from 1 July 2003 until 31 March 2005. Results We studied 10 384 patients on rosuvastatin and 14 854 taking other statins. Two cases of myopathy were identified (one on rosuvastatin, one on another statin). The relative risk (RR) of myopathy in patients currently taking rosuvastatin compared with other statins was 1.31 (95% confidence interval [CI]: 0.13-13.41). Two cases of rhabdomyolysis were detected among current rosuvastatin users (incidence: 2.9 [95% CI: 0.8-10.71 per 10 000 person-years). No cases of acute liver injury occurred among rosuvastatin patients. Seventeen cases of acute renal failure were identified (five among rosuvastatin users, 12 taking other statins). The RR of acute renal failure in current rosuvastatin users compared with other statins was 0.49 (95% CI: 0.16-1.50). We identified 285 deaths during the study period (87 among rosuvastatin users, 198 taking other statins). The RR of death in current rosuvastatin users compared with other statins was 0.42 (95% CI: 0.32-0.57). Conclusions We found no evidence that patients prescribed rosuvastatin were at greater risk of the study outcomes than patients prescribed other statins. There was no evidence of increased mortality among patients taking rosuvastatin, even after allowing for age, sex and prior statin use.

  • 23. García Rodríguez, LA
    et al.
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology.
    Johansson, Saga
    Bjorck, S
    Renal disease and acid-suppressing drugs.1997In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 6, no 4, p. 247-251Article in journal (Refereed)
    Abstract [en]

    No comparative epidemiological data can be found in the literature on the renal safety of acid-suppressing drugs. We followed-up a cohort of close to 180,000 persons during periods of treatment and non-treatment with five anti-ulcer drugs to evaluate the risk of idiopathic acute renal failure and/or nephrotic syndrome. After reviewing medical records, five patients were found to be cases. Two presented with acute renal failure and three had nephrotic syndrome. Three cases occurred during periods of non-exposure to anti-ulcer drugs. Two cases occurred during current use of ranitidine: one of acute renal failure and one of nephrotic syndrome. No case was encountered during treatment with cimetidine, famotidine, nizatidine or omeprazole. The incidence of idiopathic renal disease in the general population was 1 per 100,000 person-years. The relative risk associated with use of acid-suppressing drugs was 1.8 (95% CI, 0.3-10.7) compared to non-use. These results do not suggest a major increased risk for acute renal injury and/or nephrotic syndrome associated with use of anti-ulcer drugs.

  • 24. García-Rodríguez, Luis Alberto
    et al.
    Massó-González, Elvira Luján
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology.
    Johansson, Saga
    The safety of rosuvastatin in comparison with other statins in over 100,000 statin users in UK primary care2008In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 17, no 10, p. 943-52Article in journal (Refereed)
    Abstract [en]

    PURPOSE: To compare mortality and the incidence of hospitalization for myopathy, rhabdomyolysis, acute renal failure and acute liver injury in patients receiving rosuvastatin and those taking other statins. METHODS: Patients prescribed a statin that they had not used before were selected from the UK General Practice Research Database (GPRD) and followed up from 1 April 2003 to 31 December 2005. RESULTS: We studied 10 289 patients on rosuvastatin and 117 102 taking other statins. No cases of myopathy, rhabdomyolysis or acute liver injury occurred among rosuvastatin users. In those taking statins other than rosuvastatin, the incidence of myopathy was 0.4 (95% confidence interval (CI): 0.1-0.9), of rhabdomyolysis was 0.4 (95%CI: 0.1-0.9) and of acute liver injury was 0.4 (95%CI: 0.2-1.0), per 10 000 person-years. Fourteen cases of acute renal failure were identified (two among rosuvastatin users and 12 among other statin users). Among current users, the relative risk (RR) of acute renal failure in rosuvastatin users compared with other statin users was 1.16 (95%CI: 0.15-9.03).We identified 3232 deaths during the study period (173 in the rosuvastatin-treated group and 3059 in the other statin group). The RR of death associated with current use of rosuvastatin compared with other statins was 0.55 (95%CI: 0.44-0.68). CONCLUSIONS: We found no evidence that patients prescribed rosuvastatin were at greater risk of these outcomes than patients prescribed other statins. There was no evidence of increased mortality among patients taking rosuvastatin, even after allowing for age, sex and prior statin use.

  • 25.
    Gedeborg, Rolf
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Anaesthesiology and Intensive Care. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Med Prod Agcy, Dept Sci Expertise, POB 26, SE-75103 Uppsala, Sweden..
    Svennblad, Bodil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Holm, Lennart
    Med Prod Agcy, Dept Usage, Uppsala, Sweden..
    Sjögren, Hans
    Med Prod Agcy, Dept Efficacy & Safety 1, Uppsala, Sweden..
    Bardage, Carola
    Med Prod Agcy, Dept Usage, Uppsala, Sweden..
    Personne, Mark
    Med Prod Agcy, Swedish Poisons Informat Ctr, Uppsala, Sweden..
    Sjöberg, Gunilla
    Med Prod Agcy, Swedish Poisons Informat Ctr, Uppsala, Sweden..
    Feltelius, Nils
    Med Prod Agcy, Dept Sci Expertise, POB 26, SE-75103 Uppsala, Sweden..
    Zethelius, Björn
    Med Prod Agcy, Dept Sci Expertise, POB 26, SE-75103 Uppsala, Sweden..
    Increased availability of paracetamol in Sweden and incidence of paracetamol poisoning: using laboratory data to increase validity of a population-based registry study2017In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 26, no 5, p. 518-527Article in journal (Refereed)
    Abstract [en]

    Purpose: To estimate the incidence trend and outcome of paracetamol poisoning, in relation to increased availability of paracetamol from non-pharmacy outlets in 2009.

    Method: Patients' serum paracetamol results over 14years (2000-2013) from 20 (out of 21) regions in Sweden were linked to national registers of hospital care, cause of death, and prescriptions. Paracetamol poisonings were defined by serum paracetamol levels, hospital diagnoses, or cause of death. The change in incidence of poisonings following increased availability of paracetamol was analysed by using segmental regression of time series.

    Results: Of the 12068 paracetamol poisonings, 85% were classified as intentional self-harm. Following increased availability from non-pharmacy outlets, there was a 40.5% increase in the incidence of paracetamol poisoning, from 11.5/100000 in 2009 to 16.2/100000 in 2013. Regression analyses indicated a change in the trend (p<0.0001) but not an immediate jump in the incidence (p=0.5991) following the increased availability. Adjusting for trends in hospital episodes for self-harm, suicides, and the sales volume of paracetamol did not influence the result. All-cause mortality at 30days (3.2%) did not change over time.

    Conclusions: The incidence of paracetamol poisoning in Sweden has increased since 2009, contrasting the decreased incidence in the period of 2007-2009. The change in trend was temporally associated with the introduction of availability of paracetamol from non-pharmacy outlets but did not appear to be related to sales volume of paracetamol or general trends in self-harm or suicides.

  • 26. Ghadimi, Hadi
    et al.
    Esmaily, Hamideh M.
    Wahlström, Rolf
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    General practitioners' prescribing patterns for the elderly in a province of Iran2011In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 20, no 5, p. 482-487Article in journal (Refereed)
    Abstract [en]

    Purpose To determine prescribing patterns by general physicians working in primary care (GPs) in Iran for the elderly and the prevalence of inappropriate prescribing. Methods We collected information about prescribed medicines for 10% of patients in primary care aged 65 years or above in six cities in one province during two separate months 1 year apart. Inappropriate prescribing was determined using Beers criteria, excluding diagnosis-related medications. The WHO indicators for appropriateness of prescribing in general practice and drug-drug interactions (DDIs) were also assessed. Results A total of 2041 patients were studied (mean age 73 years, 56% were women). Drugs for the alimentary system (20%), nervous system (15%), cardiovascular system (14%), and anti-infectives (12%) were most frequently prescribed. Almost all drugs (96%) were prescribed by generic names. Thirty percent of patients received at least one inappropriate drug (27% for men; 33% for women), whereof 94% were categorized as high risk for adverse effects. Indomethacin, diphenhydramine, and methocarbamol were the most common inappropriate medications. The average number of drugs per patient was 4.4 (4.2 for men; 4.5 for women). Forty-four percent of patients received five or more drugs. Antibiotics and injections were prescribed in 39 and 55% of all patients, respectively. Clinically relevant DDIs were observed for 14% of the patients. Conclusion Our findings call for further interventions aiming at educating GPs to reduce potential errors. National drug policies and prescribing guidelines should be implemented to address the problem of inappropriate drug usage among the elderly.

  • 27. Gutiérrez, Lia P
    et al.
    Kołtowska-Häggström, Maria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Jönsson, Peter J
    Mattsson, Anders F
    Svensson, Dag
    Westberg, Björn
    Luger, Anton
    Registries as a tool in evidence-based medicine: example of KIMS (Pfizer International Metabolic Database)2008In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 17, no 1, p. 90-102Article in journal (Refereed)
    Abstract [en]

    Purpose To evaluate the value of a registry, set in 'real-life practice', as a contribution to evidence-based medicine and to estimate the impact of information collected in such a registry, on the up to date knowledge in growth hormone (GH)-related disorders. Methods Analysis of data collected prospectively for a pharmacoepidemiological registry-KIMS (Pfizer International Metabolic Database)-in assessing long-term clinical and safety outcomes of GH treatment (Genotropin (R)) in patients with GH deficiency. The study was based on 11374 treated (40000 patient-years of observation) and 263 untreated adult GH deficient patients from 30 countries, in whom background characteristics, clinical values such as lipids and body composition, quality of life (QoL) and GH dosage as well as safety profile were evaluated. Citation analysis for the published papers was also performed. Results The study depicts the clinical picture of adult patients with GH deficiency managed in current clinical settings. It confirms the features previously detected such as increased cardiovascular risk, mostly dyslipidemia and abnormal body composition as well as impaired QoL. There was considerable heterogeneity of conditions resulting in GH deficiency. The large database also enabled study of rare causes of the condition. The 31 out of 36 KIMS papers were cited 544 times, in 125 different journals. Conclusions These findings and the further insight into the response to GH replacement therapy show that the registry methodology is valuable for filling the gaps of information in evidence-based medicine that cannot be addressed by clinical trials.

  • 28.
    Hedenmalm, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Pharmacology.
    Alvan, Gunnar
    Öhagen, Patrik
    Dahl, Marja-Liisa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Pharmacology.
    Muscle toxicity with statins2010In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 19, no 3, p. 223-231Article in journal (Refereed)
    Abstract [en]

    PURPOSE: Statins rarely cause serious muscle toxicity and rhabdomyolysis. The aim of our investigation was to identify and quantify potential risk factors for statin-induced rhabdomyolysis. METHODS: All cases of suspected adverse reactions to statins reported to the Swedish Adverse Drug Reactions Advisory Committee until 15 September 2006 containing the codes myalgia, myopathy, increased serum creatine kinase (CK), myoglobinuria or rhabdomyolysis were included in the study. Cases were classified into different CK categories, where cases with CK levels >10 times the upper limit of normal (ULN) laboratory range were compared with cases with normal CK levels (in some analyses cases with CK not measured were also included as controls). Fisher's test and multiple logistic regression were used to test the degree of association. RESULTS: A total of 338 cases with muscle toxicity were identified. CK had not been measured in 148 cases. Of the remaining 190 cases, 59 were classified as rhabdomyolysis, 62 had CK increases below the level of rhabdomyolysis, 69 had normal CK and 2 contained insufficient information to classify the degree of CK increase. A high statin dose and concomitant interacting drug treatment were over-represented among cases with rhabdomyolysis compared with cases with normal CK. Renal disease and unusual strenuous muscular activity were also associated with an increased risk of rhabdomyolysis when the control group included cases with CK not measured. CONCLUSION: Results from our study support previous studies indicating that the risk of rhabdomyolysis with statin treatment increases with increase in systemic exposure to the statin. Renal disease and unusual strenuous muscular activity may also contribute to an increased risk of rhabdomyolysis.

  • 29.
    Hedenmalm, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Sundström, Anders
    Medical Products Agency.
    Spigset, Olav
    Norwegian University of science and technology, Trondheim.
    Alopecia associated with treatment with selective serotonin reuptake inhibitors (SSRIs)2006In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 15, no 10, p. 719-725Article in journal (Refereed)
    Abstract [en]

    PURPOSE: To study the association between alopecia and selective serotonin reuptake inhibitors (SSRIs) by estimating reporting rates and by making association comparisons within databases of adverse drug reactions (ADRs). METHODS: All reports of alopecia with marketed SSRIs until the end of 2004 were identified in SWEDIS, the national Swedish database for spontaneously reported ADRs, and in Vigibase, the international ADR database of the World Health Organization. Total SSRI sales volumes in Sweden until the end of 2004 were obtained from the National Corporation of Swedish Pharmacies. The Bayes' Confidence Propagation Neural Network (BCPNN) method was used to estimate associations between alopecia and each of the SSRIs within the two databases. RESULTS: A total of 27 reports of alopecia were identified in SWEDIS. As two reports concerned the use of two SSRIs, there was a total of 29 drug-ADR combinations. All except three reports concerned women (88.9%). The reporting rate of alopecia in Sweden was significantly higher with sertraline compared with citalopram; 20.1 (95%CI 10.7-34.4) reports per million patient-years versus 4.5 (95%CI 1.8-9.3) reports per million patient-years. No significant differences in reporting rates were noted for the remaining SSRIs. Sertraline also showed a statistically significant association with alopecia in both SWEDIS and Vigibase. Citalopram was significantly associated with alopecia in Vigibase, but not in SWEDIS. No statistically significant associations were found for any of the other SSRIs. CONCLUSIONS: Alopecia appears to be a rare ADR to SSRIs. The risk of alopecia seems to vary between the different SSRIs, and might be higher in women than in men.

  • 30.
    Henriksson, Karin M.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Eriksson, Marie
    Åsberg, Signild
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Statin Therapy is Associated with Decreased Risk of First Intracerebral Hemorrhage and Reduced 30-Day Fatality: Results of a Nationwide Observational Study Including 7,696 Cases and 14,670 Controls2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no S1, p. 399-400Article in journal (Other academic)
  • 31. Hernandez, Rohini K.
    et al.
    Banefelt, Jonas
    Mesterton, Johan
    Stålhammar, Jan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Persson, Bo-Eric
    Ke, Chunlei
    Sobocki, Patrik
    Liede, Alexander
    Impact of PSA Doubling Time (DT) Calculation Method on Estimate of Association With Bone Metastases in a Cohort of Prostate Cancer Patients Treated With Androgen Deprivation Therapy (ADT)2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no S1, p. 220-220Article in journal (Other academic)
  • 32. Hernandez, Rohini K.
    et al.
    Mesterton, Johan
    Banefelt, Jonas
    Stålhammar, Jan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Sobocki, Patrik
    Persson, Bo-Eric
    Liede, Alexander
    Predictors of Clinical Metastases and Survival among Non-Metastatic Prostate Cancer (PC) Patients (pts) Treated with Androgen-Deprivation Therapy (ADT) in Sweden2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no S1, p. 6-6Article in journal (Other academic)
  • 33.
    Hoti, Fabian
    et al.
    EPID Res, Espoo, Finland..
    Mushnikov, Vasili
    EPID Res, Espoo, Finland..
    Mehtala, Juha
    EPID Res, Espoo, Finland..
    Wentzell, Nadine
    Leibniz Inst Prevent Res & Epidemiol BIPS, Bremen, Germany..
    Kollhorst, Bianca
    Leibniz Inst Prevent Res & Epidemiol BIPS, Bremen, Germany..
    Schink, Tania
    Leibniz Inst Prevent Res & Epidemiol BIPS, Bremen, Germany..
    Garbe, Edeltraut
    Leibniz Inst Prevent Res & Epidemiol BIPS, Bremen, Germany..
    Mountford, William K.
    Quintiles, Cambridge, MA USA..
    Knox, Caitlin
    Quintiles, Cambridge, MA USA..
    Kaufman, Elise
    Quintiles, Cambridge, MA USA..
    Johansson, Gunnar
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Korhonen, Pasi
    EPID Res, Espoo, Finland..
    COPD Patients Initiating Roflumilast in Sweden, Germany and the United States: Findings from the Roflumilast PASS Study2016In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 25, no Suppl. 3, p. 679-679, article id Abstr. 1169Article in journal (Refereed)
  • 34. Huerta, C
    et al.
    Garcia Rodriguez, LA
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences.
    Johansson, Saga
    Risk of irritable bowel syndrome among asthma patients.2002In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 11, no 1, p. 31-35Article in journal (Refereed)
    Abstract [en]

    Background

    An association between Irritable Bowel Syndrome (IBS) and bronchial hyper-responsiveness has been suggested. Only a few studies have specifically studied the association between IBS and asthma.

    Aim

    To estimate the incidence rate of IBS among asthma patients and to compare it with the general population. We also examined the association between use of asthma drugs, specifically corticosteroids, and IBS.

    Methods

    Population-based cohort study using the General Practice Research Database (GPRD) in the UK. The cohort comprised a random sample of 50 000 asthma patients aged 10–79 years and a similar number of sex-and age-matched individuals free of asthma and identified from the source population. A nested case–control analysis was performed within the asthma cohort to examine the association between asthma drugs and IBS.

    Results

    The incidence rate of IBS in the asthma cohort was 2.5 per 1000 persons-years and 2.0 in the general population. The relative risk (RR) was 1.3 (95% CI 1.1–1.5). A medical history of neurotic and psychologic disorders, pain-related diseases and gastroenteritis were all associated with the occurrence of IBS. In the asthma cohort, current users of oral steroids presented a RR of 0.5 (95% CI 0.2–1.2) for developing IBS. The risk estimate was similar in short-and long-term users of steroids.

    Conclusions

    We found a slightly increased risk of IBS in asthma patients compared to the general population and that the risk of IBS was reduced by use of oral steroids in asthma patients. Additional studies in the general population are necessary in order to confirm whether use of corticosteroids irrespective of asthma has a protective effect on the risk of IBS.

  • 35. Huerta, C
    et al.
    Garcia Rodriguez, LA
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology.
    Johansson, Saga
    Users of oral steroids are at a reduced risk of developing irritable bowelsyndrome2003In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 12, no 7, p. 583-588Article in journal (Refereed)
    Abstract [en]

    Purpose

    To study whether irritable bowel syndrome (IBS) is associated with the use of oral steroids and whether there is a dose- or duration-response.

    Methods

    We followed up a cohort of 65 270 patients aged 20–74 years old enrolled in the General Practice Research Database in the UK with at least one prescription for steroids between 1994 and 1999. We performed a nested case-control analysis to estimate the adjusted relative risk (RR) associated with the use of steroids using unconditional logistic regression. Cases were 466 patients with a first episode of IBS during follow-up and controls were 5000 individuals randomly selected from the study cohort.

    Results

    Current users of oral steroids presented an RR of 0.6 (95%CI: 0.4–0.9) compared to non-users. Doses greater than 10 mg of prednisolone daily were associated with an RR of 0.4 (95%CI: 0.2–0.9). When we stratified by age, no reduced risk of IBS was apparent under the age of 40 years. The reduced risk of IBS was greater among females than males.

    Conclusions

    Our results suggest that oral steroids can reduce the risk of a diagnosis of IBS. The apparent effect modification of age and sex deserves further research.

  • 36. Jobski, Kathrin
    et al.
    Enders, Dirk
    Amann, Ute
    Suzart-Woischnik, Kiliana
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
    Schink, Tania
    Garbe, Edeltraut
    Drug Use Pattern of Rivaroxaban in Germany2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no S1, p. 474-475Article in journal (Other academic)
  • 37. Joelson, S
    et al.
    Joelson, IB
    Wallander, Mari-Ann
    Research Laboratories, Astra Hässle AB, Mölndal.
    Geographical variation in adverse event reporting rates in clinical trials1997In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 6, no Suppl. 3, p. S31-S35Article in journal (Refereed)
    Abstract [en]

    A group of 13,698 patients from 127 gastro-intestinal clinical trials, conducted in 13 countries was included in the analyses. All adverse events reported were included in the evaluation. The general adverse event reporting rate, the mean number of adverse events reported, the serious adverse event reporting rate and the mean number of serious adverse events reported were calculated for each country. In addition, the pattern of adverse events reported in each country was studied. The general adverse event reporting rate varied between 17% and 68% with a mean of 47% and the serious adverse event reporting rate varied between 1% and 20% with a mean of 8%. The mean number of adverse events, reported by patients reporting adverse events, varied between 1.5 and 2.7 with a mean of 2.1 and the mean number of serious adverse events, reported by patients reporting serious adverse events, varied between 1.1 and 1.7 with a mean of 1.4. In addition to these differences, patients/investigators had a tendency to put emphasis on different kinds of adverse events in different countries.

  • 38. Johansson, Saga
    et al.
    Ming, Eileen E
    Wallander, Mari-Ann
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology.
    García Rodríguez, Luis A.
    Herings, Ron M. C.
    Goettsch, Wim G.
    González-Pérez, Antonio
    McAfee, Andrew T.
    Walker, Alexander M.
    Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme2006In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 15, no 7, p. 454-461Article in journal (Refereed)
    Abstract [en]

    Results from clinical trials and clinical practice have shown statins to be generally well tolerated with a low frequency of clinically relevant side effects. Nevertheless, there are rare occasions when adverse events (AEs), sometimes serious, may occur. Rosuvastatin is the newest statin to be approved in the USA and many other countries. As part of the continued assessment of the benefit-risk profile of rosuvastatin, AstraZeneca has developed a progressive, comprehensive pharmacoepidentiology programme to complement safety data obtained from randomised clinical trials and spontaneous reporting systems, which have demonstrated that rosuvastatin has a safety profile in line with comparator statins. This programme comprises nine studies conducted in recognised centres of excellence assessing over 50000 patients treated with rosuvastatin. It consists of three components: patient characteristics studies (four studies), safety evaluation studies (four studies); and review of data generated from the Prescription-Event Monitoring (PEM) study, designed and run by an independent third party. Patient characteristics studies are designed to describe the characteristics and drug utilisation patterns of new users of rosuvastatin compared with new users of other statins in automated databases. Safety evaluation studies will examine the rates of specific AEs in different cohorts of statin users and determine risk factors for these events using data recorded prospectively in automated databases with case adjudication via medical record review. The independent PEM study will monitor any significant events recorded by general practitioners since starting rosuvastatin treatment. This article is an overview of the rationale and methodology of the rosuvastatin pharmacoepiderniology programme.

  • 39.
    Juhlin, Kristina
    et al.
    WHO Collaborating Ctr Int Drug Monitoring, Uppsala Monitoring Ctr, Box 1051, S-75140 Uppsala, Sweden..
    Star, Kristina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences. WHO Collaborating Ctr Int Drug Monitoring, Uppsala Monitoring Ctr, Box 1051, S-75140 Uppsala, Sweden.
    Noren, G. Niklas
    WHO Collaborating Ctr Int Drug Monitoring, Uppsala Monitoring Ctr, Box 1051, S-75140 Uppsala, Sweden..
    A method for data-driven exploration to pinpoint key features in medical data and facilitate expert review2017In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 26, no 10, p. 1256-1265Article in journal (Refereed)
    Abstract [en]

    Purpose

    To develop a method for data‐driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors.

    Methods

    We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of interest to those within one or more comparators, utilizing odds ratios with adaptive statistical shrinkage. Nested analyses identify higher order patterns, and permutation analysis is employed to protect against chance findings. For illustration, a total of 164 000 adverse event reports related to medication errors were characterized and contrasted to the other 7 833 000 reports in VigiBase, the WHO global database of individual case safety reports, as of May 2013. The initial scope included 2000 features, such as patient age groups, reporter qualifications, and countries of origin.

    Results

    vigiPoint highlighted 109 key features of medication error reports. The most prominent were that the vast majority of medication error reports were from the United States (89% compared with 49% for other reports in VigiBase); that the majority of reports were sent by consumers (53% vs 17% for other reports); that pharmacists (12% vs 5.3%) and lawyers (2.9% vs 1.5%) were overrepresented; and that there were more medication error reports than expected for patients aged 2‐11 years (10% vs 5.7%), particularly in Germany (16%).

    Conclusions

    vigiPoint effectively identified key features of medication error reports in VigiBase. More generally, it reduces lead times for analysis and ensures reproducibility and transparency. An important next step is to evaluate its use in other data.

  • 40. Juhlin, Kristina
    et al.
    Ye, Xiaofei
    Star, Kristina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
    Noren, G. Niklas
    Outlier Removal Expedites Adverse Drug Reaction Surveillance - Evaluation of a Simple Unmasking Strategy2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no S1, p. 92-92Article in journal (Other academic)
  • 41. Juhlin, Kristina
    et al.
    Ye, Xiaofei
    Star, Kristina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
    Noren, G. Niklas
    Outlier removal to uncover patterns in adverse drug reaction surveillance - a simple unmasking strategy2013In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 22, no 10, p. 1119-1129Article in journal (Refereed)
    Abstract [en]

    PurposeThis study aimed to develop an algorithm for uncovering associations masked by extreme reporting rates, characterize the occurrence of masking by influential outliers in two spontaneous reporting databases and evaluate the impact of outlier removal on disproportionality analysis. MethodsWe propose an algorithm that identifies influential outliers and carries out parallel analysis after their omission. It considers masking of drugs as well as of adverse drug reactions (ADRs), uses a direct measure of the masking effect and makes no assumptions regarding the number of outliers per drug or ADR. The occurrence of masking is characterized in the WHO Global Individual Case Safety Report database, VigiBase and a regional collection of reports from Shanghai, China. ResultsFor WHO-ART critical terms such as myocardial infarction, rhabdomyolysis and hypoglycaemia outlier removal led to a 25-50% increase in the number of Statistics of Disproportionate Reporting (SDR) and gains in time to detection of 1-2years, while keeping the rate of spurious SDRs from the parallel analysis at 1%. Twenty-three per cent of VigiBase and 18% of Shanghai SRS reports listed an influential outlier. Twenty-seven per cent of the ADRs and 5% of the drugs in VigiBase, and 2% of the ADRs and 3% of the drugs in Shanghai SRS were involved in an outlier. The overall increase in the number of SDRs for both datasets was 3%. ConclusionMasking by outliers has substantial impact on specific ADRs including, in VigiBase, rhabdomyolysis, myocardial infarction and hypoglycaemia. It is a local phenomenon involving a fair number of reports but yielding a limited number of additional SDRs. 

  • 42.
    Kihlbom, Ulrik
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Russo, Selena
    European Inst Oncol, Milan, Italy.
    Monzani, Dario
    European Inst Oncol, Milan, Italy.
    Stichele, Geert Vander
    MindBytes, Ghent, Belgium.
    Verscheuren, Sarah
    MindBytes, Ghent, Belgium.
    Pinto, Cathy Anne
    Merck & Co Inc, Rahway, NJ 07065 USA.
    Patient-centered benefit-risk decision-making and the role of educational tools and psychological instruments in preference elicitation-Year 1 of IMI prefer2018In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 27, no Suppl. 2, p. 512-512, article id 1123Article in journal (Other academic)
  • 43.
    Krigsman, Kristin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Nilsson, J. Lars G.
    Ring, Lena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Adherence to multiple drug therapies: Refill adherence to concomitant use of diabetes and asthma/COPD medication2007In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 16, no 10, p. 1120-1128Article in journal (Refereed)
    Abstract [en]

    PurposeTo investigate whether patients with drugs for two chronic diseases, type 2 diabetes and asthma/chronic obstructive pulmonary diseases (COPD), showed the same refill adherence pattern in relation to their drug treatments during a 3-year period.MethodsPatients 50 years and older who had been dispensed diabetes and asthma/COPD drugs in the county of Jämtland during 2001-2003 were included. The refill adherence was calculated based either on prescribed dosage or defined daily dose (DDD). A patient profile graph for each patient was constructed including the date of each dispensation and the time period covered by the dispensed drugs. For each patient, the dispensation pattern and the treatment persistency over time were determined.ResultsIn total, 56 patients were included in the study. Satisfactory refill adherence was found for 68% of the repeat prescriptions for diabetes drugs and for 42% of the repeat prescriptions for asthma/COPD drugs. About half (52%; 29/56) of the patients showed the same dispensation patterns for both diabetes and asthma/COPD drugs, and 86% (25/29) of these patients had a satisfactory refill adherence. However, there was no correlation or agreement regarding the dispensation patterns for diabetes and asthma/COPD drugs.ConclusionsPatients showed higher refill adherence for their diabetes drugs than their asthma/COPD drugs. Our hypothesis that patients with satisfactory refill adherence to antihyperglycaemic drugs would also have satisfactory refill adherence to asthma/COPD drugs, was not supported.

  • 44.
    Krigsman, Kristin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Nilsson, J. Lars G.
    Ring, Lena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
    Refill adherence for patients with asthma and COPD: comparison of a pharmacy record database with manually collected repeat prescriptions2007In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 16, no 4, p. 441-448Article in journal (Refereed)
    Abstract [en]

    PurposeTo compare refill adherence data based on two different methods of data capturing, that is, manually collected repeat prescriptions and a pharmacy record database.MethodsThe study comprised a comparison of adherence data from manually collected repeat prescriptions of asthma and chronic obstructive pulmonary disease (COPD) drugs with fixed dosages dispensed in 2002 and the corresponding data from a pharmacy record database. Data were collected in the county of Jämtland in Sweden. Refill adherence was calculated for the different collection methods.ResultsData from 285 manually collected repeat prescriptions for asthma/COPD drugs for 2002 showed that 35% of the prescribings had been satisfactory refilled, while 42% showed an undersupply and 23% an oversupply. The pharmacy record database had 490 prescribings for asthma/COPD drugs registered in 2002, 28% of these had a satisfactory refill adherence, while 43% showed an undersupply, and 29% an oversupply. Based on the database it could be shown that 11% of the individuals had used more than one repeat prescription of the same medicine during 2002. Based on the pharmacy record database for 1999-2002, it was shown that 29% of the prescribings had been satisfactory refilled whereas undersupply increased (53%) and oversupply decreased (18%) as compared to the 1-year data.ConclusionsRefill adherence determined from manually collected repeat prescriptions and from a pharmacy record database did not differ for a 1-year period. Four-year data might give a better overview of patients' refill adherence than 1-year data.

  • 45. Larsen, Michael D.
    et al.
    Cars, Thomas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Hallas, Jesper
    A Review of the Use of Hospital-Based Databases in Observational Inpatient Studies of Drugs2012In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 21, p. 48-48Article in journal (Other academic)
  • 46.
    Lofling, Lukas
    et al.
    Karolinska Inst, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Linder, Marie
    Karolinska Inst, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Ekstrand, Charlotta
    Karolinska Inst, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Cherif, Honar
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.
    Kieler, Helle
    Karolinska Inst, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    Bahmanyar, Shahram
    Karolinska Inst, Ctr Pharmacoepidemiol, Stockholm, Sweden..
    General Pharmacological Treatments Preceding A Primary Chronic Immune Thrombocytopenia Diagnosis2016In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 25, no Suppl. 3, p. 645-646, article id Abstr. 1110Article in journal (Refereed)
  • 47. Lovdahl, Susanna
    et al.
    Henriksson, Karin M.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology.
    Baghaei, Fariba
    Holmstrom, Margareta
    Berntorp, Erik
    Astermark, Jan
    Malignant Diseases in Swedish Person with Heamophilia-A Longitudinal Registry Study2014In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 23, no S1, p. 209-210Article in journal (Other academic)
  • 48.
    Makady, Amr
    et al.
    Zorginst Nederland, Diemen, Netherlands;Univ Utrecht, Utrecht, Netherlands.
    Kalf, Rachel
    Zorginst Nederland, Diemen, Netherlands;Univ Utrecht, Utrecht, Netherlands.
    Ryll, Bettina
    Uppsala University, Disciplinary Domain of Science and Technology, Biology, Department of Organismal Biology, Evolution and Developmental Biology. Melanoma Patient Network Europe, Brussels, Belgium.
    Spurrier, Gilliosa
    Melanoma Patient Network Europe, Brussels, Belgium.
    de Boer, Anthonius
    Univ Utrecht, Utrecht, Netherlands.
    Hillege, Hans
    Univ Med Ctr Groningen, Groningen, Netherlands.
    Klungel, Olaf
    Univ Utrecht, Utrecht, Netherlands.
    Goettsch, Wim
    Zorginst Nederland, Diemen, Netherlands;Univ Utrecht, Utrecht, Netherlands.
    Using social media to collect patient perspectives on quality of life: A feasibility study2018In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 27, no Suppl. 2, p. 56-56, article id 117Article in journal (Other academic)
  • 49. Mannino, S
    et al.
    Troncon, MG
    Wallander, Mari-Ann
    National Research Council, Institute of Advanced Biomedical Technologies, Milano, Italy.
    Cattaruzzi, C
    Romano, F
    Agostinis, L
    Marighi, PE
    Walker, A
    Ocular disorders in users of H2 antagonists and of Omeprazole1998In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 7, no 4, p. 233-241Article in journal (Refereed)
    Abstract [en]

    We have conducted a cohort study of users of omeprazole and H2 antagonists in Italy to investigate whether the peroral use of these drugs may be associated with an increased incidence of ocular disorders leading to loss of vision. We have used the Sistema Informativo Sanitario Regionale (SISR database) in Friuli-Venezia-Giulia to identify all subjects who received at least one prescription for cimetidine, famotidine, niperotidine, nizatidine, omeprazole, ranitidine or roxatidine between 1 January 1991 and 31 December 1994. We have identified all hospital admissions for serious vascular or inflammatory ocular disorders following any such prescription, reviewed and validated all medical records. There were 71,108 users of any of the study drugs, contributing a total of 101,827 person years of observation. Seven cases of serious eye disorders were identified, giving an annual incidence rate of 7/100,000 persons. By comparison to non-users, the incidence rate ratio for current users of all of the study drugs together was 0, with a 95% confidence interval of 0 to 2·1. By comparison to non-users, the incidence rate ratio for past users was 0·47 (95% CI: 0·06–2·4). Our data are consistent with previous studies and add weight to the general impression of the ocular safety of these drugs.

  • 50.
    Päären, Aivar
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Child and Adolescent Psychiatry.
    von Knorring, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Psychiatry, University Hospital.
    Jonsson, Ulf
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Child and Adolescent Psychiatry.
    Bohman, Hannes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Child and Adolescent Psychiatry.
    Olsson, Gunilla
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Child and Adolescent Psychiatry.
    von Knorring, Anne-Liis
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Child and Adolescent Psychiatry.
    Drug prescriptions of adults with adolescent depression in a community sample2012In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 21, no 2, p. 130-136Article in journal (Refereed)
    Abstract [en]

    Purpose

    The prescription drugs have, to our knowledge, not been much studied in epidemiological samples with long-term follow-up. Accordingly, our purpose was to analyze the use of prescription drugs in adults with adolescent depression.

    Methods

    A population-based cohort of adolescents (n = 2465) was screened for the presence of depressive symptoms and diagnosed according to a structured interview. Totally, 362 individuals were identified as depressed and compared with 250 non-depressed controls. The prescription drugs were evaluated at the age of 29-31 years from a register kept by the National Health and Welfare Board.

    Results

    The formerly depressed females received significantly more prescription drugs, such as antidepressants, antiepileptics, antibacterials, antimycotics, and antihistamines for systemic use as well as other drugs, compared with controls (15.6 +/- 27.4 vs 8.2 +/- 7.4 recipes, p < 0.001). Formerly depressed males did not differ from controls regarding prescription drugs.

    Conclusions

    The females but not males with adolescent depression subsequently received more prescription drugs than non-depressed peers. Depressed female adolescents received more psychotropic and non-psychotropic drugs later in life compared to the non-depressed. This might be as a result of physical illnesses, different treatment-seeking behaviors, or somatizing reactions.

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