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Anti-androgen prescribing patterns, patient treatment adherence and influencing factors: results from the nationwide PCBaSe Sweden
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Geriatrics.
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2012 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 68, no 12, 1619-1630 p.Article in journal (Refereed) Published
Abstract [en]


Adherence has not been studied in male oncology populations. The aim of this study on both the prescriber and user perspectives in prostate cancer treatment was to analyse real-life prescribing patterns of anti-androgens (AA), primarily bicalutamide, and factors influencing the patients' adherence to treatment.


A nationwide clinical cohort of incident prostate cancer, PCBaSe, was linked to the Swedish Prescribed Drug Register. Men with a planned first line monotherapy AA treatment were identified; dosages and extent of off-label treatment were investigated. Cumulative incidence proportions for reasons for drug discontinuation were calculated. Factors potentially influencing adherence were explored using the medical possession ratio based on the individual prescribed daily dose.


First line monotherapy AA was planned in 4.4 % of all incident cases and in 2.1 % of low risk disease cases. Among 1,406 men prescribed bicalutamide, 1,109 (79 %) received the approved daily dose of 150 mg. Discontinuation reasons differed with disease severity. Off-label, low-dose prescription associated with age above 75 years and disease categorised as low risk was noted in 297 men (21 %). Sixty percent of the men adhered well, i.e. to ≥80 %. Age above 75 years and less severe disease were both negatively associated with adherence.


Patient age and tumour risk group influenced the prescriber's choice of dose, pointing to important issues for critical reflection. Possible over-treatment was noted in low risk disease. Interventions to increase adherence in older men and in men with less severe disease are worth considering after critically reviewing the appropriateness of the treatment indication, especially in the latter case.

Place, publisher, year, edition, pages
2012. Vol. 68, no 12, 1619-1630 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:uu:diva-181552DOI: 10.1007/s00228-012-1290-xISI: 000310999700006PubMedID: 22562608OAI: oai:DiVA.org:uu-181552DiVA: diva2:556683
Available from: 2012-09-26 Created: 2012-09-26 Last updated: 2013-04-02Bibliographically approved
In thesis
1. Prostate Cancer; Metabolic Risk Factors, Drug Utilisation, Adverse Drug Reactions
Open this publication in new window or tab >>Prostate Cancer; Metabolic Risk Factors, Drug Utilisation, Adverse Drug Reactions
2013 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Increased possibilities during the last decades for early detection of prostate cancer have sparked research on preventable or treatable risk factors and on improvements in therapy. Treatments of the disease still entail significant side effects potentially affecting men during the rest of their lives. The studies of the present thesis concern different aspects of prostate cancer from etiological risk factors and factors influencing treatment to an improved methodology for the detection of treatment side effects.

Papers I, II, both based in the population based cohort ULSAM (Uppsala Longitudinal Study of Adult Men), investigate possible risk factors of prostate cancer with options for intervention: selenium levels and the metabolic syndrome. The phenomenon of competing risk of death from other causes than prostate cancer and its impact on and importance for choice of statistical methods is also exemplified and discussed for the first time in prostate cancer research.

-Smokers with low selenium status have an increased future risk of later development of prostate cancer. Influence of genetic variability appears plausible.

-The metabolic syndrome and especially its increased waist circumference component are associated with later development of prostate cancer – taking competing risks of death from other causes into account.

Papers III and IV using pharmacoepidemiological methods investigate aspects of drug utilisation in prostate cancer using nationwide and international databases. In Paper III factors influencing anti-androgen use in prostate cancer are investigated, both from a prescriber- and patient perspective.  The age and disease risk group of the patient, unsupported scientifically, influence both the prescribers’ choice of dose and the patients’ adherence to treatment.

-Adherence, not previously investigated in male cancer patients, was considerably higher than reported for adjuvant breast cancer treatment. Subgroups of men suitable for intervention to increase adherence were identified.

Paper IV, investigates the feasibility of improving an established method for screening large adverse drug reactions databases, the proportional reporting ratio (PRR), this by using restricted sub-databases according to treatment area (TA), introducing the concept of PRR-TA.

-The PRR-TA method increases the signal-noise relationship of analyses; a finding highly relevant for possibly conserving manual resources in Pharmacovigilance work in a drug-authority setting.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2013. 115 p.
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 870
Prostate cancer, Epidemiology, Pharmacoepidemiology, Metabolic Syndrome, Selenium, Smoking, hOGG1, MnSOD, Competing Risk, Adherence, Persistance, Medical Possession Ratio, MPR, Signal Detection, PRR, proportional reporting ratio, ULSAM, PcBaSE, EudraVigilance, SPDR, Swedish Prescribe Drug Registry, NPCR, National Prostate Cancer Registry, SDR, Signal, disproportionality analysis, PRR-TA, EudraVigilance
National Category
Research subject
Epidemiology; Urology; Oncology; Geriatrics
urn:nbn:se:uu:diva-194297 (URN)978-91-554-8609-9 (ISBN)
Public defence
2013-04-25, Universitetshuset, Biskopsgatan 3, Uppsala, 09:00 (Swedish)
Available from: 2013-03-26 Created: 2013-02-12 Last updated: 2013-06-27

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