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  • 1. Costabel, Ulrich
    et al.
    Bendstrup, Elisabeth
    Cottin, Vincent
    Dewint, Pieter
    Egan, Jim J. J.
    Ferguson, James
    Groves, Richard
    Hellström, Per M.
    Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för medicinska vetenskaper, Gastroenterologi/hepatologi.
    Kreuter, Michael
    Maher, Toby M.
    Molina-Molina, Maria
    Nordlind, Klas
    Sarafidis, Alexandre
    Vancheri, Carlo
    Pirfenidone in Idiopathic Pulmonary Fibrosis: Expert Panel Discussion on the Management of Drug-Related Adverse Events2014Ingår i: Advances in Therapy, ISSN 0741-238X, E-ISSN 1865-8652, Vol. 31, nr 4, s. 375-391Artikel, forskningsöversikt (Refereegranskat)
    Abstract [en]

    Pirfenidone is currently the only approved therapy for idiopathic pulmonary fibrosis, following studies demonstrating that treatment reduces the decline in lung function and improves progression-free survival. Although generally well tolerated, a minority of patients discontinue therapy due to gastrointestinal and skin-related adverse events (AEs). This review summarizes recommendations based on existing guidelines, research evidence, and consensus opinions of expert authors, with the aim of providing practicing physicians with the specific clinical information needed to educate the patient and better manage pirfenidone-related AEs with continued pirfenidone treatment. The main recommendations to help prevent and/or mitigate gastrointestinal and skin-related AEs include taking pirfenidone during (or after) a meal, avoiding sun exposure, wearing protective clothing, and applying a broad-spectrum sunscreen with high ultraviolet (UV) A and UVB protection. These measures can help optimize AE management, which is key to maintaining patients on an optimal treatment dose.

  • 2.
    Potpara, Tatjana S.
    et al.
    Univ Belgrade, Sch Med, Belgrade, Serbia.;Clin Ctr Serbia, Cardiol Clin, Belgrade, Serbia..
    Dagres, Nikolaos
    Heart Ctr Leipzig, Dept Electrophysiol, Leipzig, Germany..
    Mujovic, Nebojsa
    Univ Belgrade, Sch Med, Belgrade, Serbia.;Clin Ctr Serbia, Cardiol Clin, Belgrade, Serbia..
    Vasic, Dragan
    Ctr Clin, Vasc Surg Clin, Belgrade, Serbia..
    Asanin, Milika
    Univ Belgrade, Sch Med, Belgrade, Serbia.;Clin Ctr Serbia, Cardiol Clin, Belgrade, Serbia..
    Nedeljkovic, Milan
    Univ Belgrade, Sch Med, Belgrade, Serbia.;Clin Ctr Serbia, Cardiol Clin, Belgrade, Serbia..
    Marin, Francisco
    Hosp Univ Virgen de la Arrixaca, Dept Cardiol, IMIB Arrixaca, Murcia, Spain..
    Fauchier, Laurent
    Univ Tours, Ctr Hosp Univ Trousseau, Serv Cardiol, Tours, France.;Univ Tours, Fac Med, Tours, France..
    Blomström-Lundqvist, Carina
    Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för medicinska vetenskaper, Kardiologi.
    Lip, Gregory Y. H.
    Univ Belgrade, Sch Med, Belgrade, Serbia.;Univ Birmingham, City Hosp, Inst Cardiovasc Sci, Birmingham, W Midlands, England.;Aalborg Univ, Dept Clin Med, Aalborg Thrombosis Res Unit, Aalborg, Denmark..
    Decision-Making in Clinical Practice: Oral Anticoagulant Therapy in Patients with Non-valvular Atrial Fibrillation and a Single Additional Stroke Risk Factor2017Ingår i: Advances in Therapy, ISSN 0741-238X, E-ISSN 1865-8652, Vol. 34, nr 2, s. 357-377Artikel, forskningsöversikt (Refereegranskat)
    Abstract [en]

    Approximately 1 in 3-4 patients presenting with an ischemic stroke will also have atrial fibrillation (AF), and AF-related strokes can be effectively prevented using oral anticoagulant therapy (OAC), either with well-controlled vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs). In addition, OAC use (both VKAs and NOACs) is associated with a 26% reduction in all-cause mortality (VKAs) or an additional 10% mortality reduction with NOACs relative to VKAs. The decision to use OAC in individual AF patient is based on the estimated balance of the benefit from ischemic stroke reduction against the risk of major OAC-related bleeding [essentially intracranial hemorrhage (ICH)]. Better appreciation of the importance of VKAs' anticoagulation quality [a target time in therapeutic range (TTR) of ae<yen>70%] and the availability of NOACs (which offer better safety compared to VKAs) have decreased the estimated threshold for OAC treatment in AF patients towards lower stroke risk levels. Still, contemporary registry-based data show that OAC is often underused in AF patients at increased risk of stroke. The uncertainty whether to use OAC may be particularly pronounced in AF patients with a single additional stroke risk factor, who are often (mis)perceived as having a "borderline" or insufficient stroke risk to trigger the use of OAC. However, observational data from real-world AF cohorts show that the annual stroke rates in such patients are higher than in patients with no additional stroke risk factors, and OAC use has been associated with reduction in stroke, systemic embolism, or death in comparison to no therapy or aspirin, with no increase in the risk of bleeding relative to aspirin. In this review article, we summarize the basic principles of stroke risk stratification in AF patients and discuss contemporary real-world evidence on OAC use and outcomes of OAC treatment in AF patients with a single additional stroke risk factor in various real-world AF cohorts.

  • 3.
    Syk, Jörgen
    et al.
    Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för kvinnors och barns hälsa, Forskargrupper (Inst. för kvinnor och barns hälsa), Pediatrisk inflammationsforskning. Karolinska Inst, Care Sci & Soc, Dept Neurobiol, Stockholm, Sweden;Acad Primary Hlth Care Ctr, Stockholm, Sweden.
    Vinge, Ines
    Lidingo Hosp, Asthma Allergy Lung Dept, Lidingo, Sweden.
    Sorberg, Mikael
    Orion Pharma, Sollentuna, Sweden.
    Vahteristo, Mikko
    Orion Corp, Orion Pharma, Kuopio, Finland.
    Rytila, Paula
    Orion Corp, Orion Pharma, Espoo, Finland.
    A Multicenter, Observational, Prospective Study of the Effectiveness of Switching from Budesonide/Formoterol Turbuhaler® to Budesonide/Formoterol Easyhaler®2019Ingår i: Advances in Therapy, ISSN 0741-238X, E-ISSN 1865-8652, Vol. 36, nr 7, s. 1756-1769Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Introduction

    In real-life practice, asthma remains poorly controlled, with a considerable burden on patients’ quality of life. Budesonide/formoterol (B/F) Easyhaler® has demonstrated similar dose consistency, therapeutic equivalence, and equivalent bronchodilator efficacy to B/F Turbuhaler®, but no real-life comparisons are yet available in patients switching from B/F Turbuhaler® to B/F Easyhaler®.

    Methods

    The primary objective of this real-life, non-interventional, observational study was to show non-inferiority of asthma control when adult patients in Swedish primary care with persistent asthma switched from B/F Turbuhaler® to B/F Easyhaler®. At visit 1, baseline demographic and endpoint data were recorded, and eligible patients switched to B/F Easyhaler®. The study comprised a control visit (visit 2) and a concluding examination (visit 3) after 12 weeks. Asthma control was assessed using the Asthma Control Test (ACT). The mini-Asthma Quality of Life Questionnaire (AQLQ) and lung function test were performed, and participants and investigators answered questionnaires about ease-of-use and teaching.

    Results

    A total of 117 patients were enrolled in the on-treatment population; 81 (64.8%) were female. At visit 3, B/F Easyhaler® demonstrated non-inferiority to B/F Turbuhaler®; the mean difference in change from baseline ACT was statistically significant (18.9 vs. 20.7, respectively; p < 0.0001) and met the non-inferiority criteria of B/F Easyhaler® being greater than − 1.5 points versus the reference product. Asthma was well controlled in 62 (53.0%) patients at baseline, increasing to 83 patients (70.9%) at visit 3. Patients experienced statistically significant improvements in mini-AQLQ score after B/F Easyhaler® treatment and lung function remained stable across the treatment period. B/F Easyhaler® was easy to learn and prepare for use.

    Conclusion

    This real-life, non-interventional, non-inferiority study in adults with persist asthma demonstrates equivalent or better disease control when patients switch from B/F Turbuhaler® to B/F Easyhaler®. A further study with direct comparison between treatments could add to the understanding of inhaler switch.

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