Adherence and outcomes of patients prescribed dabigatran (<scp>P</scp>radaxa) in routine clinical practice

Thorne, Katie; Jayathissa, Sisira; Dee, Stephen; Briggs, Nancy; Taylor, Jeff; Reid, Susan; Silva, K. De; Dean, J.

doi:10.1111/imj.12370

Cited by 34 publications

(42 citation statements)

References 4 publications

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“…However, we are now seeing even high income countries struggling to fund new premium-priced medicines including new therapies to treat patients with cancer (4)(5)(6)(7)(8)(9). Unless these problems are addressed, the number of struggling countries will grow driven by factors including changing demographics, increasing prevalence of non-communicable diseases (NCDs), rising patient expectations and the continued launch of new premium priced technologies (10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20).…”

Section: Introductionmentioning

confidence: 99%

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Godman

Malmström

Diogène³

et al. 2014

Expert Review of Clinical Pharmacology

115

132

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Are new models needed to optimise the utilisation of new medicines to sustain healthcare systems?Godman B 1,2,3 , Malmström RE 4 , Diogene E 5 , Gray A 6 , Jayathissa S 7 , Timoney A 8 , Acurcio FA 9,10 , Alkan A 11 , Brzezinska A 12 , Bucsics A 13 , Campbell S 14,15 AbstractIntroduction: Medicines have made an appreciable contribution to improving health. However, even high income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimise their use. Objective: Review case histories among health authorities to improve the utilisation and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. Challenges and proposed models: A number of issues and challenges have been identified including the limited innovation level of new medicines alongside increasing requested prices for their reimbursement especially for oncology, orphan diseases, diabetes and HCV. Models centre on the three pillars of pre-, peri, and post-launch including critical drug evaluation and multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure Discussion: Proposed models which involve all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.

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Section: Introductionmentioning

confidence: 99%

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Godman

Malmström

Diogène³

et al. 2014

Expert Review of Clinical Pharmacology

115

132

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“…The nine prospective cohort studies were conducted in seven (countries (the UK, the US, Denmark, New Zealand, China, Taiwan, and Germany). The study duration ranged from 10 ( Thorne et al, 2014) to 23 (Gorst-Rasmussen et al, 2015) months and the sample sizes ranged from 150 (Hu et al, 2015) to 27,514 (Martinez et al, 2016) subjects. The data collection method involved electronic medical record reviews (Donaldson and Norbeck, 2013;Lee et al, 2013;Cutler et al, 2014;Ho et al, 2014;Monteagudo et al, 2015;Martinez et al, 2016), electronic national database searches Larsen et al, 2013;Graham et al, 2014;Beyer-Westendorf et al, 2015;Chang et al, 2015;Gorst-Rasmussen et al, 2015;Hu et al, 2015;Chan et al, 2016;Forslund et al, 2016;Nishtala et al 2016), questionnaires (Thorne et al, 2014;Hu et al, 2015), and a reporting system (Andreica and Grissinger, 2015).…”

Section: Resultsmentioning

confidence: 99%

“…Four of the retrospective studies investigated ADRs (Larsen et al, 2013;Graham et al, 2014;Chang et al, 2015;Nishtala et al, 2016], one investigate medication errors (Andreica and Grissinger, 2015), one investigated persistence (Forslund et al, 2016), and two investigated adherence (Lee et al, 2013;Cutler et al, 2014). Furthermore, six prospective studies investigate ADRs (Donaldson and Norbeck, 2013;Ho et al, 2014;Thorne et al, 2014;Beyer-Westendorf et al, 2015;Monteagudo et al, 2015;Chan et al, 2016), one study investigate persistence (Martinez et al, 2016), and two investigate adherence (Gorst-Rasmussen et al, 2015;Hu et al, 2015). In addition, most of the studies investigated dabigatran, which was the first DOAC available in the market.…”

Section: Discussionmentioning

confidence: 99%

“…The rate of non-compliance to dabigatran was 11.3% (Hu et al, 2015) and rates of adherence after one year was 76.8% (Gorst-Rasmussen et al, 2015). In China, dabigatran had a high discontinuation rate of 17.4% associated with gastrointestinal complications (Thorne et al, 2014). However, in the UK, there was a greater persistence (72.9%) for DOAC therapy than there was for warfarin therapy (Martinez et al, 2016).…”

Section: Types and Causes Of Medicine-related Problems Identified Acrmentioning

confidence: 99%

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Systematic Review of Medicine-Related Problems in Adult Patients with Atrial Fibrillation on Direct Oral Anticoagulants

2017

British Journal of Pharmacy

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New oral anticoagulant agents continue to emerge on the market and their safety requires assessment to provide evidence of their suitability for clinical use. Therefore, we searched standard databases to summarize the English language literature on medicine-related problems (MRPs) of direct oral anticoagulants DOACs (dabigtran, rivaroxban, apixban, and edoxban) in the treatment of adults with atrial fibrillation. Electronic databases including Medline, Embase, International Pharmaceutical Abstract (IPA), Scopus, CINAHL, the Web of Science and Cochrane were searched from 2008 through 2016 for original articles. Studies published in English reporting MRPs of DOACs in adult patients with AF were included. Seventeen studies were identified using standardized protocols, and two reviewers serially abstracted data from each article. Most articles were inconclusive on major safety end points including major bleeding. Data on major safety end points were combined with efficacy. Most studies inconsistently reported adverse drug reactions and not adverse events or medication error, and no definitions were consistent across studies. Some harmful drug effects were not assessed in studies and may have been overlooked. Little evidence is provided on MRPs of DOACs in patients with AF and, therefore, further studies are needed to establish the safety of DOACs in real-life clinical practice.

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“…The European Heart Rhythm Association (EHRA) Practical Guide on the use of TSOACs stresses the need for patient education, suggests documentation of remaining medication, emphasizes adhering to strict intake schedules, and proposes the use of aids to address and improve patient compliance [31]. The TSOACs are still relatively new to market, and data on adherence to therapy are limited; however, two studies of dabigatran report adherence rates of~70% [32,33], suggesting that proactive steps to improve compliance are necessary.…”

Section: Introductionmentioning

confidence: 99%

Target-specific oral anticoagulants and the hospitalist

Deitelzweig

Amin

2015

Hospital Practice

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As a class, the target-specific oral anticoagulants (TSOACs) are at least as effective as warfarin, often with superior safety for the prevention of stroke in patients with nonvalvular atrial fibrillation (AF) and the treatment of acute venous thromboembolism (VTE) and prevention of recurrent VTE. Currently, dabigatran, the direct thrombin inhibitor, along with rivaroxaban and apixaban, direct factor Xa inhibitors, has been approved in multiple countries for these indications. Edoxaban, which has received approval for the abovementioned indications in Japan, has demonstrated efficacy and safety comparable to or better than warfarin in Phase III clinical trials and is under further regulatory consideration. It is anticipated that the use of TSOACs will increase as practitioners and healthcare systems gain familiarity with these drugs and adopt their use into clinical practice. This review will provide a brief overview of the TSOAC Phase III clinical trials for prevention of stroke and systemic embolic events in patients with AF and the Phase III clinical trials for the prevention of recurrent VTE, discuss current treatment guidelines, address how TSOACs may help meet national safety goals, and provide clinical decision-making guidance regarding the use of TSOACs for hospitalists.

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Adherence and outcomes of patients prescribed dabigatran (Pradaxa) in routine clinical practice

Abstract: A high rate of discontinuation of dabigatran, mainly due to GI symptoms, was observed. There does not appear to be any specific predictor of dabigatran tolerance. When prescribed according to guidelines, rates of serious adverse events associated with dabigatran appear to be low.

Cited by 34 publications

References 4 publications

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Systematic Review of Medicine-Related Problems in Adult Patients with Atrial Fibrillation on Direct Oral Anticoagulants

Target-specific oral anticoagulants and the hospitalist

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