ReviewFrontiers in pharmacology2014
Dabigatran - a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs.
Review in Frontiers in pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- Global access to affordable direct oral anticoagulants.Bulletin of the World Health Organization · 2021Article
- Structural Changes of Sodium Warfarin in Tablets Affecting the Dissolution Profiles and Potential Safety of Generic Substitution.Pharmaceutics · 2021Article
- Strategies to Improve Antimicrobial Utilization with a Special Focus on Developing Countries.Life (Basel, Switzerland) · 2021Review
- Rapid review of suspected adverse drug events due to remdesivir in the WHO database; findings and implications.Expert review of clinical pharmacology · 2021Article
- Real-World Prevalence of Direct Oral Anticoagulant Off-Label Doses in Atrial Fibrillation: An Epidemiological Meta-Analysis.Frontiers in pharmacology · 2021Review
- Integrative Review of Managed Entry Agreements: Chances and Limitations.PharmacoEconomics · 2020Review
- Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages.Frontiers in medicine · 2020Article
- Mapping of Current Obstacles for Rationalizing Use of Medicines (CORUM) in Europe: Current Situation and Potential Solutions.Frontiers in pharmacology · 2020Article
- Review of Ongoing Activities and Challenges to Improve the Care of Patients With Type 2 Diabetes Across Africa and the Implications for the Future.Frontiers in pharmacology · 2020Review
- Formulary Management Activities and Practice Implications Among Public Sector Hospital Pharmaceutical and Therapeutics Committees in a South African Province.Frontiers in pharmacology · 2020Article
- Response to the Novel Corona Virus (COVID-19) Pandemic Across Africa: Successes, Challenges, and Implications for the Future.Frontiers in pharmacology · 2020Review
- The Expiry of HumiraFrontiers in pharmacology · 2020Article
- Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets.Frontiers in public health · 2018Review
- Clinical and Financial Implications of Medicine Consumption Patterns at a Leading Referral Hospital in Kenya to Guide Future Planning of Care.Frontiers in pharmacology · 2018Article
- Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.Frontiers in pharmacology · 2017Review
- Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways.Frontiers in pharmacology · 2016Article
- Introduction and Utilization of High Priced HCV Medicines across Europe; Implications for the Future.Frontiers in pharmacology · 2016Article
- Clinical utility of dabigatran in United Arab Emirates. A pharmacovigilance study.Saudi medical journal · 2015Article
- Public health service options for affordable and accessible noncommunicable disease and related chronic disease prevention and management.Journal of multidisciplinary healthcare · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
36 authors.
Funding
Abstract
backgroundThere are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction.
objectiveTo (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities. METHODOLOGY: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies.
resultsPlethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice.
conclusionModels for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.