Concerns over data in key dabigatran trial

BMJ (Online)

Volumn 349, Issue , 2014, Pages

  Cohen, Deborah ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN; WARFARIN;

ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CEREBROVASCULAR ACCIDENT; DATA ANALYSIS; DOCUMENT EXAMINATION; DRUG INDUSTRY; DRUG INFORMATION; DRUG LEGISLATION; DRUG MONITORING; DRUG SAFETY; HUMAN; LAW SUIT; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS;

ANTITHROMBINS; BENZIMIDAZOLES; BETA-ALANINE; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; DRUG INDUSTRY; DRUG MONITORING; HEMORRHAGE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84904646254     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.g4747     Document Type: Article

References (11)

1. Cohen D. Dabigatran: how the drug company withheld important analyses. BMJ 2014;349:g4670.
2. Dabigatran for atrial fibrillation. Why we cannot rely on RE-LY. Therapeutics Letter 2011;80 (Jan to Mar). www.ti.ubc.ca/letter80.
3. Chatterjee S,Sardar P, Biondi-Zoccai G, Kumbhani DJ. New oral anticoagulants and the risk for intracranial hemorrhage: authors' reply. JAMA Neurol 2014;71:371.
4. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-51.
5. Center for Drug Evaluation and Research. Application number 22-512. administrative and correspondence documents. www.accessdata.fda.gov/drugsatfda- docs/nda/2010/022512Orig1s000Admin.pdf.
6. Connolly SJ, Ezekowitz MD, Yusuf S, Reilly PA, Wallentin L, Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly identified events in the RE-LY trial. N Engl J Med 2010;363:1875-6.
7. Hohnloser SH, Oldgren J, Yang S, Wallentin L, Ezekowitz M, Reilly P, et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial. Circulation 2012;125:669-76.
8. SPORTIF Executive Steering Committee for the SPORTIF V Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. A randomised trial. JAMA 2005;293:690-8.
9. Executive Steering Committee on behalf of the SPORTIF III Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with nonvalvular atrial fibrillation (SPORTIF III): randomised controlled trial. Lancet 2003;362:1691-8.
10. Cardio-Renal Advisory Committee, 20 September 2010. www.fda.gov/ downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ CardiovascularandRenalDrugsAdvisoryCommittee/UCM247244.pdf.
11. Boehringer Ingelheim announces comprehensive settlement of U.S. Pradaxa® (dabigatran etexilate) litigation. Press release, 28 May 2014. www.businesswire.com/news/home/20140528005924/en/Boehringer-Ingelheim-announces- comprehensive-settlement-U.S.-Pradaxa%C2%AE#.U4X7MvldWcx.