Magazine article Drug Topics

Dabigatran Bleeding Events Subject of New Published Data

Magazine article Drug Topics

Dabigatran Bleeding Events Subject of New Published Data

Article excerpt


Two separate analyses of data reported to FDA about bleeding events and dabigatran have resulted in conflicting findings.

A new analysis of the FDA Mini-Sentinel database has given reassuring results on the rates of gastrointestinal (GI) and intracranial bleeds connected with dabigatran.

However, a separate analysis of dabigatran bleeding reports submitted to FDA presented at the American College of Cardiology (ACC) 2013 Scientific Sessions, has suggested a much higher case-fatality rate than that reported in the major clinical trials of the drug.

The Mini-Sentinel analysis was conducted by three FDA employees in response to the high numbers of bleeding reports associated with dabigatran when it was first approved in the United States. Results showed that bleeding rates associated with dabigatran use during the study period did not appear to be higher than those associated with warfarin.

The other analysis, presented at the ACC meeting, examined publicly available data from adverse-event reports on dabigatran submitted to FDA between January 1, 2010, and June 30, 2012. Of the 2,453 adverse events associated with dabigatran bleeding that were reported to FDA 393 (16%) were fatal, almost double the case-fatality rate of patients who had bleeding episodes in the five phase 3 trials of the drug.

Both authors noted limitations of their studies and cautioned against using the data to draw definite conclusions. Post-marketing surveillance is ongoing.

Sources: Southworth MR, Rahman ME, Unger ER Dabigatran and postmarketing reports of bleeding. ? Engl J Med httpJlwww.nejm.orgl MfuW10.1056/NEJMpl3028M?query=featwed_home. Accessed March 30, 2013. Hughes S. Mixed messages on new bleeding data with dabigatran. http://www.meascape.ccm/vkwartkk/78087L Accessed March 30, 2013.

Clopidogrel/atorvastatin combination may improve outcomes after stenting

A recently published study evaluated a Clopidogrel loading dose combined with a high-dose atorvastatin reload for efficacy in preventing stroke, transient ischemic attack, or new ischemic lesions in patients who have undergone carotid stenting.

A total of 1 56 patients were randomized to receive either a 600-mg or 300-mg Clopidogrel load given six hours before the intervention and either an atorvastatin reload (80 mg + 40 mg 12 hours before the procedure) or no statin reload. The primary end point was the 30-day incidence of transient ischemic attack/ stroke or new ischemic lesions on cerebral diffusion- weighted magnetic resonance imaging performed at 24 hours to 48 hours. …

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