Posts Tagged ‘dabigatran’

December 12th, 2012

Boehringer Ends Phase 2 Trial of Dabigatran in Mechanical Valve Patients

Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board. The RE-ALIGN trial was an open-label, 12-week randomized comparison of […]

November 2nd, 2012

FDA Investigation Finds No Excess Bleeding Risk for Dabigatran

In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the full FDA […]

October 23rd, 2012

Setback for Trial Studying Dabigatran After Mechanical Valve Surgery

Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year, Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase 2, […]

October 23rd, 2012

High Rate of Warfarin Discontinuation Observed in Study

One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now an observational study published in the Archives of Internal Medicine raises the possibility that the problem may be even worse than many have suspected, as discontinuation rates in clinical trials appear […]

June 7th, 2012

Growing Popularity of Dabigatran Leads to Increased Complications

Since its approval in the United States in October 2010, dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now includes the statement […]

April 25th, 2012

When You’re Hot, You’re Hot: Salim Yusuf Second Most Influential Scientist in 2011

McMaster University’s Salim Yusuf has tied for second place in the annual ranking of the “hottest” scientific researchers, according to Thomson Reuter’s Science Watch. Yusuf was a co-author of 13 of the most cited papers in 2011. Only one other researcher, genomic pioneer Eric Lander of the Broad Institute of MIT and Harvard, had more highly-cited papers than Yusuf. Two of […]

March 19th, 2012

Selections from Richard Lehman’s Literature Review: Week of March 19th

This week’s topics include percutaneous PFO closure and dabigatran risks.

February 2nd, 2012

Study Explores Role of Periprocedural Dabigatran in AF Ablation

As dabigatran becomes more widely used in AF patients, electrophysiologists are trying to figure out how to handle anticoagulation in patients taking the drug and for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues report on a multicenter, observational study of 290 patients […]

January 9th, 2012

Excess Risk for Cardiac Events Associated with Dabigatran

A new meta-analysis finds that dabigatran is associated with a higher risk of myocardial infarction and acute coronary syndromes. An editorial raises questions about the enthusiasm to embrace new drugs.

December 7th, 2011

FDA Undertakes Safety Review of Dabigatran (Pradaxa)

The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of bleeding […]