Showing posts with label Pradaxa. Show all posts
Showing posts with label Pradaxa. Show all posts

Wednesday, January 11, 2012

Dabigatran, New Blood Thinner Linked To Higher Heart Attack Risk


In continuation of my update on Dabigatran...

Researchers lead by Dr.Ken Uchino from the Cleveland Clinic in Ohio looked at seven trials involving Pradaxa (Dabigatran) that included more than 30,000 patients. This process, called a meta-analysis, uses data from published clinical trials to tease out a pattern that might not show up in a single study. Researchers found Pradaxa was associated with an increased risk of heart attack or acute coronary syndrome (heart attack or angina), compared with two other commonly used blood thinners, warfarin (Coumadin, Jantoven) and enoxaparin (Lovenox).

As per the claim by the researchers,  those taking Pradaxa, 1.19 percent had a heart attack or suffered from acute coronary syndrome compared with 0.79 percent of those taking either of the other drugs, they noted. Although there was a 33 percent increase in relative risk for a heart attack among those taking Pradaxa, the absolute increased risk -- that is, the added risk for any one individual of having a heart attack if on Pradaxa -- was 0.27 percent, researchers said.

Pradaxa was approved by the U.S. Food and Drug Administration in October 2010 for people with a common heart rhythm problem called atrial fibrillation. People with atrial fibrillation are at a higher risk for stroke and are often prescribed medication to prevent clotting....

Ref : http://my.clevelandclinic.org/cerebrovascular_center/medical_professionals/clinical_trials.aspx

Sunday, November 7, 2010

FDA approves Pradaxa to prevent stroke in people with atrial fibrillation....

We knew that, Dabigatran (see structure, Pradaxa in Europe and USA, Pradax in Canada) is an anticoagulant from the class of the direct thrombin inhibitors. It is being studied for various clinical indications and in many cases it offers an alternative to warfarin as the preferred orally administered blood thinner since it does not require prothrombin time monitoring while offering similar results in terms of efficacy. It was developed by the pharmaceutical company Boehringer Ingelheim. Though it was approved in Europe in 2008, now FDA has approved the drug in October 2010 for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting. The safety and efficacy of Pradaxa were studied in a clinical trial comparing Pradaxa with the anticoagulant warfarin. In the trial, patients taking Pradaxa had fewer strokes than those who took warfarin.

 "Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," Dr. Norman Stockbridge(director of the Division of Cardiovascular and Renal Products in the FDA's ) says.

Pradaxa, manufactured by Boehringer Ingelheim Pharmaceuticals Inc. of Ridgefield, Conn., will be available in 75 milligram and 150 milligram capsules....

Ref : http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm