Wednesday, September 9, 2009

FDA Approves New Medication to Reduce the Risk of Heart Attack in Angioplasty Patients

The U.S. Food and Drug Administration approved Effient (Prasugrel) in July 2009. Effient is approved to reduce the risk of blood clots from forming in patients who undergo angioplasty. It is a blood thinning drug that prevents platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke.

A study enrolling 13,608 patients which compared Effient to another blood thinning medication, Plavix (Clopidogrel) was completed. These patients presented with a heart attack or threatened heart attack and were about to undergo angioplasty, a procedure where a balloon is used to open the artery that has been narrowed.

Effient is more efficacious than Clopidogrel in preventing deaths from blood clots, non-fatal heart attacks and nonfatal strokes in patients receiving stents. However, those receiving Effient had a greater risk of bleeding than those taking Clopidogrel. Patients who have a history of stroke were more likely to have another stroke while taking Effient.

Effient appears to be an excellent alternative treatment for preventing dangerous blood clots from forming and causing a heart attack in those patients who present with a heart attack and are in need of stenting.

However, it is recommended to not use Effient in those patients who have active pathological bleeding, history of transient ischemic attacks (TIAs) or strokes. Effient should not be used in patients who are in urgent need for surgery-including open heart surgery. Due to the fact, that when possible, patients should discontinue Effient at least 7 days prior to any surgery (as directed by a physician). In general, patients who are 75 years of age or older it is not recommended to use Effient because of increased risk of fatal and intracranial bleeding and uncertain benefit.

As with any treatment, physicians and patients must carefully analyze the potential benefits and risks associated with the use of Effient – as each individualized case is unique.

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