Investigational Heart Medicine May Replace Popular Use of Plavix

By Jeanine Kendle

Plavix (clopidogrel) is a fairly well-known drug with considerable media coverage for cardiac conditions to prevent platelet (blood cell component) aggregation (sticking/clumping together).

There is developing concerns regarding the use of Plavix and aspirin resistance, as well as a concern that up to 30 percent of patients do not respond to Plavix. These concerns have prompted researchers to continually look for better antiplatelet — decrease blood cell sticking/clumping together.

Ticlid, a drug prior to Plavix, and Plavix may soon have some competition from a new investigational drug, in the same family, known as Effient (prasugrel). Effient is presently undergoing priority FDA review.

A priority designation by the FDA sets the goal date. The goal for priority applications is to have an action provided for 90 percent of applications within six months. FDA can take three different actions — approved, approvable with further discussion or not approved.

On Feb. 21, Daiichi Sankyo Company, Limited and Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) accepted and designated Priority Review for the New Drug Application for prasugrel for patients with acute coronary syndrome being managed with percutaneous coronary intervention (PCI).

If prasugrel is approved, it will provide physicians and acute coronary syndrome patients an alternative medicine that may further help reduce the risk of heart attacks — with several potential advantages.

Preclinical studies have shown prasugrel is about ten times more potent than clopidogrel. Prasugrel has demonstrated significantly faster onset of action compared to clopidogrel. Prasugrel has demonstrated desired effects in as early as 15 to 30 minutes as compared to clopidogrel’s 90 minutes. There also appears to be less variability in patient response with prasugrel. Prevention (inhibition) of platelet aggregation has been determined to last up to five days.

At present, contraindications for prasugrel have not been determined. Serious adverse effects include major bleeding and an association with colon cancer (neoplasms).

Gastrointestinal side effects include indigestion associated with prasugrel.

Blood effects include major bleeding was seen in study patents at 2.4 percent, minor bleeding was witnessed in 22 percent of patients, bruising in 22 percent of patients and a pooling of blood known as a hematoma.

Nervous system effects included dizziness and headaches. Respiratory side effects demonstrated the possibility of nose bleeds in the early studies.

Although prasugrel has yet to be approved in the United States or Canada, it is presently undergoing priority review by the FDA and is investigational in Canada. Based on disease-oriented evidence, prasugrel has a faster onset of action and more complete platelet inhibition when compared with clopidogrel. Prasugrel also seems to reduce the risk of nonfatal MI (myocardial infarction/heart attack) with a corresponding increase in the risk of major bleeding.

While some experts think prasugrel will replace clopidogrel in many uses, it remains to be seen if the potential benefits outweigh the bleeding risks in certain patient populations.

Though not as yet approved, you may obtain more information regarding this new drug from your pharmacist, physician or cardiologist.

(c) 2008 Daily Record, The Wooster, OH. Provided by ProQuest Information and Learning. All rights Reserved.