April 2, 2010

Study examines heart patients’ mix of drugs

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Wayne Ray, M.D., and colleagues are studying the impact of combining popular blood-thinning and stomach acid reducing medications. (photo by Anne Rayner)

Study examines heart patients’ mix of drugs

A study by Vanderbilt researchers may ease concerns about one of the most common drug combinations for heart patients.

In addition, their findings more clearly describe benefits of the combination, in a large study conducted for the Centers for Education and Research on Therapeutics (CERT).

Clopidogrel (sold as Plavix, Clopilet, and Ceruvin) is commonly prescribed to prevent clot formation following angioplasty, stent placement or other treatments for serious coronary heart disease. This same patient population often takes common stomach acid-reducing medications called proton-pump inhibitors (PPIs) to prevent ulcers.

There has long been concern that PPIs might reduce the effectiveness of clot prevention drugs, leaving patients at higher risk for another heart attack. Vanderbilt researchers, however, found this was not the case. In fact, patients taking a combination of clopidogrel and a PPI had half the number of serious gastro-intestinal bleeds when compared with patients who only took clopidogrel.

“This was a critical question because there are millions of heart patients

Wayne Ray, Ph.D.

Wayne Ray, Ph.D.

The study, published in the recently in the Annals of Internal Medicine, was based on data from nearly 21,000 patients in the TennCare program between 1999 and 2005.

Clopidogrel is one of the most frequently prescribed blood thinners, and is the only type thought to interact in this way with PPIs.

Since 62 percent of PPI use in this study was pantoprazole, the researchers concluded its use did not increase patients' risk of heart attack, sudden cardiac death, stroke or other cardiovascular problems, although PPI risk could not be completely ruled out.

The Vanderbilt research team is one of 14 CERT centers, supported by the Department of Health and Human Services' Agency for Healthcare Research and Quality (AHRQ) and the National Heart, Lung, and Blood Institute at the National Institutes of Health.

“We need to make sure that the medicines we give patients help and don't harm” said AHRQ Director Carolyn Clancy, M.D. “This evidence on benefits and risks helps inform the combined use of these two drugs.”

Ray says Vanderbilt's 11-year involvement in CERT trials has been important for public health.

“There are many questions regarding safety and efficacy that don't have an obvious champion. The goal for CERT studies is to look at what is most important for public health,” Ray said.

Previous CERT studies conducted by Vanderbilt researchers discovered a dose-related association between sudden cardiac death and atypical antipsychotics, and some of the earliest evidence to suggest a heart risk from Cox-2 inhibitors like Vioxx.