Brilinta Has Advantages Over Plavix for Heart
Study Shows Blood Thinner Brilinta May Be Effective in Patients With a Genetic Variant
Aug. 30, 2010 (Stockholm, Sweden) -- The experimental blood-thinning pill Brilinta works regardless of whether patients have a genetic variant that is often associated with poor outcomes in patients taking the standard medication, Plavix, researchers report.
"This finding is a real win that strengthens Brilinta's position," study head Lars Wallentin, MD, of Uppsala University in Sweden, tells WebMD.
Using Brilinta instead of Plavix eliminates the need for genetic testing, simplifying treatment and cutting costs, he says.
Brilinta has recently been recommended for approval by an FDA advisory committee. The FDA, which usually, but doesn't always, follows the committee's advice, will vote on the issue on Sept. 16.
The new findings were presented at the European Society of Cardiology Congress and simultaneously published online in the medical journal The Lancet.
Brilinta Works Better Regardless of Genetic Makeup
The findings come from a sub-study of the PLATO trial, which showed that Brilinta works better than Plavix at preventing heart attacks, strokes, and deaths from heart disease in people with acute coronary syndrome (ACS).
ACS is an umbrella term for a group of symptoms for any condition, such as heart attack, that could result from reduced blood flow to the heart.
The sub-study of more than 10,000 patients was designed to determine whether variants in the CYP2C19 gene have an impact on the effectiveness of Brilinta, Wallentin says.
Patients with a certain CYP2C19 variant are so-called poor metabolizers of Plavix. This can lead to a potentially deadly lack of effect in 2% to 14% of patients.
"We knew that if people had the variant, Brilinta would work better. But would it also work better in people who are normal metabolizers? The answer is yes," Wallentin says.
Brilinta Linked to Slight Increase in Bleeding
In patients who received Brilinta, the annual rate of cardiac events -- heart attacks, strokes, or death from heart disease -- was 8.6% in CYP2C19 carriers and 8.8% in non-carriers.
Among patients on Plavix that carried the CYP2C19 variant, there was an 11.2% per year cardiac event rate. In patients without the variant, it was 10.0%.
There was a "slight" increase in major bleeding among patients on Brilinta, but the benefits far outweigh the risks, Wallentin says.
A genetic test can tell whether a person is a poor metabolizer of Plavix. But there are real advantages to be able to skip the test, he says.
For starters, it costs about $500. Then there's the time to get the results -- it may be a few hours or days, or weeks, Wallentin says.
The study was sponsored by AztraZeneca, which makes Brilinta. No price has been set, according to a company spokesperson.
American Heart Association spokesman Ray Gibbons, MD, of the Mayo Clinic in Rochester, Minn., says the data "show a clear advantage for Brilinta over Plavix.
"But you can't be absolutely certain based on a single study," he tells WebMD.
If the findings do pan out, "they will relieve clinicians of the uncertainty of whether they need to be testing for certain genetic variants," Gibbons says.