Study finds aspirin still the best for heart risk
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Adding the blood-thinning drug Plavix to a daily dose of aspirin does not lower the risk of death, heart attack or stroke in high-risk patients, researchers said on Sunday.
“The overall findings were negative, but a benefit was seen in patients with established cardiovascular disease,” said Dr. Deepak Bhatt, associate director of the Cleveland Clinic Cardiovascular Coordinating Center and the study’s lead investigator.
He said that study of more than 15,000 patients showed that combining Plavix, sold by Sanofi-Aventis SA and Bristol-Myers Squibb Co., with aspirin may do more harm than good for patients at risk of developing heart disease, but it can help those who have already suffered a heart attack or stroke.
The results confirm that aspirin is “the gold standard” for treating heart risk, said Dr. Charles Hennekens, professor of medicine, epidemiology and public Health at the University of Miami School of Medicine.
He warned that results from sub-groups of trials are “only useful to raise questions, not to test them.”
Plavix is the current standard treatment among so-called anti-platelet drugs, which are used to prevent blood clots that can cause a heart attack, unstable angina, or stroke.
Aspirin, also a blood thinner, acts on a different platelet receptor than Plavix, which has more potent effects.
The trial results “redouble the message that aspirin has the best benefit-to-risk and the best benefit-to-cost ratios of any heart drug out there,” Hennekens said.
Plavix has been proven in previous trials to help prevent second heart attacks, strokes and death among patients with acute heart disease.
The latest study included patients with more stable cardiovascular disease—defined by a previous heart attack or stroke, or evidence of poor blood supply to the legs—as well as patients with risk factors for future atherosclerosis, such as diabetes, high blood pressure and high cholesterol.
After a 28-month follow-up, the trial showed a combined rate of death, heart attack or stroke of 7.3 percent in the group taking placebo plus aspirin, compared with 6.8 percent for patients on Plavix plus aspirin. The difference is not statistically significant.
The addition of Plavix did reduce the rate of hospitalization from 17.9 percent to 16.7 percent.
When the analysis was limited to the 12,153 patients with heart disease, Plavix reduced the combined rate of death, heart attack, or stroke from 7.9 percent to 6.9 percent.
“There is no reason to use the combination therapy for primary prevention, whereas it might be useful in patients who have already had a heart attack or stroke,” Bhatt said.
The trial showed no significant increase in severe bleeding in patients with cardiovascular disease.
But Plavix did not improve outcomes—and may even have increased the risk of severe bleeding and death—in patients with risk factors for heart disease, the researchers said.
“Aspirin is tough to beat, but it too has bleeding risk,” Bhatt said.
Results of the trial were presented at a meeting here of the American College of Cardiology.
Other companies, including AstraZeneca Plc and Eli Lilly and Co. are developing potential competitors to Plavix.
The potential prize is large as Plavix is the world’s fourth-biggest-selling drug, with annual sales of more than $5 billion, although its future is uncertain since generic makers are challenging the validity of the drug’s patents.
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