For long, heart patients have popped aspirin pills to keep their rickety pumps from collapsing. Now they can choose from among a new class of drugs called super aspirins which, their makers claim, can do the same job much better, either solo or in concert with aspirin.
Last year, clinical trials in the US involving more than 3,700 patients found the drug clopidogrel to be more effective than aspirin in preventing blood from clotting in patients with high cholesterol. And in March this year, a worldwide trial involving 12,562 patients in 28 countries found that the drug worked even better if taken along with aspirin. Patients were randomly assigned to receive either clopidogrel plus standard therapy or just the latter. Standard therapy consists of aspirin, beta-blockers and cholesterol-lowering drugs, all proven to reduce the risk of dying in heart ailments.
The results of the nine-month trial are now available. Up to 11.5 per cent of those receiving standard treatment had died or had had a heart attack or stroke, against 9.3 per cent of those receiving clopidogrel as well. The benefits, the study concludes, are clinically important. Treating 1,000 patients for nine months, the study estimates, prevented 28 heart complications and required transfusions in only four patients. This treatment would also benefit heart attack victims who end up in hospital, 40 per cent of whom die or suffer a major heart attack within a year. Doctors claim the evidence is so overwhelming that people should go right ahead and use the treatment based on these results.
Clopidogrel is what doctors call an anti-platelet drug, the same class of medication that includes the time-tested aspirin. Like aspirin, clopidogrel helps keep blood cells called platelets from clumping and forming clots which could travel to arteries feeding the heart or brain, choking off blood supply and triggering a heart attack or stroke.
Clopidogrel, marketed by pharmaceutical company Bristol-Myers Squibb (which developed the drug) as Plavix, hit Indian chemist shops early this year. It is sold under at least 10 different names—Seruvian (Ranbaxy), Deplatt (Torrent), Clopigril (US Vitamins), among others—and prices range from Rs 20 to Rs 50 per tablet.
Naresh Trehan, executive director of Delhi's Escorts Heart Institute, says cardiologists have been prescribing clopidogrel for the past one year. "But it became standard dispensation only after it was freely available here. And I think most cardiologists in India are now familiar with it," he says.
The clopidogrel-aspirin combination has not been tested in any large-scale trials in India, so there is little data to say anything conclusive about its efficacy or its impact in terms of quality of life and cost of treatment. "But," says cardiologist V.K. Bahl of the Delhi-based All India Institute of Medical Sciences, "it's safe to say most patients with unstable angina have benefited from it." Cardiologist S.K. Gupta of Delhi's Apollo Hospital agrees that the two drugs work better in tandem than separately.
It also works out to be cheaper than other super aspirins, such as reopro and integrelin, which are also being used in very high-risk patients. While the clopidogrel-aspirin combination costs about Rs 20 per day, the latter cost Rs 60,000 and Rs 15,000 per day respectively. Besides, clopidogrel can be administered orally while the other two have to be given intravenously.
Some worry about the higher risk of bleeding and suggest that patients on chronic clopidogrel therapy might need to discontinue it and so delay emergency bypass surgery. But others feel the risks are not alarming; they predict that with prolonged use, clopidogrel will become standard in high-risk patients, including those with large thrombin or plaque burdens, unstable angina and in post-bypass patients.
The results, however, do not answer the question whether high-risk patients need to be on clopidogrel therapy indefinitely. Says Gupta: "Many high-risk patients take it for a long time so it could be something you take chronically, like the beta-blocker."
Can this therapy be used in low-risk patients? Although the trials suggest the drug could work as a preventive, warding off heart attacks in low-risk, healthy people, Bahl says the therapy should be confined to high-risk groups until further research. It's not a vitamin tablet you can pop in to keep your ticker ticking.
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