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Can a "Polypill" Cut Heart Disease Risk in People With HIV?
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Exclusive report for NATAP
Dublin, November 17, 2005
Plans are afoot to test a tablet combining several drugs that quell cardiovascular risk factors in people with HIV. But not all experts who heard the idea aired at the November 13-16, 2005 Lipodystrophy Workshop believed the proposed "polypill" is the best way to keep HIV-infected people out of the coronary care unit.
Stephen MacMahon from Sydney’s George Institute for International Health and David Cooper from the University of New South Wales sketched plans for the "large simple" trial, which would pit placebo against a pill melding an antihypertensive, an cholesterol-lowering drug, and perhaps low-dose aspirin.
An Indian firm would use generic constituents to make the megapill, and MacMahon estimated treatment could cost as little as $20 a year. Researchers from the CPCRA and ESPRIT trial groups would try to enroll 8000 HIV-infected people with a moderate risk of heart disease and assign them to the polypill or placebo. People who need prompt treatment for heart disease risk factors would not be eligible for the trial.
The pill will probably combine the antihypertensive agents lisinopril (an ACE inhibitor) and hydrochlorothiazide (a diuretic) with pravastatin, an anticholesterol drug.
The trial rests on the rationale that addressing several risk factors simultaneously stands the best chance of warding off myocardial infarction and other ischemic heart disease. MacMahon cited evidence indicating that a 10 mm Hg drop in systolic blood pressure cuts heart disease risk about 20% in the general population, while lowering cholesterol 1 mmol/L trims the risk 25%. Combining the two strategies would slice the risk of ischemic heart disease about 40%. Adding an antiplatelet like aspirin to the mix could push the risk down about 65%.
But the plan drew some probing questions from the HIV metabolic experts assembled for the 7th annual Lipodystrophy Workshop. Steven Grinspoon from Boston’s Massachusetts General Hospital cautioned that a "one-size-fits-all" pharmacologic plan would have long odds on success in a population as mixed as people with HIV.
Grinspoon also observed that two of the risk factors addressed—hypertension and high cholesterol—are not among the most common heart threats in HIV-infected people. He added that hydrochlorothiazide and lisinopril are "not totally benign drugs," especially in people already taking complicated regimens.
MacMahon argued, though, that research confirms the value of lowering cholesterol and high blood pressure and giving antiplatelets in warding off heart disease in the general population. Surprisingly little evidence, he maintained, shows a similar effect from lowering triglycerides or glucose or boosting high-density lipoprotein cholesterol.
James Neaton from the University of Minnesota, a long-time advocate of large simple trials, would plan the polypill study.
Stephen MacMahon. Prevention of cardiovascular disease. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. November 13-16, 2005. Dublin. Abstract P6.
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