Cardiovascular complications of HIV: an overview of risk and a novel approach to prevention ??? the HIV polypill study

Abstract

To review the risk of cardiovascular complications in HIV-infected patients receiving combination antiretroviral treatment. Recent data suggest that patients with chronic HIV infection will require continuous lifelong combination antiretroviral treatment, which may increase the risk of cardiovascular disease in all populations by substantial amounts. Simple, safe and effective interventions to reduce cardiovascular complications in HIV-infected patients will be required. Studies in the general population suggest that the primary prevention of cardiovascular disease with a pill combining blood-pressure-lowering, cholesterol-lowering and antiplatelet treatments (a polypill) might decrease cardiovascular events. An HIV polypill study with 8000 HIV-infected patients with a moderate risk of cardiovascular disease randomized to either a polypill of low-dose pravastatin, aspirin, hydrochlorothiazide and lisinopril or to placebo is described. The primary clinical endpoint would be a composite of cardiovascular mortality, non-fatal myocardial infarction and stroke. A vanguard study of 400 patients could assess changes in cholesterol, blood pressure and other risk factors. The clinical endpoint study described would have 80% power to detect a 23% reduction in the rate of cardiovascular events in the polypill arm. A study of a polypill like that proposed for the general population will provide crucial information on the risks and benefits of primary cardiovascular prevention in HIV-infected patients.