Does pitavastatin reduce the likelihood of cardiovascular events in persons with human immunodeficiency virus infection?
In adults aged 40 to 75 years with HIV disease and at low to moderate risk for cardiovascular disease, pitavastatin 4 mg once daily resulted in a modest reduction in the risk of a major cardiovascular event (NNT = 400). Based on the survival curve, it looks like the benefit was consistent across the follow-up period, so over 10 years that NNT would be only 40. The cost of pitavastatin (Livalo) is $332 per month, so it may be worth working with a pharmacist to identify a lower cost statin that does not interact with your patient's specific antiretroviral regimen.
Plan de l'etude:
Randomized controlled trial (double-blinded)
Industry + govt
Although it is known that the risk of cardiovascular events is higher in persons living with human immunodeficiency virus (HIV) infection, no randomized trials have been done in this population. In this study, researchers identified 7769 adults, aged 40 to 75 years, with HIV infection who were being treated with antiretroviral therapy. Patients were randomized to receive pitavastatin 4 mg or placebo. (Pitavastatin was chosen because it does not interact with any antiretrovirals, unlike most other statins.) At baseline, the patients' median age was 50 years, their median CD4 count was 621 cells/mm3, median low-density lipoprotein (LDL) level was 108 mg/dL, and 87% had undetectable levels of HIV RNA. Patients at high cardiovascular risk were excluded. Groups were balanced at baseline and analysis was by intention to treat. The primary outcome was a broad composite of cardiovascular death; myocardial infarction; stroke; hospitalization for unstable angina; transient ischemic attack; peripheral arterial ischemia; revascularization of a coronary, carotid, or peripheral artery; or death from an unknown cause. The study was stopped early after 5.1 years because of detection of an efficacy signal. There were relatively high rates of loss to follow-up (17%) and discontinuation of medications (27%), though discontinuation was lower in the pitavastatin group. The primary outcome occurred significantly less often in the pitavastatin arm (4.81 vs 7.32 events per 1000 person years; hazard ratio = 0.65; 95% CI 0.48 - 0.90, number needed to treat [NNT] = 82 over 5 years to prevent one event). Each individual component of the composite was numerically less likely in the pitavastatin group, although only myocardial infarction achieved statistical significance. Patients without hypertension had a greater likelihood of benefit. Serious adverse events were rare and similar between groups: myalgias, muscle weakness, or myopathy occurred in only 2.3% of the pitavastatin group and in 1.4% of the placebo group (number needed to treat to harm = 111). At 5 years, the LDL cholesterol level was 75 mg/dl in the pitavastatin group.
Mark H. Ebell, MD, MS
University of Georgia