People with HIV who are at low to moderate risk for cardiovascular events can reduce their risk even further by taking a daily statin medication, according to long-awaited results from the REPRIEVE study.
The international Phase III trial enrolled nearly 7,800 HIV-positive people ages 40 to 75. Their demographics, comorbidities and laboratory values reflected low to moderate cardiovascular risk, so they ordinarily would not have been prescribed a statin. But standard risk scores developed for the general population tend to underestimate the risk for people with HIV, who are about twice as likely to develop cardiovascular disease.
The study participants were randomly assigned to receive oral pitavastatin or a placebo. Statins reduce low-density lipoprotein (LDL) cholesterol and also have anti-inflammatory properties. The drugs have been shown to lower the risk for cardiovascular problems and death in the population at large, but their benefits for people living with HIV were uncertain.
The trial was stopped ahead of schedule in April after an interim analysis showed that pitavastatin reduced the risk for heart attacks, strokes, severe chest pains, heart surgery and cardiovascular death by 35%. The effect was consistent for men and women, across racial/ethnic groups and regardless of CD4 count or baseline LDL level. Pitavastatin was generally safe and well tolerated, but people who used the drug were more likely than placebo recipients to develop diabetes (about 5% versus 4%, respectively).
“We would highly recommend that guidelines be changed” to include statin therapy for people with HIV, says lead investigator Steven Grinspoon, MD, of Massachusetts General Hospital. “Pitavastatin is effective, prevents major adverse cardiovascular events and will save lives.”