Study: Are Statins Safe for Use in HIV Patients?
Pitavastatin may be safe and effective therapy for treating dyslipidemia in HIV-infected individuals, according to the results of the HIV-infected Patients and Treatment with Pitavastatin vs Pravastatin for Dyslipidemia (INTREPID) trial.
Pitavastatin and pravastatin were chosen because both drugs do not depend on cytochrome P450 for primary metabolism, and therefore would not have the same interactions with commonly used antiretroviral agents as other statins.
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The randomized, double-blind, active-controlled phase 4 trial included 252 adults between 18 and 70 years of age who had controlled HIV and dyslipidemia. Participants were divided evenly and took either an oral dose of 4 mg of pitavastatin or an oral dose of 40 mg of pravastatin with matching placebos once a day for 12 weeks. Changes in fasting serum low-density lipoprotein (LDL) cholesterol from baseline to 12 weeks were compared, and a 40-week safety extension was included to evaluate the long-term safety profile of the drugs.
At 12 weeks, LDL cholesterol reduction was 31.1% for participants taking pitavastatin and 20.9% for participants taking pravastatin.
Four patients (3%) in the pitavastatin group and 6 (5%) in the pravastatin group had virological failure at 52 weeks, but no significant differences between treatments were observed.
Overall, 85 patients taking pitavastatin (68%) and 88 patients taking pravastatin (70%) reported adverse events associated with treatment, and 6 patients in the pitavastatin group (5%) and 5 patients in the pravastatin group (4%) discontinued participation in the study. According to an investigator assessment, no serious adverse event occurred in more than 1 patient, and none of the adverse events were treatment-related.
The most common treatment-emergent adverse events were diarrhea in participants taking pitavastatin, which occurred in 12 (10%) patients, and upper respiratory tract infection in participants taking pravastatin, which occurred in 14 patients (11%).
In addition, 11 treatment-emergent serious adverse events occurred in 7 (6%) patients taking pitavastatin, including chronic obstructive pulmonary disease, transient ischemic attack, and gastroenteritis. Four events occurred in 3 patients (2%) taking pravastatin, including arteriosclerosis coronary artery, myocardial infarction, and muscle hemorrhage.
“The INTREPID results support guideline recommendations for pitavastatin as a preferred drug in the treatment of dyslipidemia in people with HIV,” the researchers concluded.
—Melissa Weiss
Reference:
Aberg JA, Sponseller CA, Ward DJ, Kryzhanovski VA, Campbell SE, and Thompson MA. Pitavastatin verses pravastatin in adults with HIV-1 infection and dyslipidemia (INTREPID): 12 week and 52 week results of a phase 4, multicentre, randmised double-blind, superiority trial [published online April 13, 2017]. LANCET HIV. dx.doi.org/10.1016/S2352-3018(17)30075-9.