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Pitavastatin bested pravastatin in lowering LDL in HIV, dyslipidemia

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ATLANTA — Pitavastatin 4 mg led to better reductions in LDL cholesterol compared with pravastatin 40 mg in adults with HIV who also had dyslipidemia, data from a late breaker presented here suggest.

For the 12-week, phase 4, randomized, double blind, double dummy, active-controlled, parallel-group study, researchers randomly assigned 247 patients in a 1:1 fashion to receive once-daily pitavastatin (Livalo, Kowa Pharmaceuticals) 4 mg (n=121) or pravastatin 40 mg (n=126). The overall mean age of the patients was 50 years; 80% white; and 90% negative for hepatitis B or C infection. The primary endpoint was percent reduction in LDL cholesterol.

Twelve-week data indicated a 31% decrease in LDL cholesterol levels in patients assigned pitavastatin vs. 21% among those assigned pravastatin (P<.001).

“These are just 12-week results and we have to make sure that the results are durable,” Judith Aberg, MD, director of virology at Bellevue Hospital Center, and director in the division of infectious diseases and immunology at NYU School of Medicine, and researcher for the study, told Infectious Disease News.  “The fundamental issue is that dyslipidemia is one of the cardiac risk factors now that HIV patients are living longer, so we need to have efficacious lipid-lowering therapies. What’s exciting about this data is that, for someone like me who treats HIV patients with dyslipidemia, pitavastatin appears to be more potent than pravastatin, and to date, the drug interactions studies suggest there are no significant drug interactions. This is important news for us, and I look forward to the longer-term data.”

 

Judith Aberg

Increased levels of HDL cholesterol and decreased triglycerides did not significantly differ between the two study arms (P=.51 for HDL and P=.37 for triglycerides).   

Treatment-emergent adverse events also were similar between the two arms (61.1% for pitavastatin vs. 62.7% for pravastatin). Overall, the most common events were diarrhea, upper respiratory tract infection, sinusitis, headache, nausea and nasopharyngitis. Study discontinuation occurred in 11 patients.

Current guidelines for patients with HIV and dyslipidemia recommend the use of statins with the lowest potential for drug-drug interactions with ART. Pitavastatin has a reduced potential for cytochrome P450-mediated drug-drug interaction, according to the study abstract.

 “I hope the drug continues to show safety and tolerability,” Aberg said. “Sometimes, we get surprised with drug-drug interactions, as we cannot always predict what will happen. It’s important to pursue other studies looking at drug-drug interactions and to see if this drug not only reduces lipids but potentially can reduce some of the associated inflammation that is associated with HIV.”

For more information:

Sponsellar C. #187LB. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6; Atlanta.

Disclosure: Aberg reports no relevant financial disclosures.