Kowa Pharmaceuticals announced data from the Phase 4 INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) trial showing that Livalo (pitavastatin) 4mg was superior to pravastatin 40mg in lowering LDL cholesterol (LDL-C) in adults with HIV and dyslipidemia. Findings from the study are published in The Lancet.
Treating dyslipidemia in patients with HIV is difficult due to the drug interactions between antiretroviral agents and statins. The INTREPID trial was the first to report on the efficacy and safety of Livalo in this patient population. In the prospective, randomized, double-blind, active, controlled superiority trial, 252 adults with HIV and dyslipidemia (LDL-C 130–220mg/dL and triglycerides ≤400mg/dL) were randomized to either Livalo 4mg or pravastatin 40mg with matching placebos once-daily for 12 weeks plus a 40-week safety extension.
Researchers evaluated the percent change in fasting serum LDL-C from baseline to Week 12 in the modified intent-to-treat population (primary endpoint). The data found treatment with Livalo led to a statistically significant and superior reduction in LDL-C vs. pravastatin at Week 12 (31.1% vs. 20.9%; P<0.0001). The differences remained significant between the two groups through Week 52.
Treatment with Livalo also led to significantly greater reductions in non-HDL-cholesterol (–26.9% vs. –18.7%; P<0.0001) and apo B levels (–23.3% vs. –16.5%; P<0.0001) from baseline after 12 weeks vs. pravastatin, and after 52 weeks (–26.1% vs. –19.0%; P=0.012 [non-HDL-cholesterol] and –25.4% vs. –19.6%; P=0.018 [apo B]).
At Week 12 or 52, study authors did not observe significant changes in parameters of glucose metabolism and insulin resistance for either treatment group. Also, no significant effects on fasting glucose or HbA1c were seen for either treatment group at Week 52, and there were no reports of post-baseline abnormal fasting glucose or HbA1c level as a treatment-emergent adverse event (TEAE). Fasting plasma insulin did not vary significantly from baseline for either treatment group.
Douglas Ward, MD, co-author of the study, added, “The finding that Livalo was more effective than pravastatin in lowering LDL cholesterol and was well tolerated in HIV patients with dyslipidemia suggests it could be a viable treatment option for managing dyslipidemia and contributing factors in adults with HIV.”
Livalo, an HMG-CoA reductase inhibitor, is available as 1mg, 2mg, and 4mg strength tablets in 90-count bottles.
For more information visit thelancet.com.