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INTREPID: Livalo safe, effective in patients with HIV at 1 year
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New data from the phase 4 INTREPID study demonstrate that 1 year of treatment with pitavastatin was safe and effective in patients with HIV and dyslipidemia.
Researchers randomly assigned patients with HIV and dyslipidemia to 4 mg pitavastatin (Livalo, Kowa Pharmaceuticals America Inc.; n=126) or 40 mg pravastatin (Pravachol, Bristol-Myers Squibb; n=126). INTREPID was a 12-week randomized superiority study followed by a 40-week safety extension to compare safety and lipid profiles, according to a press release.
At 1 year, the rate of treatment-emergent adverse events was 67.5% for the pitavastatin group vs. 69.8% for the pravastatin group. The most common overall adverse event was upper respiratory infection (7.5%); 11 patients discontinued treatment due to adverse events and there were no deaths, according to the release.
Consistent with 12-week results, the pitavastatin group had a lower reduction in LDL at 1 year vs. the pravastatin group (–47.8 mg/dL vs. –32.6 mg/dL; 30% reduction vs. 20% reduction; P<.001), according to the release.
In addition, in men aged 45 years and older and women aged 55 years and older, those assigned pitavastatin had greater reductions in LCL, apolipoprotein B and non-HDL vs. those assigned pravastatin.
Judith Aberg
“The findings of the INTREPID study are an important advance in potential treatment options for HIV-infected adults with high cholesterol,” researcher Judith Aberg, MD, FIDA, FACP, director of infectious disease at Icahn School of Medicine at Mount Sinai, stated in the release. “These results will serve to further physician education on statin use for HIV-infected individuals.”
The data were presented at the National Lipid Association Scientific Sessions.