Kowa Pharmaceuticals announced the results of a pre-specified safety analysis from the INTREPID trial that evaluated the effect of Livalo (pitavastatin) 4mg vs. pravastatin 40mg in HIV-infected adults with dyslipidemia following completion of the 40-week safety extension.

INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) was a Phase 4, multicenter, 12-week randomized superiority study that randomized 252 patients to receive once-daily Livalo 4mg or pravastatin 40mg. The study showed significantly greater LDL-C reduction for Livalo 4mg compared to pravastatin 40mg at Week 12. This also included a 40-week safety extension with secondary endpoints that compared the safety and lipid profiles at Week 52.

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At Week 52, safety profiles were maintained and consistent with Week 12 results with an overall incidence of treatment emergent adverse events (TEAEs) of 67.5% for pitavastatin (n=126) and 69.8% for pravastatin (n=126). Further, pitavastatin 4mg sustained more superior LDL-C reductions compared with pravastatin 40mg at Week 52 (-47.8mg/dL vs. -32.6mg/dL, respectively; LS mean % change -8.4, P<0.001).

Separate post-hoc analysis data from the INTREPID study showed that >70% of patients had age as a risk factor and that pitavastatin 4mg showed significantly greater atherogenic lipid reductions vs. pravastatin 40mg in men >45 years old and women >55 years old.

Livalo is an HMG-CoA reductase inhibitor approved as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, and TG, and to increase HDL-C in primary hyperlipidemia and mixed dyslipidemia.

For more information call (877) 854-8256 or visit LivaloRx.com.