18 June 2013 - 18 June 2013 - Kowa Pharmaceuticals America Inc and US Eli Lilly and Co (NYSE:LLY) said Monday a pre-specified safety analysis from a Phase IV study had shown that Livalo (pitavastatin) 4 mg had neutral effects on fasting serum glucose (FSG) and HbA1c levels in HIV-infected adults with dyslipidemia.

The multi-centre, 12-week randomised, double-blind, double-dummy, active-controlled, parallel-group superiority trial, called INTREPID, compared once-daily pitavastatin 4 mg with pravastatin 40 mg in 252 HIV-infected adults with dyslipidemia. The study was followed by a 40-week safety extension trial examining the lipid-lowering effects of the drug and comparator in the above-mentioned indication.

The safety analysis demonstrated that by week 12, the mean change in FSG for pitavastatin (n=109) was -0.1mg/dL and pravastatin (n=112) was 0.6 mg/dL, while the adjusted change in FSG was 0.6 mg/dL for pitavastatin and 2.5 mg/dL for pravastatin with no significant differences in each treatment group (p=0.68 and 0.09, respectively).

The mean change in HbA1c was -0.02% for pitavastatin (n=110) and -0.01% for pravastatin (n=113), while the adjusted change in HbA1c was 0.04% for pitavastatin and 0.05% for pravastatin with no significant differences in each treatment group (p=0.27 and 0.09, respectively).

Kowa Pharmaceuticals America is part of Japanese Kowa Co Ltd.