Kowa, Eli Lilly report results of pre-specified safety analysis of INTREPID trial

18th June 2013 (Last Updated June 18th, 2013 18:30)

Kowa Pharmaceuticals America and Eli Lilly and Company have reported results of the pre-specified safety analysis from the INTREPID trial, a phase IV study designed to evaluate Livalo (pitavastatin) 4mg against pravastatin 40mg in HIV-infected patients with dyslipidemia.

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Kowa Pharmaceuticals America and Eli Lilly and Company have reported results of the pre-specified safety analysis from the INTREPID trial, a phase IV study designed to evaluate Livalo (pitavastatin) 4mg against pravastatin 40mg in HIV-infected patients with dyslipidemia.

The new data showed that pitavastatin 4mg demonstrated neutral effects on fasting serum glucose (FSG) and levels of blood glucose and glycated haemoglobin (HbA1c) levels over 12 weeks.

Kowa Pharmaceuticals America medical affairs vice president Dr. Craig Sponseller said: "We are pleased with the results of this safety analysis that showed neutrality for the maximum dose of pitavastatin 4mg on parameters of glucose metabolism, which are consistent with our previous findings in non-HIV-infected adult populations with dyslipidemia."

The multicentre, 12-week randomised superiority study trial compared the efficacy of Livalo 4mg with pravastatin 40mg on changes in HbA1c levels in adults with HIV infection and dyslipidemia.

A 40-week safety extension study following the INTREPID trial compared the efficacy of both the study candidates in lowering lipid levels in the same patient group.

"The multicentre, 12-week randomised superiority study trial compared the efficacy of Livalo 4mg with pravastatin 40mg."

At week 12, the INTREPID trial observed the mean change of -0.1mg/dL in FSG, 0.6mg/dL adjusted change in FSG for pitavastatin against 0.6mg/dL the mean change in FSG and 2.5mg/dL adjusted change for pravastatin.

According to the data, -0.02% of mean change in HbA1c and 0.04% adjusted change in HbA1c was observed for pitavastatin against -0.01% of mean change in HbA1c and 0.05% adjusted change for pravastatin.

With no significant difference between treatment groups, the pitavastatin group demonstrated considerably higher decrease in LDL-C over 12 weeks, compared with pravastatin group.

The primary endpoint of mean percent change was -31.1% and -20.9%, while mean change in LDL-C was -49.4 mg/dL and -33.6 mg/dL for pitavastatin 4mg and pravastatin 40mg respectively.

Bellevue Hospital Center virology director, NYU School of Medicine division of infectious diseases and immunology director, study investigator Dr. Judith Aberg said: "Based on treatment guidelines, statins are often the first line treatment for the management of dyslipidemia when therapeutic lifestyle changes are not effective in HIV-infected patients."


Image: Safety analysis of the Kowa-Eli Lilly study showed neutrality for maximum dose of pitavastatin 4mg on parameters of glucose metabolism. Photo courtesy of Guanaco152003.