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BOSTON, June 21, 2016 /PRNewswire/ -- Kowa Pharmaceuticals America, Inc. today announced the presentation of new data from the INTREPID (HIV PatieNts and TREatment with Pitavastatin versus PravastatIn for Dyslipidemia) trial, showing pitavastatin significantly lowered key arterial inflammation and immune activation markers in HIV patients on chronic antiretroviral therapy (ART) compared to pravastatin, a commonly prescribed statin for HIV-infected patients with dyslipidemia. Combined with previously reported INTREPID data demonstrating superior LDL-C reduction with pitavastatin versus pravastatin (-31% vs. -21%, respectively), results suggest pitavastatin may be an ideal statin to optimally improve lipids and inflammatory markers in HIV patients.

Data were presented at the American Society for Microbiology (ASM) Microbe 2016 conference in Boston on June 20.

"Advances in medicine have dramatically reduced mortality in HIV patients – now, our challenge is to ensure these millions of patients live longer, healthier lives, and do not succumb to cardiovascular risk factors even as they survive their HIV," said Steven Grinspoon, MD, a co-author of the study and Professor of Medicine, Harvard Medical School, MGH Endowed Chair in Neuroendocrinology and Metabolism and Director of the Nutrition Obesity Research Center at Harvard. "HIV-infected patients are at increased risk of developing dyslipidemia and coronary heart disease, but commonly prescribed medications can pose a risk of drug interactions with their needed antiretroviral regimens. These new data from INTREPID over 52 weeks of study show that not only is pitavastatin safe for these patients, with no known significant interactions with antiretrovirals, it results in more significant reductions than pravastatin in key arterial inflammation markers, immune activation markers, and LDL-C – suggesting pitavastatin may be an ideal statin therapy for HIV-infected patients."

INTREPID was a randomized, double-blind, double-dummy, active-controlled, parallel-group, superiority trial conducted at 45 sites in the United States and Puerto Rico. Participants included 252 HIV-infected males and females on ART for more than six months. Select inflammatory and immune activation biomarkers were assessed at baseline, Week 12, and Week 52.

• Participants were randomized 1:1 to receive pitavastatin 4mg once daily and a matching pravastatin placebo vs. pravastatin 40mg once daily and a matching pitavastatin placebo.
  • Baseline demographics including gender, total cholesterol, log HIV RNA, CHD risk score, nor baseline levels of inflammatory markers were not different between the treatment groups.

• At Week 52, participants randomized to pitavastatin demonstrated significantly greater reductions in sCD14 (-8.2% vs. 0.6%; P=0.007), oxLDL (-26.6% vs. -17.6%; P=0.02) and Lp-PLA2 (-25.0% vs. -14.9%; P=0.003), compared to participants randomized to pravastatin.
  • Changes in other markers were similar between the groups at 52 weeks.
  • Superior LDL-C reductions were seen in the pitavastatin group (-31% vs. -21% pitavastatin vs. pravastatin).
  • Adverse event profiles and overall safety were maintained and remained similar for both pitavastatin 4 mg and pravastatin 40 mg.

"Managing blood cholesterol and cardiovascular risk in HIV-infected patients with dyslipidemia can be very challenging – patients are at greater risk for cardiovascular disease due to the virus itself, high inflammatory burden and the complex HAART drug regimens," said Craig Sponseller, MD, Chief Medical Officer, Kowa Pharmaceuticals America, Inc.  "Not all statins are the same, and these data – demonstrating superior LDL-C reduction, significantly greater reductions in markers of inflammation and immune activation, and a reduced potential for certain drug interactions – represent critically important clinical information that can help guide treatment decisions for lipid management in this population."

For additional information please see the full Prescribing Information.

© Kowa Pharmaceuticals America, Inc. – GEN-1208 6/2016

Chuck Hrushka
Kowa Pharmaceuticals America, Inc.
chrushka@kowapharma.com

Eliza Oristano
Makovsky for Kowa Pharmaceuticals America, Inc.
Office (212) 508-9631
eoristano@makovsky.com

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SOURCE Kowa Pharmaceuticals America, Inc.