Pharmacokinetic Study Results Released Evaluating Interactions Between LIVALO® (pitavastatin) And Protease Inhibitor Combination (darunavir/ritonavir) In Healthy Volunteers

WASHINGTON, July 22, 2012 /PRNewswire/ -- Kowa Pharmaceuticals America, Inc. (Kowa Pharmaceuticals) and Eli Lilly and Company (Lilly) (NYSE: LLY) today released results from a pharmacokinetic (PK) study exploring potential drug interaction between the cholesterol medication pitavastatin (LIVALO) 4 mg and the protease inhibitor (PI) combination darunavir/ritonavir (Prezista ^®/Norvir ^®) 800mg/100mg in healthy volunteers. ¹ The study, presented at the 19 ^th International AIDS Conference in Washington, DC, found that when co-administered, the blood levels for LIVALO and each of the PIs were not significantly affected. ¹   In February 2012, the PK data darunavir/ritonavir were added to the LIVALO label.

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"Examining drug interactions has been an ongoing part of product development, and  we are pleased that results show no clinically significant drug interaction between pitavastatin and the protease inhibitor combination darunavir/ritonavir," said Dr. Craig Sponseller, Vice President of Medical Affairs, Kowa Pharmaceuticals America, Inc.

The current study was designed to assess the changes in pharmacokinetic parameters when pitavastatin 4 mg and darunavir/ritonavir 800mg/100mg were administered alone or in combination.  Pitavastatin and darunavir/ritonavir were co-administered in 28 healthy, adult volunteers over a 16-day period.  When co-administered with darunavir/ritonavir, pitavastatin peak exposure, as measured by C _max, decreased by 4%, while total exposure of pitavastatin, as measured by AUC _0-τ, decreased by approximately 26%. When co-administered with pitavastatin, the C _max and AUC _0-τ of darunavir increased by 6% and 3% respectively, and the C _max and AUC _0-τ of ritonavir increased by 2% and 8%, respectively. These effects were not considered to be clinically significant. ^1,2

A secondary objective of the study was to investigate the safety of pitavastatin and darunavir/ritonavir when each treatment was given alone or in combination. The majority of treatment emergent adverse events (TEAEs) were mild in severity, and no serious or severe adverse events were reported. Nineteen of 28 patients reported at least one TEAE, of which 10 were from the darunavir/ritonavir only group; 7 from the pitavastatin and darunavir/ritonavir group; 2 from the pitavastatin only group. ¹

For TEAEs occurring in >/= 2 subjects in any treatment group, the most frequently reported drug-related TEAEs were diarrhea (7.1% darunavir/ritonavir only group; 7.4% pitavastatin and darunavir/ritonavir; 3.6% pitavastatin only), headache, (10.7% darunavir/ritonavir only group; 0% pitavastatin and darunavir/ritonavir; 0% from the pitavastatin only group) and myalgia (7.1% darunavir/ritonavir only; 3.7% pitavastatin and darunavir/ritonavir group; 3.6% pitavastatin only). One subject was discontinued from the study due to maculopapular rash during treatment with darunavir/ritonavir only. ¹

About LIVALO

LIVALO is a HMG-CoA reductase inhibitor indicated for patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). 

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