Kowa-Eli Lilly PK study finds no clinically significant drug interactions

22nd July 2012 (Last Updated July 22nd, 2012 18:30)

Kowa Pharmaceuticals America and Eli Lilly and Company have reported pharmacokinetic (PK) study results evaluating interactions between Livalo (pitavastatin) and protease inhibitor combination (darunavir/ritonavir) in healthy volunteers.

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Kowa Pharmaceuticals America and Eli Lilly and Company have reported pharmacokinetic (PK) study results evaluating interactions between Livalo (pitavastatin) and protease inhibitor combination (darunavir/ritonavir) in healthy volunteers.

The PK study investigated potential drug interaction between the cholesterol medication pitavastatin (Livalo) 4mg and the protease inhibitor (PI) combination darunavir/ritonavir (Prezista/Norvir) 800mg/100mg.

The study, in which 28 healthy adult volunteers were co-administered with pitavastatin and darunavir/ritonavir over a 16-day period, showed no clinically significant change in blood levels for pitavastatin or protease inhibitor combination darunavir/ritonavir .

Kowa Pharmaceuticals America medical affairs vice president Dr Craig Sponseller said, "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."

When co-administered with darunavir/ritonavir, pitavastatin peak exposure, as measured by Cmax, decreased by 4%, while total exposure of pitavastatin, as measured by AUC0-t, decreased by approximately 26%.

When co-administered with pitavastatin, the Cmax and AUC0-t of darunavir increased by 6% and 3% respectively, and the Cmax and AUC0-t of ritonavir increased by 2% and 8%, respectively, the study reported.

"The majority of treatment emergent adverse events (TEAEs) were mild in severity, and no serious or severe adverse events were reported."

The evaluation of the safety of pitavastatin and darunavir/ritonavir when each treatment was given alone or in combination was the secondary objective of the study.

According to the company, the majority of treatment emergent adverse events (TEAEs) were mild in severity, and no serious or severe adverse events were reported.

Livalo, a HMG-CoA reductase inhibitor, is indicated for patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides, and to increase high-density lipoprotein cholesterol.


Image: Eli Lilly's headquarters in Indianapolis, Indiana, US. Photo: Guanaco152003.