Kowa Pharmaceuticals America, Inc. and Eli Lilly and Co. (LLY: Quote) released results from a pharmacokinetic or PK study exploring potential drug interaction between the cholesterol medication pitavastatin or LIVALO 4 mg and the protease inhibitor combination darunavir/ritonavir 800mg/100mg in healthy volunteers.
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, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol.
The company said that the study, presented at the 19th 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. In February 2012, the PK data darunavir/ritonavir were added to the LIVALO label.
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.
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 or TEAEs were mild in severity, and no serious or severe adverse events were reported, Eli Lilly noted.
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by RTT Staff Writer
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