J Clin Pharmacol
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DRUG INTERACTIONS

Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters

J. M. McKenney, PharmD, D. Swearingen, MD, M. Di Spirito, MSc, R. Doyle, C. Pantaleon, D. Kling and R. A. Shalwitz, MD

From National Clinical Research Inc, Richmond, Virginia (Dr McKenney); MDS Pharma Services, Phoenix, Arizona (Dr Swearingen); MDS Pharma Services, Saint-Laurent (Montreal), Quebec, Canada (Mr Di Spirito); and Reliant Pharmaceuticals Inc, Liberty Corner, New Jersey (Mr Doyle, Ms Pantaleon, Mr Kling, Dr Shalwitz).

The coadministration of prescription omega-3-acid ethyl esters (P-OM3) with a statin may present a treatment option for patients with mixed hyperlipidemia. This open-label, randomized, 2-way crossover, drug-drug interaction study evaluated the impact of P-OM3 capsules on plasma simvastatin pharmacokinetics in 24 healthy volunteers. Under fasted conditions, 80 mg simvastatin was administered with or without 4 g P-OM3 for two 14-day periods. After 14 days of dosing to achieve steady state, no significant differences were found in either the extent (AUC{tau}) or rate (Cmax) of exposure to simvastatin or its major ß-hydroxy metabolite after coadministration of P-OM3 with simvastatin compared with administration of simvastatin alone. At steady state, the coadministration of P-OM3 capsules did not appear to affect the pharmacokinetics of simvastatin tablets. The combination of P-OM3 capsules and simvastatin appeared to be well tolerated.

Key Words: Omega-3 fatty acids • omega-3-acid ethyl esters • P-OM3 • statins • hyperlipidemia • hypertriglyceridemia

Address for reprints: Ralph Doyle; Reliant Pharmaceuticals Inc, 110 Allen Road, Liberty Corner, NJ 07938.






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