Effect of omega-3-acid ethyl esters on the steady-state plasma pharmacokinetics of rosuvastatin in healthy adults.

Author(s): Gosai P, Liu J, Doyle RT, Johnson J, Carter R, Sica D, McKenney JM

Affiliation(s): Virginia Commonwealth University, 2809 Emerywood Parkway, Suite 140, Richmond, VA 23294, USA.

Publication date & source: 2008-12, Expert Opin Pharmacother., 9(17):2947-53.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Patients with persistent hypertriglyceridemia while on statin therapy may require adjunctive lipid-lowering therapy to meet treatment goals. OBJECTIVE: To assess the effect of concomitant administration of prescription omega-3-acid ethyl esters (P-OM3), triglyceride-lowering agents, on the steady-state pharmacokinetics of rosuvastatin. METHODS: A randomized, open-label, repeated-dose, two-way crossover drug interaction study of two treatments - 4 g P-OM3 plus 40 mg rosuvastatin or 40 mg rosuvastatin alone administered daily for 14 days each under fasting conditions--was conducted in 48 non-smoking healthy adults. Main outcome measures: The primary determinants of drug interaction were the ln-transformed area under the plasma concentration versus time curve [AUC(t(ss))] over the final (day 14) 24 h dosing interval and maximum measured steady-state plasma rosuvastatin concentration [C(max(ss))] on day 14. Safety was assessed by clinical and laboratory testing and recording of adverse events. RESULTS: AUC(t(ss)) and C(max(ss)) following daily administration of rosuvastatin with P-OM3 were similar to those following monotherapy with rosuvastatin. All adverse events recorded during the study were classified as mild and self-limited. CONCLUSIONS: Administration of P-OM3 with rosuvastatin did not affect the pharmacokinetics of rosuvastatin under steady-state conditions in healthy individuals.