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


METHODS
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.
Gosai
Pritti
P
Virginia Commonwealth University, 2809 Emerywood Parkway, Suite 140, Richmond, VA 23294, USA.
Liu
Jianhua
J
Doyle
Ralph T
RT
Johnson
Judith
J
Carter
Roderick
R
Sica
Domenic
D
McKenney
James M
JM
D000328:Adult; D015525:Fatty Acids, Omega-3 / Q000494:pharmacology*; D005260:Female; D005464:Fluorobenzenes / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics*; D006262:Health; D006801:Humans; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood* / Q000493:pharmacokinetics*; D013997:Time Factors
D015525:Fatty Acids, Omega-3; D005464:Fluorobenzenes; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium