Abstract:
BACKGROUND:Prescription omega-3-acid ethyl esters (P-OM3) have been used as adjunctive therapy to statin drugs in patients with mixed hyperlipidemia. OBJECTIVE:To assess the effect of concomitant administration of 4 g P-OM3 on the steady-state pharmacokinetics of the maximum recommended daily dose of atorvastatin (80 mg) in healthy volunteers. METHODS:This was a randomized, open-label, repeated-dose, two-way crossover, drug interaction study of two treatments: 4 g of P-OM3 with 80 mg atorvastatin daily or 80 mg atorvastatin daily, each administered for 14 days under fasting conditions to 50 healthy adults. MAIN OUTCOME MEASURES:The primary determinants of drug interaction were the ln-transformed area under the plasma concentration versus time curve (AUCtau) and maximum measured steady-state plasma concentration (C(max,ss)) over the final 24 h dosing interval (day 14) for atorvastatin and 2-hydroxyatorvastatin. Safety assessment included clinical laboratory evaluations and adverse event reporting. RESULTS:The extent and rate of exposure (AUCtau, C(max,ss)) to atorvastatin and its active metabolites following daily administration of P-OM3 with atorvastatin (80 mg) were similar to those following the administration of atorvastatin (80 mg) alone. Both treatments were well tolerated. CONCLUSIONS:After 14 days of dosing, the rate and extent of exposure (AUCtau, C(max,ss)) to atorvastatin and its active metabolites were similar with both treatments, indicating that administration of P-OM3 did not affect the steady-state bioavailability of orally administered atorvastatin.
journal_name
Expert Opin Pharmacotherjournal_title
Expert opinion on pharmacotherapyauthors
Di Spirito M,Morelli G,Doyle RT,Johnson J,McKenney Jdoi
10.1517/14656560802233827subject
Has Abstractpub_date
2008-12-01 00:00:00pages
2939-45issue
17eissn
1465-6566issn
1744-7666journal_volume
9pub_type
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