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news.Reliant Pharmaceuticals has reported good news in the form of new data demonstrating that the co-administration of Omacor and simvastatin shows minimal interaction between the two drugs.
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The open-label, randomized, two-way crossover, drug-drug interaction study evaluated the impact of Omacor (omega-3-acid ethyl esters) capsules on plasma simvastatin pharmacokinetics in 24 healthy patients. Patients were given 4g of Omacor co-administered with 80mg of simvastatin (which is marketed under the brand name Zocor by Merck & Co) or 80mg of simvastatin alone.
The primary pharmacokinetic end points for the determination of drug interaction were AUC (area under the plasma concentration-time curve over the final 0 to 24 hour dosing interval) and Cmax (maximum plasma concentration over the final dosing interval) on day 14.
The study, results of which were results published in the Journal of Clinical Pharmacology, found that Omacor plus simvastatin did not significantly affect the steady-state pharmacokinetics of simvastatin and was well-tolerated in healthy patients.
After 14 days of dosing, both the extent and rate of exposure to simvastatin and its major active metabolite, beta-hydroxy simvastatin, were similar after co-administration of Omacor and simvastatin compared with administration of simvastatin alone. Additionally, after single-dose administration, rates of exposure (Cmax) following either treatment were similar for both simvastatin and its beta-hydroxy metabolite.
With single dosing, the AUC of simvastatin, but not that of its beta-hydroxy metabolite, increased when Omacor and simvastatin were co-administered.
Omacor is the first and only FDA-approved omega-3 fatty acid. It was approved by the FDA in November 2004 as an adjunct to diet to reduce very high triglyceride levels (greater than or equal to 500mg/dL) in adult patients. At that time, Reliant also received an FDA new drug application (NDA) approvable letter for Omacor in combination with a statin to treat high triglyceride levels (200mg/dL to 499mg/dL) in adult patients. To gain final approval, Reliant is conducting a clinical trial to evaluate the efficacy and safety of Omacor as adjunctive therapy to simvastatin for the treatment of high triglycerides.
“Many Americans who receive statin therapy continue to have elevated triglycerides. It’s important to evaluate the safety and efficacy of Omacor as adjunctive therapy in these patients,” said Dr Robert Shalwitz, vice president of clinical development at Reliant.