New Data Demonstrates Minimal Interactions Between Omacor(R) (Omega-3-Acid Ethyl Esters) And Simvastatin
Reliant Pharmaceuticalstoday announced the publication of new data in the July edition of theJournal of medical institution al Pharmacology finding the co-direction of Omacor(omega-3-acid ethyl esters) with simvastatin has minimal interactionbetween the two medicate s. Omacor (4 g) plus simvastatin (80 mg) did notsignificantly affect the steady-state pharmacokinetics of simvastatin andwas well-tolerated in healthy patients.(1)
Omacor is the first and only Food and Drug Administration (Food and Drug Administration)-approved omega-3 fatty acid. Omacor was approved by the Food and Drug Administration in November 2004 as an adjunct to diet to reduce very high triglyceride levels(greater than or equal to 500 mg/dL) in adult patients.(2) At that time,Reliant Pharmaceuticals also received an Food and Drug Administration New Drug Application (NDA)approvable letter for Omacor in combination with a statin to treat hightriglyceride levels (200-499 mg/dL) in adult patients. To gain finalacceptance , Reliant is conducting a clinical trial to evaluate the efficacyand safety of Omacor as adjunctive medical aid to simvastatin for the medical aidof high triglycerides.(3)
“Many Americans who receive statin medical aid continue to have elevatedtriglycerides. It’s important to evaluate the safety and efficacy of Omacoras adjunctive medical aid in these patients,” said Robert Shalwitz, MD, VicePresident of medical institution al Development, Reliant Pharmaceuticals. “ReliantPharmaceuticals is committed to patient safety and ongoing research for theeffective use of Omacor.”
About the Study
The open-label, randomized, 2-way crossover, medicate -medicate interactionmeditate evaluated the impact of Omacor capsules on plasma simvastatinpharmacokinetics in 24 healthy patients. Patients were given 4 g of Omacorco-administered with 80 mg of simvastatin or 80 mg of simvastatin alone.(4)The primary pharmacokinetic end points for the determination of medicate interaction were AUC (area under the plasma concentration-time curve overthe final 0-24 h.dosing interval) and C(max) (maximum plasmaconcentration over the final dosing interval) on day 14.(5)
After 14 days of dosing, both the extent and rate of exposure tosimvastatin and its major active metabolite, beta-hydroxy simvastatin, weresimilar after co-direction of Omacor and simvastatin compared withdirection of simvastatin alone. Additionally, after single-dosedirection, rates of exposure (C(max)) following either medical aid weresimilar for both simvastatin and its beta-hydroxy metabolite. With singledosing, the AUC of simvastatin, but not that of its beta-hydroxymetabolite, increased (by 19percent for AUC(0-t) and 24percent for AUC(inf)) whenOmacor and simvastatin were co-administered.(6)
Important Information About Omacor
— Omacor is used along with diet to reduce very high triglycerides in adult patients. Before taking Omacor your healthcare provider should help you try to control your high triglyceride level by:
— Exercising and losing weight if you are overweight.
— Decreasing alcohol use.
— Controlling medical problems that can cause high triglyceride levels (such as polygenic disease mellitus and hypothyroidism).
— Stopping or changing medicines that can increase triglyceride levels (such as estrogens, thiazide diuretics, beta blockers).
— Omacor should be used with caution in group allergic to fish. Pharmacomedical aid to reduce very high triglyceride levels may result in elevations in LDL-C and non-HDL-C in some individuals. The effect of Omacor on cardiovascular morbidity and mortality in patients with very high triglyceride levels has not been determined.
— Tell your healthcare provider about all your medical conditions, including if you have liver problems, are pregnant, are trying to become pregnant or are breast-feeding. Tell your healthcare provider if you take blood thinners. If you take both Omacor and a blood thinner, your healthcare provider should check you occasionally to see if an effect has occurred.
— Some possible side effects of Omacor include belching, infection, flu syndromes, upset stomach, rash and change in your sense of taste. This is not a complete list Omacor side effects.
— For more detailed information about Omacor, ask your healthcare provider or go to http://www.omacorrx.com.
About Reliant Pharmaceuticals
Reliant Pharmaceuticals is a pharmaceutical company with integratedsales, marketing and development expertise that markets a portfolio ofbranded cardiovascular pharmaceutical products. Reliant focuses onmarketing promotionally sensitive pharmaceutical products to the highprescribing primary care, cardiovascular and specialist physician marketsin the United States. Reliant also acquires rights to and develops productcandidates in mid- to late-stage clinical development. Reliant’s salesforce infrastructure is comprised of approximately 850 sales professionalsnationwide.
“Safe Harbor” statement under the Private Securities Litigation ReformAct of 1995. To the extent any statements made in this release containinformation that is not historical, these statements are essentiallyforward looking and are subject to risks and uncertainties, including thedifficulty of predicting Food and Drug Administration acceptance s, acceptance and demand for newpharmaceutical products, the impact of competitive products and pricing,new product development and launch, reliance on key strategic alliances,availability of raw materials, the regulatory environment, fluctuations inoperating results and otherness risks detailed from time to time in thecompany’s filings with the Securities and Exchange Commission.
References:
(1) McKenney J, Swearingen D, Di Spirito M, Doyle R, Pantaleon C, Kling D, Shalwitz R. Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters. J Clin Pharmacol. 2006; 46:785-791.
(2) OMACOR Prescribing Information, Liberty Corner, NJ: Reliant Pharmaceuticals, Inc.; 2005.
(3) Data on file. Reliant Pharmaceuticals, Inc.
(4) McKenney J, Swearingen D, Di Spirito M, Doyle R, Pantaleon C, Kling D, Shalwitz R. Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters. J Clin Pharmacol. 2006; 46:785-791.
(5) Ibid
(6) Ibid
Reliant Pharmaceuticals
http://www.omacorrx.com