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Reliant Pharmaceuticals, Liberty Corner, N.J., recently launched Omacor, an omega-3-acid ethyl esters product approved by the Food & Drug Administration in November 2004.
Said Ernest Mario, Ph.D., Reliant chairman and CEO, "Only Omacor delivers the triglyceride-lowering benefits of omega-3 fatty acids as a pure, clinically proven, and FDA-approved prescription drug."
"Being FDA-approved will provide some assurance that capsule quantity and quality are consistent," said Judy Cheng, Pharm.D., FCCP, BCPS, associate professor of pharmacy practice at Long Island University. "Also, a purified form will better ensure that environmental pollutants such as mercury, which may be in some fish products, will not get into this product."
"Fish oils have side effects, and some may be of concern to patients with hypertriglyceridemia," Cheng said. The most commonly seen adverse effects with Omacor are burping, flu syndrome, upset stomach, back pain, rash, and taste perversion.
Cheng added that clinical bleeding, a rise in low-density lipoprotein cholesterol (LDL-C), and worsening glucose control in patients with impaired glucose tolerance and diabetes are other concerns. Patients receiving concomitant therapy with anticoagulants should also be monitored periodically.
Omacor (4 gm/day, with meals), in two randomized, placebo-controlled clinical studies involving 84 patients, reduced TG levels by a median of 45% (p<0.0001). The recommended dosage is 4 gm daily- as a single 4-gm dose or as 2 gm taken twice daily.
There is no current study available examining the additive effect of fish oil with other antihyperlipidemic agents (e.g., fibric acid or niacin) used to lower TG levels. Cheng believes omega-3s will likely be used for TG management in patients who cannot tolerate any other therapy.
Periodic monitoring of serum TG, LDL-C, and alanine aminotransferase levels are recommended by the manufacturer. Prolonged bleeding times have been seen in some studies with omega-3s, but did not exceed normal limits and did not produce clinically significant bleeding episodes. If the drug does not elicit an adequate response after two months of therapy, it should be discontinued.
FDA and the American Heart Association recommend that patients taking higher doses of omega-3 fatty acid products (> 2 or 3 gm per day) for the treatment of very high TG levels be under a physician's care. Omacor is available in pharmacies at a suggested wholesale price of $70.50 for a bottle of 60 1-gm capsules.
"Omega-3 fatty acids are not yet recommended as a first-line of treatment for high TG," said Cheng. Limited data make it difficult to determine the right individual dose, but "having a purified form may now promote a dose/response study and eventually lead to dosing guidelines" for omega-3s.