Lovaza

Lovaza is a medication that contains ethyl esters of omega-3-acids, fish oils, and is marketed by GlaxoSmithKline. On November 10, 2004, it became the only prescription fish oil medication. Lovaza is used to reduce very high triglyceride levels in adults. Side effects are generally mild, and drug interactions are unlikely.

History

Lovaza was approved by the Food and Drug Administration (FDA) on November 10, 2004, under the trade name Omacor through Reliant Pharmaceuticals, Inc. In July of 2007, the FDA mandated a drug name change because of the chance that pharmacies may mis-fill Omacor with Amicar, a medication used to treat severe bleeding. Consequently, on August 1, 2007, Omacor was renamed Lovaza. It is now marketed by GlaxoSmithKline.

Uses/Indications

Lovaza is used along with diet to lower very high triglyceride levels in adults with hyperlipidemia (triglyceride levels greater than 500mg/dL). It is only used if other attempts to control triglycerides and cholesterol fail. Lifestyle approaches to controlling cholesterol include the following:

• Weight loss
• Exercise
• Low alcohol use
• Control of medical problems that can cause high triglyceride levels (e.g., diabetes mellitus and hypothyroidism)

How Lovaza Is Taken

Lovaza is available in one gram capsules. The dosage is four capsules taken daily, either all at once or split into two doses of two capsules. Each one gram capsule contains 465 mg of eicosapentaenoic acid (EPA) and 375 mg docosanexaenoic acid (DHA).

How Lovaza Works

Triglycerides are fats, or lipids, that have several functions in the body. They are components of cell membranes and contribute to numerous chemical reactions, such as fat metabolism. However, high triglyceride levels are associated with an increased risk of stroke, heart attack, and cardiovascular diseases such as coronary artery disease. Lovaza reduces the amount of triglycerides in the blood by a mechanism that is not fully understood. The oils in Lovaza may inhibit enzymes in the liver that synthesize triglycerides. They also increase the breakdown of triglycerides.

How the Body Affects Lovaza

The fatty acids in Lovaza are well absorbed into the body. Age does not affect absorption, but absorption tends to be higher in females compared to males. Whether this has any significance to the effectiveness of the drug is not known.

Side Effects

Side effects of treatment with Lovaza are mild and infrequent. Some side effects of Lovaza include the following:

• Belching
• Infection
• Flu-like symptoms
• Upset stomach
• Rash
• Change in the sense of taste
• Back pain

Risks and Precautions

The effect of Lovaza on the fetus is not known. Lovaza is used during pregnancy only if the benefits outweigh the potential risk. Women who are breastfeeding should use caution when taking Lovaza.

To reduce the risk of side effects, especially allergic reactions, Lovaza is not used in people who are allergic to fish oils or any other component of Lovaza. People who have allergies to fish oil should use caution when taking Lovaza.

Drug Interactions

Very few drug interactions with Lovaza are expected. Lovaza can increase the international normalized ratio (a measure of bleeding) when given with blood thinners such as warfarin. Bleeding is carefully monitored when blood thinners and Lovaza are given together.

Research

When used in addition to diet, Lovaza can decrease very high triglyceride levels by 30% to 45%. The effectiveness of Lovaza in combination with the statin simvastatin (Zocor) was studied in patients with high triglyceride levels.^[1] Eight-week treatment with both Lovaza and simvastatin reduced triglyceride levels 30% compared to levels obtained with simvastatin alone. The combination treatment also lowered low-density lipoprotein levels (“bad” cholesterol) by 28%. Placebo treatment in combination with simvastatin reduced triglycerides by 6% and low-density lipoprotein levels by 7.2%.

Sales

Sales of Lovaza were $65.9 million in 2007 and rose to $102.8 million in the first two months of 2008 alone. ^[2] The increase is attributed to GlaxoSmithKline’s takeover of Lovaza and an aggressive marketing campaign.By the end of April 2008, almost 12% of prescriptions for dyslipidemia were for Lovaza.

Alternatives

Gemfibrozil (Lopid) and fenofibrate (Tricor) are also used to treat high triglyceride levels.

References

1. ↑ Davidson MH, Stein EA, Bays HE, et al. Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2007 Jul;29(7):1354-67. Abstract
2. ↑ Douglas J. SmartMoney.com. UPDATE: Pronova Lovaza Gets Sales Boost From GlaxoSmithKline.

External Links

Lovaza website