Omacor, which was renamed Lovaza shortly after its launch, is considered safer than statins. The two types of drugs, while both reducing risk of heart disease, have different compositions, different modes of action and different safety profiles. Lovaza contains omega-3 fatty acids, akin to fish oil, but at a higher concentration and as fatty acid ethyl esters rather than triglycerides. Statins lower blood cholesterol by interfering with cholesterol synthesis in the liver.
Two Histories
Omacor received approval as a prescription drug from the U.S. Food and Drug Administration in 2004. Marketing in the United States under the brand name Lovaza began in the fall of 2005. Product composition did not change. GlaxoSmithKline owns Lovaza and no generic equivalent products are available. Statins refers to a class of drugs with similar chemical structures, all with "-statin" in the generic names. Lovastatin, the first, was approved by the FDA in 1987. As of July 2010, seven statin drugs have been approved for use in the United States, including Lipitor and Zocor.
Two Functions
Omacor/Lovaza consists of highly purified fatty acids extracted from fish oil and packaged in gelatin capsules. Each 1g capsule contains about 465mg of EPA and 375mg of DHA, two omega-3 fatty acids with proven health benefits. Dosing is four capsules per day. Intended use is for people with elevated triglycerides. Triglyceride lowering is on the order of 45 percent, with little change to cholesterol levels. Statin drugs are prescribed for elevated cholesterol. Doses range from 1mg to 80mg, depending on drug and desired effect.
Omacor/Lovaza Safety
As with all drugs, safety questions should be addressed with the prescribing physician. According to the Lovaza website, the most common side effects are burping, upset stomach, increased risk of infection, flu-like symptoms, back pains, skin rash and distortions to sense of taste. Use is cautioned in patients with known allergy to fish. Safety evaluations have not been conducted in children or in women who are pregnant or nursing. In 2009, the FDA required additional warning of potential for anaphylactic reaction or hemorrhagic diathesis, to the list of possible adverse effects. The first refers to severe, life-threatening allergic reaction while the latter refers to increased susceptibility to bleeding.
Statin Safety
As with all drugs, safety questions should be addressed with the prescribing physician. All statins have a similar adverse effects profile. Common symptoms include muscle pain and muscle weakness. The cause, muscle damage, can also result in kidney damage. Estimates for risk of developing muscle pain range from 1 percent to 8 percent. For most, the effect is reversed when the drug is stopped, but if severe, the kidney damage can be permanent and in rare instances result in death. Other serious side effects of statin drugs include liver damage, damage to nerves in arms and legs, and memory loss. Minor side effects include nausea, diarrhea and constipation.
Safety of Combining Omacor/Lovaza with Statins
Patients with elevated cholesterol and triglycerides can benefit from the combination. Given different mechanisms of action, no side effect synergy is expected when the two types of drugs are used together. In other words, each set of side effects might be present, but one does not make the other worse. Dr. Michael Davidson reported on a combination trial in the July 2007 issue of Clinical Therapy that patients already using simvastatin got either Lovaza or placebo for eight weeks. As expected, the Lovaza group had a higher frequency of respiratory tract infections, diarrhea and upset stomach. There was no increase in statin-associated adverse effects. Triglycerides dropped by 29.5 percent.
