Cholesterol Drug Trilipix May Not Prevent Heart Attacks, Strokes, FDA Warns

According to new warnings from federal health regulators, the cholesterol drug Trilipix may not actually reduce the risk of heart attack or stroke, and may actually increase the risk of heart problems among women. 

The FDA issued a Trilipix drug safety communication on November 9, indicating that clinical trials have raised doubts about the effectiveness of the drug, and introduced new questions about the potential risk of Trilipix side effects.

Abbott Laboratories, which manufactures the medication, is being required to conduct new clinical trials to measure Trilipix heart effects for patients at high risk of cardiovascular disease, according to the agency.

The announcement came after the FDA analyzed data from a clinical trial known as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The trial compared the safety and efficacy of Trilipix plus Zocor therapy against taking Zocor alone.

The findings of that trial appear to indicate that Trilipix does not decrease the rate of heart attack or stroke on its own, according to the FDA. Also, when compared to men, women appeared to suffer an increased rate of cardiovascular events while on Trilipix.

Trilipix (fenofibric acid) is an Abbott Laboratories drug approved by the FDA in December 2008. It is supposed to work by lowering “bad” cholesterol and increasing “good” cholesterol. It is often used in combination with cholesterol-lowering drugs like Zocor, known as statins. The drug is also approved to lower high levels of triglycerides in the blood to help reduce the risk of pancreatitis.

The FDA is warning patients that the drug has not been shown to lower the risk of heart attack or stroke, and said patients should consult with their primary healthcare provider about the benefits and risks of taking Trilipix.

Zocor (simvastatin) is a synthetic statin developed by Merck & Co., which is widely available as generic simvastatin from a number of different drug makers, including Dr. Reddy’s. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005.

In June, the FDA placed restrictions on the use of 80 mg Zocor, which could include twice-a-day 40mg doses, due to the risk of myopathy and rhabdomyolysis, a potentially life-threatening muscle injury.

Rhabdomyolysis from Zocor causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.