And yet another drug has now been added to the list of worrisome drugs. But, which one is it this time?
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.
But wait a second- isn’t high cholesterol linked to heart trouble?! So, now they are saying a drug meant to help decrease heart risks, now increases them. My goodness.
The new Drug Safety Communication states, “The U.S. Food and Drug Administration (FDA) is informing the public that the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient’s risk of having a heart attack or stroke. This is based on data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial, which evaluated the efficacy and safety of fenofibrate plus simvastatin combination therapy versus simvastatin alone in patients with type 2 diabetes mellitus. FDA reviewed this trial as part of its ongoing investigation of the safety and efficacy of Trilipix.”
The warning was issued 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.
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 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.
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.
According to the report, in the ACCORD Lipid trial, there was no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone. In addition, a subgroup analysis showed that relative to treatment in men, there was an increase in the risk for major adverse cardiac events in women receiving the combination therapy versus simvastatin alone. The clinical significance of this subgroup finding is unclear, as this finding was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo.
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.
Based on results from the ACCORD Lipid trial and other clinical trials of drugs similar to Trilipix, FDA is requiring the manufacturer of Trilipix to conduct a clinical trial to evaluate the cardiovascular effects of Trilipix in patients at high risk for cardiovascular disease who are already taking statins.