- Journal of Clinical Lipidology publishes largest study comparing cancer risk of ezetimibe and ezetimibe/simvastatin to statin therapies using FDA database -
BOSTON, March 25 /PRNewswire-USNewswire/ -- A new study shows no increased cancer risk with ezetimibe mono and ezetimibe/simvastatin combination treatments, compared to cancer rates of other powerful lipid-lowering statin therapies. The study, conducted by Tufts Medical Center lipid and health policy experts, was published in the April issue of the Journal of Clinical Lipidology (www.lipidjournal.com).
"This real-world examination shows no increased risk to patients taking ezetimibe alone or the ezetimibe/simvastatin combination to lower their lipid levels -- an issue that sparked many policy and health safety conversations," said lipidologist Richard Karas, MD, PhD, Professor of Medicine, Tufts University School of Medicine and Associate Director, Molecular Cardiology Research Institute, Tufts Medical Center, who co-authored the study along with Tufts Medical Center colleague, Alawi A. Alsheikh-Ali, MD, Institute for Clinical Research and Health Policy Studies.
Researchers at Tufts Medical Center and Tufts University School of Medicine studied rates of reports of cancer as an adverse event filed with the U.S. Food and Drug and Administration (FDA) for patients taking ezetimibe or ezetimibe/simvastatin compared to patients on mono-therapy with simvastatin, atorvastatin or rosuvastatin, during a four-year period. This is the first study to use the FDA database to evaluate potential cancer risk of cholesterol-lowering medications.
The Tufts researchers found 2,334 cases of cancers reported in the total population studied. Cancer rates were analyzed accounting for the number of prescriptions for each treatment dispensed across the country, based on a total of 559 million prescriptions for all of the cholesterol-lowering medications evaluated. The analysis found cancer reported in 2.9 per million prescriptions for ezetimibe, 1.3 per million prescriptions for ezetimibe/simvastatin therapy and an average of 4.1 per million prescriptions for other lipid lowering treatment. These rates demonstrate no increase in cancer for ezetimibe and ezetimibe/simvastatin regimen versus the other treatments studied.
"These data will hopefully return the conversation between physicians and patients back toward the most pressing public health risk in America -- unmanaged high LDL that can result in heart disease or stroke -- the nation's number one and number three killers," continued Dr. Karas.
This research, which explored three times more cancers than analyzed by Sir Richard Peto from the SEAS, SHARP and IMPROVE-IT studies published in the New England Journal of Medicine, September 2, 2008, is consistent with Peto's final report supporting no credible evidence that ezetimibe or ezetimibe/simvastatin increase the risk of developing cancer.
Funding Sources and Disclosures
No specific corporate funding was requested or obtained for data collection, analysis and publication of these findings. Dr. Karas has received speaker's fees and/or consulting fees from Merck, Abbott, and Schering-Plough. Dr. Alsheikh-Ali is a recipient of a faculty development award from Pfizer/Tufts Medical Center.
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