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FDA’s Ongoing Safety Review Shows No Link Between Ezetimibe/Simvastatin, Cancer Risk ROCKVILLE, Md -- December 23, 2009 -- In August 2008, the US Food and Drug Administration (FDA) issued an Early Communication describing a possible association between the use of the combination tablet ezetimibe/simvastatin (Vytorin) and an increased risk of cancer and cancer-related death compared with placebo. The Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial. The FDA has now completed its review of the data from the SEAS trial as well as a review of interim data from 2 large-scale ongoing cardiovascular trials with ezetimibe/simvastatin - the Study of Heart and Renal Protection (SHARP) and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT). Based on the currently available information, the FDA believes it is unlikely that ezetimibe/simvastatin increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out. The FDA is not advising healthcare professionals or consumers to stop using these medications, but to continue to evaluate the clinical benefits and potential risks of ezetimibe/simvastatin compared with other FDA-approved cholesterol lowering medications. The FDA weighed the following factors when evaluating the association between use of ezetimibe/simvastatin and cancer development: · Preclinical studies did not find that ezetimibe was associated with an increased incidence of cancer. · A large body of long-term clinical data indicates that simvastatin is not associated with an increased risk of cancer, but long-term clinical data on ezetimibe is insufficient to definitely rule out a cancer risk at this time. · Risk of cancer in the SEAS trial did not increase consistently over time with longer use of ezetimibe/simvastatin, as would be expected if a drug caused cancer or promoted the growth of pre-existing cancers. · The reported increase in cancer and cancer-related deaths in the SEAS trial was the result of combining a wide variety of cancer types together. It is biologically less likely that a single drug increases the risk of a wide variety of cancer types. · When the cancer findings from the SEAS trial were compared with those from the SHARP and IMPROVE-IT trials, there was no consistent pattern of increased cancer risk among those being treated with ezetimibe/simvastatin. · The SEAS trial was not designed to evaluate cancer risk and the analysis of the cancer findings was not pre-specified, but rather was performed after the fact and without statistical correction to account for multiple comparisons. Therefore, the true statistical significance of the cancer imbalance is unknown. The SEAS trial consisted of 1,873 patients with aortic stenosis who were given ezetimibe 10 mg plus simvastatin 40 mg (or 10/40 mg) or placebo and followed for 4 years to determine if lowering LDL-cholesterol with ezetimibe/simvastatin would reduce the number of major cardiovascular adverse events. A lower overall cardiovascular risk was not found with ezetimibe/simvastatin. During the trial, investigators reported an increased number of cancers and cancer-related deaths in patients using ezetimibe/simvastatin compared with placebo. Cancer was reported in 105 patients (11.1%) in the ezetimibe/simvastatin group and in 70 patients (7.5%) in the placebo group. The number of deaths from cancer was also higher in the ezetimibe/simvastatin group, with 39 deaths compared with 23 deaths in the placebo group. The SHARP trial is placebo-controlled, but uses a lower dose of ezetimibe/simvastatin (10/20 mg) than was used in the SEAS trial. The IMPROVE-IT trial compares ezetimibe/simvastatin 10/40 mg with simvastatin 40 mg. An interim analysis of the cancer data from these 2 trials, which includes a total of 20,617 patients, did not show an increased risk of cancer with ezetimibe/simvastatin. There was an increase in the number of cancer-related deaths, with 97 deaths in the ezetimibe/simvastatin groups compared with 72 deaths in the control groups, but this finding was not statistically significant. When completed, the SHARP and IMPROVE-IT trials will provide additional data to further assess cancer risk with simvastatin and ezetimibe. The SHARP trial is expected to be completed in 2010 and IMPROVE-IT in 2012. The FDA urges both healthcare professionals and consumers to report side effects from the use of ezetimibe and simvastatin to FDA’s MedWatch Adverse Event Reporting program: 1-800-332-1088 1-800-FDA-0178 Fax MedWatch Online Regular Mail: Use postage-paid FDA Form 3500 Mail to: MedWatch 5600 Fishers Lane Rockville, MD 20852-9787 SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version