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FDA: LDL-lowering drug may be linked to cancer risk
The FDA alerted healthcare professionals of the possible relationship between simvastatin plus ezetimibe and an increased incidence of cancer. The alert comes after the FDA received preliminary data from the Simvastatin Ezetimibe Aortic Stenosis trial.
Researchers from the SEAS trial enrolled 1,873 patients with mild to moderate aortic stenosis into the randomized, placebo-controlled study. They assigned patients either placebo or an aggressive LDL-lowering therapy that included a combination of 40 mg/day simvastatin and 10 mg/day of ezetimibe (Vytorin, Merck). They followed the participants for up to four years.
The combination of simvastatin and ezetimibe lowered LDL by an average of 76 mg/dL (61%). The researchers also reported that 688 patients had one or more of the primary endpoint events. There was no difference between the placebo group and the treatment group for the combined primary endpoint of major cardiovascular events (333 vs. 355; HR=0.96; 95% CI, 0.83-1.12).
During subsequent safety analyses, 158 patients had serious adverse events attributed to cancer. A higher percentage of these incidents were reported in patients receiving simvastatin and ezetimibe (9.9%) than in the placebo group (7.0%; P=.05). Deaths were also higher in the combination group vs. placebo group (4.1% vs. 2.5%).
“The observed difference in cancer in the SEAS study is based on small numbers and could have occurred as a result of chance,” the researchers said in a press release.
The FDA announced it is investigating the possible increased cancer risk. The agency expects to receive a final report in approximately three months and expects to evaluate the clinical trial data within six months after that. In the meantime, the FDA said that health care professionals and caregivers should monitor patients taking the combination drug and report any side effects from its use. – by Eric Raible
The SEAS trial failed to meet its primary endpoints, which is how we always judge a trial. It does not provide any additional evidence of a benefit from the drug. Nobody knows what to do with the signal of cancer. An effort was made to imply that this was not significant, but it certainly does not increase confidence in the drug. We are still waiting to see whether there is any evidence of a benefit on health outcomes.
– Steven Nissen, MD
Chairman, Department of Cardiovascular Medicine, Cleveland Clinic