I’m not an astrologist, but sometimes you have to wonder whether plans were hatched under a bad sign. It certainly seems that way for “Vytorin,” a cholesterol-lowering drug that combines simvastatin and “Zetia.” The drug, introduced by Merck and Schering-Plough, has suffered damaging revelations.
Last week, the US Food and Drug Administration announced it was investigating a possible link between Vytorin and an increased incidence of cancer. The investigation was prompted by the results of the Simvastatin and Ezetimibe in Aortic Stenosis trial, which showed that 4.1% of patients treated with Vytorin were diagnosed with and died from cancer, as opposed to 2.5% of those treated with a placebo.
As frightening as these results are, I’m not sure there’s immediate cause for alarm. As FDA noted, two large, ongoing trials of Vytorin (the Study of Heart and Renal Protection and the Improved Reduction in High-Risk Subjects Presenting with Acute Coronary Syndrome) show no increased risk of cancer at all. In fact, most large studies of statin drugs in general have not found evidence that they increase the risk of cancer.
What’s more damning is the evidence from the Enhance trial that Vytorin is no more effective than simvastatin alone. Efficacy ought to be a patient or doctor’s first criterion for deciding whether to take a drug. If a generic drug will help me just as much as a new branded therapy, I’ll opt for the generic. For me, this is an even better reason not to worry about Vytorin’s potential side effects.