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Vytorin Cancer Analysis Questioned by NEJM

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An editorial in the New England Journal of Medicine (NEJM) has criticized a safety analysis that purported to show that a cancer risk possibly associated with Vytorin was an anomaly. Vytorin is a combination of cholesterol-lowering Zetia (ezetimibe) and the statin Zocor (simvastin). As mentioned in the NEJM editorial, some have theorized that Zetia could cause cancer because it blocks chemicals called plant sterols, which may cause heart disease but could also have some anti-cancer effect. Unfortunately, some experts feel that Zetia’ potential cancer connection hasn’t been studied enough.

“[Zetia] is certainly worthy of ongoing study, but it should not be used in clinical medicine until the justifiable and substantial cloud of uncertainty over it is resolved,” Allen Taylor of the Walter Reed Army Medical Center, told Forbes.com.

Concern about Vytorin and cancer surfaced in July, when the SEAS study was published. The SEAS study investigated the effects of Vytorin in patients with partial blockages of the aortic valve of the heart, known as aortic stenosis . According to the SEAS findings, Vytorin did little to help patients with aortic stenosis avoid other heart problems.

SEAS also found that Vytorin patients in the study had higher rates of cancer and cancer deaths. In the trial 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo.

Merck and Schering-Plough downplayed the SEAS findings, however, by using an analysis of SEAS conducted by Richard Peto, an Oxford University statistician. That analysis pooled data from two much larger ongoing studies of Vytorin and said they showed that the cancer risk was a statistical fluke. Based on his analysis, Peto called the Vytorin cancer connection ‘bizarre’.

But in their editorial, the NEJM editors wrote that a link to cancer deaths “should not be assumed to be a chance finding until further data are in,” the editors wrote, adding that doctors and patients “are unfortunately left for now with uncertainty about the safety and efficacy of the drug.”

For his analysis, Peto lumped together data from two ongoing studies, SHARP and IMPROVE-IT, and found 97 cancer deaths on Zetia vs. 72 on placebo or Zocor. But if he had lumped the SEAS data together with SHARP and IMPROVE-IT, the cancer findings for Zetia would have become statistically significant.

The editors at the NEJM think he should have combined all three studies. Dr. Stephen Nissen, the prominent Cleveland Clinic cardiologists whose studies of drugs like Avandia have raised important safety issues, agrees. Nissen told Forbes that the cancer risk – along with a lack of evidence showing that either Zetia or Vytorin is more effective at stopping heart attacks than other cholesterol drugs – raises serious questions about whether either should be used.

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