What a doozy!

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Here's the latest about Vytorin. No, it's not the cholesterol meds that cause cancer it's the low level of cholesterol!!!! Read this article carefully.

D

Medscape Alerts

FDA Looking Into Vytorin and Cancer Risk, but Interim Analysis Reassuring for Patients to Continue With Medication

from Heartwire — a professional news service of WebMD

O'Riordan

Information from Industry

The Institute for Advances in Point-of-Care TestingKeep up with emerging trends in glycemic control, anticoagulation management, and other areas of point-of-care testing, to help reduce costs, enhance the efficacy of healthcare management, and improve patient outcomes. August 22, 2008 — The Food and Drug Administration (FDA) has issued a statement informing clinicians about its investigation into the possible link between Vytorin, a

combination of ezetimibe and simvastatin (Merck/Schering-Plough Pharmaceuticals), and an increased risk of cancer [1]. At this point, however, the FDA states the review should not prompt patients to stop taking Vytorin or any other cholesterol-lowering drug.

The ongoing safety review is based on findings from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, a study that missed its primary end point when the combination failed to reduce the composite end point of aortic-valve and cardiovascular events. Although there was a reduction in ischemic events, significantly more subjects treated with Vytorin developed and died from all types of cancer when compared with those taking placebo during the five-year study.

Presented in July by steering committee chair Dr Terje Pedersen (Ulleval University Hospital, Oslo, Norway), the SEAS data prompted a review of interim data of two other ongoing trials of Vytorin. The analysis of the Study of Heart and Renal Protection (SHARP) and the Improved Reduction in High-Risk Subjects Presenting with Acute Coronary Syndrome (IMPROVE-IT), performed by Sir Peto (Clinical Trials Service Unit [CTSU], Oxford, UK), showed no increased risk of cancer with the combination of simvastatin plus ezetimibe. Based on these interim data, the FDA said patients should not stop taking Vytorin.

The FDA expects to see a final SEAS study report from the drug sponsors in three months, and completion of its review of the clinical trial data and other information will take another six months. "As soon as this review is complete, FDA will communicate our conclusions and recommendations to the public," according to the FDA's report.

In its letter, the FDA adds it is aware of previous studies suggesting a link between low on-treatment cholesterol levels and an increased risk of cancer. Data from large prospective statin studies, however, have shown no difference in cancer incidence between the active and placebo arms. A study published this week and reported by heartwire confirmed the inverse association between on-treatment LDL-cholesterol levels and cancer in statin-treated patients, but a similar relationship between LDL-cholesterol levels and incident cancer among control patients was also observed. Investigators concluded that statins, despite significantly reducing LDL-cholesterol levels, are not associated with an increased risk of cancer.

US House Energy and Commerce Committee Continues to Ask Questions

In July, the US House Energy and Commerce Committee sent a letter to the FDA asking for the results of the Peto analysis. Now the committee has sent letters to Merck and Schering-Plough asking for the same analysis, and according to a report in the Wall Street Journal, committee chair Rep Dingell (D-MI), and Rep Bart Stupak (D-MI), chair of the Subcommittee on Oversight and Investigations, say they are "troubled" by the confusing data the companies released about the study [2]. The confusion stems from a discrepancy in the cancer numbers presented by Peto and numbers issued by the sponsors. The lawmakers also questioned Peto's independence as a consultant to the study, because Dr Rory , also from the CTSU where Peto is located, is carrying out the SHARP trial, a study funded by Merck and Schering-Plough.

Merck and Schering-Plough refuse to release the Peto analysis to the committee without assurances that it won't be leaked. The discrepancy with the cancer data, they said, is the result of different time periods measured, calling the suggestion that the independent interim analysis was influenced by Merck and Schering-Plough insulting to Peto and entirely untrue.

Expect more news on Vytorin soon. Data from the SEAS trial will be presented at the European Society of Cardiology (ESC) 2008 Congress in Munich, Germany. The presentation is scheduled for Tuesday, September 2, 2008 during an ESC hotline session.

Food and Drug Administration. Early communication about an ongoing safety review of ezetimibe/simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia). August 21, 2008. Available at: http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin_SEAS.htm. Favole JA, Mundy A. FDA disputes Vytorin study. Wall Street Journal, August 22, 2008; B7. Available at www.wsj.com.