Unpublished data cast doubt on NICE cholesterol guidance

The value of ezetimibe as an add-on therapy to statins has been called into question, by research findings left unpublished for two years.

In November 2007, NICE said GPs should prescribe ezetimibe alongside statins if total or LDL cholesterol is not appropriately controlled with statins alone.

But this guidance has been thrown into doubt after a US Congressional inquiry forced manufacturers Merck and Schering-Plough Pharmaceuticals to reveal the results of a study carried out two years ago.

The ENHANCE study compared 356 patients treated with ezetimibe (10mg) plus simvastatin (80mg) with 360 patients treated with simvastatin alone.

Ezetimibe did cause additional lowering of cholesterol, but plaque progression was found to be worse in the ezetimibe arm of the study.

Dr Peter Kim, president of Merck Research Laboratories, said: 'We stand behind ezetimibe and our science which has brought these cholesterol-lowering medications to millions of patients around the world.'

Dr Graham Archard, a GP in Dorset with an interest in cardiovascular disease, said: 'If ezetimibe is found to be interfering with the statins and affecting plaque progression, then we need to look at whether we should be using ezetimibe.'


BMJ 2008; 336: 180-1, live links at www.healthcarerepublic.com


  • October 2002: First patient enrolled for ENHANCE study.
  • November 2007: NICE issues technology appraisal on ezetimibe.
  • January 2008: Merck and Schering-Plough forced to publish results of ENHANCE study.
  • March 2008: More data on the study to be announced at the American Cardiology Conference.

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