Carotid intima-media thickness (cIMT): a useful clinic tool or research luxury? Another view of the ENHANCE trial.
The ENHANCE trial was the first trial of ezetimibe- simvastatin with a surrogate marker as a primary endpoint. The combination of the 2 drugs is highly effective in reducing total cholesterol and low-density lipoprotein cholesterol levels and with a positive profile on high-density lipoprotein cholesterol. However, there are no data as yet about the clinical effectiveness of the addition of ezetimibe on statin therapy and whether this provides a further reduction of cardiovascular events. The answer to the clinical hard endpoints question will be provided in 2012 by the IMPROVE-IT trial comparing the effectiveness of simvastatin 40 mg plus ezetimibe versus simvastatin 40 mg on 18,000 acute coronary syndrome patients. The ENHANCE study failed in its primary endpoint, carotid intima-media thickness reduction, but has various methodological weaknesses that makes it very difficult to accept the American College of Cardiology statement that ezetimibe should be the last resort after trying all other available treatments.
Toutouzas
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P
Department of Cardiology, Hellenic Heart Foundation, University of Athens, Athens, Greece.
Richter
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D
D000924:Anticholesteremic Agents / Q000627:therapeutic use; D001384:Azetidines / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000473:pathology* / Q000517:prevention & control; D002339:Carotid Arteries / Q000473:pathology*; D002986:Clinical Trials as Topic; D004338:Drug Combinations; D000069499:Ezetimibe, Simvastatin Drug Combination; D006801:Humans; D017063:Outcome Assessment, Health Care; D015203:Reproducibility of Results; D019821:Simvastatin / Q000627:therapeutic use; D017539:Tunica Intima / Q000473:pathology*; D017540:Tunica Media / Q000473:pathology*
D000924:Anticholesteremic Agents; D001384:Azetidines; D004338:Drug Combinations; D000069499:Ezetimibe, Simvastatin Drug Combination; D019821:Simvastatin