Promising trial on statin add-in falls flat; studies continue

Physicians look ahead to future studies intended to show whether ezetimibe added to a statin will bring reductions in heart disease.

By Susan J. Landers, AMNews staff. Feb. 4, 2008.

Washington -- The Jan. 14 announcement of findings from the Enhance trial, which compared patients on the cholesterol-lowering drug Vytorin -- a combination of ezetimibe and simvastatin -- with a statin alone, sent shockwaves through the medical community. After all, many physicians viewed this as a promising approach in reducing heart disease risk because the drugs it combined work differently to reduce LDL cholesterol.

However, the study results showed no real difference between the two treatment groups in the two-year, randomized trial -- at least when it came to measuring plaque buildup in carotid arteries.

The initial response was to question whether the drug still had a place in physicians' medicine chests. But physician groups, including the American College of Cardiology and the American Heart Assn., soon adopted more measured positions, weighing in to say physicians should stay the course in prescribing Vytorin, and patients now taking the drug should not panic.

The study also found that patients using the combination drug experienced a 58% drop in LDL cholesterol, while those on the statin alone had a 41% drop. Overall, the safety profiles of the drugs were similar.

The data were released by the pharmaceutical companies Merck and Schering-Plough, which make the drugs. They also have been submitted for presentation at the American College of Cardiology's Annual Scientific Session this spring.

"Obviously a positive study would have been more favorable," said Skip Irvine, a spokesman for Merck/Schering Plough Joint Ventures. "This was a very challenging study, given the high hurdle [it] set, the population [people with heterozygous familial hypercholesterolemia], and their very high LDL levels at baseline."