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Doctors are trying to calm patients' concerns after a study released in January found that the cholesterol-lowering drug Vytorin failed to slow the clogging of arteries (a potential predictor of heart disease and stroke) and could even put patients at greater risk.

The two-year ENHANCE study of 720 patients showed that Vytorin lowered levels of "bad" (LDL) cholesterol but was no more effective than an older drug, the statin Zocor, in curbing the buildup of arterial plaque. In fact, plaque increased slightly with Vytorin, which is a combination of Zocor and Zetia, a nonstatin.

"It wasn't statistically significant, but it was going in the wrong direction," says Steven Nissen, M.D., head of cardiology at the Cleveland Clinic.

Vytorin manufacturer Merck/Schering-Plough Pharmaceuticals, which before the study had contended that adding Zetia to Zocor slowed plaque buildup in the carotid (neck) arteries, defends the drug and says it protects against heart attacks. "Vytorin was approved by the FDA [Food and Drug Administration]," says spokesman Skip Levine, "and was proven to lower LDL cholesterol, the well-established risk factor for the onset of cardiovascular disease.

"In the study we did ... demonstrate that Vytorin lowered LDL cholesterol by a significant amount over Zocor."

Nissen urges patients taking Vytorin to talk to their doctors before deciding whether to continue with the drug. "Ask if you would do as well on a generic statin alone, which would also save you money," he says. Vytorin costs two to three times as much as a generic.

"Until there's better evidence," Nissen adds, "physicians should only prescribe these [nonstatin] drugs for patients who can't tolerate statins or don't get to their ideal [cholesterol levels] using statins alone."

The American Heart Association played down the ENHANCE results, saying the study wasn't "large enough or long enough" to determine whether Vytorin was more or less effective than a single drug. Merck/Schering-Plough is conducting two large clinical trials due to end in 2011.

Family practitioner Kavian Milani, M.D., of Fairfax, Va., called the ENHANCE results meaningless. "I would prefer to see a study measuring outcomes such as morbidity, hospital stays and proof that the drug saves lives," he says.

Sidney Wolfe, M.D., director of Public Citizen's Health Research Group, blamed the FDA for the Vytorin controversy. "The FDA should require drug companies to prove their medications have a clinical advantage over other drugs," Wolfe says. "You don't use any new drug until it's been on the market for seven year—unless it's a breakthrough drug—because of the preponderance of problems that will arrive in those first seven years." He says Vytorin was listed as "do not use" on the group's website, WorstPills.org, in 2004.

Meanwhile, the U.S. House Energy and Commerce Committee and the Senate Finance Committee launched an investigation into the drug amid concerns that its manufacturers waited nearly two years to divulge its disappointing results. The ENHANCE study ended in April 2006 but wasn’t disclosed by the drug makers until January.

Now Merck/Schering-Plough is being sued in a handful of states over allegations that the company misled consumers into believing Vytorin was more effective than a generic and delayed telling the public otherwise. At least 10 lawsuits have been filed in federal courts, with half the filings in New Jersey, where both parent companies are based. Other federal suits were filed in California, New York, Ohio and Colorado.