Vytorin’s Shortcoming a Boon for Statins
Disappointing Results of Vytorin Study Lead Doctors to Call for Return to Proven Cholesterol-Lowering Drugs
‘Turn Back to Statins’
Speaking on behalf of the ACC panel, Harlan Krumholz, MD, a cardiologist at Yale University, says that the publication of the full results leave little room for debate: Vytorin should be used as a last resort.
"There is no new evidence to support use of [Vytorin]. People need to turn back to statins," he told the audience of cardiologists, drawing applause.
"We are all aware that with aggressive marketing, people used Zetia then Vytorin without exhausting the statin option. ... We believe that to get to a $5 billion drug, there was a lot of movement to premature use of [Zetia/Vytorin] before statin use was exhausted," he says.
The ENHANCE trial included 720 patients with a rare genetic condition predisposing them to very high cholesterol.
During the two-year study, patients were treated with high doses of either Zocor or Vytorin.
Vytorin was found to lower LDL cholesterol by 58% vs. a 41% drop for those on Zocor, a significant difference.
But Vytorin users had slightly more plaque buildup in their carotid arteries, although the difference was so small it could have been due to chance.
The ACC panel notes that some other treatments, such as hormone therapy for postmenopausal women, have also been shown to lower cholesterol, but not the risk of heart disease.
Bob Spiegel, MD, chief medical officer of Schering-Plough, tells WebMD that this was just one study.
"We hope doctors will come away from this information saying there was an experiment that failed," he says.
What to Do
So what's a patient to take home from all of this?
First and foremost, don't just stop taking Vytorin, the experts say. Talk to your doctor about any concerns.
Second, keep in mind that lowering a high LDL cholesterol level is still one of the most important steps you can take to improve your heart health, Nissen says.
If one statin doesn't work, ask your doctor about trying a higher dose or a stronger statin such as Crestor, he says.
If that doesn't work or patients can't tolerate higher doses, it's time to reach for other medications that have proven benefit, says Harvard cardiologist Patrick O'Gara, MD, another member of the ACC panel.
Panel member Joseph Messer, MD, of Rush University Medical Center in Chicago, says he typically starts patients with slow-release niacin. Drugs called fibrates and bile acid resins can also be considered, although the latter can be difficult for some patients to tolerate, he tells WebMD.
Additionally, efforts to improve your diet and exercise more should be redoubled, says American Heart Association (AHA) past president Sidney Smith, MD, of the University of North Carolina at Chapel Hill.