- Lowering bad cholesterol has long been an important treatment strategy for decreasing the risk of cardiovascular (CVD) events, with 20 million Americans taking cholesterol-lowering drugs.
- There has been an ongoing controversy about whether Zetia (ezetimbe), which has a different mode of action than statins, improves outcomes. This controversy boiled over when Schering-Plough, which was partnered with Merck at the time, buried negative Zetia data.
- Now, results are in from an 18,000-person, seven-year study. Patients who already had a heart attack or chest pain were treated with either simvastatin alone or Vytorin (which is simply Zetia combined with simvastatin). During the trial, 34.7% of simvastatin-only patients had either a heart attack, stroke, were hospitalized, or had to have a related procedure. Compare that to 32.7% of Vytorin patients who experienced those events, and you've got a 2% difference. Small? Maybe—but it's enough to be statistically significant given the size and design of the trial.
Can 2% really make a difference? Can you really call one treatment superior to another based on a 2% difference in outcomes?
Empirically speaking, yes, you can, especially when the overall sample size is comprised of 18,000 patients. So in terms of statistically significant outcomes, Vytorin is superior to simvastatin alone.
However, there are a couple of caveats. Vytorin is not yet genericized, so the cost of preventing a CVD with the drug is considered expensive by many treating practitioners. And as Forbes' Matt Herper points out, researchers at Harvard's Brigham and Women's Hospital found that you would have to treat 50 patients over a seven-year period or 70 patients over a five-year period in order to prevent a heart attack or stroke with Vytorin (significantly more than with other statins).
Nonetheless, these findings are very important. The implication is that lowering LDL-C decreases the risk of CVD events in at-risk patients, and given the prevalence of cardiovascular disease, that's big news.