Finally, a bit of good news for Merck and Schering-Plough, which have seen their overall share of the cholesterol market decline month after month. A small study sponsored by the National Institutes of Health has found that the Zetia cholesterol pill can slow the progression of cardiovascular disease.
The findings contrast with the controversial Enhance trial, which failed to show any benefit based on a measure of the carotid artery in the neck (back story). The results, which spurred congresional investigations due to handling of the clinical trial data, prompted docs to write fewer scrips for Zetia, as well as Vytorin, which combines Zetia and Zocor and insurers to change formulary status (back story).
The study, which was published by the Journal of the American College of Cardiology (here is the abstract), appears to support the argument by Merck and Schering-Plough that Enhance was insufficient for determining whether their drugs were truly effective, although it remains unclear whether the meds can reduce heart attacks risks. "The SANDS (Stop Atherosclerosis in Native Diabetics Study) Study provides (the drugmakers) with some ammunition in their efforts to rebuild their cholesterol franchise," Credit Suisse analyst Catherine Arnold writes in an investor note today.
The study analyzed 223 Native Americans with Type 2 diabetes whose LDL cholesterols were brought down to an agressively low level and found a reduction in the thickness of the carotid artery. Nearly all of the patients were given statins, but 69 also received because they couldn't reach the target on a statin alone. "Notably, those patients who needed Zetia were also able to obtain similar reductions in their CIMT levels as those on statins alone during the 36-month study," Arnold wrote.
"They achieved a very similar degree of regression," James Howard, a principal investigator of the study and director of the lipid treatment center at Washington Hospital Center, Washington, DC, tells The Wall Street Journal. "If we had not added ezetimibe they would have not gotten to that LDL target, and we are certain they wouldn't have gotten that degree of regression."
Howard, by the way, receives grants and speaking fees from Merck and Schering-Plough among other drugmakers. The Zetia analysis, the Journal notes, wasn't planned as part of an original study and was done after the Enhance trial was released.
Such a post-hoc analysis isn't as reliable statistically as one specified at the beginning of a study, according to Steve Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who has cautioned against using Zetia and Vytorin. He tells the paper the number of patients on Zetia in the study was too small to detect a meaningful difference, nor was getting the Zetia based on randomization.