This morning, the American Heart Association issues a similar statement, prompting Tim Anderson, an analyst at Sanford Bernstein, to write that "the two biggest organizations representing cardiovascular medicine have now weighed in on the matter, in support of Vytorin. This should help to quell the hysteria around Enhance results, which have been blown out of proportion in our view." Separately, Congress will still probe the delay and the reasons why the primary endpoint was, briefly, changed.
The AHA statement notes that the Enhance trial found the combo was no more effective in reducing artery plaque build-up than Zocor alone....but "there were no statistically significant differences in the safety of the drugs, which are used to lower cholesterol...and the LDL levels in both groups remained well above target level."
Plaque build-up (atherosclerosis) in the arteries can lead to coronary heart disease or stroke, the AHA statement continues. However, the study was not large enough or long enough to determine whether the combination drug is more or less effective than the single drug in reducing heart attacks or deaths, the AHA argues. Because high cholesterol levels are a very important risk factor for coronary heart disease, the AHA urges patients to consult with their physician before changing or stopping any medication treatment.
â€œIt will be very important for those larger studies, directed at assessing cardiac outcomes, to be completed, so we can fairly assess the potential of (Vytorin),â€ says AHA president Dan Jones, in the statement. â€œBecause Vytorin does not appear to be unsafe, lipid-lowering therapy with (Zocor) is of proven benefit, and some patients have been prescribed Vytorin, because a statin alone may not have been sufficiently effective in lowering their LDL or was not appropriate for them because of other medical conditions, we do not believe patients should stop taking the drug on their own,â€ says Jones.