Switch From Lipitor To Generic Zocor, And Die
15 CommentsBy Ed Silverman // September 5th, 2007 // 7:44 am
That’s the less-than-subtle message from a Pfizer-backed study that was presented today at the European Society of Cardiology Congress. The findings were based on observations from a primary case database in the UK, which found that patients making the switch are more likely to have a heart attack or die. This is potentially terrific news for Pfizer, yes?
The study covered records from 1997 to 2005 and compared outcomes for 2,511 patients who took Lipitor for six months and then switched to simvastatin, or generic name Zocor, with 9,009 who stayed on Lipitor. The upshot - switching was associated with a 30 percent increase in the relative risk of major cardiovascular events, including heart attacks, strokes and death.
The reasons for switching weren’t given and patients weren’t randomly assigned to each arm of the study, which limits its significance and is only good for generating a hypothesis. Pfizer, nonetheless, says this is a red flag, especially as third-party payers - such as the UK’s National Health Service - push for greater generic use.
“Today, many health care payors including governments and managed care companies are encouraging patients who are well-established on one therapy to switch to a different statin therapy,†Mike Berelowitz, senior vp of Pfizer’s global medical division says in a statement. “This study raises concerns about those policies. It suggests the potential for poorer cardiovascular outcomes associated with switching patients from established Lipitor therapy to simvastatin.â€
Generic Zocor was launched in the summer of 2006 after Merck’s brand-name version lost patent protection. Since then, Lipitor sales have plummeted - in this year’s second quarter, US sales fell 25 percent and worldwide sells declined 13 percent.
Peter Lansberg of the University of Amsterdam’s Academic Medical Centre, one of the investigators, tells Reuters the difference was not surprising since Lipitor was known to be more potent at lowering levels of harmful cholesterol in the blood.
Dr. Remulac
more desperation by Pfizer. They lose ~$11 billion in revenues from Lipitor in 2011 (and maybe even as early as 2010) and they have absolutely nothing in their pipeline to fill that void!
Hank
Lots of limits in this study. 30% relative risk is also roughly the Avandia relative risk number, but we still need to know NNT numbers = how many people out of how many we’re actually talking about. Also, at least as reported here, we don’t know either what the dosing was on each side and the mean difference in relevant lipid numbers. Without that, we know little or nothing. The study appears so uncontrolled that a small relative risk difference out of large numbers could happen for lots of reasons besides any inherent benefits of Lipitor.
Dr. Remulac
Good comments Hank. This was a retospective database analysis using a database that doesn’t contain all the variables needed to do a thorough analysis. The results are most likely tainted by “confounding by indication” or some other undescribed variable or variables influencing the CV events. The published abstract is remarkably vague, and if I had been a reviewer I would have rejected it. This is clearly a case where Pfizer is trying to raise questions about the “safety” of switching patients from Lipitor to a generic statin (simvastatin dominates at this point), but they are doing so with very thin science. This abstract should be considered hypothesis forming only, and SHOULD NOT prevent the very appropriate switching from Lipitor at $4/day to generic simvastatin at 50 cents a day.
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