Pargluva, a new diabetes drug just approved by the FDA has been shown to, in fact, increase the risk of heart attacks, strokes, and death in patients taking it.
For patients with Type Two diabetes, which makes up 90 percent of all diabetes cases, new treatments are met with great excitement. The drug muraglitazar, which goes by the trade name Pargluva, and developed by Bristol-Myers Squibb, has been one of them--endorsed last month by an FDA advisory panel by a count of 8-1.
Two days ago, the company received an approvable letter from the FDA, meaning, with some additional information, including safety medication, Pargluva is soon to be given the green light to be marketed in the U.S. as a monotherapy--to be used alone in treating diabetes.
But the details of the data on Pargluva that led to the approvable letter raised eyebrows among the same Cleveland Clinic researchers that first reported the heart risks posed by the anti-inflammatory drug vioxx, which has been withdrawn from the market.
“I had concerns about the cardiovascular safety of Pargluva based on their document filed by the company with the FDA for this advisory panel meeting,” says Dr. Steven Nissen, the study author.
In their new study published on line early Thursday by the Journal of the American Medical Association, Pargluva was shown to be fraught with the worst possible side effects.
“My colleagues and I performed a statistical analysis on Pargluva, in which we counted the number of serious cardiovascular events, death, heart attack and stroke, and what we found was the incidence of those adverse outcomes was 2.23 times higher, more than twofold greater,” Dr. Nissen states.
When other complications, congestive heart failure and TIA, or ministroke, were included in the study, that risk was more than 2 and a half times greater than those getting placebo.
Some experts say the data is interesting, but the jury is still out.
Dr. Spyros Mezitis, an endocrinologist at Lenox Hill Hospital, suggests, “It’s not the original data we’re looking at first. The comparisons that have been done are lumping several studies together.”
“I think the advisory panel had the same information but I think they didn’t see it. They didn’t connect the dots and they didn’t seem to understand the implications of what they were looking at. They were primarily focused on the effects of Pargluva in lowering blood sugar and blood fats,” Dr. Nissen adds.
Regardless, the conclusion is quite clear.
“I think we need one big study looking at cardiovascular end points, heart attacks, for example,” says Dr. Mezitis.
“We recommend in this manuscript that the FDA not approve Pargluva,” insists Dr. Nissen.
Tony Plohoros, a spokesman from Bristol-Myers Squibb said today, in response to the study:
“Following the receipt of an approvable letter for Pargluva (muraglitazar) earlier this week, Bristol-Myers Squibb and Merck said that we are eager to begin discussions with the FDA to address more fully the cardiovascular safety profile of the compound and to determine what additional information may be necessary. Pargluva was extensively studied and all available data were reported to the FDA. This information was presented by Bristol-Myers Squibb and the FDA at a recent Advisory Committee meeting, an open, public forum.”
The authors believe one out of every hundred patients taking Pargluva would die from this if the findings are confirmed. They are calling for a much larger study looking at cardiovascular risk of Pargluva.
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