All concepts, explanations, trials, and studies have been
re-written in plain English and may contain errors. I am
not a doctor
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NOTE: You can make the print bigger with the font button
on your browser! (It's usually a big "A")

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Jon's Note: I only send this to remind us all that we
            must educate ourselves and watch over our
            own therapy - those designated to watch out
            for us often do a lousy job. At least this
            one was caught before the drug was actually
            approved.

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Is New Diabetes Drug Heart Safe?

October 20, 2005 - A drug called muraglitazar was recently
recommended for approval by an FDA committee for diabetes
treatment. It is a dual-peroxisome  proliferator-activated
receptor (PPAR) blocker. The drug is meant to control blood
sugar levels in people with type 2 diabetes.
	Doctors Steven Nissen and Eric Topol from Cleveland
Clinic studied trial data on the drug. Diabetics taking
muraglitazar had 2.2 times (more than twice) the risk of death,
heart attack, or stroke versus diabetics taking a placebo or
taking pioglitazone (a different PPAR blocker). Muraglitazar
patients were also 2.6 times as likely to have a TIA (mini-
stroke) or heart failure.
	Dr. Nissen said he was surprised the FDA panel okayed
the drug for approval. Studies on the FDA's own web site showed
a significant risk of heart-related problems in patients taking
the drug.
	Nissen and Kathy Wolski studied all muraglitazar trials
already given to the FDA. Since higher doses were not part of
the approval process, no diabetic patients taking over 5 mg of
the drug were included. Note that the reason higher doses were
not submitted to the FDA is that such patients had high risk
for edema.
	A total of 2374 trial patients taking 5 mg per day or
less and 1351 taking placebo or pioglitazone were studied.
Trials included in the study only lasted between 24 and 104
weeks.Primary end point was death, heart attack or stroke.

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End point		Death, heart attack or stroke

Muraglitazar		1.47
Other drug/placebo	0.67
Relative risk		2.23 higher than placebo or other drug

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End point		Death, heart attack, stroke, TIA, or HF

Muraglitazar		2.11
Other drug/placebo	0.81
Relative risk		2.62 higher than placebo or other drug

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Title:   Effect of muraglitazar on death and major adverse
         cardiovascular events in patients with type 2 diabetes
         mellitus.
Authors: Nissen SE, Wolski K, and Topol EJ.
Source:  JAMA 2005; DOI:10.1001/jama.294.20.joc50147.