published in the May 21, 2007 issue of New England Journal of Medicine (Nissen SE and Wolski K. N Engl J Med 2007; 356:2457-71), and reported by heartwire at that time, suggested that rosiglitazone increased the risk of MI 43% and might also increase the risk of cardiovascular death,

On rosiglitazone my Mum has had 3 MI's , almost died, and a fracture to ankle.. She has gained weight, and lately her blood sugar levels are not well controlled.
Admittedly the weight gain is probably due to not cutting down sufficiently on food intake despite not being able to walk much any more after the fracture and sore knees.. BUT she does puff extremely easily and find it difficult to catch her breath since her heart attacks..
There us NO known heart attacks anywhere else in family history on any side of family, so it's not genetic.

Guess what, I won't be following in her footsteps, at least with metaformin and then rosiglitazone.

Nissen Responds to Rosiglitazone Debate at ADA Meeting
"Nissen lamented the fact that in the eight years since the approval of rosiglitazone no definitive end-point trials have been published, despite the signal of increased risk of ischemic events observed in the earliest studies. "
Heartwire 2007

"it is important to wait for cardiovascular-end-point trials before making regulatory decisions".   
What incentive is there to run these cardiovascular-end-point trials  .. It's been  8 years without having run any?

. These end points were primarily collected as serious adverse events." Despite these limitations, however, "patients and providers should consider the potential for serious cardiovascular effects of treatment with rosiglitazone for type 2 diabetes"

 "Nathan reminded the audience that rosiglitazone, at this time, is intended for glycemic control to prevent microvascular and neurologic complications, not for the prevention of cardiovascular disease.".. good to see how their logic 

ADOPT Analysis Shows Rosiglitazone Increases Risk of Fracture in Women
Not unlike a prizefighter battered and bruised, rosiglitazone continued to take it on the chin this week with an analysis of ADOPT expanding upon the increased risk of fracture among diabetic women taking the controversial TZD.
Heartwire 2007
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Cochrane Review Urges Caution on Rosiglitazone Use
The new review found no evidence of any benefits with the drug over other available treatments for diabetes and, because of side effects such as edema, fractures, and possible increased risk of MI, recommends that other antidiabetic medications be used in preference.
Heartwire 2007
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http://www.medscape.com/viewarticle/560402?src=mp
U.S. Senators: FDA Pulled Reviewer off Glaxo Drug
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FDA Advisory Panels Acknowledge Signal of Risk With Rosiglitazone, but Stop Short of Recommending Its Withdrawal
http://www.medscape.com/viewarticle/560709?src=mp 
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Rosiglitazone Story a Reminder of Need for FDA Reform

August 8, 2007 (Boston, MA) - The man who chaired the recent FDA advisory panel hearing on rosiglitazone summarizes the sorry saga as follows: "A new 'wonder drug,' approved prematurely and for the wrong reasons by a weakened and underfunded government agency subjected to pressure from industry, had caused undue harm to patients."

That's the synopsis of Dr Clifford Rosen (St Joseph Hospital, Bangor, ME), whose Perspective in the New England Journal of Medicine this week argues that the FDA's advisory panel's struggle to resolve safety concerns about the drug should serve as a reminder for the ways in which the drug-approval process could be improved [1].
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FDA Announces Boxed Warnings on All Thiazolidinediones

The entire class of thiazolidinedione drugs used to treat type 2 diabetes must carry boxed warnings about the drugs' ability to cause or worsen heart failure, the FDA announced late yesterday.

The affected drugs are Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride).

The action addresses the FDA's worry that "despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure," says the agency's chief of drug evaluation and research.

FDA announcement
Rosiglitazone alert
Pioglitazone alert


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Another research group analyzed four long-term, randomized controlled trials of rosiglitazone in which cardiovascular safety was a prespecified endpoint; some 14,000 patients were included. Overall, rosiglitazone increased the risk for MI by 42%.

Long-term Risk of Cardiovascular Events With Rosiglitazone
A Meta-analysis
Sonal Singh, MD; Yoon K. Loke, MBBS, MD; Curt D. Furberg, MD, PhD
JAMA. 2007;298:1189-1195.

Context Recent reports of serious adverse events with rosiglitazone use have raised questions about whether the evidence of harm justifies its use for treatment of type 2 diabetes.

Objective To systematically review the long-term cardiovascular risks of rosiglitazone, including myocardial infarction, heart failure, and cardiovascular mortality.

Data Sources We searched MEDLINE, the GlaxoSmithKline clinical trials register, the US Food and Drug Administration Web site, and product information sheets for randomized controlled trials, systematic reviews, and meta-analyses published in English through May 2007.

Study Selection Studies were selected for inclusion if they were randomized controlled trials of rosiglitazone for prevention or treatment of type 2 diabetes, had at least 12 months of follow-up, and monitored cardiovascular adverse events and provided numerical data on all adverse events. Four studies were included after detailed screening of 140 trials for cardiovascular events.

Data Extraction Relative risks (RRs) of myocardial infarction, heart failure, and cardiovascular mortality were estimated using a fixed-effects meta-analysis of 4 randomized controlled trials (n = 14 291, including 6421 receiving rosiglitazone and 7870 receiving control therapy, with a duration of follow-up of 1-4 years).

Results Rosiglitazone significantly increased the risk of myocardial infarction (n = 94/6421 vs 83/7870; RR, 1.42; 95% confidence interval [CI], 1.06-1.91; P = .02) and heart failure (n = 102/6421 vs 62/7870; RR, 2.09; 95% CI, 1.52-2.88; P < .001) without a significant increase in risk of cardiovascular mortality (n = 59/6421 vs 72/7870; RR, 0.90; 95% CI, 0.63-1.26; P = .53). There was no evidence of substantial heterogeneity among the trials for these end points (I2 = 0% for myocardial infarction, 18% for heart failure, and 0% for cardiovascular mortality).

Conclusion Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.
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UPDATE Dec 2007
Guidelines Revised for Management of Type 2 Diabetes Mellitus

New information suggests additional hazards associated with the use of either thiazolidinedione, and rosiglitazone in particular may result in an increased frequency of myocardial infarctions...

http://www.medscape.com/viewarticle/566734?src=mp
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Might help.. vinegar at bedtime
Vinegar at Bedtime Moderates Waking Glucose Level in Type 2 Diabetics
Results of a study published in the November issue of Diabetes Care suggest that a dose of vinegar taken at bedtime may favorably impact waking glucose concentrations in patients with type 2 diabetes.
Reuters Health Information 2007