r an alternative medication or a placebo. Most of the trials lasted about 6 months, although the longest one followed patients for four years.
All of the published studies aimed primarily to evaluate metabolic or glycemic control, which is the drugs ability to lower blood sugar levels, the review authors say. Rosiglitazone treatment produced about the same reductions as other oral antidiabetic drugs.
When the reviewers looked at patient-oriented results of the treatments such as side effects, diabetic complications or death, they found a more negative picture.
The pooled data revealed that patients taking rosiglitazone gained up to 11 pounds in body weight and that the chance of developing edema (swelling) doubled. These changes indicate that the drug causes fluid retention, which can lead to shortness of breath and heart failure.
The largest single trial included in the review involved more than 4,000 patients and showed evidence of raised cardiovascular risk, as well as increased numbers of broken bones in women.
Existing treatment strategies concentrating on lowering of blood sugar alone are not sufficient due to the complex nature of the diabetic condition, Richter said. The use of proxy indicators like metabolic control is not sufficient to approve drugs that many patients have to take for the rest of their lives.
He advises patients who suffer from heart disease, especially congestive heart failure, to speak with their doctors about switching to another antidiabetic treatment. If you are a woman and especially if you are thin you probably should avoid this medication due to the risk of bone fractures, he said.
Avandia manufacturer GlaxoSmithKline takes issue with the use of meta-analyses in a May 12 statement, saying they are not the most rigorous way to reach definite conclusions about adverse events.
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