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Rosiglitazone Seen No Better than Other Drugs in Diabetic Control

Posted: Friday, August 03, 2007

The data from 8,432 patients found that glycemic control, as measured by levels of HbA1c, was no better in patients given rosiglitazone than those given other antidiabetic drugs, found Bernd Richter, M.D., of the University of Duesseldorf, and colleagues.

But the authors did not weigh in on the issue of potentially increased cardiovascular risk because they said the studies reviewed reported on 26 weeks or less of rosiglitazone therapy, which was not enough time to evaluate mortality, diabetes-related morbidity, or quality of life.

They concluded that "new studies should focus on patient-oriented outcomes to clarify the benefit-risk radio of rosiglitazone therapy. Safety data and adverse events of all investigations (published and unpublished) should be made available to the public."

But in a statement, Dr. Richter raised doubts about the likelihood of such studies noting that "it is questionable whether new studies with rosiglitazone will be ethical given the fact that less dangerous therapeutic alternatives exist."

In many ways the Cochrane review echoed conclusions of a systematic review published Monday in the Annals of Internal Medicine which found that older drugs were as effective as rosiglitazone and pioglitazone and were less expensive as well. ( See For Type 2 Diabetes, Older Drugs Seem Tried and True)

Both reviews are likely to be added to the data that an FDA advisory panel will tackle on July 30 when it meets to consider concerns about the cardiovascular safety of rosiglitazone.

The cardiovascular safety furor was ignited by publication of a meta-analysis of 42 trials that found a 43% increase in relative risk of myocardial infarction for type 2 diabetes patients treated with rosiglitazone.

Practice Pearls :

Explain to interested patients that this review concurs with other reviews that found that rosiglitazone was not superior to other therapies for control of glycosylated hemoglobin.
Point out that the report found that published studies of at least 24 weeks of rosiglitazone treatment in people with type 2 diabetes mellitus did not provide evidence that patient-oriented outcomes like mortality, morbidity, adverse effects, costs and health-related quality of life are positively influenced by this compound. The authors however suggested that the studies were of too short duration to evaluate these issues.
Explain to interested patients that the data reviewed in this report did not address long term safety of rosiglitazone.

Source: Diabetes In Control: Richter B et al "Rosiglitazone for type 2 diabetes mellitus."Cochrane Database of Systematic Reviews 2007; Issue 3 Art.No.: CD006063. DOI: 10.1002/14651858.CD006063.pub2.