By Jill Stein
ROME -- September 8, 2008 -- Many patients who discontinued their rosiglitazone as a result of recent reports that the oral antidiabetic might increase the risk of ischaemic cardiovascular events were not switched to another oral antidiabetic drug and developed poor glucose control, researchers reported here at the European Association for the Study of Diabetes (EASD) 2008.
Peter Weissman, MD, University of Miami School of Medicine, Miami, Florida, and colleagues evaluated the effect of rosiglitazone discontinuation on glycaemic control in type 2 diabetics.
Their study, presented on September 8, represents an interim analysis of data from a large database that contains about 7.9 million patient records of treatment by 2,600 US-based doctors.
The researchers identified 5,933 patients with type 2 diabetes with 2 or more prescriptions for rosiglitazone monotherapy or combination therapy in a 12-month period prior to May 21, 2007, who received no new prescriptions for rosiglitazone in the subsequent 90-day period.
Of these patients, 11% had receiving the drug as monotherapy and 89% as part of combination therapy. After discontinuation, 45% were switched to another oral antidiabetic drug as monotherapy, 33% received combination oral antidiabetic therapy, 9% received insulin alone, and nearly 13% had no evidence of being switched to any oral antidiabetic drug or insulin.
Patients who had previously been on rosiglitazone monotherapy experienced an increase in fasting plasma glucose (FPG) levels from 132.5 to 140.4 mg/dL after discontinuation of the drug, with 53% of patients at goal before stopping rosiglitazone versus 49% afterwards.
Likewise, patients who had been on combination rosiglitazone therapy developed a significant increase in FPG levels after discontinuation (134.5 to 143.7 mg/dL, P = .025). This group had a decrease in the number of patients at their target FPG from 43% before to 39.8% after discontinuation.
Dr. Weissman noted that a possible shortcoming of the trial is that the length of follow-up was short. Also, the number of monotherapy patients with lab values pre- and post-May 21 was small.
"These preliminary analyses suggest concern for patients who stopped rosiglitazone after May 21, 2007, particularly those on combination therapy, who had a decrease in glycaemic control," Dr. Weissman and colleagues wrote in their poster presentation. "Evidence has demonstrated that a loss of glycaemic control is associated with an increased risk of long-term complications."
Funding for the study was provided by GSK.
[Presentation title: Impact of Rosiglitazone Discontinuation on Glycemic Control. Abstract 918]
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