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Title: Rosiglitazone May Increase Mortality Among Diabetic Patients Undergoing Haemodialysis: Presented at ASN

"Rosiglitazone May Increase Mortality Among Diabetic Patients Undergoing Haemodialysis: Presented at ASN"

By Bryan DeBusk, PhD SAN FRANCISCO, CA -- November 5, 2007 -- Haemodialysis patients receiving rosiglitazone to treat diabetes have a greater risk of mortality from cardiovascular causes and all causes compared with patients receiving other nonthiazolidinedione oral hypoglycaemic agents, according to the Dialysis Outcomes and Practice Patterns Study (DOPPS). Justin Albert, Project Manager, DOPPS Program, Arbor Research, Michigan, United States, reported the findings here at Renal Week 2007, the American Society of Nephrology (ASN) Annual Meeting. The study examined 2,393 patients with diabetes enrolled between 1999 and 2004 and compared the rates of all cause and cardiovascular mortality between patients receiving rosiglitazone and patients receiving other nonthiazoladinedione oral hypoglycaemic agents. In the study, haemodialysis patients on rosiglitazone had a 50% greater risk of mortality from cardiovascular causes (adjusted hazard ratio [AHR] 1.50; 95% confidence interval [CI] 1.06-2.21) and a 34% greater risk of mortality from all causes (AHR 1.34; 95% CI 1.01-1.77) compared with patients receiving other nonthiazolidinedione oral hypoglycaemic agents Patients receiving rosiglitazone made up 7% of the sample and were more likely ([P <.05) to have one or more factors associated with higher mortality, including more years with end-stage renal disease (ERSD), a diagnosis of coronary artery disease, and/or hypertension. These patients were also more likely to be Black (P <.05). The authors adjusted for these and a number of factors including other comorbidities, insulin use, and demographics.

In addition to identifying increased between-patient risk for mortality from both cardiovascular and all causes, the results indicate that increased risk is not confined to patients at specific haemodialysis facilities. At the facility level, the increase in risk was 23% for all causes (AHR 1.23; 95% CI 1.12-1.35) and 18% for cardiovascular mortality (AHR 1.18; 95% CI 1.01-1.38).

Strikingly, the divergence in mortality occurs between 3 and 9 months after initiation of rosiglitazone treatment and is maintained over time.

"The key points here are the findings that there is a significantly elevated risk of all-cause and cardiovascular mortality associated with rosiglitazone use among our diabetic dialysis patients," Mr. Albert concluded.

DOPPS is supported by Amgen and Kirin without restrictions on publications.

[Presentation title: Rosiglitazone is Associated With Increased Mortality Among Diabetic HD Patients in the US DOPPS. Abstract SA-FC043]

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