OBJECTIVES: The purpose of this study was to assess the impact of rosiglitazone on survival in patients with diabetes mellitus (DM) and coronary artery disease (CAD). METHODS: We carried out a drug-exposure analysis in 801 patients with DM and CAD in a cardiac catheterization laboratory registry (490 patients treated with a percutaneous coronary intervention, 224 patients treated with coronary artery bypass grafting, and 87 patients treated with medication alone). RESULTS: A total of 193 patients (24.1%) were exposed to rosiglitazone. The median survival from the date of cardiac catheterization in the rosiglitazone group was 146.7 months versus 109.1 months in the unexposed group (P<0.001). At 5 years, the unadjusted survival was 82% in the rosiglitazone-exposed group versus 69% in the unexposed group (P<0.001). There was no difference in survival between rosiglitazone-exposed and rosiglitazone-unexposed patients in the groups treated with coronary artery bypass grafting or medical therapy (P=0.37 and 0.11, respectively). In a multivariable model, rosiglitazone exposure had no effect on mortality (hazard ratio=0.737; 95% confidence interval: 0.521-1.044, P=0.86). CONCLUSION: We conclude that exposure to rosiglitazone is not associated with increased mortality in diabetics who are treated for CAD. These findings support the notion that insulin sensitization with a thiazolidinedione is safe in carefully selected and treated patients with DM and CAD.
OBJECTIVES: The purpose of this study was to assess the impact of rosiglitazone on survival in patients with diabetes mellitus (DM) and coronary artery disease (CAD). METHODS: We carried out a drug-exposure analysis in 801 patients with DM and CAD in a cardiac catheterization laboratory registry (490 patients treated with a percutaneous coronary intervention, 224 patients treated with coronary artery bypass grafting, and 87 patients treated with medication alone). RESULTS: A total of 193 patients (24.1%) were exposed to rosiglitazone. The median survival from the date of cardiac catheterization in the rosiglitazone group was 146.7 months versus 109.1 months in the unexposed group (P<0.001). At 5 years, the unadjusted survival was 82% in the rosiglitazone-exposed group versus 69% in the unexposed group (P<0.001). There was no difference in survival between rosiglitazone-exposed and rosiglitazone-unexposed patients in the groups treated with coronary artery bypass grafting or medical therapy (P=0.37 and 0.11, respectively). In a multivariable model, rosiglitazone exposure had no effect on mortality (hazard ratio=0.737; 95% confidence interval: 0.521-1.044, P=0.86). CONCLUSION: We conclude that exposure to rosiglitazone is not associated with increased mortality in diabetics who are treated for CAD. These findings support the notion that insulin sensitization with a thiazolidinedione is safe in carefully selected and treated patients with DM and CAD.
Authors: Elisabetta Patorno; Elizabeth M Garry; Amanda R Patrick; Sebastian Schneeweiss; Victoria G Gillet; Olesya Zorina; Dorothee B Bartels; John D Seeger Journal: Drug Saf Date: 2015-03 Impact factor: 5.606
Authors: Elisabetta Patorno; Amanda R Patrick; Elizabeth M Garry; Sebastian Schneeweiss; Victoria G Gillet; Dorothee B Bartels; Elvira Masso-Gonzalez; John D Seeger Journal: Diabetologia Date: 2014-09-12 Impact factor: 10.122