Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the bypass angioplasty revascularization investigation 2 diabetes (BARI 2D) Trial

Richard G. Bach, Maria Mori Brooks, Manuel Lombardero, Saul Genuth, Thomas W. Donner, Alan Garber, Laurence Kennedy, E. Scott Monrad, Rodica Pop-Busui, Sheryl F. Kelsey, Robert L. Frye

Research output: Contribution to journalArticle

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Abstract

BACKGROUND - : Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease remain unknown. METHODS AND RESULTS - : To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes mellitus and coronary artery disease, we analyzed events among 2368 patients with type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction, and stroke, and the individual incidence of death, myocardial infarction, stroke, congestive heart failure, and fractures, were compared during 4.5 years of follow-up among patients treated with rosiglitazone versus patients not receiving a thiazolidinedione by use of Cox proportional hazards and Kaplan-Meier analyses that included propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.58-1.18), whereas there was a lower incidence of composite death, myocardial infarction, and stroke (HR, 0.72; 95% CI, 0.55-0.93) and stroke (HR, 0.36; 95% CI, 0.16-0.86) and a higher incidence of fractures (HR, 1.62; 95% CI, 1.05-2.51); the incidence of myocardial infarction (HR, 0.77; 95% CI, 0.54-1.10) and congestive heart failure (HR, 1.22; 95% CI, 0.84-1.82) did not differ significantly. Among propensity-matched patients, rates of major ischemic cardiovascular events and congestive heart failure were not significantly different. CONCLUSIONS - : Among patients with type 2 diabetes mellitus and coronary artery disease in the BARI 2D trial, neither on-treatment nor propensity-matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events.

Original languageEnglish (US)
Pages (from-to)785-794
Number of pages10
JournalCirculation
Volume128
Issue number8
DOIs
StatePublished - Aug 20 2013

Fingerprint

rosiglitazone
Angioplasty
Coronary Artery Disease
Diabetes Mellitus
Confidence Intervals
Stroke
Myocardial Infarction
Type 2 Diabetes Mellitus
Heart Failure
Incidence
Mortality
Kaplan-Meier Estimate

Keywords

  • coronary disease
  • diabetes mellitus
  • myocardial infarction
  • pharmaceutical preparations
  • rosiglitazone
  • thiazolidinediones

ASJC Scopus subject areas

  • Physiology (medical)
  • Cardiology and Cardiovascular Medicine

Cite this

Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the bypass angioplasty revascularization investigation 2 diabetes (BARI 2D) Trial. / Bach, Richard G.; Brooks, Maria Mori; Lombardero, Manuel; Genuth, Saul; Donner, Thomas W.; Garber, Alan; Kennedy, Laurence; Monrad, E. Scott; Pop-Busui, Rodica; Kelsey, Sheryl F.; Frye, Robert L.

In: Circulation, Vol. 128, No. 8, 20.08.2013, p. 785-794.

Research output: Contribution to journalArticle

Bach, Richard G. ; Brooks, Maria Mori ; Lombardero, Manuel ; Genuth, Saul ; Donner, Thomas W. ; Garber, Alan ; Kennedy, Laurence ; Monrad, E. Scott ; Pop-Busui, Rodica ; Kelsey, Sheryl F. ; Frye, Robert L. / Rosiglitazone and outcomes for patients with diabetes mellitus and coronary artery disease in the bypass angioplasty revascularization investigation 2 diabetes (BARI 2D) Trial. In: Circulation. 2013 ; Vol. 128, No. 8. pp. 785-794.
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abstract = "BACKGROUND - : Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease remain unknown. METHODS AND RESULTS - : To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes mellitus and coronary artery disease, we analyzed events among 2368 patients with type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction, and stroke, and the individual incidence of death, myocardial infarction, stroke, congestive heart failure, and fractures, were compared during 4.5 years of follow-up among patients treated with rosiglitazone versus patients not receiving a thiazolidinedione by use of Cox proportional hazards and Kaplan-Meier analyses that included propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (hazard ratio [HR], 0.83; 95{\%} confidence interval [CI], 0.58-1.18), whereas there was a lower incidence of composite death, myocardial infarction, and stroke (HR, 0.72; 95{\%} CI, 0.55-0.93) and stroke (HR, 0.36; 95{\%} CI, 0.16-0.86) and a higher incidence of fractures (HR, 1.62; 95{\%} CI, 1.05-2.51); the incidence of myocardial infarction (HR, 0.77; 95{\%} CI, 0.54-1.10) and congestive heart failure (HR, 1.22; 95{\%} CI, 0.84-1.82) did not differ significantly. Among propensity-matched patients, rates of major ischemic cardiovascular events and congestive heart failure were not significantly different. CONCLUSIONS - : Among patients with type 2 diabetes mellitus and coronary artery disease in the BARI 2D trial, neither on-treatment nor propensity-matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events.",
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AU - Brooks, Maria Mori

AU - Lombardero, Manuel

AU - Genuth, Saul

AU - Donner, Thomas W.

AU - Garber, Alan

AU - Kennedy, Laurence

AU - Monrad, E. Scott

AU - Pop-Busui, Rodica

AU - Kelsey, Sheryl F.

AU - Frye, Robert L.

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N2 - BACKGROUND - : Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease remain unknown. METHODS AND RESULTS - : To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes mellitus and coronary artery disease, we analyzed events among 2368 patients with type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction, and stroke, and the individual incidence of death, myocardial infarction, stroke, congestive heart failure, and fractures, were compared during 4.5 years of follow-up among patients treated with rosiglitazone versus patients not receiving a thiazolidinedione by use of Cox proportional hazards and Kaplan-Meier analyses that included propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.58-1.18), whereas there was a lower incidence of composite death, myocardial infarction, and stroke (HR, 0.72; 95% CI, 0.55-0.93) and stroke (HR, 0.36; 95% CI, 0.16-0.86) and a higher incidence of fractures (HR, 1.62; 95% CI, 1.05-2.51); the incidence of myocardial infarction (HR, 0.77; 95% CI, 0.54-1.10) and congestive heart failure (HR, 1.22; 95% CI, 0.84-1.82) did not differ significantly. Among propensity-matched patients, rates of major ischemic cardiovascular events and congestive heart failure were not significantly different. CONCLUSIONS - : Among patients with type 2 diabetes mellitus and coronary artery disease in the BARI 2D trial, neither on-treatment nor propensity-matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events.

AB - BACKGROUND - : Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease remain unknown. METHODS AND RESULTS - : To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes mellitus and coronary artery disease, we analyzed events among 2368 patients with type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction, and stroke, and the individual incidence of death, myocardial infarction, stroke, congestive heart failure, and fractures, were compared during 4.5 years of follow-up among patients treated with rosiglitazone versus patients not receiving a thiazolidinedione by use of Cox proportional hazards and Kaplan-Meier analyses that included propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.58-1.18), whereas there was a lower incidence of composite death, myocardial infarction, and stroke (HR, 0.72; 95% CI, 0.55-0.93) and stroke (HR, 0.36; 95% CI, 0.16-0.86) and a higher incidence of fractures (HR, 1.62; 95% CI, 1.05-2.51); the incidence of myocardial infarction (HR, 0.77; 95% CI, 0.54-1.10) and congestive heart failure (HR, 1.22; 95% CI, 0.84-1.82) did not differ significantly. Among propensity-matched patients, rates of major ischemic cardiovascular events and congestive heart failure were not significantly different. CONCLUSIONS - : Among patients with type 2 diabetes mellitus and coronary artery disease in the BARI 2D trial, neither on-treatment nor propensity-matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events.

KW - coronary disease

KW - diabetes mellitus

KW - myocardial infarction

KW - pharmaceutical preparations

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KW - thiazolidinediones

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