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Randomized Controlled Trial
Glucose control and vascular complications in veterans with type 2 diabetes.
- William Duckworth, Carlos Abraira, Thomas Moritz, Domenic Reda, Nicholas Emanuele, Peter D Reaven, Franklin J Zieve, Jennifer Marks, Stephen N Davis, Rodney Hayward, Stuart R Warren, Steven Goldman, Madeline McCarren, Mary Ellen Vitek, William G Henderson, Grant D Huang, and VADT Investigators.
- Phoenix Veterans Affairs Health Care Center, Phoenix, AZ 85012, USA. william.duckworth@va.gov
- N. Engl. J. Med. 2009 Jan 8; 360 (2): 129139129-39.
BackgroundThe effects of intensive glucose control on cardiovascular events in patients with long-standing type 2 diabetes mellitus remain uncertain.MethodsWe randomly assigned 1791 military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard-therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene.ResultsThe median follow-up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard-therapy group and 6.9% in the intensive-therapy group. The primary outcome occurred in 264 patients in the standard-therapy group and 235 patients in the intensive-therapy group (hazard ratio in the intensive-therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P=0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause (hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P=0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group.ConclusionsIntensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications with the exception of progression of albuminuria (P = 0.01) [added]. (ClinicalTrials.gov number, NCT00032487.)2009 Massachusetts Medical Society
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