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.
Results The 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.
Though a bit disappointing it’s no surprise, and consistent with what we already knew, that intensive glycemic control had no impact on macrovascular outcomes over the first 5 years or so of treatment. It was mildly surprising that microvascular disease was not impacted. What we recently learned from the long term follow up of the UKPDS was that it may take up to 10 years to realize beneficial clinical outcomes. If the FDA insists on “hard” clinical outcomes the development of new diabetes drugs may be doomed. A related editorial in the Journal of Clinical Endocrinology and Metabolism makes the same point here.