Does an intensive multifactorial intervention reduce mortality in type 2 diabetes mellitus?

摘要

BackgroundPatients with type 2 diabetes meliitus and its comorbidities have an increased death rate when compared with the general population.ObjectiveTo determine whether an intensive, multifactorial treatment regimen would influence mortality in adults with type 2 diabetes mellitus.Design and InterventionThis was the observational, follow-up component of the previously published Steno-2 study, a prospective, randomized, open-label trial that compared the efficacy of conventional multi-factorial therapy and intensive multifactorial therapy in 160 white Danish patients with type 2 diabetes mellitus and persistent micro-albuminuria. The intensive-therapy regimen was goal-oriented, with prespecified targets for HbA_(1c), lipids, and blood pressure. Intervention was for a mean duration of 7.8 years; follow-up was for a mean duration of 5.5 years after the initial trial had ended. At the start of the follow-up period all participants were informed of the benefits of treatment intensification.Outcome MeasuresThe primary Outcome Measure was death from any cause. Secondary Outcome Measures included a composite of cardiovascular events and death from cardiovascular causes. Tertiary Outcome Measures included diabetic nephropathy, retinopathy and neuropathy.ResultsA total of 67 patients in the intensive therapy group and 63 patients in the conventional therapy group entered the follow-up study. At the end of the intervention period, patients in the intensive therapy group had greater improvements in the treatment goals than did patients in the conventional therapy group. By contrast, there were no significant differences between the two groups after the follow-up period. Death occurred in 24 patients in the intensive therapy group and 40 patients in the conventional therapy group (hazard ratio [HR] 0.54, 95% CI 0.32-0.89; P = 0.02). Death from cardiovascular causes was reported for 9 patients in the intensive therapy group and 19 patients in the conventional therapy group (HR 0.43, 95% Cl 0.19-0.94; P = 0.04).Atotal of 209 cardiovascular events were reported: 51 events in 25 patients who received intensive therapy and 158 events in 48 patients who received conventional therapy (HR 0.41, 95% CI 0.25-0.67; P < 0.001). Diabetic nephropathy developed in 20 patients in the intensive therapy group and 37 patients in the conventional therapy group (relative risk [RR] 0.44, 95% CI 0.25-0.77; P = 0.004). Endstagerenal disease developed in one patient in the intensive therapy group and six patients in the conventional therapy group (P = 0.04). Intensive therapy also reduced the risk of diabetic retinopathy (RR 0.57, 95% CI 0.37-0.88; P = 0.01) and autonomic neuropathy (RR 0.53, 95% CI 0.34-0.81;P = 0.004). The rate of symptomatic hypoglycemia in the two groups was not significantly different.ConclusionIntensive multifactorial intervention for type 2 diabetes mellitus was associated with sustained improvements in comorbidities and mortality.