Intense multifactorial intervention associated with increased life span, time to CVD events in type 2 diabetes
The intensive intervention was initially conducted for a median of 7.8 years and used both pharmacologic and behavioral methods to target coexisting risk factors for late complications of diabetes.
A long-term intensive multifactorial intervention was associated with gains in years of life and in time free of incident cardiovascular disease compared with conventional treatment in diabetes patients with microalbuminuria.
In 1993, Danish researchers randomly assigned 160 patients in Denmark with type 2 diabetes and microalbuminuria to intensive treatment or to conventional treatment. Intensive treatment used both pharmacologic and behavioral methods to target coexisting risk factors for late complications of diabetes, while conventional treatment used treatment goals outlined in existing national guidelines. The original intervention lasted for a median of 7.8 years, after which all patients received the intensive therapy treatment and the study continued as an observational follow-up. The observational study lasted a median of 21.2 years and the primary end point was difference in median survival time between the treatment groups with or without incident cardiovascular disease. The secondary end point was a composite of cardiovascular events, plus mortality and rates of cardiovascular disease. The study results were published online Aug. 16 by Diabetologia.
Of the 160 patients originally enrolled, 130 patients, 63 in the conventional treatment group and 67 in the intensive treatment group, completed the 7.8-year intervention period. Forty-two patients originally assigned to the intensive treatment group and 24 patients originally assigned to the conventional treatment group completed the entire follow-up period. Thirty-eight patients in the intensive treatment group (48%) and 55 patients in the conventional treatment group (69%) died during follow-up (hazard ratio, 0.55; 95% CI, 0.36 to 0.83; P=0.005). Patients in the intensive treatment group lived for a median of 7.9 years longer than those in the conventional treatment group, with a median of 8.1 years longer before a first cardiovascular event after randomization (P=0.001). Thirty-five patients in the intensive treatment group versus 51 patients in the conventional treatment group had a cardiovascular event during follow-up, while 28 and 13 patients, respectively, had no incident macrovascular events. Those in the intensive treatment group also had a lower risk for all microvascular complications, except peripheral neuropathy, versus the conventional treatment group.
The authors noted that all patients originally assigned to the conventional treatment group began intensive treatment during the follow-up period, meaning that beginning at approximately year 8, all patients in the study received the same therapy. They attributed the beneficial effects seen throughout follow-up in the intensive treatment group to “early intervention intensification in patients at lower absolute risk for late diabetic complications compared with a situation wherein increased vascular damage is already present with intensification in later stages of the disease.” Their findings, they wrote, should increase the focus on the potentially preventive effects of early, intensified control of risk factors in patients with type 2 diabetes and microalbuminuria.