Intensified approach cut long-term heart failure risk in type 2 diabetes

A 70 percent reduction in the risk of hospitalization for heart failure was achieved in people with type 2 diabetes mellitus given an intensified treatment in a long-term follow up of the STENO-2 study.

Over 21 years, 34 (21 percent) of 160 study subjects developed heart failure; 24 (30 percent) had initially received intense treatment. The annualized rates of heart failure were calculated as a respective 2.4 percent and 0.8 percent (hazard ratio, 0.30; P less than .002), as reported at the annual meeting of the European Association for the Study of Diabetes.

 Furthermore, after adjustment was made for subject age, gender, prohormone brain natriuretic peptide levels, and ejection fraction at recruitment, there was a 76 percent relative risk reduction in heart failure with the intensified strategy versus conventional treatment.

“Heart failure in diabetes is frequent, fatal, and at least until very recently, quite forgotten, as commented during the research performed while he was at the STENO Diabetes Center in Copenhagen.

It was noted that heart failure was four times more likely to occur in patients with T2DM who had microalbuminuria than in those with normal albumin levels in the urine, and the median survival was around 3.5 years. While there is no regulatory requirement at present to stipulate that heart failure should be assessed in trials looking at the cardiovascular safety of T2DM treatments, recording such information is something that the STENO-2 investigators would recommend.

STENO-2 was open, parallel-group study initiated in 1993 to compare conventional multifactorial treatment of T2DM with an intensified approach over an 8-year period. After the primary composite cardiovascular endpoint was assessed, the trial continued as an observational study, with all patients given the intensified, multifactorial treatment that consisted of lifestyle measures and medications targeting hyperglycemia, hypertension, hypercholesterolemia, and hypercoagulation.

The primary endpoint of the long-term follow-up study was the difference in median survival time between the original treatment groups with and without incident cardiovascular disease. The results showed a 48 percent relative reduction in the risk of death; those initially given the intensified treatment had an increased lifespan of 7.9 years and an 8.1 year increased survival without cardiovascular disease versus those who had initially received conventional treatment.

Data were presented on heart failure outcomes obtained from a post-hoc analysis of prospectively collected and externally adjudicated patient records.

In addition to the reductions in the primary outcome of time to heart failure, the secondary outcomes of time to heart failure or cardiovascular mortality (HR, 0.38;P=.006) and heart failure or all-cause mortality (relative risk reduction, 49 percent; P=.001) also favored initial intensive treatment versus conventional treatment.