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Intensive lifestyle intervention failed to prevent CV events in obese patients with diabetes
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A long-term, intensive lifestyle intervention targeting weight loss in overweight and obese patients with type 2 diabetes did not reduce the rate of CV events, including nonfatal MI and stroke, according to primary results from the Look AHEAD trial. The intervention, however, yielded other benefits in this patient population.
Investigators randomly assigned 5,145 overweight and obese patients with type 2 diabetes at 16 US centers to an intensive lifestyle intervention promoting weight loss or a combination of diabetes support and education. The intervention included decreased caloric intake and increased physical activity. A composite of death from CV causes, nonfatal MI, nonfatal stroke or hospitalization for angina during a maximum of 13.5 years follow-up served as the primary endpoint.
“The rationale for Look AHEAD is that we did not know whether weight loss achieved through a behavioral intervention program could help people with diabetes, specifically type 2 diabetes, live longer and develop less CVD,” Mary Evans, PhD, director of Look AHEAD and from the special projects in nutrition, obesity and digestive diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, said during a press conference at the American Diabetes Association Scientific Sessions in June.
No improvement in CVD outcomes
The trial was terminated early based on futility at a median follow-up of 9.6 years, according to Rena Wing, PhD, Look AHEAD chair and professor of psychiatry and human behavior at the Alpert Medical School, Brown University. Mean weight loss was greater in the intervention group at 1 year (8.6% vs. 0.7%) and at the study’s conclusion (6% vs. 3.5%). Data also linked the intervention to greater decreases in glycated hemoglobin and greater improvements in fitness and overall CV risk factors, with the exception of LDL levels.
However, the CVD-focused primary outcome was not significantly different between the groups (intervention: 403 patients, 1.83 events per 100 person-years; control: 418, 1.92 events per 100 person years). These data translated to an HR of 0.95 (95% CI, 0.83-1.09) for the intervention group.
“Look AHEAD showed that participants with diabetes can lose weight and maintain it,” Wing said. “This weight loss has many beneficial effects on glycemic control and CVD risk factors; however, it did not affect risk for CVD.”
Other benefits
According to William Knowler, MD, PhD, MPH, of the diabetes epidemiology and clinical research section at NIDDK, the intervention was associated with other improvements in common diabetes complications, including less advanced kidney disease, retinopathy and neuropathy.
Lucy Faulconbridge, PhD, assistant professor of psychology and director of research at the Center for Weight and Eating Disorders, Perelman School of Medicine at University of Pennsylvania, said the intervention ameliorated depressive symptoms and improved quality of life, as well.
“We found that participants in the intervention group were 20% less likely than those in the diabetes support and education group to develop symptoms of depression over the course of the study, suggesting that weight loss was protective against developing depression in this population,” Faulconbridge said at the meeting.
In addition, the intensive intervention reduced the average number of annual hospitalizations by 11.9%, which translated into savings of $294 per year and $2,600 discounted over 10 years, compared with the diabetes support and education group, according to Henry A. Glick, PhD, health economist from the Perelman School of Medicine at the University of Pennsylvania. Moreover, number of medications was reduced by 6.3%.
Implications
In an accompanying editorial published in The New England Journal of Medicine, Hertzel C. Gerstein, MD, of the department of medicine and Population Health Research Institute at McMaster University, said these findings suggest that weight loss may not mitigate significant CV risks, but confer other benefits for patients with type 2 diabetes.
“With respect to cardiovascular outcomes, inspection of the confidence intervals should allow clinicians to reassure their patients that intensive lifestyle interventions are unlikely to cause harm and may provide a modest benefit. However, even with no clear evidence of cardiovascular benefit, the Look AHEAD investigators have shown that attention to activity and diet can safely reduce the burden of diabetes and have reaffirmed the importance of lifestyle approaches as one of the foundations of modern diabetes care.” – by Samantha Costa
Perspective
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M. Sue Kirkman, MD
This presentation certainly highlighted interesting findings about the many benefits of the intensive lifestyle intervention on other outcomes beyond the primary outcome. We already knew that the study had been stopped because the primary outcome was not met. I think we’ve all had time to process that a little bit, and it’s nice to hear about the other benefits in terms of depression, onset of diabetes, measures of fitness and quality of life. I think there continues to be reasons to recommend that patients adopt a healthy lifestyle if they’re overweight with type 2 diabetes; we shouldn’t just throw it all out.
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