Look AHEAD: Despite ‘negative’ findings, trial offers insight and benefits
LAS VEGAS – Despite findings of futility in its primary endpoint of cardiovascular improvement, experts here said the Look AHEAD trial gave insight into how intensive lifestyle interventions affected patients with diabetes.
“This was a very positive study. While we didn’t see a difference in the primary endpoint, which [were] cardiovascular events, there are many other positive findings that are coming out from an intensive lifestyle program,” Edward S. Horton, MD, professor of medicine at the Harvard School of Medicine, said during his presentation at the AACE 23rd Annual Scientific & Clinical Congress. “This has really brought us to look at … some of the other long-term outcomes.”
In the Look AHEAD trial, approximately 5,000 patients with diabetes were assigned intensive lifestyle interventions (n=2,570) or diabetes support and education (n=2,575). Intensive lifestyle interventions included weekly meetings with physicians, adoption of a controlled-calorie diet and increased activity. Data showed that the primary endpoints of reduced cardiovascular morbidity and mortality were not statistically different from the group not receiving intensive lifestyle interventions (HR=0.95; (0.83, 1.09 P=.505), so the trial was deemed futile.
Yet, as he reported these results the first time, Horton said patients assigned the lifestyle interventions testified that they no longer suffered from sleep apnea or were no longer reliant upon their CPAP machines.
Horton said upon looking into these statements, the researchers found that more patients in the lifestyle intervention group had a full remission of sleep apnea at year 4 compared with those who relied on diabetes support and education.
This piqued the interest of the researchers and they plan to continue follow-up of these patients up to and beyond August 2015. Though intensive lifestyle intervention has been discontinued due to the primary endpoint results, all patients will now be offered group meetings throughout the year, he said. The researchers hope to look at obesity, cognitive function, mobility and falls, and more.
“We have a lot to learn about the natural history and the long-term impact in patients with diabetes and the impact of diabetes on many, many health issues,” Horton said. “The participants in the study don’t want to quit. They are very enthusiastic. They have loved the program and they want to keep going for many, many years.”
For more information: Horton ES. W22. Presented at: AACE 23rd Annual Scientific & Clinical Congress; May 13-18, 2014; Las Vegas, Nevada.
Disclosures: Horton reports no relevant financial relationships.