Intensive lifestyle intervention for folks with type 2 diabetes fails to reduce cardiovascular events and death from same, a study Rick and I discuss this week on PodMed and published in the New England Journal of Medicine sadly concludes. Results were so lackluster in fact that the study was stopped early! Sigh. A sacred cow has been slaughtered, and I for one am sorry. Let's take a closer look at the carnage.
Look AHEAD (the name of the study) researchers investigated whether weight loss and increased exercise in people with a BMI greater than 25, who were also using a medication for glucose lowering, some of whom were on insulin, and were 45 to 75 years of age, among other study entry criteria, reduced cardiovascular events or death from cardiac problems. The intention was to follow these participants for up to 13.5 years, and they were recruited from 16 clinical sites in the United States. 5145 patients were randomized to either intensive intervention with caloric restriction and exercise about 3 hours a week, or usual care involving diabetes support and education. Outcome measures included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina.
The study was stopped early when an interim analysis revealed that the intervention was futile with regard to the outcome measures. At a mean follow-up of 9.6 years, 418 subjects in the control group and 403 of those in the intervention group had experienced one of the primary outcomes. Wow, what a disappointment! What about other measures of potential benefit? Turns out the intervention group did experience greater weight loss, a greater reduction in waist circumference, a lower hemoglobin A1c, improvements in blood pressure and other measures of cardiovascular risk except low-density lipoprotein levels. The intervention group also used fewer antihypertensive medications, statins, and insulin. Yet these did not translate into fewer cardiovascular events, a finding I find nearly incomprehensible. Does this mean we can just back off and tell folks with type 2 diabetes to simply take their medicines and otherwise do as they like ?
Rick and I agree that although the hard endpoints were distressingly unchanged, the other aspects of life for the intervention group, specifically being able to take fewer medicines, are worth advocating, and we're sticking with our story. Things like arthritis and mobility will also be positively affected by weight loss and exercise, and additional quality of life measures would no doubt be improved.
It would be remiss of us, of course, not to mention that the very best strategy for type 2 diabetes is prevention, and that's where we'd put our money. If obesity is prevented by a multipronged and societally sanctioned approach, type 2 diabetes incidence will be dramatically reduced. We're also willing to bet that those cardiovascular outcomes would also occur much less frequently.
Other topics this week include an implantable insulin pump that detects nighttime blood sugars, also in NEJM, strategies to lower costs in high risk Medicare patients in JAMA, and advanced treatment use in men with low risk prostate cancer in the same journal. Until next week, y'all live well.