Saturday, October 20, 2012

Look AHEAD halted: Lifestyle management fails to reduce hard CV outcomes in diabetics - O'Riordan

Look AHEAD halted: Lifestyle management fails to reduce hard CV outcomes in diabetics

October 19, 2012
A large cardiovascular-outcomes study funded by the National Institutes of Health that included 5145 adults with diabetes and a body mass index >25 kg/m2, Look AHEAD failed to show a difference in the rate of nonfatal MI, nonfatal stroke, death, or hospitalization for angina among patients randomized to an intensive lifestyle intervention and those randomized to a control arm consisting of education alone.
Despite significant reductions in weight and improvements in physical-fitness levels among patients with diabetes, investigators concluded that the intervention arm, which included individual sessions with a nutritionist and/or personal trainer, as well as group sessions and refresher courses, failed to provide any benefit in terms of cardiovascular outcomes.
Dr Anne Peters (University of Southern California, Los Angeles), one of the study investigators, said in an interview that the trial was successful on one level—namely, that patients lost weight and improved their fitness. Data published at four years showed that the intensive intervention led to weight loss of up to 10% in the first year and that patients maintained a 6.5% reduction in body weight in the following three years. Over an 11-year follow-up period, the patients reported a 5% reduction in body weight from baseline, said Peters.
In addition, early data showed that treadmill fitness levels, hemoglobin A1c levels, systolic and diastolic blood pressure, HDL-cholesterol levels, and triglyceride levels were all significantly improved among patients in the lifestyle-intervention arm when compared with the control group. The only cardiovascular risk factor that remained unchanged with treatment was LDL-cholesterol levels.
Despite the lack of cardiovascular benefit observed in Look AHEAD, Peters stressed that diabetic patients should not stop exercising or begin eating anything they wish.
"We do know that weight loss and exercise can prevent diabetes," said Peters. "I am a big advocate of prevention, both early prevention of obesity altogether, as well as prevention of diabetes in individuals who have become overweight. Lifestyle changes can help prevent diabetes. Once you have diabetes, I think weight loss and exercise can have benefits, but they are not going to reduce the risk for the primary outcome that we set for Look AHEAD, which was a risk for macrovascular events or death."
Read the full article here.

Here is the official stated purpose of the Look AHEAD trial.

The primary objective of Look AHEAD is to examine, in overweight volunteers with type 2 diabetes, the long-term effects of an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity. This program will be compared to a control condition involving a program of diabetes support and education.
The primary hypothesis is that the incidence rate of the first post-randomization occurrence of a composite outcome, which includes
  • cardiovascular death (including fatal myocardial infarction and stroke),
  • non-fatal myocardial infarction,
  • hospitalized angina, and
  • non-fatal stroke,
over a planned follow-up period of up to 13.5 years will be reduced among participants assigned to the Lifestyle Intervention compared to those assigned to the control condition, Diabetes Support and Education.

Look AHEAD will also test for reductions in the incidence of three secondary composite outcomes and examine the effect of the intervention on cardiovascular disease risk factors, diabetes control and complications, general health, and quality of life, and psychological outcomes. The cost and cost-effectiveness of the Lifestyle Intervention relative to Diabetes Support and Education will be assessed.
from https://www.lookaheadtrial.org/public/home.cfm

A comment by Dr. Jack Kruse had this to say about the trial...

Jack Kruse said...

You said, you could not find all cause mortality data for the stop. Not surprising to some of us. The trial was stopped because their hypothesis was being demolished. You and I both know it. But this post further supports my concerns with RCT and so called evidence based medicine. The modern health care complex trump this brand of medicine. I loathe it. There is nothing more dangerous to modern humans than evidence based medicine and we all remain unaware of those pitfalls. Peter has touched on just that here.

I wrote very recently in my Brain Gut 14 blog this: The manner in which we ask questions is deeply flawed in medicine. Here is where the major causative factor lies in medicine that too few are talking about in research literature. You need to know it. Positive findings, whether they are good or bad for our biology, are twice as likely to be published as negative findings.

This dramatically skews the meaning of what the evidence is really showing us in medicine. It is at the core why people do not get better with evidence based practices and remain a medical annuity for the system. This is a cancer at the core evidence-based medicine today. When you become aware of what you do not know, it becomes easier to get to optimal. They key is for you to avoid those pitfalls before you access the healthcare system. Unfortunately, physicians are paid on this data and that is why it appears to many people that doctors just don’t get it. Many of us do get it, but if we step out of line we get punished by the system. That is how I feel about this Look Ahead nonsense. I am more cynical than Peter. I think the trial was ended because a current growth industry in healthcare might have been placed in peril if the trial continued.
from HyperLipid.

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