In the now famous ACCORD Trial the research was baffled by the outcome.
In fact the trial was halted premature because it was decided unethical
3458 Citing Articles !!!!
The inhabitants of Asd discussed this trial intensively and concluded
that this would not happen to them and that the worse outcome was solely
due to the used medication. They would stick to Low-Carb diet and survive.
There are a lot of, free articles in Pubmed with ACCORD in their title
in the follow up studies. A clear reason was never found and hypo's
caused by insulin was excluded, Iirc
The Trial :
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
The purpose of this study is to prevent major cardiovascular events
(heart attack, stroke, or cardiovascular death) in adults with type 2
diabetes mellitus using intensive glycemic control, intensive blood
pressure control, and multiple lipid management.
The first publication of the trial :
3458 Citing Articles
Effects of Intensive Glucose Lowering in Type 2 Diabetes
The Action to Control Cardiovascular Risk in Diabetes Study Group*
June 12, 2008
N Engl J Med 2008; 358:2545-2559
Epidemiologic studies have shown a relationship between glycated
hemoglobin levels and cardiovascular events in patients with type 2
diabetes. We investigated whether intensive therapy to target normal
glycated hemoglobin levels would reduce cardiovascular events in
patients with type 2 diabetes who had either established cardiovascular
disease or additional cardiovascular risk factors.
In this randomized study, 10,251 patients (mean age, 62.2 years) with a
median glycated hemoglobin level of 8.1% were assigned to receive
intensive therapy (targeting a glycated hemoglobin level below 6.0%) or
standard therapy (targeting a level from 7.0 to 7.9%). Of these
patients, 38% were women, and 35% had had a previous cardiovascular
event. The primary outcome was a composite of nonfatal myocardial
infarction, nonfatal stroke, or death from cardiovascular causes. The
finding of higher mortality in the intensive-therapy group led to a
discontinuation of intensive therapy after a mean of 3.5 years of follow-up.
At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5%
were achieved in the intensive-therapy group and the standard-therapy
group, respectively. During follow-up, the primary outcome occurred in
352 patients in the intensive-therapy group, as compared with 371 in the
standard-therapy group (hazard ratio, 0.90; 95% confidence interval
[CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the
intensive-therapy group died, as compared with 203 patients in the
standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46;
P=0.04). Hypoglycemia requiring assistance and weight gain of more than
10 kg were more frequent in the intensive-therapy group (P<0.001).
As compared with standard therapy, the use of intensive therapy to
target normal glycated hemoglobin levels for 3.5 years increased
mortality and did not significantly reduce major cardiovascular events.
These findings identify a previously unrecognized harm of intensive
glucose lowering in high-risk patients with type 2 diabetes.
(ClinicalTrials.gov number, NCT00000620.)