The European Association for the Study of Diabetes (EASD) just wrapped up their annual conference on Sept. 24th. Among the research presented in Stockholm was the following:
Conference report: Early intensive therapy of no benefit in diabetes?
Source: MedPage Today
Date published: 27/09/2010 16:08Summaryby: Nicola Pocock
According to study findings reported at the European Association for the Study of Diabetes meeting, early intensive treatment of patients with screen-detected type 2 diabetes in primary care is feasible, but may not reduce cardiovascular complications compared to standard care.
The ADDITION included 3,057 patients aged 40-69 years who were tested positive for diabetes in primary care in Britain, the Netherlands, and Denmark. They were randomised to treatment with routine care (According to national guidelines) or intensive treatment according to the following protocol:
• Antihypertensive treatment with an ACE inhibitor was started at a blood pressure of ≥120/80mmHg, with directions to intensify treatment for blood pressures of ≥135/85mmHg or greater.
• Lipid-lowering medication was initiated if lipids were ≥3.5 mmol/l (135 mg/dL) with intensification if levels were ≥4.5 mmol/l (174 mg/dL).
• The treatment target for blood glucose was a haemoglobin A1c (HbA1c) of ≤6.5%.
The risk of composite cardiovascular events after five years was 7.2% with intensive management and 8.5% for routine care (hazard ratio 0.83; P=0.12). There was no statistically significant difference in any of the individual components of this endpoint, including cardiovascular death (0.88; 95% CI 0.51 to 1.51), myocardial infarction (0.70; 95% CI 0.41 to 1.21), stroke (0.98; 95% CI 0.57 to 1.71), and revascularisation (0.79; 95% CI 0.53 to 1.18). All-cause mortality also favoured intensive management but again without a statistically significant impact (HR 0.91, 95% CI 0.69 to 1.21).
Much like the ACCORD study, this research did not find any benefit for type 2s keeping their A1cs at or under 6.5%, their lipids under 135 mg/dL, or their blood pressure under 120/80mmHg. Yet, given the limited information published here, I have to wonder about other factors that could have had an impact on the outcome. For instance, this study appears to focus solely on medications, making the main question "will medicating individuals with diabetes to lower their blood glucose, lipids, and blood pressure improve mortality rates?" There doesn't appear to be any discussion of the impact of lifestyle modification in addition to the medication as another factor in reducing the mortality rate. Perhaps there might be a difference between the two groups if, in addition to intensive medication, there were also an intensive lifestyle modification treatment, too.
However, I did find the following that sheds a little light on how the researchers interpreted their study:
But some diabetes specialists weren't ready to write off the strategy.
The "fairer conclusion" is that intensive therapy is effective, just not more so than routine care, when compared with no screening and no diabetes treatment, said study discussant William Herman, MD, MPH, of the University of Michigan in Ann Arbor, at the session.
He showed a risk prediction model projection that if the patients in the trial had gone untreated over the same period, the primary composite endpoint rate would have been twice that of either type of care.
The intensive goals are fine and it's not too hard to achieve them, concluded Peter Gottlieb, MD, of the University of Colorado Denver, who was not involved in the trial.
If anything, "their control group was too good," he commented in an interview. "If you had the original control group that they expected, their results would have been totally statistically significant."
Not surprisingly, the biggest differences were between baseline and follow-up for treatment and risk factor profiles, rather than between the intensive intervention and routine control groups, Herman noted.
The majority of patients in both groups achieved the intensive group treatment targets with differences of only 2.86 mm Hg for systolic blood pressure, 0.27 mmol/l for total cholesterol, and 0.08% for hemoglobin A1c between groups -- though all favored intensive management -- at the average 5.3 years of follow-up.
So, what's your take-away?