The Diabetes Reduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial has been made available as an early online publication in two parts. The ramipril arm of the study is available from the New England Journal of Medicine and the rosiglitazone arm is available from The Lancet.
The results from the ramipril arm appear to have been largely ignored while the results from the rosiglitazone arm have been reported in the media over the weekend, for example by the BBC.
The results in the ramipril arm of the study showed no difference between ramipril and placebo in preventing progression of impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) states to diabetes. There was a statistical difference in blood pressure with a difference of 3.9/2.7mmHg at 2 months and 3.9/2.4mmHg at the end of the study. There was no significant difference in cardiovascular outcomes however this outcome was a composite secondary outcome and conclusions should not be reached without further investigation.
The accompanying editorial concludes that ramipril should not be used to prevent type II diabetes and that the mainstay of treatment is diet and exercise.
The result of the rosiglitazone arm of the study demonstrated a statistically significant decrease in the number of patients with IFG or IGT who progressed to diabetes. The absolute risk reduction was 14.4% with a number needed to treat of 7 over 4 years. However, this benefit is not risk free. There were trends towards more cardiovascular events, although most were not statistically significant.
- 66% more likely to suffer a myocardial infarction (not significant)
- 39% more likely to suffer a stroke (not significant)
- 20% more likely to suffer a cardiovascular death (not significant)
- 20% more likely to be diagnosed with angina (not significant)
- 29% more likely to undergo a revascularisation procedure (not significant)
- 703% more likely to develop heart failure (statistically significant)
The paper concludes that more work needs to be done to examine the impact that the beneficial metabolic effects observed have on cardiovascular, renal, retinal and other health events. The accompanying editorial concludes that the benefits would need to be balanced against the increased risk of heart failure and that "given the prolonged benefits and demonstrable cost effectiveness of intensive lifestyle intervention for people at high risk of diabetes, such interventions should remain the mainstay of the prevention of type II diabetes."
Action: Lifestyle interventions including diet, exercise and smoking cessation remain as the mainstay for the prevention and treatment of diabetes and cardiovascular disease. Using drugs to prevent disease will involve an assessment of future benefits against potential risks. Based on current evidence the benefits of drug intervention do not outweigh the risks of treatment.
|« SMC reject Exubera||Yearly Bisphosphonate! »|