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Published on: February 7, 2011
The DIAB-HYCAR Study
1Diabetes Department, Saint Louis Hospital, Paris, France.
Insights
This study investigated if low-dose ramipril reduces cardiovascular events in non-insulin-dependent diabetic patients with albuminuria. Results are pending, but the trial aims to clarify ACE inhibition benefits beyond blood pressure control.
Area of Science:
- Nephrology
- Cardiology
- Endocrinology
Background:
- Microalbuminuria and proteinuria predict cardiovascular mortality in non-insulin-dependent diabetic (NIDDM) patients.
- Angiotensin-converting enzyme (ACE) inhibition benefits diabetic nephropathy but its cardiovascular impact in NIDDM is unknown.
Purpose of the Study:
- To test if low-dose ramipril (1.25 mg daily), without significant blood pressure effect, reduces cardiovascular morbidity/mortality in NIDDM patients with persistent albuminuria.
- To evaluate ACE inhibition's role in cardiovascular risk reduction in this specific diabetic population.
Main Methods:
- Randomized, double-blind, placebo-controlled trial involving 4000 NIDDM patients.
- Patients receive standard care plus either placebo or 1.25 mg ramipril daily for 3 years.
- Major endpoints include cardiovascular death, sudden death, myocardial infarction, stroke, and renal replacement therapy.
Main Results:
- Study initiated February 1995, with initial screening identifying 23% prevalence of persistent albuminuria.
- 964 patients initially included, with 619 eligible patients enrolled shortly after.
- Data collection strategies are in place to accurately record cardiovascular events and minimize patient loss to follow-up.
Conclusions:
- The Diab-Hycar study is designed to provide crucial data on the cardiovascular protective effects of low-dose ACE inhibition in NIDDM patients with albuminuria.
- Findings will inform clinical practice regarding the management of cardiovascular risk in this vulnerable patient group.
Abstract:
Microalbuminuria and proteinuria are strong independent predictors for increased cardiovascular mortality in non-insulin-dependent diabetic (NIDDM) patients. In such patients, angiotensin converting enzyme (ACE) inhibition improves the evolution of diabetic nephropathy; however, no data are currently available on the effects of such intervention on cardiovascular morbidity and mortality. The aim of the Diab-Hycar study is to test the hypothesis that ACE inhibition with a low daily dose of 1.25 mg ramipril, which has no significant effect on blood pressure, may reduce cardiovascular morbidity and/or mortality in normotensive or hypertensive NIDDM patients with persistent albuminuria. Selected and followed by general practitioners, 4000 patients will receive their usual oral antidiabetic treatment and if necessary antihypertensive treatment (ACE inhibitors excluded). In addition in a randomized, double-blind trial they will be given either a placebo or 1.25 mg ramipril daily. The follow-up is currently scheduled to last 3 years. The efficacy of ACE-inhibition will be assessed by the following major end-points: cardiovascular death, sudden death, myocardial infarction, stroke, renal replacement therapy. The Diab-Hycar study started on 3 February 1995. By 1 September 1995, 11,000 urine samples were tested. The prevalence of persistent albuminuria was 23%, 964 patients were initially included in the study, with 619 eligible patients included soon after. Different strategies have been developed to record cardiovascular events correctly and to minimize the number of patients lost to follow-up.
