Abstract | OBJECTIVE: DESIGN: Randomised, double blind, parallel group trial comparing ramipril (1.25 mg/day) with placebo (on top of usual treatment) for cardiovascular and renal outcomes for at least three years. SETTING: Multicentre, primary care study conducted mostly by general practitioners in 16 European and north African countries. PARTICIPANTS: MAIN OUTCOME MEASURES: RESULTS: Participants were followed for 3 to 6 (median 4) years. There were 362 primary events among the 2443 participants taking ramipril (37.8 per 1000 patient years) and 377 events among the 2469 participants taking placebo (38.8 per 1000 patient years; hazard ratio 1.03 (95% confidence interval 0.89 to 1.20, P = 0.65)). None of the components of the primary outcome was reduced. Ramipril lowered systolic and diastolic blood pressures (by 2.43 and 1.06 mm Hg respectively after two years) and favoured regression from microalbuminuria (20-200 mg/l) or proteinuria (> 200mg/l) to normal level (< 20 mg/l) or microalbuminuria (P < 0.07) in 1868 participants who completed the study. CONCLUSIONS: Low dose (1.25 mg) ramipril once daily has no effect on cardiovascular and renal outcomes of patients with type 2 diabetes and albuminuria, despite a slight decrease in blood pressure and urinary albumin. The cardiovascular benefits of a daily higher dose (10 mg) ramipril observed elsewhere are not found with an eightfold lower daily dose.
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Authors | Michel Marre, Michel Lievre, Gilles Chatellier, Johannes F E Mann, Philippe Passa, Joël Ménard, DIABHYCAR Study Investigators |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 328
Issue 7438
Pg. 495
(Feb 28 2004)
ISSN: 1756-1833 [Electronic] England |
PMID | 14960504
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiotensin-Converting Enzyme Inhibitors
- Ramipril
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Topics |
- Aged
- Albuminuria
(etiology)
- Angiotensin-Converting Enzyme Inhibitors
(administration & dosage, adverse effects)
- Blood Pressure
(drug effects)
- Diabetes Mellitus, Type 2
(complications)
- Diabetic Angiopathies
(prevention & control)
- Diabetic Nephropathies
(prevention & control)
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Ramipril
(administration & dosage, adverse effects)
- Risk Factors
- Treatment Outcome
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