ACE inhibitors for diabetic patients with normal BP and AER?
ACE inhibitors for diabetic patients with normal BP and AER?
Are there clinical data showing that angiotensin-converting enzyme (ACE) inhibitors are renoprotective in diabetic patients (type 1 or type 2) who are normotensive and have no microalbuminuria?
Glen Mason, MD
The short answer to this question is "we don't know," because no trial reported on to date has been of sufficient duration and has had enough hard end points.
In type 1 diabetes the largest trial is probably the EUCLID (EURODIAB Controlled Trial of Lisinopril in Insulin-Dependent Diabetes Mellitus) Study. A total of 440 initially normoalbuminuric patients were randomized to receive either lisinopril 10-20 mg/day or placebo for 2 years with a target diastolic pressure of < 75 mmHg. Baseline albumin excretion rate (AER) was about 6 mcg/min in both groups, and a nonsignificant absolute treatment difference of around 1 mcg/min was observed. Virtually no effect was seen at baseline values < 5 mcg/min. Microalbuminuric patients taking lisinopril in this study showed a significant reduction in AER, and a recent meta-analysis has confirmed the efficacy of ACE inhibitors in these patients.
Data in patients with type 2 diabetes are more scarce, largely because it is unusual to find normotensive patients with microalbuminuria. The MICRO HOPE (Health Outcomes and Prevention Evaluation) Study of patients with type 2 diabetes reported finding a reduction in the albumin-creatinine ratio (ACR) in 1808 ramipril-treated patients compared with 1769 patients in the placebo group over 4.5 years of the study. However, more than 30% of these patients had an ACR > 2.5 mg/mmol at baseline and more than 50% were hypertensive. The risk of developing an ACR > 2.5 mg/mmol in those with a baseline ACR lower than this value was nonsignificantly reduced by 9% (95% CI: -4 -20; P = .17).
Are there clinical data showing that angiotensin-converting enzyme (ACE) inhibitors are renoprotective in diabetic patients (type 1 or type 2) who are normotensive and have no microalbuminuria?
Glen Mason, MD
The short answer to this question is "we don't know," because no trial reported on to date has been of sufficient duration and has had enough hard end points.
In type 1 diabetes the largest trial is probably the EUCLID (EURODIAB Controlled Trial of Lisinopril in Insulin-Dependent Diabetes Mellitus) Study. A total of 440 initially normoalbuminuric patients were randomized to receive either lisinopril 10-20 mg/day or placebo for 2 years with a target diastolic pressure of < 75 mmHg. Baseline albumin excretion rate (AER) was about 6 mcg/min in both groups, and a nonsignificant absolute treatment difference of around 1 mcg/min was observed. Virtually no effect was seen at baseline values < 5 mcg/min. Microalbuminuric patients taking lisinopril in this study showed a significant reduction in AER, and a recent meta-analysis has confirmed the efficacy of ACE inhibitors in these patients.
Data in patients with type 2 diabetes are more scarce, largely because it is unusual to find normotensive patients with microalbuminuria. The MICRO HOPE (Health Outcomes and Prevention Evaluation) Study of patients with type 2 diabetes reported finding a reduction in the albumin-creatinine ratio (ACR) in 1808 ramipril-treated patients compared with 1769 patients in the placebo group over 4.5 years of the study. However, more than 30% of these patients had an ACR > 2.5 mg/mmol at baseline and more than 50% were hypertensive. The risk of developing an ACR > 2.5 mg/mmol in those with a baseline ACR lower than this value was nonsignificantly reduced by 9% (95% CI: -4 -20; P = .17).