The efficacy and tolerability of fosinopril in Chinese type 2 diabetic patients with moderate renal insufficiency

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Abstract

Background

The renoprotective effect of angiotensin II antagonists has been demonstrated in type 2 diabetic patients with nephropathy but similar data on angiotensin-converting enzyme (ACE) inhibitors are limited. We examined the efficacy and tolerability of fosinopril, an ACE inhibitor with dual hepatic and renal clearance, in 38 type 2 diabetic patients with moderate renal impairment (plasma creatinine 130–300 μmol/l) over a 2-year period.

Methods

This was a single-centre, randomized, double-blinded, placebo-controlled trial comparing fosinopril 20 mg daily vs. placebo in addition to conventional antihypertensive treatment over a 2-year period. The primary endpoints were the rate of change and the percentage change in both 24-h urinary albumin excretion (UAE) and creatinine clearance (CrCl).

Results

The mean age of the patients was 65 ± 6 years (range 47–76 years, median 66 years) and plasma creatinine 190 ± 49 μmol/l. For similar blood pressure control, the percentage change of UAE in patients with microalbuminuria was greater in the fosinopril than the placebo group (−24.2 ± 28.8 vs. 11.6 ± 42.1%, p = 0.003 after adjustment for baseline covariates). In the fosinopril group, the rate of change of endogenous CrCl was slower than the placebo group (−0.07 ± 0.19 vs. −0.24 ± 0.35 ml/min/week, p = 0.026). The incidence of adverse events was similar between the two groups.

Conclusions

Fosinopril treatment reduced albuminuria and rate of decline in renal function in type 2 diabetic patients with moderate renal insufficiency and did not increase the incidence of adverse events.

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