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Abstract

Microalbuminuria is a strong predictor of nephropathy and cardiovascular disease in patients with diabetes mellitus. ACE inhibitors have been shown to significantly reduce microalbuminuria and the progression to overt nephropathy, but there are a limited number of controlled trials evaluating the effects of the angiotensin receptor blockers.

A multicentre, randomised, double blind, active controlled, parallel group study. Patients aged 35-75 years with type II diabetes and microalbuminuria were randomised to receive valsartan 80mg od or amlodipine 5mg od over 24 weeks. Target blood pressure of 135/85 mmHg was aimed for by dose doubling and the addition of bendrofluazide and doxazosin therapy. Measurements of urinary albumin excretion rate (UAER) by timed overnight urine samples, and sitting blood pressure measurements were made at entry, 4, 8, 12, 18 and 24 weeks. The primary endpoint was the change in UAER and the study was designed to show a 15% difference between the two arms with 90% power, at the 5% level.

A total of 332 patients were randomised (169 valsartan, 163 amlodipine). A significant reduction in the primary endpoint of UAER was found at 24 weeks with valsartan, compared with that in the amlodipine group (p<0.001). Geometric mean (lower and upper quartiles) in UAER (μg/min) from baseline to end of study were: for valsartan 57.97(33.0,102.3) to 32.3(18.2,59.7) and for amlodipine 55.4(34.3,84.6) to 50.7(31.8,85.6) (p<0.001; for between group difference). Significant reductions with valsartan were equally seen in the hypertensive group. Significantly more patients in the valsartan group returned to normoalbuminuria status than with amlodipine (29.9% vs 14.5%)(p=0.001). Changes in blood pressure were not different between the groups. Mean systolic blood pressure decreased by 11.2 mmHg in the valsartan and 11.6 mmHg in the amlodipine group at 24 weeks; mean diastolic blood pressure decreased by 6.2 mmHg in the valsartan and 5.8 mmHg in the amlodipine group (ns).

For the same level of blood pressure reduction valsartan is significantly more effective in reducing UAER in patients with type II diabetes and microalbuminuria in comparison to amlodipine.

valsartan, microalbuminuria, diabetes
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© American Journal of Hypertension, Ltd. 2001
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