O-6: Microalbuminuria reduction with valsartan

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