Abstract 426: The Diovan Reduction Of Proteinutria (Drop) Study: Albuminuria Response to High-Doses Of Valsartan in Type 2 Diabetes Mellitus
We evaluated whether high doses of valsartan (V), an angiotensin receptor blocker (ARB), are superior to conventional doses to reduce urinary albumin excretion rates (UAER) in type 2 diabetes mellitus (T2DM). In a multicenter, double-blind study, 391 hypertensive patients with T2DM and UAER 20 –700 g/min were randomized to V160 mg (V160), 320 mg (V320) or 640 mg (V640). All patients received V160 for the first 4 wks, then treatment was maintained in one group and increased in the other two groups to V320 or V640 for a total of 30 wks. Comparable UAER reductions from baseline were seen in all groups at wk 4 (P<.001). Then, a highly significant incremental UAER reduction occurred with V320 and V640, vs a modest additional change with V160 (p<.03; Table). Greater UAER reductions also occurred with V640 vs V160 during wk 0 –30 in patients achieving BP<30/80 mmHg (Table). Correlation analysis showed independence between BP and UAER. At wk 30, twice as many patients returned to normal UAER with V640 vs. V160 (24% vs 12%, respectively; p<.01). Except for slightly more dizziness and headache with V640, high doses were well tolerated, with no dose-related increases in other AEs, including hypotension and hyperkalemia. Thus, high doses of V produce greater UAER reduction in hypertensive patients with T2DM vs the 160 mg dose, apparently independent of BP. This information supports the need for use of higher doses of ARB for renal protection in T2DM.