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Olmesartan medoxomil delayed microalbuminuria in patients with type 2 diabetes

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Renal Week 2009

Olmesartan medoxomil significantly delayed the occurrence of microalbuminura in patients with type 2 diabetes, according to recent data from the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study.

"We assessed whether early prevention could reduce the occurrence of microalbuminuria in patients with type 2 diabetes - the first sign of diabetic nephropathy," Hermann Haller, MD, director of the department of Nephrology and Hypertension at the Hannover Medical School in Hannover, Germany, told Endocrine Today.

ROADMAP is a placebo-controlled, multicenter, double-blind, parallel group study including 4,400 patients aged 18 to 75 years with type 2 diabetes and normoalbuminuria.

Patients were assigned to either once-daily olmesartan medoxomil 40 mg (n=2,200; Benicar, Daiichi Sankyo) or placebo (n=2,200) and were followed for 3.2 years. At baseline, patients had a mean HbA1c level of 7.6% and BMI of 31.

Approximately 80% achieved target blood pressure at 42 months. “We saw quite an effect on BP,” Haller said. “Percentage of patients reaching BP goal of 130/80 mm Hg was very high — in fact the highest in any trial in patients with diabetes.”

Time to first occurrence of microalbuminuria was significant. After one year, the curves were significantly different (178 patients in the treatment group vs. 210 in the placebo group).

The researchers reported no differences in renal morbidity events or endpoints for CV morbidity between the two groups. However, a higher incidence for CV mortality was found in the olmesartan medoxomil group when compared with the placebo group (15 vs. 3).

"Data showed no difference in overall mortality, but there was an imbalance with very low numbers for cardiovascular mortality and we will see how this develops further down the road," Haller said. "BP control is still necessary for reduced cardiovascular risk and we will examine how olmesartan will later affect cardiovascular outcome within the next couple of years in the follow-up study." - by Jennifer Southall

Haller HG. J Hypertens. 2009;24:403-408.

Haller HG. Late-breaking clinical trial. Presented at: Renal Week 2009; Oct. 27-Nov. 1; San Diego.