Major Finding: The cumulative incidence of microalbuminuria was 8.2% of patients on olmesartan vs. 9.8% of placebo patients, for a highly significant risk reduction of 23%.
Data Source: Randomized, placebo-controlled, double-blind, multicenter ROADMAP trial of 4,447 patients with type 2 diabetes and one or more other cardiovascular risk factors but with normoalbuminuria.
Disclosures: The study was funded by Daiichi-Sankyo, which manufactures olmesartan under the name Benicar.
STOCKHOLM – Olmesartan significantly reduced the time to microalbuminuria in a randomized, placebo-controlled, double-blind multicenter study of 4,447 patients with type 2 diabetes.
The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial investigated whether early treatment with the angiotensin receptor blocker olmesartan would delay the occurrence of microalbuminuria in patients with type 2 diabetes who had at least one other cardiovascular risk factor but who had normal albumin excretion at baseline.
At baseline, the patients had a mean age of 58 years, diabetes duration of 6 years, body mass index of 30 kg/m
In both groups, additional antihypertensive drug treatment other than ARBs or ACE inhibitors was used to reach the target BP of less than 130/80 mm Hg. That goal was reached by 78% of the olmesartan group and 71% of the placebo group by 48 months, Dr. Hermann Haller reported at the meeting.
The cumulative incidence of microalbuminuria was 8.2% in the olmesartan patients vs. 9.8% in the placebo group, giving a highly significant risk reduction of 23%, reported Dr. Haller of Hannover (Germany) Medical School.
Correction for the small differences in blood pressure between the two groups showed that the majority of the effect was BP-independent, he said.
Overall cardiovascular morbidity and mortality rates were low and similar between the two groups, with 4.3% of the olmesartan group and 4.2% of the placebo group experiencing any cardiovascular event or death. Total mortality occurred in 1.2% and 1.7%, respectively. Cardiovascular mortality, however, was higher in the olmesartan group (15 deaths vs. 3 deaths, or 0.7% vs. 0.1%), possibly because of hypotensive episodes in patients with preexisting cardiovascular disease.
There were no adverse effects of olmesartan on hard renal outcomes, Dr. Haller said.
Correction for the small differences in blood pressure between groups showed that most of the effect was BP-independent.
Source DR. HALLER