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Olmesartan Delays Occurrence of Microalbuminuria in Type 2 Diabetes: Presented at Renal Week 2009

By Kristina Rebelo

SAN DIEGO -- November 1, 2009 -- Olmesartan conferred vascular protection by delaying the occurrence of microalbuminuria (risk reduction of 23%) and controlling blood pressure in patients with type 2 diabetes, according to recent trial results released here at the American Society of Nephrology (ASN) Renal Week 2009.

"In patients with type 2 diabetes, microalbuminuria is a hallmark of diabetic nephropathy and a major therapeutic challenge," stated lead investigator Hermann G. Haller, MD, University of Hannover, and Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany, speaking here at a late-breaking, clinical-trials press briefing on October 30. "It is also an important prognostic marker for the development of cardiovascular disease."

Individuals with hypertension are at a significantly greater risk of morbidity and mortality from cardiovascular disease. The stated aim of the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study was to determine whether the angiotensin-receptor blocker olmesartan medoxomil would prevent the development of microalbuminuria in normoalbuminuric patients with type 2 diabetes plus 1 additional cardiovascular risk factor, who had not been on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker within the last 6 months.

In the double-blind, placebo-controlled, randomised, prospective, multinational study, there were 4,449 patients (ages 18-75 years, mean age 57.7 +- 8.7 years) with type 2 diabetes with a duration of 6.1 +- 5.9 years and a glycated haemoglobin (Hb A1C) of 7.6% +- 1.6%. Mean body mass index was 31.0 +- 4.9 kg/m².

Inclusion criteria included at least 1 additional cardiovascular risk factor, such as hypercholesterolaemia, low high-density lipoprotein cholesterol, high triglycerides, obesity, large waist circumference, hypertension, and/or being a smoker.

In the 2 arms of the study (both n = 2,200), patients were followed for 3.2 years; one arm received 40 mg olmesartan medoxomil ("a relatively high dose," said Dr. Haller) and the other received placebo. The primary endpoint of the study was the time to first onset of persistent microalbuminuria as documented by morning spot urine measurements.

Secondary endpoints included cardiovascular events, morbidity and mortality, end-stage renal disease, and microvascular morbidity. Urine albumin-to-creatinine ratio levels were determined every 6 months.

Baseline blood pressure was 140.8 +- 16.3/84.0 +- 9.8 mm Hg. Seventy-five percent of the patients achieved the blood pressure target in the study (approximately 80% achieved target blood pressure at 42 months). "The study yielded unprecedented blood pressure control for this population of type 2 diabetes mellitus patients," noted Dr. Haller.

There was virtually no difference in renal morbidity events between the 2 groups, and cardiovascular events were also very similar. "We were early in the disease, but we thought we would have more," Dr. Haller pointed out.

Olmesartan medoxomil was well tolerated, with an adverse-event profile similar to placebo. Nine participants were lost to follow-up -- 7 (4.3%) in the olmesartan medoxomil group and 2 (1.1%) in the placebo group. Olmesartan medoxomil had no detrimental effect on hard renal outcomes in the patient population.

There is an observational follow-up study that is ongoing to understand the long-term benefits of microalbuminuria prevention, Dr. Haller noted.

[Presentation title: Prevention of Albuminuria and Cardiovascular Morbidity With Olmesartan -- The ROADMAP Trial. Abstract 7026]

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