Olmesartan for treatment of hypertension in patients with DM2 - concern

January 01, 0001

Olmesartan for treatment of hypertension in patients with DM2 - concern

These authors from multiple countries investigated whether treatment with an angiotensin-receptor blocker (ARB) would delay or prevent the occurrence of microalbuminuria in patients with type 2 diabetes and normoalbuminuria. They conducted a randomized, double-blind, multicenter, controlled trial, and assigned 4447 patients with type 2 diabetes to receive olmesartan (at a dose of 40 mg once daily) or placebo for a median of 3.2 years. Additional antihypertensive drugs (except angiotensin-converting-enzyme inhibitors or ARBs) were used as needed to lower blood pressure to less than 130/80 mm Hg. The primary outcome was the time to the first onset of microalbuminuria.

They found: "The target blood pressure (less than 130/80 mm Hg) was achieved in nearly 80% of the patients taking olmesartan and 71% taking placebo; blood pressure measured in the clinic was lower by 3.1/1.9 mm Hg in the olmesartan group than in the placebo group. Microalbuminuria developed in 8.2% of the patients in the olmesartan group (178 of 2160 patients who could be evaluated) and 9.8% in the placebo group (210 of 2139); the time to the onset of microalbuminuria was increased by 23% with olmesartan (hazard ratio for onset of microalbuminuria, 0.77). The serum creatinine level doubled in 1% of the patients in each group. Slightly fewer patients in the olmesartan group than in the placebo group had nonfatal cardiovascular events — 81 of 2232 patients (3.6%) as compared with 91 of 2215 patients (4.1%) (NS) — but a greater number had fatal cardiovascular events — 15 patients (0.7%) as compared with 3 patients (0.1%) (significant), a difference that was attributable in part to a higher rate of death from cardiovascular causes in the olmesartan group than in the placebo group among patients with preexisting coronary heart disease (11 of 564 patients {2.0%} vs. 1 of 540 {0.2)."

The authors concluded: "Olmesartan was associated with a delayed onset of microalbuminuria, even though blood-pressure control in both groups was excellent according to current standards. The higher rate of fatal cardiovascular events with olmesartan among patients with preexisting coronary heart disease is of concern."

Best to avoid olmesartan and probably other ARBs for treatment of hypertension in diabetic patients with coronary heart disease.

For the full abstract, click here.

N Engl J Med 364:907-917, 10 March 2011 © 2011 to the Massachusetts Medical Society
Olmesartan for the Delay or Prevention of Microalbuminuria in Type 2 Diabetes. Hermann Haller, Sadayoshi Ito, Joseph L. Izzo, Jr., et al. Correspondence to Dr. Haller: [email protected]

Category: U. Urinary System, K. Circulatory, T. Endocrine/Metabolic/Nutritional. Keywords: angiotensin receptor blocker, ARB, microalbuminuria, coronary heart disease, death, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 29 March 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.