The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) trial Randomized, double-blind, multicenter, controlled trial. 4447 patients with type 2 diabetes and at least one additional cardiovascular risk factor, but with no evidence of renal dysfunction Olmesartan (at a dose of 40 mg once daily) versus placebo for median 3.2 years Other antihypertensive drugs (except ACE inhibitors and ARBs) were used as required for BP control (<130/80 mm Hg). The primary outcome was the time to the first onset of microalbuminuria 1.Haller H, et al. Olmesartan for delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011;364:907-917.

ROADMAP trial: Occurrence of microalbuminuria during the 48-month follow-up period in the two study groups RESULTS The target blood pressure (<130/80 mm Hg) was achieved in nearly 80% of the patients taking olmesartan and 71% taking placebo; blood pressure was lower by 3.1/1.9 mm Hg in the olmesartan group than in the placebo group. Olmesartan was associated with increased time to the onset of microalbuminuria by 23% (hazard ratio 0.77; P=0.01), There was a cumulative incidence of microalbuminuria of 8.2% with olmesartan and 9.8% with placebo .   1.Haller H, et al. Olmesartan for delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011;364:907-917.

Patients with events (%) ROADMAP trial: olmesartan delays onset of albuminuria, while increasing mortality End point Olmesartan (n=2232) Placebo (n=2215) Hazard ratio (95% CI) P value Patients with events (%) Primary end point Time to onset of microalbuminuria 178 (8.2) 210 (9.8) 0.77 (0.63-0.94) 0.01 Secondary end points Composite of cardiovascular complications or death from cardiovascular causes 96 (4.3) 94 (4.2) 1.00 (0.75-1.33) 0.99 Death from any cause 26 (1.2) 15 (0.7) 1.70 (0.90-3.22) 0.10 Death from cardiovascular causes 3 (0.1) 4.94 (1.43-17.06) Composite of cardiovascular complications, excluding new-onset atrial fibrillation and transient ischemic attack 63 (2.8) 71 (3.2) 0.87 (0.62-1.22) 0.42 Composite of new-onset atrial fibrillation or transiet ischemic attack 19 (0.9) 28 (1.3) 0.67 (0.37-1.19) 0.17 Composite of all cardiovascular complications 81 (3.6) 91 (4.1) 0.87 (.65-1.18) 0.37 Nonfatal cardiovascular events occurred in 81 patients in the olmesartan group (3.6%) and 91 in the control group (4.1%). However, fatal cardiovascular events occurred in more patients in the olmesartan group (15 (0.7%)) than in the placebo group (3 (0.1%)) and this difference was statistically significant (P = 0.01). 1.Haller H, et al. Olmesartan for delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011;364:907-917.

Randomized Olmesartan And Diabetes MicroAlbuminuriA Prevention (ROADMAP) trial Conclusion Olmesartan was associated with a delayed onset of microalbuminuria. The higher rate of fatal cardiovascular events with olmesartan among patients with pre-existing coronary heart disease is of concern. In the editorial Dr2 Ingelfinger raised a question “Should the question of increases in fatal cardiovascular cardiovascular events in ROADMAP change our approach to renoprotective therapy?” She suggested that some “of the nephrologists and cardiologists have argued that the benefits of olmesartan outweigh the very small risks” when “others would argue that there are many ACE inhibitors and ARBs that have not been associated with a signal of increased cardiovascular death, so why not prescribe one of those agents?” Ingelfinger JR. Preemptive olmesartan for the delay or prevention of microalbuminuria in diabetes. N Engl J Med 2011; 364: 970-971. 1.Haller H, et al. Olmesartan for delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011;364:907-917.