Transcript The ROADMAP trial: main results

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