ROADMAP
Trial question
What is the role of olmesartan in preventing the occurrence of microalbuminuria in patients with T2DM?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 4447
4447 patients (2395 female, 2052 male).
Inclusion criteria: adult patients with T2DM.
Key exclusion criteria: CrCl < 30 mL/min; severe uncontrolled hypertension; renal or renal-vascular disease; treatment with ARB or ACE inhibitors within 6 month prior to screening.
Interventions
N=2232 olmesartan (a dose of 40 mg once daily).
N=2215 placebo (matching placebo tablets).
Primary outcome
Time to first onset of microalbuminuria
722 days
576 days
722.0 days
541.5 days
361.0 days
180.5 days
0.0 days
Olmesartan
Placebo
Significant
increase ▲
Significantly longer time to the first onset of microalbuminuria (722 days vs. 576 days; HR 1.3, 95% CI 1.06 to 1.59).
Secondary outcomes
No significant difference in cardiovascular complications or CV death (4.3% vs. 4.2%; HR 1, 95% CI 0.75 to 1.33).
Significant increase in decline in eGFR (4.9 vs. 1; MD 3.9, 95% CI 1.59 to 6.21).
Significant increase in CV death (0.7% vs. 0.1%; HR 4.94, 95% CI 1.43 to 17.06).
Safety outcomes
No significant differences in serious adverse events, renal events.
Significant difference in drug-related adverse events (11.4% vs. 7.5%).
Conclusion
In adult patients with T2DM, olmesartan was superior to placebo with respect to time to the first onset of microalbuminuria.
Reference
Hermann Haller, Sadayoshi Ito, Joseph L Izzo Jr et al. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17.
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