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
576
722.0 days
541.5 days
361.0 days
180.5 days
0.0 days
Olmesartan
Placebo
Significant
increase ▲
Significant increase in 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 composite of cardiovascular complications or death from cardiovascular causes (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 death from cardiovascular causes (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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