OMAN
Trial question
What is the role of bedtime dosing for nocturnal BP reduction in patients with hypertension?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 720
720 patients (311 female, 409 male).
Inclusion criteria: adult patients, aged 18-75 years, with hypertension who never used or discontinued antihypertensive drugs for 2 weeks.
Key exclusion criteria: extreme dipper; pregnancy or lactation; renal artery stenosis; hyperkalemia; history of or progression toward hypertensive urgencies or emergencies during the 2-week antihypertensive drug withdrawal phase and enrolment; history of alcohol or drug abuse; night or shift work; CVD; history of hemorrhagic stroke; allergy to amlodipine.
Interventions
N=368 bedtime dosing (olmesartan 20 mg and amlodipine 5 mg daily at bedtime 6-10 PM).
N=352 morning dosing (olmesartan 20 mg and amlodipine 5 mg daily at morning 6-10 AM).
Primary outcome
Mean reduction in nighttime systolic blood pressure at week 12
25.3 mm Hg
22.3 mm Hg
25.3 mm Hg
19.0 mm Hg
12.7 mm Hg
6.3 mm Hg
0.0 mm Hg
Bedtime
dosing
Morning
dosing
Significant
increase ▲
Significantly greater reduction in mean nighttime SBP at week 12 (25.3 mm Hg vs. 22.3 mm Hg; MD 3, 95% CI 1 to 5.1).
Secondary outcomes
No significant difference in mean reduction in nighttime DBP at week 12 (14.8 mm Hg vs. 13.2 mm Hg; MD 1.4, 95% CI -0.1 to 2.8).
Significant increase in nocturnal SBP control at week 12 (79% vs. 69.8%; AD 9.2%, 95% CI 2.2 to 16.2).
Significant increase in office SBP control rate at week 12 (88.7% vs. 82.2%; AD 6.5%, 95% CI 1.02 to 11.98).
Safety outcomes
No significant differences in adverse events, nocturnal hypotension.
Conclusion
In adult patients, aged 18-75 years, with hypertension who never used or discontinued antihypertensive drugs for 2 weeks, bedtime dosing was superior to morning dosing with respect to mean reduction in nighttime SBP at week 12.
Reference
Runyu Ye, Xiangyu Yang, Xin Zhang et al. Morning vs Bedtime Dosing and Nocturnal Blood Pressure Reduction in Patients With Hypertension: The OMAN Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519354.
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