BedMed-Frail
Trial question
What is the effect of bedtime administration of antihypertensive medications in frail older patients with hypertension?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
72.0% female
28.0% male
N = 776
776 patients (562 female, 214 male).
Inclusion criteria: frail older patients with hypertension taking at least one once-daily antihypertensive medication.
Key exclusion criteria: glaucoma.
Interventions
N=394 bedtime antihypertensive medication (taking all once-daily antihypertensive medications while readying for bed).
N=382 morning antihypertensive medication (taking antihypertensive medications largely in the morning).
Primary outcome
Incidence of first occurrence of all-cause death or hospitalization/emergency department visit for stroke, acute coronary syndrome, or heart failure
29.4
31.5
31.5/100 py
23.6/100 py
15.8/100 py
7.9/100 py
0.0/100 py
Bedtime antihypertensive
medication
Morning antihypertensive
medication
No significant
difference ↔
No significant difference in the incidence of first occurrence of all-cause death or hospitalization/emergency department visit for stroke, acute coronary syndrome, or HF (29.4 events /100 py vs. 31.5 events /100 py; HR 0.88, 95% CI 0.71 to 1.11).
Secondary outcomes
No significant difference in the incidence of all-cause mortality (28.7 events /100 py vs. 30.7 events /100 py; HR 0.89, 95% CI 0.71 to 1.11).
No significant difference in the incidence of hospitalization for stroke (0.5 events /100 py vs. 1.4 events /100 py; HR 0.4, 95% CI 0.1 to 1.57).
Significant decrease in the incidence of all-cause unplanned hospitalization/emergency department visit (22.6 events /100 py vs. 30 events /100 py; HR 0.74, 95% CI 0.57 to 0.96).
Safety outcomes
No significant differences in falls or fractures, cognitive decline, urinary incontinence.
Conclusion
In frail older patients with hypertension taking at least one once-daily antihypertensive medication, bedtime antihypertensive medication was not superior to morning antihypertensive medication with respect to the incidence of first occurrence of all-cause death or hospitalization/emergency department visit for stroke, acute coronary syndrome, or HF.
Reference
Scott R Garrison, Erik R E Youngson, Danielle A Perry et al. Bedtime vs Morning Antihypertensive Medications in Frail Older Adults: The BedMed-Frail Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513812.
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