Effects of Bedtime vs. Morning Administration of the Long-Acting Lipophilic Angiotensin-Converting Enzyme Inhibitor Trandolapril on Morning Blood Pressure in Hypertensive Patients
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Key result
Bedtime administration of trandolapril reduced prewaking systolic blood pressure by 11 mmHg, though the difference in reduction compared to morning administration (3.9 mmHg) was not statistically significant.
Why the study?
Does bedtime administration of trandolapril improve morning blood pressure control compared to morning administration in hypertensive patients?
Population
37 older Japanese hypertensive patients. Excluded: diabetes, renal failure, atrial fibrillation, or any…
Comparison
Trandolapril 1-2 mg oral once daily administered… vs Trandolapril 1-2 mg oral once daily administered…
Design
RCT, randomized, open-label
Follow-up
8 weeks
Authors
Discussion
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Overview
May not yet support bedtime trandolapril dosing; leaves open chronotherapy benefit for prewaking BP in larger trials.
Key Points
- To compare the effects of bedtime versus morning administration of trandolapril on morning blood pressure in hypertensive patients.
- Conducted ambulatory blood pressure monitoring in 37 hypertensive patients before and after trandolapril administration.
- Divided patients into bedtime-administered (n=17) and morning-administered (n=20) groups.
- Analyzed systolic blood pressure reductions prewaking and in the morning.
- Morning-administered group had a significant reduction of 7.2 mmHg (p=0.02) in 24-h systolic BP.
- Bedtime-administered group showed a reduction of 5.2 mmHg (p=0.04) in 24-h systolic BP.
- Only bedtime administration significantly decreased prewaking SBP by 11 mmHg (p=0.005).
Study Design
Type
RCT (n=37)
Blinding
Open-label
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does bedtime administration of trandolapril improve morning blood pressure control compared to morning administration in hypertensive patients?
P
Population
37 older Japanese adults with essential hypertension were randomized to bedtime or morning administration of trandolapril and followed for 8 weeks.
I
Intervention
Trandolapril 1-2 mg oral once daily administered at bedtime for 8 weeks
C
Comparator
Trandolapril 1-2 mg oral once daily administered in the morning (just after breakfast) for 8 weeks
O
Outcome
Change in morning blood pressure (prewaking SBP and morning SBP) and 24-h SBP measured by ambulatory blood pressure monitoring (ABPM) at 8 weekssurrogate
Main Result
Absolute Event Rate: 11% vs 3.9%
p-value: p=0.186
Bedtime administration of the long-acting ACE inhibitor trandolapril effectively controls morning blood pressure without causing excessive nocturnal blood pressure reduction in hypertensive patients.
Limitations
- Lack of a placebo control group
- Small sample size
- Reproducibility of each ABPM parameter was not sufficiently clear
- lack of a control group
- reproducibility of each ABPM parameter was not sufficiently clear to render the results conclusive
Cite This Study
Kuroda et al. (2004) conducted an RCT in Essential hypertension (n=37). Trandolapril (bedtime administration) vs. Trandolapril (morning administration) was evaluated on Reduction in prewaking systolic blood pressure (p=0.186). Bedtime administration of trandolapril reduced prewaking systolic blood pressure by 11 mmHg, though the difference in reduction compared to morning administration (3.9 mmHg) was not statistically significant.
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