February 1, 1997Hypertension
Determining the Trough-to-Peak Ratio in Parallel-Group Trials
Why the study?
How do interindividual variability, correction for placebo effects, and smoothing of blood pressure profiles affect the measurement of the trough-to-peak ratio in parallel-group trials?
Population
244 individuals with isolated systolic hypertension enrolled in the placebo-controlled Systolic Hypertension…
Comparison
Nitrendipine, with the possible addition of… vs Placebo (n=133)
Design
Parallel-group, double-blind
Authors
Discussion
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Implication
Standard trough-to-peak ratios overestimate antihypertensive duration; challenges conventional analyses and supports variability-adjusted methods in future trials.
Structured PICO
How do interindividual variability, correction for placebo effects, and smoothing of blood pressure profiles affect the measurement of the trough-to-peak ratio in parallel-group trials?
P
Population
244 individuals with isolated systolic hypertension (≥ 60 years) enrolled in the placebo-controlled Systolic Hypertension in Europe Trial
I
Intervention
Nitrendipine (10 to 40 mg/d), with the possible addition of enalapril (5 to 20 mg/d) and/or hydrochlorothiazide (12.5 to 25 mg/d) (n=111)
C
Comparator
Placebo (n=133)
O
Outcome
Net trough-to-peak ratio of blood pressure reductionsurrogate
Accounting for interindividual variability in parallel-group trials reduces the calculated trough-to-peak ratio for antihypertensive medications, and smoothing of blood pressure profiles introduces unpredictable effects and should be avoided.
Cite This Study
Staessen et al. (1997) studied this question.