Comparison of the Fixed Combination of Enalapril/Diltiazem ER and Their Monotherapies in Stage 1 to 3 Essential Hypertension
Key result
Fixed combinations of enalapril and diltiazem ER significantly reduced trough sitting diastolic blood pressure by 7.6 and 8.3 mm Hg versus monotherapies (P < .05).
Why the study?
Does a fixed combination of enalapril and diltiazem ER reduce blood pressure more effectively than their monotherapies or placebo in patients with stage 1 to 3 essential hypertension?
Population
891 patients with stage 1 to 3 essential hypertension and sitting diastolic blood pressure between 95 and…
Comparison
Fixed dose combinations of enalapril 5… vs Monotherapies or placebo.
Design
RCT, randomly assigned, double blind, placebo controlled
Follow-up
12 week treatment phase, followed by a 36 week open label…
Authors
Discussion
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Implication
Supports fixed enalapril-diltiazem ER combinations in stage 1-3 hypertension; extends RCT evidence for combination over monotherapy.
Study Design
Type
RCT (n=891)
Blinding
Double-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does a fixed combination of enalapril and diltiazem ER reduce blood pressure more effectively than their monotherapies or placebo in patients with stage 1 to 3 essential hypertension?
P
Population
891 patients with stage 1 to 3 essential hypertension and sitting diastolic blood pressure between 95 and 115 mm Hg, followed for a 12-week double-blind phase and a 36-week open-label phase.
I
Intervention
Fixed dose combinations of enalapril 5 mg/diltiazem ER 120 mg (E5/D120) or enalapril 5 mg/diltiazem ER 180 mg (E5/D180).
C
Comparator
Monotherapies (enalapril 5 mg, diltiazem ER 120 mg, diltiazem ER 180 mg) or placebo.
O
Outcome
Trough (24 +/- 2 h postdose) sitting diastolic blood pressure (SiDBP) and sitting systolic blood pressure (SiSBP) at week 12.surrogate
Main Result
Mean Difference: -7.6
p-value: p=< .05
Fixed combinations of enalapril and diltiazem ER provide greater blood pressure lowering efficacy than their individual components in patients with stage 1 to 3 hypertension, with a similar tolerability profile.
Cite This Study
William C. Cushman (1998) conducted an RCT in Stage 1 to 3 essential hypertension (n=891). Fixed combination of enalapril and diltiazem ER vs. Enalapril 5 mg, diltiazem ER 120 mg, diltiazem ER 180 mg, or placebo was evaluated on Trough sitting diastolic blood pressure at week 12 (MD -7.6 and -8.3 mm Hg, p=< .05). Fixed combinations of enalapril and diltiazem ER significantly reduced trough sitting diastolic blood pressure by 7.6 and 8.3 mm Hg versus monotherapies (P < .05).