Efficacy of Combination Therapy for Systolic Blood Pressure in Patients With Severe Systolic Hypertension: The Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) Study
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Key result
Amlodipine/benazepril combination therapy reduced mean 24-hour systolic blood pressure by 21.1 mm Hg, significantly more than amlodipine (-12.4 mm Hg) or benazepril (-10.8 mm Hg) monotherapy (p<0.0001).
Why the study?
Does amlodipine/benazepril combination therapy reduce mean 24-hour systolic blood pressure in patients aged 55 and older with severe systolic hypertension compared to monotherapy?
Population
505 randomized men and women aged 55 and older with severe systolic hypertension. Mean age 67.7 years, 60.9%…
Comparison
Amlodipine besylate/benazepril HCl 5/20 mg… vs Amlodipine besylate 5 mg monotherapy OR…
Design
RCT, randomized, double-blind
Follow-up
8 weeks
Authors
Discussion
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Implication
Supports initial combination therapy for stage 2 systolic hypertension in older adults; reinforces JNC 7 and extends comparative RCT evidence.
Key Points
- To evaluate the efficacy and safety of amlodipine besylate/benazepril HCl combination therapy compared with each monotherapy component in patients with severe systolic hypertension.
- The SELECT study utilized 24-hour ambulatory blood pressure monitoring to identify patients with systolic hypertension.
- Participants received 8 weeks of treatment with amlodipine besylate/benazepril HCl 5/20 mg (n=149), amlodipine besylate 5 mg (n=146), or benazepril HCl 20 mg (n=148).
- Combination therapy produced significantly greater reductions in systolic blood pressure and pulse pressure than either monotherapy alone (p<0.0001).
- Significantly higher percentages of patients in the combination group achieved target blood pressure control compared with either monotherapy group (p<0.0001).
- Adverse events remained low across groups, with lower rates of peripheral edema observed with combination therapy than with amlodipine monotherapy.
Study Design
Type
RCT (n=505)
Blinding
Double-blind
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does amlodipine/benazepril combination therapy reduce mean 24-hour systolic blood pressure in patients aged 55 and older with severe systolic hypertension compared to monotherapy?
P
Population
505 older adults (aged ≥55 years) with severe systolic hypertension confirmed by ambulatory monitoring, followed for 8 weeks of active treatment.
I
Intervention
Amlodipine besylate/benazepril HCl 5/20 mg fixed-dose combination oral therapy daily for 8 weeks.
C
Comparator
Amlodipine besylate 5 mg monotherapy OR benazepril HCl 20 mg monotherapy daily for 8 weeks.
O
Outcome
Mean 24-hour systolic blood pressure (SBP) during 8 weeks of daily treatment.surrogate
Main Result
Absolute Event Rate: -21.1% vs -12.4%
p-value: p=<0.0001
In older patients with severe systolic hypertension, initial combination therapy with amlodipine and benazepril provides superior blood pressure reduction and higher control rates with less peripheral edema compared to monotherapy.
Limitations
- Short active treatment duration of 8 weeks
- High screen failure rate (306 of 813 patients) due to stringent ambulatory blood pressure monitoring criteria
Cite This Study
Neutel et al. (2005) conducted an RCT in Severe Systolic Hypertension (n=505). Amlodipine besylate/benazepril HCl vs. Amlodipine besylate 5 mg or benazepril HCl 20 mg was evaluated on Change from baseline in mean 24-hour ambulatory systolic blood pressure (p=<0.0001). Amlodipine/benazepril combination therapy reduced mean 24-hour systolic blood pressure by 21.1 mm Hg, significantly more than amlodipine (-12.4 mm Hg) or benazepril (-10.8 mm Hg) monotherapy (p<0.0001).
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