Abstract | BACKGROUND:
Hypertension is often inadequately controlled in older people. OBJECTIVE: This prespecified subgroup analysis assessed the efficacy and safety of an olmesartan medoxomil (OM) 40 mg/ amlodipine besylate (AML) 10 mg/ hydrochlorothiazide ( HCTZ) 25 mg triple-combination treatment compared with the 3 components as dual-combination treatments in participants with hypertension who were <65 and ≥ 65 years of age. Within the ≥ 65 years of age subgroup, efficacy and safety were also summarized for participants ≥ 75 years of age. STUDY DESIGN: 12-week, multicenter, double-blind, randomized, parallel-group study. SETTING: PARTICIPANTS: INTERVENTION: Participants were randomized, stratified by age, diabetes status, and race to one of four treatment assignments: OM 40/AML 10/ HCTZ 25 mg, OM 40/AML 10 mg, OM 40/ HCTZ 25 mg, or AML 10/ HCTZ 25 mg. MAIN OUTCOME MEASURE: Least squares (LS) mean change from baseline in seated diastolic blood pressure (SeDBP) at week 12 (last observation carried forward) in each age subgroup (prespecified analysis). RESULTS: Of the 2492 randomized participants in the study (total cohort), 2021 (81.1 %) were <65 and 471 (18.9 %) were ≥ 65 years of age, including 79 (3.2 %) who were ≥ 75 years of age. OM 40/AML 10/ HCTZ 25 mg triple-combination treatment resulted in a significantly greater reduction in LS mean SeDBP at week 12 than dual-combination component treatments in participants in both cohorts: <65 years (21.0 vs. 14.2-17.2 mmHg; p < 0.0001) and ≥ 65 years (23.7 vs. 17.3-20.0 mmHg; p ≤ 0.002). Similarly, triple-combination treatment resulted in a greater reduction in LS mean seated systolic blood pressure (SeSBP) at week 12 than dual-combination component treatments: <65 years (38.2 vs. 28.3-31.4 mmHg; p < 0.0001) and ≥ 65 years (39.2 vs. 29.3-31.1 mmHg; p < 0.0001). Triple-combination treatment was more effective than dual-combination treatments in enabling participants to reach SeBP goal (<140/90 mmHg [<130/80 mmHg in participants with diabetes, chronic kidney disease, or chronic cardiovascular disease]) in both age subgroups (<65 years: 65 vs. 34-50 %, respectively, p < 0.0001 and ≥ 65 years: 63 vs. 32-39 %; p ≤ 0.0004). All 4 treatments were safe and well tolerated with low discontinuation rates in both age subgroups. There were no clinically relevant differences in the incidence of treatment-emergent adverse events between participants <65 and ≥ 65 years of age receiving triple-combination treatment. CONCLUSION: Triple-combination treatment with OM 40/AML 10/ HCTZ 25 mg was well tolerated and more effective in lowering BP than the component dual-combination treatments in elderly and non-elderly subgroups.
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Authors | Andrew J Lewin, Joseph L Izzo Jr, Michael Melino, James Lee, Victor Fernandez, Reinilde Heyrman |
Journal | Drugs & aging
(Drugs Aging)
Vol. 30
Issue 7
Pg. 549-60
(Jul 2013)
ISSN: 1179-1969 [Electronic] New Zealand |
PMID | 23549909
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antihypertensive Agents
- Drug Combinations
- Imidazoles
- Tetrazoles
- Hydrochlorothiazide
- Amlodipine
- Olmesartan Medoxomil
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Topics |
- Adolescent
- Adult
- Age Factors
- Aged
- Amlodipine
(adverse effects, therapeutic use)
- Antihypertensive Agents
(adverse effects, therapeutic use)
- Blood Pressure
(drug effects)
- Double-Blind Method
- Drug Combinations
- Female
- Humans
- Hydrochlorothiazide
(adverse effects, therapeutic use)
- Hypertension
(drug therapy)
- Imidazoles
(adverse effects, therapeutic use)
- Male
- Middle Aged
- Olmesartan Medoxomil
- Tetrazoles
(adverse effects, therapeutic use)
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