Efficacy and Tolerability of Amlodipine Camsylate/Losartan 5/100-mg Versus Losartan/Hydrochlorothiazide 100/12.5-mg Fixed-Dose Combination in Hypertensive Patients Nonresponsive to Losartan 100-mg Monotherapy

Abstract Purpose The aim of this study was to determine whether the efficacy and tolerability of amlodipine camsylate/losartan 5/100 mg/d (AML/LOS) are noninferior to those of losartan/hydrochlorothiazide 100/12.5 mg/d (LOS/HCTZ) fixed-dose combination in hypertensive patients unresponsive to losart...

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Published in:Clinical therapeutics 2014-10, Vol.36 (10), p.1402-1411
Main Authors: Suh, Soon Yong, MD, PhD, Ahn, Taehoon, MD, PhD, Bae, Jang-Ho, MD, PhD, Lim, Do-Sun, MD, PhD, Lee, Seoung Uk, MD, PhD, Kim, Young Kwon, MD, PhD, Hyon, Min Su, MD, PhD, Kim, Won Ho, MD, PhD, Han, Kyoo Rok, MD, PhD, Park, Hoon Ki, MD
Format: Article
Language:English
Subjects:
Adult
amlodipine
Amlodipine - administration & dosage
Amlodipine - adverse effects
Amlodipine - therapeutic use
Antihypertensive Agents - administration & dosage
Antihypertensive Agents - adverse effects
Antihypertensive Agents - therapeutic use
Arterial hypertension. Arterial hypotension
Biological and medical sciences
Blood and lymphatic vessels
Blood Pressure - drug effects
Cardiology. Vascular system
Cholesterol
Double-Blind Method
Drug Combinations
Drug dosages
Drug therapy
Female
Heart attacks
Humans
Hydrochlorothiazide - administration & dosage
Hydrochlorothiazide - adverse effects
Hydrochlorothiazide - therapeutic use
Hypertension
Hypertension - drug therapy
Hypertension - physiopathology
Internal Medicine
Laboratories
losartan
Losartan - administration & dosage
Losartan - adverse effects
Losartan - therapeutic use
Male
Medical Education
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Population
Treatment Outcome
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Summary:Abstract Purpose The aim of this study was to determine whether the efficacy and tolerability of amlodipine camsylate/losartan 5/100 mg/d (AML/LOS) are noninferior to those of losartan/hydrochlorothiazide 100/12.5 mg/d (LOS/HCTZ) fixed-dose combination in hypertensive patients unresponsive to losartan 100-mg/d monotherapy. Methods Male and female patients aged ≥18 years with hypertension despite 4-week, stable treatment with losartan 100-mg/d monotherapy were eligible for inclusion in this multicenter, randomized, double-blind study. Patients were randomly assigned to receive AML/LOS or LOS/HCTZ once daily for 8 weeks. The primary end point was the change from baseline to week 8 in sitting diastolic blood pressure (ΔsiDBP), and the secondary end points were the changes from baseline to 4 weeks in siDBP and sitting systolic BP (ΔsiSBP) and changes from baseline to 4 and 8 weeks in BP response rate. Tolerability was evaluated by physical examination, including vital sign measurement; laboratory analysis; and ECG. Findings Of 275 patients screened at 9 cardiovascular centers, 199 were enrolled (AML/LOS, n = 101; LOS/HCTZ, n = 98), and 183 completed the study. The demographic characteristics were similar between the 2 groups (mean age, 51.56 [9.97] years; men, 70.53%). At 8 weeks, the mean ΔsiDBP values were –11.54 (7.89) and –9.05 (6.57) mm Hg in the AML/LOS and LOS/HCTZ groups, respectively (both, P < 0.0001 vs baseline). The mean difference between the 2 groups was –2.57 mm Hg, a nonsignificant difference, meaning that AML/LOS was noninferior to LOS/HCTZ with regard to the primary end point. At 8 weeks, the mean uric acid level was changed significantly from baseline in the LOS/HCTZ group (+0.41 [0.80] mg/dL; P < 0.0001) but not in the AML/LOS group (–0.12 [0.82] mg/dL), representing a significant intergroup difference ( P < 0.0001). Nineteen patients each in the AML/LOS (18.81%) and LOS/HCTZ (20.00%) groups experienced ≥1 adverse event, with 4 (3.96%) and 3 (3.16%) patients, respectively, experiencing 1 or more events considered by the investigators to have been treatment related. Implications The efficacy and tolerability of AML/LOS 5/100 mg/d was found to have been noninferior to those of LOS/HCTZ 100/12.5 mg/d in these hypertensive patients nonresponsive to losartan 100-mg/d monotherapy.
ISSN:0149-2918
1879-114X
DOI:10.1016/j.clinthera.2014.07.003