An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in chinese patients with mild to moderate hypertension.
OBJECTIVE
This study sought to compare the antihypertensive efficacy and tolerability of a fixed-dose combination with amlodipine/benazepril with that of amlodipine monotherapy in Chinese hypertensive subjects.


RESULTS
This multicenter, double-blind, 8-week study randomized 111 patients to fixed-dose amlodipine besylate/benazepril HCl (2.5/5 mg/day titrated to 5/10 mg/day as needed at week 4 to reach goal blood pressure (BP) <140/90 mmHg) or amlodipine besylate monotherapy (5 mg/day titrated to 10 mg/day as needed). At week 8, patients randomized to combination therapy compared with monotherapy had a comparable BP control rate (56.0% vs. 46.2%; p = 0.32). Fixed-dose combination resulted in similar reductions in sitting systolic (SBP) and diastolic BP (DBP) compared with monotherapy (SBP: -19.3 +/- 12.5 vs. -20.9 +/- 13.3 mmHg; DBP: -9.2 +/- 10.4 vs. -11.3 +/-9.3 mmHg; both p=NS). Safety profiles did not differ between groups, but cough was more common in the combination group (11.0% vs. 0%; p = 0.013).


CONCLUSIONS
In this group of patients, comparable antihypertensive effects were seen with the fixed-dose combination therapy, compared with amlodipine monotherapy. Both treatments appeared well tolerated in the studied population, but cough was more common in the fixed-dose combination group.
Ueng
Kwo-Chang
KC
Division of Cardiology and Cardiovascular Research Group, Institute of Medicine, Chung-Shan Medical University Hospital, Taiwan. ueng.kc@msa.hinet.net
Lin
Lung-Chun
LC
Voon
Wen-Chol
WC
Lin
Ming-Cheng
MC
Liu
Yen-Bin
YB
Su
Ho-Ming
HM
Chang
Po-Yuan
PY
Lin
Tsung-Hsien
TH
Chen
Wei-Liang
WL
Wu
Chau-Chung
CC
Lai
Wen-Ter
WT
Lin
Chung-Sheng
CS
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000627:therapeutic use*; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001552:Benzazepines / Q000008:administration & dosage*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D001552:Benzazepines; D002121:Calcium Channel Blockers; D004338:Drug Combinations; D017311:Amlodipine; C044946:benazepril