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

Ueng, Kwo-ChangKwo-ChangUengLin, Lung-ChunLung-ChunLinVoon, Wen-CholWen-CholVoonLin, Ming-ChengMing-ChengLinYEN BIN LIUSu, Ho-MingHo-MingSuPO-YUAN CHANGLin, Tsung-HsienTsung-HsienLinChen, Wei-LiangWei-LiangChenCHAU-CHUNG WULai, Wen-TerWen-TerLaiTSUNG-HSIEN LIN2020-03-042020-03-0420080803-7051https://www.scopus.com/inward/record.uri?eid=2-s2.0-75449086084&doi=10.1080%2f08037050802102660&partnerID=40&md5=8aa95e65427dfc0cff7bf519c031dad0https://scholars.lib.ntu.edu.tw/handle/123456789/469808Aims. 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.[SDGs]SDG3amlodipine besylate; amlodipine besylate plus benazepril; antihypertensive agent; amlodipine; antihypertensive agent; benazepril; benzazepine derivative; calcium channel blocking agent; dipeptidyl carboxypeptidase inhibitor; adult; aged; ankle edema; antihypertensive activity; article; blood pressure regulation; Chinese; clinical trial; combination chemotherapy; comparative study; controlled clinical trial; controlled study; coughing; diastolic blood pressure; disease severity; dizziness; double blind procedure; drug dose comparison; drug dose titration; drug efficacy; drug induced headache; drug safety; drug tolerability; female; heart palpitation; human; hypertension; hypotension; low drug dose; major clinical study; male; monotherapy; multicenter study; priority journal; randomized controlled trial; risk reduction; systolic blood pressure; therapy effect; drug combination; middle aged; Adult; Amlodipine; Benzazepines; Blood Pressure; China; Cough; Dose-Response Relationship, Drug; Double-Blind Method; Drug Toxicity; Female; Humans; Hypertension; Male; Middle Aged; Treatment Outcome; Aged; Amlodipine; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Benzazepines; Calcium Channel Blockers; Drug CombinationsAn 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 hypertensionjournal article10.1080/08037050802102660186491562-s2.0-75449086084