title: Efficacy and safety of olmesartan medoxomil/amlodipine fixed-dose combination for hypertensive patients uncontrolled with monotherapy.
abstract: This study aimed to evaluate the efficacy and safety of olmesartan medoxomil (OM)/amlodipine (AML) 20/5 mg fixed-dose combination tablet in Chinese mild to moderately hypertensive patients with inadequate blood pressure (BP) control on monotherapy. Two multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group clinical trials were conducted. After screening and a 2-week placebo run-in period, patients with 95 mmHg ≤ seated diastolic blood pressure (SeDBP) < 110 mmHg received monotherapy with OM 20 mg (in Study 1) or AML 5 mg (in Study 2), once daily for 4 weeks. Patients with 90 mmHg ≤ mean SeDBP < 110 mmHg at the end of the monotherapy period were randomized to receive OM/AML 20/5 mg treatment or continue with the monotherapy, once daily for 8 weeks. OM/AML (20/5 mg) treatment significantly lowered both systolic and diastolic BP at 4 and 8 weeks compared to 40 mg olmesartan or 5 mg AML. The incidence of drug-related adverse effects did not differ significantly between the groups. OM/AML 20/5 mg was superior to OM 40 mg or AML 5 mg monotherapy in lowering BP in Chinese mild to moderately hypertensive patients with inadequate BP control on monotherapy. No new or unexpected safety issues were identified with OM/AML combination therapy compared to monotherapy.
authors: Department of Cardiology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China, zhu.junren@zs-hospital.sh.cn.
authors: Jun-Ren
authors: JR
authors: Zhu
authors: Shu-Yang
authors: SY
authors: Zhang
authors: Ping-Jin
authors: PJ
authors: Gao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D002681:China; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000068557:Olmesartan Medoxomil; D012720:Severity of Illness Index; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000959:Antihypertensive Agents; D004338:Drug Combinations; D007093:Imidazoles; D013777:Tetrazoles; D017311:Amlodipine; D000068557:Olmesartan Medoxomil