title: Efficacy and safety of aranidipine enteric-coated tablets compared with amlodipine in Chinese patients with mild to moderate essential hypertension: a multicenter, randomized, double-blind, parallel-controlled clinical trial.
abstract: This is a multicenter, randomized, double-blind, parallel-controlled study, conducted in Chinese patients with mild to moderate essential hypertension. After a 2-week washout period, 236 eligible patients were randomly to receive aranidipine 5-10 mg/d (n = 118) or amlodipine 5-10 mg/d (n = 118) for 10 weeks. The blood pressure and heart rate were evaluated in outpatient clinics, and ambulatory blood pressure monitoring was performed in 24 patients in each group. The blood pressure was significantly decreased in both groups. Compared with amlodipine, the patients who received aranidipine had less response in blood pressure (P < 0.01). The trough/peak ratios of diastolic blood pressure in aranidipine and amlodipine groups were 0.57 ± 0.20 and 0.68 ± 0.19, respectively (P = 0.119). Adverse events occurred at 11.86% and 7.63% in the aranidipine and amlodipine groups, respectively (P = 0.348). Headache was observed at an incidence of >3.0% in both groups, and the serum glucose and lipid profile had no significant change in the amlodipine group. In conclusion, once-daily administration of aranidipine (5-10 mg) effectively controlled blood pressure, and the short-term treatment might result in it being less effective than amlodipine. It had a stable action over 24-hour period, and the mechanism of that is not yet clear. Aranidipine had a good safety similar to that of amlodipine.
authors.affiliation: Peking Union Medical College and Chinese Academy of Medical Sciences, Ministry of Health, Cardiovascular Institute and FuWai Hospital, Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, Beijing, China.
authors.forename: Li-rong
authors.initials: LR
authors.lastname: Yan
authors.forename: Yi-shi
authors.initials: YS
authors.lastname: Li
authors.forename: Guo-liang
authors.initials: GL
authors.lastname: Chen
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.forename: Hui-min
authors.initials: HM
authors.lastname: Pang
authors.forename: Shi-yao
authors.initials: SY
authors.lastname: Wu
authors.forename: Jing
authors.initials: J
authors.lastname: Yu
authors.forename: Hui-min
authors.initials: HM
authors.lastname: Li
authors.forename: Ying-zhong
authors.initials: YZ
authors.lastname: Lin
authors.forename: Rui-ping
authors.initials: RP
authors.lastname: Zhao
authors.forename: Chao-mei
authors.initials: CM
authors.lastname: Fan
mesh_terms: D000328:Adult; 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; D018660:Blood Pressure Monitoring, Ambulatory; D004095:Dihydropyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013608:Tablets, Enteric-Coated
chemical_list: D000959:Antihypertensive Agents; D004095:Dihydropyridines; D013608:Tablets, Enteric-Coated; D017311:Amlodipine; C059427:aranidipine