title: Efficacy and safety of 10-mg azilsartan compared with 8-mg candesartan cilexetil in Japanese patients with hypertension: a randomized crossover non-inferiority trial.
abstract: We investigated whether 10 mg per day of azilsartan, one-half of the normal dosage, would be non-inferior to 8 mg per day of candesartan cilexetil for controlling blood pressure in Japanese patients with hypertension. In this open-label, randomized, crossover trial, 309 hypertensive Japanese adults treated with 8-mg candesartan cilexetil were randomized into two arms and received either 10-mg azilsartan or 8-mg candesartan cilexetil in a crossover manner. The primary efficacy outcome was systolic blood pressure, and the margin of non-inferiority was set to be 2.5 mm Hg. The participants were 67±11 years old, and 180 (58%) were male. The baseline systolic and diastolic blood pressure levels were 127.1±13.2 and 69.7±11.2 mm Hg, respectively. During the study period, the difference in systolic blood pressure between the treatments with 10-mg azilsartan and 8-mg candesartan cilexetil was -1.7 mm Hg, with the two-sided 95% confidence interval (CI) ranged from -3.2 to -0.2 mm Hg. The upper boundary of the 95% CI was below the margin of 2.5 mm Hg, confirming the non-inferiority of 10-mg azilsartan to 8-mg candesartan cilexetil. The difference also reached significance (P=0.037). The corresponding difference in diastolic blood pressure was -1.4 (95% CI: -2.4 to -0.4) mm Hg (P=0.006). Treatment with 10-mg azilsartan was similar to 8-mg candesartan cilexetil in its association with rare adverse events. In conclusion, 10-mg azilsartan was non-inferior to 8-mg candesartan cilexetil for controlling systolic blood pressure in Japanese hypertensive patients already being treated with 8-mg candesartan cilexetil.
authors.affiliation: Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Takahara
authors.affiliation: Shiraiwa Medical Clinic, Kashiwara City, Osaka, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Shiraiwa
authors.affiliation: Shiraiwa Medical Clinic, Kashiwara City, Osaka, Japan.
authors.forename: Megumi
authors.initials: M
authors.lastname: Shindo
authors.affiliation: Shiraiwa Medical Clinic, Kashiwara City, Osaka, Japan.
authors.forename: Akie
authors.initials: A
authors.lastname: Arai
authors.affiliation: Shiraiwa Medical Clinic, Kashiwara City, Osaka, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Kusuda
authors.affiliation: Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Katakami
authors.affiliation: Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kaneto
authors.affiliation: Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.
authors.forename: Taka-Aki
authors.initials: TA
authors.lastname: Matsuoka
authors.affiliation: Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.
authors.forename: Iichiro
authors.initials: I
authors.lastname: Shimomura
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007564:Japan; D008297:Male; D008875:Middle Aged; D010069:Oxadiazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013777:Tetrazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D010069:Oxadiazoles; D013777:Tetrazoles; C521273:azilsartan; C077793:candesartan cilexetil