Comparative Effects of an Angiotensin II Receptor Blocker (ARB)/Diuretic vs. ARB/Calcium-Channel Blocker Combination on Uncontrolled Nocturnal Hypertension Evaluated by Information and Communication Technology-Based Nocturnal Home Blood Pressure Monitoring　- The NOCTURNE Study.
Nocturnal blood pressure (BP) is an independent risk factor of cardiovascular events. The NOCTURNE study, a multicenter, randomized controlled trial (RCT) using our recently developed information and communication technology (ICT) nocturnal home BP monitoring (HBPM) device, was performed to compare the nocturnal HBP-lowering effects of differential ARB-based combination therapies in 411 Japanese patients with nocturnal hypertension (HT).



Patients with nocturnal BP ≥120/70 mmHg at baseline even under ARB therapy (100 mg irbesartan daily) were enrolled. The ARB/CCB combination therapy (irbesartan 100 mg+amlodipine 5 mg) achieved a significantly greater reduction in nocturnal home systolic BP (primary endpoint) than the ARB/diuretic combination (daily irbesartan 100 mg+trichlormethiazide 1 mg) (-14.4 vs. -10.5 mmHg, P<0.0001), independently of urinary sodium excretion and/or nocturnal BP dipping status. However, the change in nocturnal home systolic BP was comparable among the post-hoc subgroups with higher salt sensitivity (diabetes, chronic kidney disease, and elderly patients).



This is the first RCT demonstrating the feasibility of clinical assessment of nocturnal BP by ICT-nocturnal HBPM. The ARB/CCB combination was shown to be superior to ARB/diuretic in patients with uncontrolled nocturnal HT independently of sodium intake, despite the similar impact of the 2 combinations in patients with higher salt sensitivity.
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine.
Kazuomi
K
Kario
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine.
Naoko
N
Tomitani
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine.|Genki Plaza Medical Center for Health Care.
Hiroshi
H
Kanegae
Kashinoki Internal Medicine.
Hajime
H
Ishii
Uchiyama Clinic.
Kazuaki
K
Uchiyama
Yamagiwa Clinic.
Kayo
K
Yamagiwa
Shiraiwa Medical Clinic.
Toshihiko
T
Shiraiwa
Katsuya Iin.
Tomohiro
T
Katsuya
Onga Nakama Medical Association Onga Hospital.
Tetsuro
T
Yoshida
Medical Affairs Department, Shionogi & Co., Ltd.
Kiyomi
K
Kanda
Medical Affairs Department, Shionogi & Co., Ltd.
Shinji
S
Hasegawa
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine.
Satoshi
S
Hoshide
D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage*; D057911:Angiotensin Receptor Antagonists / Q000008:administration & dosage*; D001713:Biphenyl Compounds / Q000008:administration & dosage*; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods; D002121:Calcium Channel Blockers / Q000008:administration & dosage*; D003142:Communication; D004232:Diuretics / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000503:physiopathology; D000077405:Irbesartan; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage*; D014237:Trichlormethiazide / Q000008:administration & dosage*
D057911:Angiotensin Receptor Antagonists; D001713:Biphenyl Compounds; D002121:Calcium Channel Blockers; D004232:Diuretics; D013777:Tetrazoles; D017311:Amlodipine; D000077405:Irbesartan; D014237:Trichlormethiazide
Angiotensin II receptor blockers (ARBs); Calcium-channel blockers (CCBs); Diuretics; Information and communication technology (ICT)-based home blood pressure monitoring; Nocturnal blood pressure