Ahn, Youngkeun; Kim, Yongcheol; Chang, Kiyuk; Kim, Weon; Rhee, Moo-Yong; Cha, Kwang Soo; Hyon, Min Su; Shim, Chi Young; Lee, Sung Yun; Kim, Doo Il; Kim, Sang Wook; Lim, Sang-Wook; Han, Kyoo-Rok; Jo, Sang-Ho; Lee, Nae-Hee; Kwan, Jun; Ahn, Taehoon
Medicine
2018Sep ; 97 ( 37 ) :e12329.
PMID : 30212981
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Ahn, Youngkeun - Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju.
Kim, Yongcheol - Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju.
Chang, Kiyuk - The Catholic University of Korea, Seoul St. Mary's Hospital.
Kim, Weon - Kyung Hee University Hospital, Seoul.
Rhee, Moo-Yong - Dongguk University Ilsan Hospital, Goyang.
Cha, Kwang Soo - Pusan National University Hospital, Busan.
Hyon, Min Su - Soonchunhyang University Seoul Hospital, Seoul.
Shim, Chi Young - Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul.
Lee, Sung Yun - Inje University Ilsan Paik Hospital, Goyang.
Kim, Doo Il - Inje University Haeundae Paik Hostpital, Busan.
Kim, Sang Wook - Chung-Ang University Hospital, Seoul.
Lim, Sang-Wook - CHA Bundang Medical Center, CHA University, Seongnam.
Han, Kyoo-Rok - Hallym University Kangdong Sacred Heart Hospital, Seoul.
Jo, Sang-Ho - Hanllym University Sacred Heart Hospital, Anyang.
Lee, Nae-Hee - Soonchunhyang University Bucheon Hospital, Bucheon.
Kwan, Jun - Inha University Hospital.
Ahn, Taehoon - Heart Center, Gachon University Gil Hospital, Incheon, Republic of Korea.
ABSTRACT
BACKGROUND: To determine whether the effectiveness and safety of fixed-dose combinations (FDCs) of amlodipine orotate/valsartan (AML/VAL) 5/160?mg are noninferior to those of valsartan/hydrochlorothiazide (VAL/HCTZ) 160/12.5?mg in hypertensive patients with inadequate response to valsartan 160?mg monotherapy.
METHODS: This 8-week, active-controlled, parallel-group, fixed-dose, multicenter, double-blind randomized controlled, and noninferiority trial was conducted at 17 cardiovascular centers in the Republic of Korea. Eligible patients had mean sitting diastolic blood pressure (msDBP) ??0?mm?Hg despite monotherapy with valsartan 160?mg for 4 weeks. Patients were randomly assigned to treatment with AML/VAL 5/160?mg FDC (AML/VAL) group or VAL/HCTZ 160/12.5?mg FDC (VAL/HCTZ) group once daily for 8 weeks. A total of 238 patients were enrolled (AML/VAL group, n?=?121; VAL/HCTZ group, n?=?117), of whom 228 completed the study.
RESULTS: At 8 weeks after randomization, msDBP was significantly decreased in both groups (-9.44?±?0.69?mm?Hg in the AML/VAL group and -7.47?±?0.71?mm?Hg in the VAL/HCTZ group, both P?
mlodipine orotate, fixed-dose combination, hypertension, valsartan
MESH
Aged, Amlodipine, Valsartan Drug Combination/*administration & dosage, Antihypertensive Agents/*administration & dosage, Blood Pressure/drug effects, Double-Blind Method, Drug Combinations, Drug Therapy, Combination, Essential Hypertension/*drug therapy, Female, Humans, Hydrochlorothiazide/*administration & dosage, Male, Middle Aged, Treatment Outcome, Valsartan/*administration & dosage
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