PMID- 28566587
OWN - NLM
STAT- MEDLINE
DCOM- 20171030
LR  - 20220310
IS  - 1349-7235 (Electronic)
IS  - 0918-2918 (Print)
IS  - 0918-2918 (Linking)
VI  - 56
IP  - 11
DP  - 2017
TI  - The Superiority of Vonoprazan-based First-line Triple Therapy with 
      Clarithromycin: A Prospective Multi-center Cohort Study on Helicobacter pylori 
      Eradication.
PG  - 1277-1285
LID - 10.2169/internalmedicine.56.7833 [doi]
AB  - Objective We evaluated the safety and efficacy of vonoprazan-based amoxicillin 
      and clarithromycin 7-day triple therapy (VAC) in comparison to proton pump 
      inhibitor (PPI)-based (PAC) as a first-line treatment and vonoprazan-based 
      amoxicillin and metronidazole 7-day triple therapy (VAM) in comparison to 
      PPI-based (PAM) as a second-line treatment for the eradication of Helicobacter 
      pylori in Japan. Methods We performed a non-randomized, multi-center, 
      parallel-group study to compare first-line VAC to PAC and second-line VAM to PAM. 
      A pre-planned subgroup analysis on CAM resistance was also performed. Safety was 
      evaluated with an adverse effects questionnaire (AEQ), which was completed by 
      patients during therapy. Results The first-line eradication rates (ER) in the 
      intention-to-treat (ITT) and per protocol (PP) analyses were 84.9% (95% CI: 
      81.9-87.6%, n=623) and 86.4% (83.5-89.1%, n=612), respectively, for VAC and 78.8% 
      (75.3-82.0%, n=608) and 79.4% (76.0-82.6%, n=603), respectively, for PAC. The ER 
      of VAC was higher than that of PAC in the ITT (p=0.0061) and PP analyses 
      (p=0.0013). The ERs for VAC in patients with CAM-resistant and CAM-susceptible 
      bacteria were 73.2% (59.7-84.2%, n=56) and 88.9% (83.4-93.1%, n=180), 
      respectively. PAC was associated with higher AEQ scores for diarrhea, nausea, 
      headache, and general malaise. In the second-line ITT and PP analyses VAM 
      achieved ERs of 80.5% (74.6-85.6%, n=216) and 82.4% (76.6-87.3%, n=211), 
      respectively, while PAM achieved ERs of 81.5% (74.2-87.4%, n=146) and 82.1% 
      (74.8-87.9%, n=145), respectively. No significant differences were observed in 
      the ITT (p=0.89) or PP (p=1.0) analyses. Conclusion The ER of first-line VAC was 
      higher than that of PAC, but still <90%. No difference was observed between 
      second-line VAM and PAM. Vonoprazan-based triple therapy was safe and well 
      tolerated.
FAU - Sue, Soichiro
AU  - Sue S
AD  - Department of Gastroenterology, Yokohama City University Graduate school of 
      Medicine, Japan.
FAU - Kuwashima, Hirofumi
AU  - Kuwashima H
AD  - Department of Gastroenterology, Yokohama Hodogaya Central Hospital, Japan.
FAU - Iwata, Yuri
AU  - Iwata Y
AD  - Department of Gastroenterology, Fujisawa City Hospital, Japan.
FAU - Oka, Hiroyuki
AU  - Oka H
AD  - Department of Gastroenterology, Yokohama Minami Kyousai Hospital, Japan.
FAU - Arima, Isao
AU  - Arima I
AD  - Department of Gastroenterology, Yokosuka City Hospital, Japan.
FAU - Fukuchi, Takehide
AU  - Fukuchi T
AD  - Department of Gastroenterology, Yokohama City University Medical Center, Japan.
FAU - Sanga, Katsuyuki
AU  - Sanga K
AD  - Department of Gastroenterology, Saiseikai Yokohamashi Nanbu Hospital, Japan.
FAU - Inokuchi, Yasuhiro
AU  - Inokuchi Y
AD  - Department of Gastroenterology, Kanagawa Cancer Center, Japan.
FAU - Ishii, Yuniba
AU  - Ishii Y
AD  - Department of Gastroenterology, Yokohama Ekisaikai Hospital, Japan.
FAU - Kanno, Masatomo
AU  - Kanno M
AD  - Department of Gastroenterology, Kanagawa Prefectual Ashigarakami Hospital, Japan.
FAU - Terada, Masahiro
AU  - Terada M
AD  - Department of Gastroenterology, Japanese Red Cross Hadano Hospital, Japan.
FAU - Amano, Hitoshi
AU  - Amano H
AD  - Department of Gastroenterology, Fujisawa Shounandai Hopsital, Japan.
FAU - Naito, Makoto
AU  - Naito M
AD  - Department of Gastroenterology, Yokohama Hodogaya Central Hospital, Japan.
FAU - Iwase, Shigeru
AU  - Iwase S
AD  - Department of Gastroenterology, Fujisawa City Hospital, Japan.
FAU - Okazaki, Hiroshi
AU  - Okazaki H
AD  - Department of Gastroenterology, Yokohama Minami Kyousai Hospital, Japan.
FAU - Komatsu, Kazuto
AU  - Komatsu K
AD  - Department of Gastroenterology, Yokosuka City Hospital, Japan.
FAU - Kokawa, Atsushi
AU  - Kokawa A
AD  - Department of Gastroenterology, Yokohama City University Medical Center, Japan.
FAU - Kawana, Ichiro
AU  - Kawana I
AD  - Department of Gastroenterology, Saiseikai Yokohamashi Nanbu Hospital, Japan.
FAU - Morimoto, Manabu
AU  - Morimoto M
AD  - Department of Gastroenterology, Kanagawa Cancer Center, Japan.
FAU - Saito, Toshifumi
AU  - Saito T
AD  - Department of Gastroenterology, Yokohama Ekisaikai Hospital, Japan.
FAU - Kunishi, Yosuke
AU  - Kunishi Y
AD  - Department of Gastroenterology, Kanagawa Prefectual Ashigarakami Hospital, Japan.
FAU - Ikeda, Akihiko
AU  - Ikeda A
AD  - Department of Gastroenterology, Japanese Red Cross Hadano Hospital, Japan.
FAU - Takahashi, Daisuke
AU  - Takahashi D
AD  - Department of Gastroenterology, Fujisawa Shounandai Hopsital, Japan.
FAU - Miwa, Haruo
AU  - Miwa H
AD  - Department of Gastroenterology, Yokohama City University Medical Center, Japan.
FAU - Sasaki, Tomohiko
AU  - Sasaki T
AD  - Department of Gastroenterology, Yokohama City University Graduate school of 
      Medicine, Japan.
FAU - Tamura, Toshihide
AU  - Tamura T
AD  - Department of Gastroenterology, Yokohama City University Graduate school of 
      Medicine, Japan.
FAU - Kondo, Masaaki
AU  - Kondo M
AD  - Department of Gastroenterology, Yokohama City University Graduate school of 
      Medicine, Japan.
FAU - Shibata, Wataru
AU  - Shibata W
AD  - Advanced Medical Research Center, Yokohama City University, Japan.
FAU - Maeda, Shin
AU  - Maeda S
AD  - Department of Gastroenterology, Yokohama City University Graduate school of 
      Medicine, Japan.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170601
PL  - Japan
TA  - Intern Med
JT  - Internal medicine (Tokyo, Japan)
JID - 9204241
RN  - 0 
      (1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine)
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0 (Pyrroles)
RN  - 0 (Sulfonamides)
RN  - 804826J2HU (Amoxicillin)
RN  - H1250JIK0A (Clarithromycin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Amoxicillin/*therapeutic use
MH  - Anti-Bacterial Agents/*therapeutic use
MH  - Clarithromycin/*therapeutic use
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - Female
MH  - Helicobacter Infections/*drug therapy
MH  - Helicobacter pylori/*drug effects
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Proton Pump Inhibitors/*therapeutic use
MH  - Pyrroles/*therapeutic use
MH  - Sulfonamides/*therapeutic use
MH  - Young Adult
PMC - PMC5498188
OTO - NOTNLM
OT  - 7-day triple therapy
OT  - Helicobacter pylori
OT  - eradication
OT  - vonoprazan
EDAT- 2017/06/02 06:00
MHDA- 2017/10/31 06:00
PMCR- 2017/06/01
CRDT- 2017/06/02 06:00
PHST- 2017/06/02 06:00 [entrez]
PHST- 2017/06/02 06:00 [pubmed]
PHST- 2017/10/31 06:00 [medline]
PHST- 2017/06/01 00:00 [pmc-release]
AID - 10.2169/internalmedicine.56.7833 [doi]
PST - ppublish
SO  - Intern Med. 2017;56(11):1277-1285. doi: 10.2169/internalmedicine.56.7833. Epub 
      2017 Jun 1.