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Comparative Study
. 2017;56(11):1277-1285.
doi: 10.2169/internalmedicine.56.7833. Epub 2017 Jun 1.

The Superiority of Vonoprazan-based First-line Triple Therapy with Clarithromycin: A Prospective Multi-center Cohort Study on Helicobacter pylori Eradication

Soichiro Sue  1 , Hirofumi Kuwashima  2 , Yuri Iwata  3 , Hiroyuki Oka  4 , Isao Arima  5 , Takehide Fukuchi  6 , Katsuyuki Sanga  7 , Yasuhiro Inokuchi  8 , Yuniba Ishii  9 , Masatomo Kanno  10 , Masahiro Terada  11 , Hitoshi Amano  12 , Makoto Naito  2 , Shigeru Iwase  3 , Hiroshi Okazaki  4 , Kazuto Komatsu  5 , Atsushi Kokawa  6 , Ichiro Kawana  7 , Manabu Morimoto  8 , Toshifumi Saito  9 , Yosuke Kunishi  10 , Akihiko Ikeda  11 , Daisuke Takahashi  12 , Haruo Miwa  6 , Tomohiko Sasaki  1 , Toshihide Tamura  1 , Masaaki Kondo  1 , Wataru Shibata  13 , Shin Maeda  1
Affiliations
Comparative Study

The Superiority of Vonoprazan-based First-line Triple Therapy with Clarithromycin: A Prospective Multi-center Cohort Study on Helicobacter pylori Eradication

Soichiro Sue et al. Intern Med. 2017.

Abstract

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.

Keywords: 7-day triple therapy; Helicobacter pylori; eradication; vonoprazan.

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Figures

Figure 1.
Figure 1.
Patient selection flow. UMIN, A registry of the International Committee of Medical Journal Editors (ICMJE). After the approval of vonoprazan (2015.2-2016.2), 1,231 first-line and 362 second-line eradication cases were analyzed in this study.
Figure 2.
Figure 2.
The first-line Helicobacter pylori eradication rates. CAM: clarithromycin, MIC: minimum inhibitory concentration, VAC: 1-week vonoprazan/AMPC/CAM eradication therapy, PAC: PPI (LPZ, RPZ, OPZ, or 1-week ESO)/AMPC/CAM eradication therapy, [ ]: 95% CI, ITT: intention-to-treat analysis, PP: per-protocol analysis
Figure 3.
Figure 3.
The relationship between susceptibility to CAM and the ER (VAC). VAC: 1-week vonoprazan/AMPC/CAM eradication therapy, MIC: minimum inhibitory concentration
Figure 4.
Figure 4.
The non-superiority of VAM versus PAM for first-line eradication. VAM: 1-week vonoprazan/AMPC/MNZ eradication therapy, PAM: 1-week PPI (LPZ, RPZ, OPZ, or ESO)/AMPC/MNZ eradication therapy, [ ]: 95% CI, ITT: intention-to-treat analysis, PP: per-protocol analysis
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