Cargando…

Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)

BACKGROUND: In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms. METHODS: This was a randomized, open-label, parallel-group multicenter st...

Descripción completa

Detalles Bibliográficos
Autores principales: Sakurai, Kouichi, Nagahara, Akihito, Akiyama, Junichi, Suzuki, Junichi, Habu, Yasuki, Araki, Akihiro, Suzuki, Tsuyoshi, Satoh, Katsuaki, Nagami, Haruhiko, Harada, Ryosaku, Tano, Nobuo, Kusaka, Masayasu, Fujioka, Yasuhiko, Fujimura, Toshikatsu, Shigeto, Nobuyuki, Oumi, Tsuneyo, Miwa, Jun, Miwa, Hiroto, Fujimoto, Kazuma, Kinoshita, Yoshikazu, Haruma, Ken
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3419613/
https://www.ncbi.nlm.nih.gov/pubmed/22548767
http://dx.doi.org/10.1186/1471-230X-12-42
_version_ 1782240743026327552
author Sakurai, Kouichi
Nagahara, Akihito
Akiyama, Junichi
Suzuki, Junichi
Habu, Yasuki
Araki, Akihiro
Suzuki, Tsuyoshi
Satoh, Katsuaki
Nagami, Haruhiko
Harada, Ryosaku
Tano, Nobuo
Kusaka, Masayasu
Fujioka, Yasuhiko
Fujimura, Toshikatsu
Shigeto, Nobuyuki
Oumi, Tsuneyo
Miwa, Jun
Miwa, Hiroto
Fujimoto, Kazuma
Kinoshita, Yoshikazu
Haruma, Ken
author_facet Sakurai, Kouichi
Nagahara, Akihito
Akiyama, Junichi
Suzuki, Junichi
Habu, Yasuki
Araki, Akihiro
Suzuki, Tsuyoshi
Satoh, Katsuaki
Nagami, Haruhiko
Harada, Ryosaku
Tano, Nobuo
Kusaka, Masayasu
Fujioka, Yasuhiko
Fujimura, Toshikatsu
Shigeto, Nobuyuki
Oumi, Tsuneyo
Miwa, Jun
Miwa, Hiroto
Fujimoto, Kazuma
Kinoshita, Yoshikazu
Haruma, Ken
author_sort Sakurai, Kouichi
collection PubMed
description BACKGROUND: In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms. METHODS: This was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients ≥ 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] ≥ 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS ≤ 2). UMIN clinical trial registration number: UMIN000005399. RESULTS: Of 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events. CONCLUSIONS: The favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy. TRIAL REGISTRATION: UMIN000005399.
format Online
Article
Text
id pubmed-3419613
institution National Center for Biotechnology Information
language English
publishDate 2012
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-34196132012-08-16 Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS) Sakurai, Kouichi Nagahara, Akihito Akiyama, Junichi Suzuki, Junichi Habu, Yasuki Araki, Akihiro Suzuki, Tsuyoshi Satoh, Katsuaki Nagami, Haruhiko Harada, Ryosaku Tano, Nobuo Kusaka, Masayasu Fujioka, Yasuhiko Fujimura, Toshikatsu Shigeto, Nobuyuki Oumi, Tsuneyo Miwa, Jun Miwa, Hiroto Fujimoto, Kazuma Kinoshita, Yoshikazu Haruma, Ken BMC Gastroenterol Research Article BACKGROUND: In Japan, treatment guidelines are lacking for patients with upper gastrointestinal symptoms. We aimed to compare the efficacy of different drugs for the treatment of uninvestigated upper gastrointestinal symptoms. METHODS: This was a randomized, open-label, parallel-group multicenter study. Helicobacter pylori-negative, endoscopically uninvestigated patients ≥ 20 years of age with upper gastrointestinal symptoms of at least moderate severity (Global Overall Symptom score [GOS] ≥ 4 on a 7-point Likert scale) were randomized to treatment with omeprazole (10 mg once daily), famotidine (10 mg twice daily), mosapride (5 mg three times daily) or teprenone (50 mg three times daily). The primary endpoint was sufficient relief of upper gastrointestinal symptoms after 4 weeks of treatment (GOS ≤ 2). UMIN clinical trial registration number: UMIN000005399. RESULTS: Of 471 randomized patients, 454 were included in the full analysis set. After 4 weeks of treatment, sufficient symptom relief was achieved by 66.9% of patients in the omeprazole group, compared with 41.0%, 36.3% and 32.3% in the famotidine, mosapride and teprenone groups, respectively (all, p < 0.001 vs omeprazole). There were no treatment-related adverse events. CONCLUSIONS: The favorable efficacy and safety profiles of omeprazole in relieving uninvestigated upper gastrointestinal symptoms support its use as first-line treatment in this patient group in Japan. Patients who show no improvement in symptoms despite PPI use, and those with alarm symptoms (such as vomiting, GI bleeding or acute weight loss) should receive further investigation, including prompt referral for endoscopy. TRIAL REGISTRATION: UMIN000005399. BioMed Central 2012-05-01 /pmc/articles/PMC3419613/ /pubmed/22548767 http://dx.doi.org/10.1186/1471-230X-12-42 Text en Copyright ©2012 Sakurai et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Sakurai, Kouichi
Nagahara, Akihito
Akiyama, Junichi
Suzuki, Junichi
Habu, Yasuki
Araki, Akihiro
Suzuki, Tsuyoshi
Satoh, Katsuaki
Nagami, Haruhiko
Harada, Ryosaku
Tano, Nobuo
Kusaka, Masayasu
Fujioka, Yasuhiko
Fujimura, Toshikatsu
Shigeto, Nobuyuki
Oumi, Tsuneyo
Miwa, Jun
Miwa, Hiroto
Fujimoto, Kazuma
Kinoshita, Yoshikazu
Haruma, Ken
Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
title Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
title_full Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
title_fullStr Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
title_full_unstemmed Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
title_short Efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (J-FOCUS)
title_sort efficacy of omeprazole, famotidine, mosapride and teprenone in patients with upper gastrointestinal symptoms: an omeprazole-controlled randomized study (j-focus)
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3419613/
https://www.ncbi.nlm.nih.gov/pubmed/22548767
http://dx.doi.org/10.1186/1471-230X-12-42
work_keys_str_mv AT sakuraikouichi efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT nagaharaakihito efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT akiyamajunichi efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT suzukijunichi efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT habuyasuki efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT arakiakihiro efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT suzukitsuyoshi efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT satohkatsuaki efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT nagamiharuhiko efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT haradaryosaku efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT tanonobuo efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT kusakamasayasu efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT fujiokayasuhiko efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT fujimuratoshikatsu efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT shigetonobuyuki efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT oumitsuneyo efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT miwajun efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT miwahiroto efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT fujimotokazuma efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT kinoshitayoshikazu efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus
AT harumaken efficacyofomeprazolefamotidinemosaprideandteprenoneinpatientswithuppergastrointestinalsymptomsanomeprazolecontrolledrandomizedstudyjfocus