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Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients.

ABSTRACT: Predicting response to proton pump inhibitor (PPI) treatment can aid the effective management of gastroesophageal reflux disease (GERD). The aim was to investigate the predictors of symptomatic response to pantoprazole in Asian patients with GERD; the first study of its kind in Asian patients.Asian patients with GERD symptoms (N = 209) received pantoprazole 40 mg daily for 8 weeks in a multinational, prospective, open-label study. Response was assessed using ReQuest™. Baseline and demographic factors were examined using logistic regression to determine if they were related to treatment response.Response rates were 44.3% (Week 4) and 63.6% (Week 8) in Asian patients versus 60.7% (P < 0.001) and 72.2% (P = 0.010) for the rest of the world. Higher response rates at 8 weeks occurred in patients with erosive reflux disease (ERD; 71.3%) versus those with non-erosive reflux disease (NERD) at baseline (48.5%). The presence of ERD (P = 0.0143) and lower ReQuest™-GI scores at baseline (P = 0.0222) were associated with response. Improvements in quality of life (QoL) and anxiety and depression at 4 and 8 weeks were associated with treatment response (both P < 0.0001). Patient satisfaction correlated with treatment response (P < 0.0001), and improvement in anxiety and depression (P < 0.0001) and QoL (P < 0.0001).Asian patients with GERD, especially those with NERD, may have lower response rates to PPIs than Western populations. ERD and less severe gastrointestinal symptoms may help to predict symptomatic responses to PPIs in Asian patients.ClinicalTrial.gov identifier: NCT00312806.

SUBMITTER: Goh KL

PROVIDER: S-EPMC4176852 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients.

Goh Khean Lee KL Choi Kee Don KD Choi Myung-Gyu MG Hsieh Tsai-Yuan TY Jung Hwoon-Yong HY Lien Han-Chung HC Menon Jayaram J Mesenas Steven S Park Hyojin H Sheu Bor-Shyang BS Wu Justin Cy JC

BMC gastroenterology 20140909

<h4>Background</h4>Predicting response to proton pump inhibitor (PPI) treatment can aid the effective management of gastroesophageal reflux disease (GERD). The aim was to investigate the predictors of symptomatic response to pantoprazole in Asian patients with GERD; the first study of its kind in Asian patients.<h4>Methods</h4>Asian patients with GERD symptoms (N = 209) received pantoprazole 40 mg daily for 8 weeks in a multinational, prospective, open-label study. Response was assessed using Re ...[more]

PMID: 25200403

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Project description:BackgroundVonoprazan results in more potent acid suppression for gastroesophageal reflux disease (GERD) than proton pump inhibitors. It has only been approved for treating erosive esophagitis in China, but 30-40% of GERD patients cannot achieve the goal of treatment with vonoprazan 20 mg daily. This study aims to investigate whether vonoprazan could relieve the symptoms of Chinese patients with non-erosive reflux disease (NERD) and whether increased dosage or different times of dosing could increase the response rate of GERD.MethodsThis study is a pragmatic, open-label, crossover-cluster, randomized controlled trial with patient preference arms. Two thousand eight hundred eighty patients with GERD from 48 hospitals in China will be enrolled. These hospitals will be divided into a compulsory randomization cluster (24 hospitals) and a patient preference cluster (24 hospitals). Patients in the compulsory randomization cluster will be randomized to three regimens according to the crossover-cluster randomization. Patients in the patient preference cluster may choose to receive any regimen if they have a preference; otherwise, patients will be randomly assigned. The three treatment regimens will last 4 weeks, including (1) vonoprazan 20 mg p.o. after breakfast, (2) vonoprazan 20 mg p.o. after dinner, and (3) vonoprazan 20 mg p.o. after breakfast and after dinner. Patients will attend a baseline visit, a 4-week e-diary, a fourth-week visit, and a sixth-month visit online. The primary outcome is the symptom relief rate of all patients after 4-week therapy. Secondary outcomes include the healing rate of EE patients, the severity of symptoms, compliance with the therapy at the fourth-week follow-up visit, recurrent symptoms, and the frequency of self-conscious doctor visits at the sixth-month follow-up visit.DiscussionThis trial will explore the effectiveness of different regimens of vonoprazan that will be implemented with GERD patients in China. The randomization with patient preferences considered and the crossover-cluster component may improve the robustness and extrapolation of study conclusions.Trial registrationhttps://www.chictr.org.cn ChiCTR2300069857. Registered on 28 March 2023.Protocol versionFebruary 18, 2023, Version 2.

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Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients.

Publications

Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients.

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