Lafutidine 10 mg versus Rabeprazole 20 mg in the Treatment of Patients with Heartburn-Dominant Uninvestigated Dyspepsia: A Randomized, Multicentric Trial (original) (raw)

2011, Gastroenterology research and practice

Background. Empirical therapy with antisecretory agents like PPIs and H2RAs has long been the traditional approach in the initial management of uninvestigated dyspepsia. Aim. The objective of the study was to examine relief of dyspepsia with lafutidine, a second-generation H(2)-RA, and rabeprazole and to compare their efficacy. Methods. This was a randomized, open, comparative trial in adult uninvestigated dyspeptic patients, who had at least moderate severity of symptoms, defined as a score of ≥4 on a 7-point global overall symptom (GOS) scale, and were randomized to receive once daily either lafutidine 10 mg or rabeprazole 20 mg for 4 weeks. Results. A total of 236 patients were enrolled, out of which 194 patients were included in the analysis. At the end of week 4, a significant difference was observed for symptom relief (lafutidine 89.90% versus rabeprazole 65.26%, P < .01) and symptom resolution (lafutidine 70.71% versus rabeprazole 25.26%, P < .01). Both the drugs were w...

Heartburn-dominant, uninvestigated dyspepsia: a comparison of 'PPI-start' and 'H2-RA-start' management strategies in primary care - the CADET-HR Study

Alimentary Pharmacology and Therapeutics, 2005

Background: There are few data on empiric, stepped therapy for heartburn relief or subsequent relapse in primary care. Aims: To compare heartburn relief produced by a proton pump inhibitor-start or an H 2 -receptor antagonist-start with step-up therapy, as needed, followed by a treatment-free period to assess relapse. Methods: Heartburn-dominant uninvestigated dyspepsia patients from 46 primary care centres were randomized to one of two active treatment strategies: omeprazole 20 mg daily (proton pump inhibitor-start) or ranitidine 150 mg bid (H 2 -receptor antagonist-start) for the first 4-8 weeks, stepping up to omeprazole 40 or 20 mg daily, respectively, for 4-8 weeks for persistent symp-toms. Daily diaries documented heartburn relief (score £ 3/7 on £ 1 of 7 prior days) and relapse (score ‡4 on ‡2 of 7 prior days).

Esomeprazole 40 mg once a day in patients with functional dyspepsia: the randomized, placebo-controlled "ENTER" trial

The American journal of gastroenterology, 2006

The etiologies of functional dyspepsia (FD) are unclear, but in some studies, treatment with a proton pump inhibitor has been beneficial. The objective of this study was to evaluate the efficacy of esomeprazole 40 mg once a day compared to placebo in achieving symptom relief in primary care patients with FD. This was a randomized, placebo-controlled trial in adult FD patients, who had at least moderate severity of symptoms, defined as a score of > or =4 on a 7-point Global Overall Symptom (GOS) scale. Patients were excluded if they had predominant symptoms of heartburn or regurgitation; after a normal baseline endoscopy, patients were randomized to esomeprazole 40 mg once daily or placebo for 8 wk. The primary outcome measure was symptom relief (GOS < or =2) at 8 wk. Of the 502 enrolled patients, 224 were randomized. The main reasons for exclusion were abnormal endoscopic findings, especially esophagitis. A significantly greater proportion of patients in the esomeprazole group...

Vonoprazan Therapy is as Effective for Functional Dyspepsia without Heartburn as Acotiamide Therapy

Journal of Gastrointestinal and Liver Diseases, 2023

Background & Aims: Acid suppression improves dyspepsia symptoms but the efficacy of vonoprazan for functional dyspepsia remains unclear. The aim of this study is to evaluate the effectiveness of vonoprazan therapy for functional dyspepsia without heartburn. Methods: Patients receiving vonoprazan 10 mg once daily or acotiamide 100 mg three times daily for more than one month were included and retrospectively reviewed. Functional dyspepsia was diagnosed based on the ROME IV criteria. Patients with heartburn were excluded. Eighty-five patients were divided into vonoprazan (n=48) and acotiamide (n=37) groups. Results: There were no significant differences at baseline between the vonoprazan and acotiamide groups. The functional dyspepsia score significantly improved in both groups (p<0.001). The degree of score reduction (55% vs 59%, p=0.559) and the resolution rates (21% vs 30%, p=0.345) were similar. Epigastric pain and postprandial distress scores were significantly improved in both groups, and the degree of improvement of each score was similar. Constipation and diarrhea scores were significantly improved in both groups, and the degree of improvement similar. Conclusion: These preliminary results suggest that vonoprazan is effective for the treatment of functional dyspepsia without heartburn in the short-term, with results similar to acotiamide therapy.

Evidence-based recommendations for short- and long-term management of uninvestigated dyspepsia in primary care: an update of the Canadian Dyspepsia Working Group (CanDys) clinical management tool

Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 2005

The present paper is an update to and extension of the previous systematic review on the primary care management of patients with uninvestigated dyspepsia (UD). The original publication of the clinical management tool focused on the initial four- to eight-week assessment of UD. This update is based on new data from systematic reviews and clinical trials relevant to UD. There is now direct clinical evidence supporting a test-and-treat approach in patients with nondominant heartburn dyspepsia symptoms, and head-to-head comparisons show that use of a proton pump inhibitor is superior to the use of H2-receptor antagonists (H2RAs) in the initial treatment of Helicobacter pylori-negative dyspepsia patients. Cisapride is no longer available as a treatment option and evidence for other prokinetic agents is lacking. In patients with long-standing heartburn-dominant (ie, gastroesophageal reflux disease) and nonheartburn-dominant dyspepsia, a once-in-a-lifetime endoscopy is recommended. Endosc...

A Prospective Study Involving Comparison of Acotiamide with Rabeprazole vs. Double Dose Rabeprazole in Patients Having Overlapping Symptoms of Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease and Functional Dyspepsia

International Journal of Research -GRANTHAALAYAH

Introduction: Gastroesophageal reflux disease (GERD) is a digestive disorder that affects the lower esophageal sphincter (LES). Functional dyspepsia (FD) is characterized by troublesome early satiety, epigastralgia or heart burn. It is often overlooked as the symptoms overlap with GERD. This study aims to compare the effectiveness of Acotiamide+Rabeprazole vs. a double dose of Rabeprazole in Indian population. Method: In this study 60 patients diagnosed with PPI refractory GERD (taking PPI>8weeks) and FD with no gastric or duodenal organic abnormalities were randomly allocated in two groups. Group 1 received a combination of Acotiamide (200mg/day) +Rabeprazole (20mg/day) and group 2 received a double dose of Rabeprazole (40mg/day). Follow ups were done every month for 3 consecutive months. The frequency and severity of symptoms were assessed using standard Izumo scale and FSSG scale. Results: The total score and GERD score from the baseline were significantly reduced in group 1 h...

Functional heartburn has more in common with functional dyspepsia than with non-erosive reflux disease

Gut, 2009

Introduction: Functional dyspepsia and non-erosive reflux disease (NERD) are prevalent gastrointestinal conditions with accumulating evidence regarding an overlap between the two. Still, patients with NERD represent a very heterogeneous group and limited data on dyspeptic symptoms in various subgroups of NERD are available. Aim: To evaluate the prevalence of dyspeptic symptoms in patients with NERD subclassified by using 24 h impedance-pH monitoring (MII-pH). Methods: Patients with typical reflux symptoms and normal endoscopy underwent impedance-pH monitoring off proton pump inhibitor treatment. Oesophageal acid exposure time (AET), type of acid and non-acid reflux episodes, and symptom association probability (SAP) were calculated. A validated dyspepsia questionnaire was used to quantify dyspeptic symptoms prior to reflux monitoring. Results: Of 200 patients with NERD (105 female; median age, 48 years), 81 (41%) had an abnormal oesophageal AET (NERD pH-POS), 65 (32%) had normal oesophageal AET and positive SAP for acid and/or non-acid reflux (hypersensitive oesophagus), and 54 (27%) had normal oesophageal AET and negative SAP (functional heartburn). Patients with functional heartburn had more frequent (p,0.01) postprandial fullness, bloating, early satiety and nausea compared to patients with NERD pH-POS and hypersensitive oesophagus. Conclusion: The increased prevalence of dyspeptic symptoms in patients with functional heartburn reinforces the concept that functional gastrointestinal disorders extend beyond the boundaries suggested by the anatomical location of symptoms. This should be regarded as a further argument to test patients with symptoms of gastro-oesophageal reflux disease in order to separate patients with functional heartburn from patients with NERD in whom symptoms are associated with gastrooesophageal reflux.

1035 Subpopulation Analysis Based on Background Responds to Rabeprazole Dose in Patients With Functional Dyspepsia in a Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial; the Samurai Study

2013

using HRM. Methods: Studies were performed in 12 healthy volunteers (5 males, median age 23 years). Nausea was induced by a motion video of a rotating and tilted view of a landscape and rated on a VAS scale ranging from 1-4 (no/mild/moderate/severe nausea) every minute until complete recovery. GEP and anatomical changes were assessed with HRM. FP was measured from the five pressure channels positioned below the LES. Reflux was assessed by impedance-pH (MII-pH). After intubation, a baseline (BL) recording of 15min was obtained. This was followed by the motion video (until the volunteer perceived nausea VAS≥3 (at least 10min, max 20min)) followed by 30min recovery recording. Results correspond to measurements at peak nausea, early recovery (first 5 min after the end of the motion video) and late recovery (last 5min of the 30min recovery period). Results: 10/12 subjects showed a drop in FP during peak nausea compared to BL (-4.0±0.8mmHg; p= 0.005) with 8/10 subjects showing a partial or complete FP return during late recovery. 8/ 10 subjects who showed FP drop also showed a drop of LES pressure during peak nausea (-8.8±2.5mmHg; p=0.04) with 9/10 subjects showing a partial or complete return of LES pressure during late recovery. Peak nausea preceded peak fundus and LES relaxation. 8/10 subjects showed increase in length of the oesophageal body during peak nausea and early recovery (+0.8±0.2cm and +0.7±0.1cm; p ,0.05) whereas a shortening of the oesophagus was observed during late recovery (-0.6±0.2cm; p ,0.05). There was a significant decrease in LES thickness during peak nausea (-0.8±0.3cm; p ,0.05). The number of swallows was comparable during BL/nausea/recovery. MII-pH showed normal acid exposure and 0-2 reflux episodes during total recording times. The number of TLESRs was significantly greater during the recovery period compared to the nausea period (p=0.01). Conclusion: Fundus and GEJ changes during nausea are different from those observed during meals, TLESRs and vomiting. Peak nausea is followed by a drop in fundus and LES pressure, oesophageal lengthening and a decrease in LES thickness. LES relaxation during nausea is incomplete and not accompanied by reflux. Whether anatomical changes provoke the sensation of nausea or vice versa is unknown, however the time sequence in our experiment suggests the latter.

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