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Tegaserod for dyspepsia and reflux symptoms in patients with chronic constipation: an exploratory open-label study

Byline: Juan Zeng (1), Xiu-Li Zuo (1), Yan-Qing Li (1), Wei Wei (2), Guo-Ping Lv (1) Keywords: Chronic constipation; Dyspepsia; Functional gastrointestinal disorders; Reflux symptoms; Tegaserod Abstract: Objective To evaluate the potential role of tegaserod in the management of functional dyspepsia... Full description

Journal Title: European Journal of Clinical Pharmacology 2007, Vol.63(6), pp.529-536
Main Author: Zeng, Juan
Other Authors: Zuo, Xiu-Li , Li, Yan-Qing , Wei, Wei , Lv, Guo-Ping
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: ISSN: 0031-6970 ; E-ISSN: 1432-1041 ; DOI: 10.1007/s00228-007-0287-3
Link: http://dx.doi.org/10.1007/s00228-007-0287-3
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recordid: springer_jour10.1007/s00228-007-0287-3
title: Tegaserod for dyspepsia and reflux symptoms in patients with chronic constipation: an exploratory open-label study
format: Article
creator:
  • Zeng, Juan
  • Zuo, Xiu-Li
  • Li, Yan-Qing
  • Wei, Wei
  • Lv, Guo-Ping
subjects:
  • Chronic constipation
  • Dyspepsia
  • Functional gastrointestinal disorders
  • Reflux symptoms
  • Tegaserod
ispartof: European Journal of Clinical Pharmacology, 2007, Vol.63(6), pp.529-536
description: Byline: Juan Zeng (1), Xiu-Li Zuo (1), Yan-Qing Li (1), Wei Wei (2), Guo-Ping Lv (1) Keywords: Chronic constipation; Dyspepsia; Functional gastrointestinal disorders; Reflux symptoms; Tegaserod Abstract: Objective To evaluate the potential role of tegaserod in the management of functional dyspepsia (FD) and gastroesophageal reflux disease (GERD) in patients with chronic constipation and to determine the possible efficacy of tegaserod on solid-phase gastric emptying and gastric hypersensitivity. Method This was an exploratory open-label trial of tegaserod therapy for dyspepsia and reflux symptoms in patients with chronic constipation. The study cohort consisted of 90 patients randomized to three treatment groups for a study period of 4 weeks (tegaserod 6 mg, twice daily esomeprazole 40 mg, once daily tegaserod 6 mg, twice daily plus esomeprazole 40 mg, once daily). Twenty healthy volunteers provided control values. Clinical symptoms were evaluated by one of the investigators using a Gastrointestinal Symptom Rating Scale (GSRS). Solid-phase gastric emptying and colonic transit were measured by the radiopaque barium marker method, and the water load test (WLT) was used to evaluate gastric sensation and the function of proximal stomach. The proportions of patients with complete relief of epigastric pain /discomfort, epigastric fullness, early satiety and heartburn in the tegaserod group and the tegaserod plus esomeprazole group were compared with the esomeprazole group, respectively. Results The mean global gastrointestinal (GI) scores of all three treatment groups reported using the GSRS showed the same trend, with decreasing scores over the 4-week study period indicating a reported decreasing severity of symptoms that was significantly different from baseline values. Patients in the tegaserod plus esomeprazole group reported the lowest global GI scores after 4 weeks, as expected. Solid-phase gastric emptying (GER) and colonic transit (CTT) increased significantly in the tegaserod 6 mg twice daily group compared with baseline. These parameters did not change in the esomeprazole group at week 4 compared with baseline. In terms of gastric sensation, in the tegaserod group, the proportions of patients with hypersensitivity of the first perception threshold did not change at week 2 or week 4 compared with baseline however, in this group and in the tegaserod plus esomeprazole group, the proportions of patients with hypersensitivity of discomfort threshold decrease
language: eng
source:
identifier: ISSN: 0031-6970 ; E-ISSN: 1432-1041 ; DOI: 10.1007/s00228-007-0287-3
fulltext: fulltext
issn:
  • 1432-1041
  • 14321041
  • 0031-6970
  • 00316970
url: Link


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titleTegaserod for dyspepsia and reflux symptoms in patients with chronic constipation: an exploratory open-label study
creatorZeng, Juan ; Zuo, Xiu-Li ; Li, Yan-Qing ; Wei, Wei ; Lv, Guo-Ping
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descriptionByline: Juan Zeng (1), Xiu-Li Zuo (1), Yan-Qing Li (1), Wei Wei (2), Guo-Ping Lv (1) Keywords: Chronic constipation; Dyspepsia; Functional gastrointestinal disorders; Reflux symptoms; Tegaserod Abstract: Objective To evaluate the potential role of tegaserod in the management of functional dyspepsia (FD) and gastroesophageal reflux disease (GERD) in patients with chronic constipation and to determine the possible efficacy of tegaserod on solid-phase gastric emptying and gastric hypersensitivity. Method This was an exploratory open-label trial of tegaserod therapy for dyspepsia and reflux symptoms in patients with chronic constipation. The study cohort consisted of 90 patients randomized to three treatment groups for a study period of 4 weeks (tegaserod 6 mg, twice daily esomeprazole 40 mg, once daily tegaserod 6 mg, twice daily plus esomeprazole 40 mg, once daily). Twenty healthy volunteers provided control values. Clinical symptoms were evaluated by one of the investigators using a Gastrointestinal Symptom Rating Scale (GSRS). Solid-phase gastric emptying and colonic transit were measured by the radiopaque barium marker method, and the water load test (WLT) was used to evaluate gastric sensation and the function of proximal stomach. The proportions of patients with complete relief of epigastric pain /discomfort, epigastric fullness, early satiety and heartburn in the tegaserod group and the tegaserod plus esomeprazole group were compared with the esomeprazole group, respectively. Results The mean global gastrointestinal (GI) scores of all three treatment groups reported using the GSRS showed the same trend, with decreasing scores over the 4-week study period indicating a reported decreasing severity of symptoms that was significantly different from baseline values. Patients in the tegaserod plus esomeprazole group reported the lowest global GI scores after 4 weeks, as expected. Solid-phase gastric emptying (GER) and colonic transit (CTT) increased significantly in the tegaserod 6 mg twice daily group compared with baseline. These parameters did not change in the esomeprazole group at week 4 compared with baseline. In terms of gastric sensation, in the tegaserod group, the proportions of patients with hypersensitivity of the first perception threshold did not change at week 2 or week 4 compared with baseline however, in this group and in the tegaserod plus esomeprazole group, the proportions of patients with hypersensitivity of discomfort threshold decreased significantly at week 4 compared with baseline. In the esomeprazole group, there were no changes in the proportions of patients with hypersensitivity of the first perception threshold and discomfort threshold at week 2 or 4 compared with baseline. No severe adverse events were recorded, and the medications were in general well-tolerated. Conclusion Tegaserod is effective and safe at improving dyspepsia and reflux symptoms in patients with chronic constipation, and tegaserod plus esomeprazole is superior to esomeprazole alone in the resolution of epigastric pain/discomfort and heartburn. Author Affiliation: (1) Department of Gastroenterology, Qilu Hospital of Shandong University, Wenhua xi Road 107, Jinan, Shandong Province, 250012, People's Republic of China (2) Department of Gastroenterology, Central Hospital of Taian, Taian, 271000, People's Republic of China Article History: Registration Date: 21/02/2007 Received Date: 14/11/2006 Accepted Date: 20/02/2007 Online Date: 20/03/2007
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