Safety and tolerability of tegaserod in patients with chronic constipation: pooled data from two phase III studies.

Hdl Handle:
http://hdl.handle.net/10147/208849
Title:
Safety and tolerability of tegaserod in patients with chronic constipation: pooled data from two phase III studies.
Authors:
Quigley, Eamonn M M; Wald, Arnold; Fidelholtz, James; Boivin, Michel; Pecher, Eckhard; Earnest, David
Affiliation:
Alimentary Pharmabiotic Centre, Department of Medicine, Cork University Hospital,, Wilton, Cork, Ireland. e.quigley@ucc.ie
Citation:
Clin Gastroenterol Hepatol. 2006 May;4(5):605-13.
Journal:
Clinical gastroenterology and hepatology : the official clinical practice journal, of the American Gastroenterological Association
Issue Date:
3-Feb-2012
URI:
http://hdl.handle.net/10147/208849
DOI:
10.1016/j.cgh.2006.02.017
PubMed ID:
16678076
Abstract:
BACKGROUND & AIMS: Studies show that tegaserod effectively relieves the symptoms of chronic constipation/idiopathic constipation (CC). This pooled analysis assessed the safety and tolerability of tegaserod in a large dataset of CC patients. METHODS: Adverse event (AE) data were pooled from 2 double-blind, placebo-controlled phase III trials of 12 weeks' duration. Post hoc analysis was conducted for the most frequent AEs (incidence, >or=3%). RESULTS: Eight hundred eighty-one, 861, and 861 patients received tegaserod 6 mg twice a day, 2 mg twice a day, or placebo, respectively. Most AEs were mild/moderately severe. AE incidence was similar for the tegaserod 6 mg and 2 mg twice a day (57.1% and 56.3%, respectively) and placebo groups (59.6%) and most frequent in the gastrointestinal system (tegaserod 6 mg twice a day, 25.8%; 2 mg twice a day, 22.5%; placebo, 24.6%). Headache, the most common AE, was slightly more frequent in the placebo group (tegaserod 6 mg twice a day, 11.0%; 2 mg twice a day, 10.1%; placebo, 13.2%). Diarrhea (generally transient and resolved with continued treatment) was the only AE with a statistically significant difference between groups (tegaserod 6 mg twice a day 6.6% vs placebo 3.0%, P=.0005). Serious AE incidence (1.4% overall) was comparable across treatment groups, although abdominal surgery was less common in the combined tegaserod (0.5%) than the placebo group (1.0%). Discontinuation as a result of AEs was slightly higher in tegaserod 6 mg twice a day patients (5.7%; 2 mg twice a day, 3.3%; placebo, 3.7%), mainly because of diarrhea. Laboratory and electrocardiogram parameters were comparable across groups. CONCLUSIONS: Tegaserod is well tolerated by patients with CC during 12 weeks of treatment.
Language:
eng
MeSH:
Administration, Oral; Adult; Aged; Aged, 80 and over; Chronic Disease; Clinical Trials, Phase III as Topic; Constipation/*diagnosis/*drug therapy; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Indoles/*administration & dosage/*adverse effects; Male; Maximum Tolerated Dose; Middle Aged; Patient Satisfaction; Randomized Controlled Trials as Topic; Reference Values; Serotonin Receptor Agonists/*administration & dosage/*adverse effects; Severity of Illness Index; Treatment Outcome
ISSN:
1542-3565 (Print); 1542-3565 (Linking)

Full metadata record

DC FieldValue Language
dc.contributor.authorQuigley, Eamonn M Men_GB
dc.contributor.authorWald, Arnolden_GB
dc.contributor.authorFidelholtz, Jamesen_GB
dc.contributor.authorBoivin, Michelen_GB
dc.contributor.authorPecher, Eckharden_GB
dc.contributor.authorEarnest, Daviden_GB
dc.date.accessioned2012-02-03T15:05:22Z-
dc.date.available2012-02-03T15:05:22Z-
dc.date.issued2012-02-03T15:05:22Z-
dc.identifier.citationClin Gastroenterol Hepatol. 2006 May;4(5):605-13.en_GB
dc.identifier.issn1542-3565 (Print)en_GB
dc.identifier.issn1542-3565 (Linking)en_GB
dc.identifier.pmid16678076en_GB
dc.identifier.doi10.1016/j.cgh.2006.02.017en_GB
dc.identifier.urihttp://hdl.handle.net/10147/208849-
dc.description.abstractBACKGROUND & AIMS: Studies show that tegaserod effectively relieves the symptoms of chronic constipation/idiopathic constipation (CC). This pooled analysis assessed the safety and tolerability of tegaserod in a large dataset of CC patients. METHODS: Adverse event (AE) data were pooled from 2 double-blind, placebo-controlled phase III trials of 12 weeks' duration. Post hoc analysis was conducted for the most frequent AEs (incidence, >or=3%). RESULTS: Eight hundred eighty-one, 861, and 861 patients received tegaserod 6 mg twice a day, 2 mg twice a day, or placebo, respectively. Most AEs were mild/moderately severe. AE incidence was similar for the tegaserod 6 mg and 2 mg twice a day (57.1% and 56.3%, respectively) and placebo groups (59.6%) and most frequent in the gastrointestinal system (tegaserod 6 mg twice a day, 25.8%; 2 mg twice a day, 22.5%; placebo, 24.6%). Headache, the most common AE, was slightly more frequent in the placebo group (tegaserod 6 mg twice a day, 11.0%; 2 mg twice a day, 10.1%; placebo, 13.2%). Diarrhea (generally transient and resolved with continued treatment) was the only AE with a statistically significant difference between groups (tegaserod 6 mg twice a day 6.6% vs placebo 3.0%, P=.0005). Serious AE incidence (1.4% overall) was comparable across treatment groups, although abdominal surgery was less common in the combined tegaserod (0.5%) than the placebo group (1.0%). Discontinuation as a result of AEs was slightly higher in tegaserod 6 mg twice a day patients (5.7%; 2 mg twice a day, 3.3%; placebo, 3.7%), mainly because of diarrhea. Laboratory and electrocardiogram parameters were comparable across groups. CONCLUSIONS: Tegaserod is well tolerated by patients with CC during 12 weeks of treatment.en_GB
dc.language.isoengen_GB
dc.subject.meshAdministration, Oralen_GB
dc.subject.meshAdulten_GB
dc.subject.meshAgeden_GB
dc.subject.meshAged, 80 and overen_GB
dc.subject.meshChronic Diseaseen_GB
dc.subject.meshClinical Trials, Phase III as Topicen_GB
dc.subject.meshConstipation/*diagnosis/*drug therapyen_GB
dc.subject.meshDose-Response Relationship, Drugen_GB
dc.subject.meshDouble-Blind Methoden_GB
dc.subject.meshDrug Administration Scheduleen_GB
dc.subject.meshFemaleen_GB
dc.subject.meshFollow-Up Studiesen_GB
dc.subject.meshHumansen_GB
dc.subject.meshIndoles/*administration & dosage/*adverse effectsen_GB
dc.subject.meshMaleen_GB
dc.subject.meshMaximum Tolerated Doseen_GB
dc.subject.meshMiddle Ageden_GB
dc.subject.meshPatient Satisfactionen_GB
dc.subject.meshRandomized Controlled Trials as Topicen_GB
dc.subject.meshReference Valuesen_GB
dc.subject.meshSerotonin Receptor Agonists/*administration & dosage/*adverse effectsen_GB
dc.subject.meshSeverity of Illness Indexen_GB
dc.subject.meshTreatment Outcomeen_GB
dc.titleSafety and tolerability of tegaserod in patients with chronic constipation: pooled data from two phase III studies.en_GB
dc.contributor.departmentAlimentary Pharmabiotic Centre, Department of Medicine, Cork University Hospital,, Wilton, Cork, Ireland. e.quigley@ucc.ieen_GB
dc.identifier.journalClinical gastroenterology and hepatology : the official clinical practice journal, of the American Gastroenterological Associationen_GB
dc.description.provinceMunster-

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