Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome

G. Tougas, W. J. Snape, M. H. Otten, D. L. Earnest, K. E. Langaker, Ronald Pruitt, E. Pecher, B. Nault, M. A. Rojavin

    Research output: Contribution to journalArticle

    77 Citations (Scopus)

    Abstract

    Background: Tegaserod is a 5-hydroxytryptamine-4 receptor partial agonist. Oral administration causes gastrointestinal effects resulting in increased gastrointestinal motility and attenuation of visceral sensation. Aim: To determine the long-term safety and tolerability of tegaserod in patients suffering from irritable bowel syndrome with constipation as the predominant symptom of altered bowel habits. Method: A multicentre, open-label study with flexible dose titration of tegaserod in out-patients suffering from constipation-predominant irritable bowel syndrome. Results: A total of 579 patients with constipation-predominant irritable bowel syndrome were treated with tegaserod. Of these, 304 (53%) completed the trial. The most common adverse events, classified as related to tegaserod for any dose, were mild and transient diarrhoea (10.1%), headache (8.3%), abdominal pain (7.4%) and flatulence (5.5%). Forty serious adverse events were reported in 25 patients (4.4% of patients) leading to discontinuation in six patients. There was one serious adverse event, acute abdominal pain, classified as possibly related to tegaserod. There were no consistent differences in adverse events between patients previously exposed to tegaserod and those treated de novo. No pattern-forming tegaserod-related abnormalities in haematological and biochemical laboratory tests, urinalysis, blood pressure, pulse rate or electrocardiograms were found. Conclusions: Tegaserod appears to be well tolerated in the treatment of patients with constipation-predominant irritable bowel syndrome. The adverse event profile, clinical laboratory evaluations, vital signs and electrocardiogram recordings revealed no evidence of any unexpected adverse events, and suggest that treatment is safe over a 12-month period.

    Original languageEnglish (US)
    Pages (from-to)1701-1708
    Number of pages8
    JournalAlimentary Pharmacology and Therapeutics
    Volume16
    Issue number10
    DOIs
    StatePublished - Oct 1 2002

    Fingerprint

    Irritable Bowel Syndrome
    Constipation
    Safety
    Abdominal Pain
    Electrocardiography
    Receptors, Serotonin, 5-HT4
    Flatulence
    tegaserod
    Gastrointestinal Motility
    Urinalysis
    Vital Signs
    Acute Pain
    Habits
    Headache
    Oral Administration
    Diarrhea
    Outpatients
    Heart Rate
    Blood Pressure
    Therapeutics

    All Science Journal Classification (ASJC) codes

    • Hepatology
    • Gastroenterology
    • Pharmacology (medical)

    Cite this

    Tougas, G., Snape, W. J., Otten, M. H., Earnest, D. L., Langaker, K. E., Pruitt, R., ... Rojavin, M. A. (2002). Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome. Alimentary Pharmacology and Therapeutics, 16(10), 1701-1708. https://doi.org/10.1046/j.1365-2036.2002.01347.x

    Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome. / Tougas, G.; Snape, W. J.; Otten, M. H.; Earnest, D. L.; Langaker, K. E.; Pruitt, Ronald; Pecher, E.; Nault, B.; Rojavin, M. A.

    In: Alimentary Pharmacology and Therapeutics, Vol. 16, No. 10, 01.10.2002, p. 1701-1708.

    Research output: Contribution to journalArticle

    Tougas, G, Snape, WJ, Otten, MH, Earnest, DL, Langaker, KE, Pruitt, R, Pecher, E, Nault, B & Rojavin, MA 2002, 'Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome', Alimentary Pharmacology and Therapeutics, vol. 16, no. 10, pp. 1701-1708. https://doi.org/10.1046/j.1365-2036.2002.01347.x
    Tougas, G. ; Snape, W. J. ; Otten, M. H. ; Earnest, D. L. ; Langaker, K. E. ; Pruitt, Ronald ; Pecher, E. ; Nault, B. ; Rojavin, M. A. / Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome. In: Alimentary Pharmacology and Therapeutics. 2002 ; Vol. 16, No. 10. pp. 1701-1708.
    @article{4114dc223ddc4729a17d651f5ad9d3af,
    title = "Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome",
    abstract = "Background: Tegaserod is a 5-hydroxytryptamine-4 receptor partial agonist. Oral administration causes gastrointestinal effects resulting in increased gastrointestinal motility and attenuation of visceral sensation. Aim: To determine the long-term safety and tolerability of tegaserod in patients suffering from irritable bowel syndrome with constipation as the predominant symptom of altered bowel habits. Method: A multicentre, open-label study with flexible dose titration of tegaserod in out-patients suffering from constipation-predominant irritable bowel syndrome. Results: A total of 579 patients with constipation-predominant irritable bowel syndrome were treated with tegaserod. Of these, 304 (53{\%}) completed the trial. The most common adverse events, classified as related to tegaserod for any dose, were mild and transient diarrhoea (10.1{\%}), headache (8.3{\%}), abdominal pain (7.4{\%}) and flatulence (5.5{\%}). Forty serious adverse events were reported in 25 patients (4.4{\%} of patients) leading to discontinuation in six patients. There was one serious adverse event, acute abdominal pain, classified as possibly related to tegaserod. There were no consistent differences in adverse events between patients previously exposed to tegaserod and those treated de novo. No pattern-forming tegaserod-related abnormalities in haematological and biochemical laboratory tests, urinalysis, blood pressure, pulse rate or electrocardiograms were found. Conclusions: Tegaserod appears to be well tolerated in the treatment of patients with constipation-predominant irritable bowel syndrome. The adverse event profile, clinical laboratory evaluations, vital signs and electrocardiogram recordings revealed no evidence of any unexpected adverse events, and suggest that treatment is safe over a 12-month period.",
    author = "G. Tougas and Snape, {W. J.} and Otten, {M. H.} and Earnest, {D. L.} and Langaker, {K. E.} and Ronald Pruitt and E. Pecher and B. Nault and Rojavin, {M. A.}",
    year = "2002",
    month = "10",
    day = "1",
    doi = "10.1046/j.1365-2036.2002.01347.x",
    language = "English (US)",
    volume = "16",
    pages = "1701--1708",
    journal = "Alimentary Pharmacology and Therapeutics",
    issn = "0269-2813",
    publisher = "Wiley-Blackwell",
    number = "10",

    }

    TY - JOUR

    T1 - Long-term safety of tegaserod in patients with constipation-predominant irritable bowel syndrome

    AU - Tougas, G.

    AU - Snape, W. J.

    AU - Otten, M. H.

    AU - Earnest, D. L.

    AU - Langaker, K. E.

    AU - Pruitt, Ronald

    AU - Pecher, E.

    AU - Nault, B.

    AU - Rojavin, M. A.

    PY - 2002/10/1

    Y1 - 2002/10/1

    N2 - Background: Tegaserod is a 5-hydroxytryptamine-4 receptor partial agonist. Oral administration causes gastrointestinal effects resulting in increased gastrointestinal motility and attenuation of visceral sensation. Aim: To determine the long-term safety and tolerability of tegaserod in patients suffering from irritable bowel syndrome with constipation as the predominant symptom of altered bowel habits. Method: A multicentre, open-label study with flexible dose titration of tegaserod in out-patients suffering from constipation-predominant irritable bowel syndrome. Results: A total of 579 patients with constipation-predominant irritable bowel syndrome were treated with tegaserod. Of these, 304 (53%) completed the trial. The most common adverse events, classified as related to tegaserod for any dose, were mild and transient diarrhoea (10.1%), headache (8.3%), abdominal pain (7.4%) and flatulence (5.5%). Forty serious adverse events were reported in 25 patients (4.4% of patients) leading to discontinuation in six patients. There was one serious adverse event, acute abdominal pain, classified as possibly related to tegaserod. There were no consistent differences in adverse events between patients previously exposed to tegaserod and those treated de novo. No pattern-forming tegaserod-related abnormalities in haematological and biochemical laboratory tests, urinalysis, blood pressure, pulse rate or electrocardiograms were found. Conclusions: Tegaserod appears to be well tolerated in the treatment of patients with constipation-predominant irritable bowel syndrome. The adverse event profile, clinical laboratory evaluations, vital signs and electrocardiogram recordings revealed no evidence of any unexpected adverse events, and suggest that treatment is safe over a 12-month period.

    AB - Background: Tegaserod is a 5-hydroxytryptamine-4 receptor partial agonist. Oral administration causes gastrointestinal effects resulting in increased gastrointestinal motility and attenuation of visceral sensation. Aim: To determine the long-term safety and tolerability of tegaserod in patients suffering from irritable bowel syndrome with constipation as the predominant symptom of altered bowel habits. Method: A multicentre, open-label study with flexible dose titration of tegaserod in out-patients suffering from constipation-predominant irritable bowel syndrome. Results: A total of 579 patients with constipation-predominant irritable bowel syndrome were treated with tegaserod. Of these, 304 (53%) completed the trial. The most common adverse events, classified as related to tegaserod for any dose, were mild and transient diarrhoea (10.1%), headache (8.3%), abdominal pain (7.4%) and flatulence (5.5%). Forty serious adverse events were reported in 25 patients (4.4% of patients) leading to discontinuation in six patients. There was one serious adverse event, acute abdominal pain, classified as possibly related to tegaserod. There were no consistent differences in adverse events between patients previously exposed to tegaserod and those treated de novo. No pattern-forming tegaserod-related abnormalities in haematological and biochemical laboratory tests, urinalysis, blood pressure, pulse rate or electrocardiograms were found. Conclusions: Tegaserod appears to be well tolerated in the treatment of patients with constipation-predominant irritable bowel syndrome. The adverse event profile, clinical laboratory evaluations, vital signs and electrocardiogram recordings revealed no evidence of any unexpected adverse events, and suggest that treatment is safe over a 12-month period.

    UR - http://www.scopus.com/inward/record.url?scp=0036792345&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=0036792345&partnerID=8YFLogxK

    U2 - 10.1046/j.1365-2036.2002.01347.x

    DO - 10.1046/j.1365-2036.2002.01347.x

    M3 - Article

    VL - 16

    SP - 1701

    EP - 1708

    JO - Alimentary Pharmacology and Therapeutics

    JF - Alimentary Pharmacology and Therapeutics

    SN - 0269-2813

    IS - 10

    ER -