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Tegaserod in the treatment of irritable bowel syndrome (IBS) with constipation as the prime symptom.

Layer P, Keller J, Loeffler H, Kreiss A - Ther Clin Risk Manag (2007)

Bottom Line: Moreover, tegaserod was associated with improvements in patients' quality of life and work productivity.Diarrhea is the only adverse event consistently associated with tegaserod and was generally mild and transient.Overall, tegaserod has been demonstrated to offer effective and well-tolerated treatment of IBS-C, providing patients with meaningful symptom relief.

View Article: PubMed Central - PubMed

ABSTRACT
Irritable bowel syndrome with constipation (IBS-C) as the predominant bowel symptom is a prevalent disorder, characterized by recurring abdominal pain/discomfort, bloating, and constipation, and imposes a significant socio-economic burden. Traditional treatments generally address just one of the multiple IBS symptoms. The efficacy and safety profile of tegaserod, a serotonin 5-HT(4) receptor agonist, has been demonstrated in several randomized, placebo-controlled, and open-label trials. This review discusses the major clinical trials of tegaserod, which have involved 8948 IBS patients. Overall, data reveal that tegaserod is an effective treatment for IBS-C, providing statistically significant relief of overall and multiple individual IBS-C symptoms (abdominal pain/discomfort, bloating, and constipation) in both placebo-controlled and "real-life" open-label settings. Repeat treatments with tegaserod were also shown to be effective, which is noteworthy given the chronic and episodic nature of IBS. Moreover, tegaserod was associated with improvements in patients' quality of life and work productivity. Data also indicate that tegaserod is well tolerated over the short-term (4 weeks), long-term (12 months), and repeated treatments. Diarrhea is the only adverse event consistently associated with tegaserod and was generally mild and transient. Overall, tegaserod has been demonstrated to offer effective and well-tolerated treatment of IBS-C, providing patients with meaningful symptom relief.

No MeSH data available.


Related in: MedlinePlus

Adverse events (≥0.5%) leading to discontinuation in pivotal phase III trials of tegaserod. Pooled data from Studies 1, 2 and 3 (Müller-Lissner et al 2001; Leftkowitz et al 1999; Novick et al 2002; Novartis, Data on file).Note: *p<0.05 vs placebo.Abbreviations: reprod, reproductive.
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fig5: Adverse events (≥0.5%) leading to discontinuation in pivotal phase III trials of tegaserod. Pooled data from Studies 1, 2 and 3 (Müller-Lissner et al 2001; Leftkowitz et al 1999; Novick et al 2002; Novartis, Data on file).Note: *p<0.05 vs placebo.Abbreviations: reprod, reproductive.

Mentions: Figure 5 shows a pooled analysis of AEs leading to discontinuation from the three pivotal IBS-C trials of 12 weeks’ treatment duration (Studies 1–3) (Lefkowitz et al 1999; Müller-Lissner et al 2001; Novick et al 2002). Similar to overall AEs, the incidence of AEs leading to study discontinuation was comparable for tegaserod and placebo patients, with the exception of diarrhea and headache. Overall, 1.6% of patients taking tegaserod discontinued from the studies due to diarrhea compared with 0.3% of patients taking placebo (p<0.05), and slightly more tegaserod patients also discontinued due to headache (1.0% and 0.8% of patients in the tegaserod and placebo groups, respectively). Tegaserod was also well tolerated in the repeat tegaserod treatment studies (Müller-Lissner et al 2005; Tack et al 2005). The AEs observed during initial and repeat treatment were comparable, while there was a tendency for their frequency to be lower upon repeat treatment (Table 4) (Tack et al 2005).


Tegaserod in the treatment of irritable bowel syndrome (IBS) with constipation as the prime symptom.

Layer P, Keller J, Loeffler H, Kreiss A - Ther Clin Risk Manag (2007)

Adverse events (≥0.5%) leading to discontinuation in pivotal phase III trials of tegaserod. Pooled data from Studies 1, 2 and 3 (Müller-Lissner et al 2001; Leftkowitz et al 1999; Novick et al 2002; Novartis, Data on file).Note: *p<0.05 vs placebo.Abbreviations: reprod, reproductive.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC1936292&req=5

fig5: Adverse events (≥0.5%) leading to discontinuation in pivotal phase III trials of tegaserod. Pooled data from Studies 1, 2 and 3 (Müller-Lissner et al 2001; Leftkowitz et al 1999; Novick et al 2002; Novartis, Data on file).Note: *p<0.05 vs placebo.Abbreviations: reprod, reproductive.
Mentions: Figure 5 shows a pooled analysis of AEs leading to discontinuation from the three pivotal IBS-C trials of 12 weeks’ treatment duration (Studies 1–3) (Lefkowitz et al 1999; Müller-Lissner et al 2001; Novick et al 2002). Similar to overall AEs, the incidence of AEs leading to study discontinuation was comparable for tegaserod and placebo patients, with the exception of diarrhea and headache. Overall, 1.6% of patients taking tegaserod discontinued from the studies due to diarrhea compared with 0.3% of patients taking placebo (p<0.05), and slightly more tegaserod patients also discontinued due to headache (1.0% and 0.8% of patients in the tegaserod and placebo groups, respectively). Tegaserod was also well tolerated in the repeat tegaserod treatment studies (Müller-Lissner et al 2005; Tack et al 2005). The AEs observed during initial and repeat treatment were comparable, while there was a tendency for their frequency to be lower upon repeat treatment (Table 4) (Tack et al 2005).

Bottom Line: Moreover, tegaserod was associated with improvements in patients' quality of life and work productivity.Diarrhea is the only adverse event consistently associated with tegaserod and was generally mild and transient.Overall, tegaserod has been demonstrated to offer effective and well-tolerated treatment of IBS-C, providing patients with meaningful symptom relief.

View Article: PubMed Central - PubMed

ABSTRACT
Irritable bowel syndrome with constipation (IBS-C) as the predominant bowel symptom is a prevalent disorder, characterized by recurring abdominal pain/discomfort, bloating, and constipation, and imposes a significant socio-economic burden. Traditional treatments generally address just one of the multiple IBS symptoms. The efficacy and safety profile of tegaserod, a serotonin 5-HT(4) receptor agonist, has been demonstrated in several randomized, placebo-controlled, and open-label trials. This review discusses the major clinical trials of tegaserod, which have involved 8948 IBS patients. Overall, data reveal that tegaserod is an effective treatment for IBS-C, providing statistically significant relief of overall and multiple individual IBS-C symptoms (abdominal pain/discomfort, bloating, and constipation) in both placebo-controlled and "real-life" open-label settings. Repeat treatments with tegaserod were also shown to be effective, which is noteworthy given the chronic and episodic nature of IBS. Moreover, tegaserod was associated with improvements in patients' quality of life and work productivity. Data also indicate that tegaserod is well tolerated over the short-term (4 weeks), long-term (12 months), and repeated treatments. Diarrhea is the only adverse event consistently associated with tegaserod and was generally mild and transient. Overall, tegaserod has been demonstrated to offer effective and well-tolerated treatment of IBS-C, providing patients with meaningful symptom relief.

No MeSH data available.


Related in: MedlinePlus