Pharmacokinetics (PK) of SDZ HTF 919 (HTF) not altered in subjects with severe renal insufficiency requiring hemodialysis

Zhou, Haitao; McLeod, James F.; Alladina, Latifa; Guerret, M.; Osborne, Stuart; Lau, Henry; Lambrecht, L.; Swan, S. K.

doi:10.1016/s0009-9236(99)80342-7

Cited by 8 publications

(3 citation statements)

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“…No dose adjustments are required in patients with mild to moderate liver impairment or renal impairment 224 ,. 225 It is unclear whether reports of surgery for ovarian or gall‐bladder ‘pathology’ during treatment of irritable bowel syndrome patients with tegaserod represent chance findings or significant risks.…”

Section: Partial 5‐ht4 Agonistsmentioning

confidence: 99%

Consensus report: clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome

Camilleri

Heading

Thompson

2002

Aliment Pharmacol Ther

114

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Summary This consensus document reviews the current status of the epidemiology, social impact, patient quality of life, pathophysiology, diagnosis and treatment of irritable bowel syndrome. Current evidence suggests that two major mechanisms may interact in irritable bowel syndrome: altered gastrointestinal motility and increased sensitivity of the intestine. However, other factors, such as psychosocial factors, intake of food and prior infection, may contribute to its development. Management of patients is based on a positive diagnosis of the symptom complex, careful history and physical examination to exclude ‘red flags’ as risk factors for organic disease, and, if indicated, investigations to exclude other disorders. Therapeutic choices include dietary fibre for constipation, opioid agents for diarrhoea and low‐dose antidepressants or infrequent use of antispasmodics for pain, although the evidence basis for efficacy is limited or in some cases absent. Psychotherapy and hypnotherapy are the subject of ongoing study. Treatment should be tailored to patient needs and fears. Novel therapies are emerging, and drugs acting on serotonin receptors have proven efficacy and a scientific rationale and, if approved, should be useful in the overall management of patients with irritable bowel syndrome. Patient and physician education, early identification of psychosocial issues and better therapies are important strategies to reduce the suffering and societal cost of irritable bowel syndrome.

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Section: Partial 5‐ht4 Agonistsmentioning

confidence: 99%

Consensus report: clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome

Camilleri

Heading

Thompson

2002

Aliment Pharmacol Ther

114

View full text Add to dashboard Cite

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“…Results showed that plasma concentrations of tegaserod in patients with mild-to-moderate liver disease, mild-to-moderate renal impairment, and in patients requiring renal dialysis were comparable with levels in healthy controls. Therefore, dose-adjustment of tegaserod is not required in these patients ( Zhou et al 1999 ; Appel-Dingemanse 2002 ).…”

Section: Drug–drug Interactions and Special Patient Populationsmentioning

confidence: 99%

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

Layer¹,

Keller²,

Loeffler³

et al. 2007

Therapeutics and Clinical Risk Management

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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.

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“…23 Similarly, there were no significant changes in the pharmacokinetics (tmax, Cmax, AUC) of tegaserod 12 mg b.i.d. in patients with severe renal insufficiency requiring dialysis 24 or in patients with hepatic cirrhQsis, 25 compared with healthy volunteers.…”

Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

Tegaserod: A Novel, Selective 5‐ht4 Receptor Partial Agonist for Irritable Bowel Syndrome

Beglinger

2002

Int J Clinical Practice

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SUMMARYIrritable bowel syndrome (IBS) is a common functional bowel disorder of unknown aetiology. It is defined by the presence of gastrointestinal (GI) symptoms including abdominal pain/discomfort, bloating and bowel motor dysfunction. No available therapy is yet effective against all the symptoms of the disorder. Current treatments therefore target individual symptoms but may be accompanied by unpleasant side‐effects. Tegaserod is a novel selective serotonin receptor type‐4 (5‐HT4) partial agonist with structural similarity to 5‐HT. Tegaserod stimulates small bowel and colonic motility and helps to normalise GI function. Clinical trials using a patient's assessment of efficacy demonstrate that tegaserod significantly improves key symptoms of IBS: abdominal pain/discomfort, bloating and constipation. Tegaserod is well tolerated with an excellent safety profile and represents a significant treatment advance in this difficult‐to‐treat disorder.

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Pharmacokinetics (PK) of SDZ HTF 919 (HTF) not altered in subjects with severe renal insufficiency requiring hemodialysis

Abstract: Clinical Pharmacology & Therapeutics (1999) 65, 203–203; doi:

Cited by 8 publications

References 0 publications

Consensus report: clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome

Consensus report: clinical perspectives, mechanisms, diagnosis and management of irritable bowel syndrome

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

Tegaserod: A Novel, Selective 5‐ht4 Receptor Partial Agonist for Irritable Bowel Syndrome

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