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Tegaserod use in children: a single-center experience
Olivia Liem1, Hayat M Mousa, Marc A Benninga
1Department of Pediatric Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands. liemo@chi.osu.edu
Insights
Tegaserod effectively treated functional gastrointestinal symptoms in children, improving constipation and reducing fecal incontinence. Further studies are needed to confirm these findings in pediatric populations.
Area of Science:
- Pediatric Gastroenterology
- Clinical Pharmacology
- Gastrointestinal Motility Disorders
Background:
- Limited published data exist on tegaserod use in pediatric patients.
- Tegaserod is increasingly prescribed by pediatric gastroenterologists.
- This study describes clinical experience with tegaserod in children.
Purpose of the Study:
- To describe the authors' experience with tegaserod in pediatric patients.
- To evaluate the efficacy of tegaserod in treating functional gastrointestinal symptoms in children.
- To assess the safety and tolerability of tegaserod in a pediatric population.
Main Methods:
- Retrospective study of 72 pediatric patients treated with tegaserod from 2004-2006.
- Assessment of defecation frequency, fecal incontinence, and global symptom relief.
- Data collected on patient demographics, indications for treatment, dosage, and adverse events.
Main Results:
- Tegaserod use significantly increased defecation frequency (1 vs 7/week) and decreased fecal incontinence (47% vs 23%) in the constipation group (P < 0.001).
- Moderate to significant symptom relief was reported by parents in 71% of constipation cases and 64-68% of other functional gastrointestinal disorders.
- Adverse events occurred in 32% of patients, primarily self-limiting diarrhea (20%) and abdominal pain (8%).
Conclusions:
- Tegaserod appears to be effective in relieving various functional gastrointestinal symptoms in children.
- The drug demonstrated a favorable safety profile with mostly mild, self-limiting side effects.
- Further randomized controlled trials are warranted to establish specific pediatric indications for tegaserod.
Background:
Tegaserod is increasingly prescribed by pediatric gastroenterologists even though there are few published data concerning its use in children. The aim of this study was to describe the authors' experience with tegaserod in children.
Patients And Methods:
Patients treated with tegaserod from 2004 through 2006 were included in this study. Defecation and fecal incontinence frequency and global assessment of relief of symptoms were assessed.
Results:
Seventy-two patients (44 girls) ranging in age from 1.1 to 18.3 years constitute the patient sample of this report. The median age was 10 years and the median follow-up after initiation of tegaserod treatment was 11.3 months (range 2.3-45.2 months). Indications to prescribe tegaserod were constipation (58%) and a variety of other conditions including functional dyspepsia or inflammatory bowel disease (42%). Defecation frequency increased after tegaserod use (1 vs 7/week, P < 0.001) and presence of fecal incontinence decreased (47% vs 23%, P < 0.001) in the constipation group. Parents rated relief of constipation as moderate or significant in 71% of cases in the constipation group. In the group with other indications to start tegaserod therapy, moderate or significant relief of abdominal pain and bloating was noted in 64% and 68% of patients, respectively. The median dose of tegaserod prescribed was 0.22 mg x kg x day (range 0.05-0.87 mg x kg(-1) x day(-1)). Adverse events were observed in 32% of the patients. The most common side effects were self-limiting diarrhea (20%) and abdominal pain (8%). Only one patient discontinued tegaserod because of side effects; this patient experienced pain at his cecostomy site.
Conclusions:
Tegaserod seems to relieve a variety of functional gastrointestinal symptoms in children. Further randomized controlled studies are needed to support the specific pediatric target of prescribing tegaserod.
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