[e-farmacos] Tegaserod (cont.)

["Roitter, Claudia" <croitter@daspu.unc.edu.ar>]

E-farmacos: Tegaserod (cont.)
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Estimado colistero,

Disculpas por el idioma pero espero que le sirva.


Claudia Roitter
Cordoba
(Argentina)
croitter@daspu.unc.edu.ar


Adjunto la informacisn de Micromedex sobre tegaserod 

TEGASEROD
CLINICAL APPLICATIONS
THERAPEUTIC USES
B. IRRITABLE BOWEL SYNDROME 
1. OVERVIEW: 
 FDA APPROVAL: Adult, no; pediatric, no 
 EFFICACY:  Adult, effective 
 DOCUMENTATION:  Adult, good 
2. SUMMARY: 
- Symptom improvement observed in unpublished studies 
3. ADULT: 
a. Oral tegaserod has improved symptoms of constipation-predominant
irritable bowel syndrome (eg, bloating, abdominal discomfort, pain,
constipation) in initial 3-month placebo-controlled studies (Anon, 1999;
Norman, 1999; Lefkowitz et al, 1999). Doses of 0.5 to 24 milligrams (mg)
twice daily have produced clinical benefit, although 2 mg twice daily
may be optimal (Lefkowitz et al, 1999). None of these studies have been
published. 
b. In one trial (n=547), significant improvements compared to placebo
were observed for overall gastrointestinal symptoms (Subject's Global
Assessment (SGA) scale), constipation, and abdominal discomfort with a
dose of 2 mg twice daily; efficacy was sustained for 12 weeks. Adverse
effects of diarrhea and flatulence were seen more often with tegaserod
than placebo (Anon, 1999). 
c. Results of an ongoing phase III trial (n=2500) (Anon, 1999a) are
needed to more fully assess the efficacy and clinical role of tegaserod. 
6.0 REFERENCES 
1. Anon: Novartis to file Zelmac for irritable bowel syndrome in
1999-2000. FDC and OTC Pharmaceuticals - The Pink Sheet, March 22,
1999a:13. 
2. Anon: Tegaserod maleate. Drugs Future 1999; 24(1):38-44. 
3. Appel-Dingemanse S, Guerret M, Hirschberg Y et al: Single- and
multiple-dose pharmacokinetics of SDZ HTF 919 in healthy subjects
(abstract PI-44). Clin Pharmacol Ther 1999a; 65(2):128. 
4. Appel-Dingemanse S, Hirschberg Y, Osborne S et al: Multiple-dose
pharmacokinetics confirm no accumulation and dose proportionality of the
novel promotile drug tegaserod (HTF 919). Eur J Clin Pharmacol 2001;
56(12):889-891. 
5. Appel-Dingemanse S, Lemarechal M-O, Kumle A et al: Integrated
modelling of the clinical pharmacokinetics of SDZ HTF 919, a novel
selective 5HT4 receptor agonist, following oral and intravenous
administration. Br J Clin Pharmacol 1999; 47(5):483-491. 
6. Appel S, Kumle A, Hubert M et al: First
pharmacokinetic-pharmacodynamic study in humans with a selective
5-hydroxytryptamine(4) receptor agonist. J Clin Pharmacol 1997a;
37(3):229-237. 
7. Appel S, Kumle A & Meier R: Clinical pharmacodynamics of SDZ HTF 919,
a new 5-HT4 receptor agonist, in a model of slow colonic transit. Clin
Pharmacol Ther 1997; 62(5):546-555. 
8. Appel S, Lemarechal M-O, Kumle A et al: Simultaneous PO and IV
pharmacokinetic modeling of the novel selective 5-HT receptor agonist
SDZ HTF 919 in humans (abstract PI-85). Clin Pharmacol Ther 1997b;
61(2):158. 
9. Hoyer D, Fehlmann D, Langenegger D et al: High affinity of SDZ
HTF-919 and related molecules for calf and human caudate 5-HT4
receptors. Ann N Y Acad Sci 1998; 861:267-268. 
10. Lefkowitz MP, Ruegg P, Shi Y et al: Relief of overall GI symptoms
and abdominal pain and discomfort as outcome measures in a clinical
trial of irritable bowel syndrome with HTF 919 (abstract).
Gastroenterology 1999; 116(part 2):1027. 
11. Norman P: Zelmac. Invest New Drugs 1999; 2(3):265-269. 
12. Scarpignato C & Pelosini I: Management of irritable bowel syndrome:
novel approaches to the pharmacology of gut motility. Can J
Gastroenterol 1999; 13(suppl A):50A-65A. 
13. Zhou H, Khalilieh S, Lau H et al: Effect of meal timing not critical
for the pharmacokinetics of tegaserod (HTF 919). J Clin Pharmacol 1999;
39(9):546-555. 
14. Zhou H, McLeod J, Alladina L et al: Pharmacokinetics (PK) of SDZ HTF
919 (HTF) not altered in subjects with severe renal insufficiency
requiring hemodialysis (abstract PIII-108). Clin Pharmacol Ther 1999a;
65(2):203. 
7.0 AUTHOR INFORMATION 
 Original publication:  12/1999 
 Most recent revision:  06/2001 

  List of contributors: 
 1.  DRUGDEX(R) Editorial Staff 

 For further information on contributing authors, 
 see editorial board listings. 


[NOTA: Mensaje sin acentos ni caracteres especiales.]
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