The U.S. Food and Drug Administration (FDA) has approved tegaserod maleate (Zelnorm) for short-term treatment of irritable bowel syndrome (IBS) in women whose primary bowel symptom is constipation.
Tegaserod, a selective serotonin type-4 receptor partial agonist, increases motility of the gastrointestinal tract. The first of its kind for this indication, tegaserod does not treat diarrhea-predominant IBS.
In addition, because the study on which the FDA based its approval only involved women, the drug’s effectiveness in men has not yet been established.
The FDA approval was based on results from three 12-week, randomized, double-blind clinical studies. A total of 2,470 women with at least a three-month history of IBS symptoms of abdominal pain, bloating, and constipation received 6 mg of tegaserod twice daily or placebo.
To measure the drug’s efficacy, study subjects in both groups were asked to rate their overall well-being, symptoms of abdominal discomfort and pain, and altered bowel habits on a weekly basis throughout the study. The rate of favorable response was 5% to 11% higher than placebo in all three studies. Because the response difference between the two groups declined at the end of the first month, the drug’s effectiveness may decrease during longer-term treatment than 12 weeks.
e-Med Tools
קצר קולע וממוקד
e-Med סמינרים
אי-מד תחקירים
Medscape Tools
Journal Club
מרכזי מידע ושירות
Facebook
מידע למפרסם
מאגר תרופות
מאגר אנשי המקצוע
אינדקס שימושי
חדשות משה"ב
eMed HealthClub
מחקרים קליניים
השאירו תגובה
רוצה להצטרף לדיון?תרגישו חופשי לתרום!