Tegaserod treatment for dysmotility-like functional dyspepsia: results of two randomized, controlled trials.
OBJECTIVE
Therapies for dysmotility-like functional dyspepsia (FD) are limited. We studied tegaserod, a selective serotonin type 4 receptor agonist, in patients with FD.


METHODS
Two identical multicenter, double-blind, randomized, placebo-controlled trials enrolled women >/=18 yr with recurring mid-upper abdominal discomfort characterized by postprandial fullness, early satiety, and/or bloating. Patients were randomized to tegaserod 6 mg b.i.d. or placebo. Two patient-reported primary variables were assessed: percentage of days with satisfactory symptom relief, and symptom severity using the composite average daily severity score (CADSS).


RESULTS
In total, 2,667 women were randomized with no differences between trials in terms of recruitment method, Helicobacter pylori status, heartburn, or medication use. Mean percentage of days with satisfactory symptom relief for tegaserod versus placebo in Trial 1: 32.2%versus 26.6% (95% CI of treatment difference 2.82, 9.27; P < 0.01), Trial 2: 31.9%versus 29.4% (95% CI of treatment difference -0.21, 6.53; P= 0.066). Mean CADSS in Trial 1: 3.14 versus 3.35 (95% CI of treatment difference -0.29, -0.10; P < 0.0001), Trial 2: 3.15 versus 3.23 (95% CI of treatment difference -0.18, 0.01; P= 0.094). Meta-analysis showed significant benefit for both end points: increase in days with satisfactory relief 4.6% (95% CI 2.29, 6.96); decrease in CADSS 0.14 (95% CI 0.21, 0.07). Treatment effect was greater in patients with severe baseline symptoms. Diarrhea requiring study discontinuation was more common with tegaserod than placebo (4.1%vs 0.3%).


CONCLUSIONS
Some improvement in dysmotility-like FD was observed with tegaserod treatment. The clinical implication of this improvement is uncertain.
Vakil
Nimish
N
University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin and Marquette University College of Health Sciences, Milwaukee, Wisconsin 53233, USA.
Laine
Loren
L
Talley
Nicholas J
NJ
Zakko
Salam F
SF
Tack
Jan
J
Chey
William D
WD
Kralstein
Jeffrey
J
Earnest
David L
DL
Ligozio
Gregory
G
Cohard-Radice
Marielle
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004415:Dyspepsia / Q000188:drug therapy* / Q000209:etiology; D015154:Esophageal Motility Disorders / Q000150:complications*; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D007211:Indoles; D017366:Serotonin Receptor Agonists; C105050:tegaserod