PMID- 19639028
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 1753-5174 (Print)
IS  - 1753-5174 (Electronic)
IS  - 1753-5174 (Linking)
VI  - 1
IP  - 3
DP  - 2008 Dec
TI  - Exploratory Study of Tegaserod for Dyspepsia in Women Receiving PPIs for 
      Heartburn.
PG  - 79-88
AB  - BACKGROUND AND AIMS: Tegaserod is a selective serotonin receptor (5-HT(4)) 
      agonist that relieves dysmotility symptoms associated with constipation. Here we 
      explore its effects on functional dyspepsia symptoms and heartburn during 
      continued proton pump inhibitor (PPI) treatment. METHODS: In this multicenter 
      pilot study, following a 2-week screening/baseline period, women with functional 
      dyspepsia and persisting heartburn treated with PPIs received add-on open-label 
      tegaserod 6 mg twice daily (bid) for 4 weeks. Treatment responders were then 
      randomized 1:1 to continue double-blind tegaserod or placebo therapy for 6 weeks. 
      Efficacy variables included the proportion of days with satisfactory relief of 
      dyspepsia symptoms (early satiety, postprandial fullness and bloating) as well as 
      the change in individual symptom severity scores for these three cardinal 
      dyspepsia symptoms. Health-related quality of life was evaluated using a 
      validated questionnaire, the Nepean Dyspepsia Index. Adverse events (AEs) were 
      monitored. RESULTS: Of 101 women enrolled, 71 completed open-label treatment, and 
      70 responders were randomized to double-blind treatment. The proportion of days 
      with satisfactory relief of dyspepsia symptoms (least squares mean, LSM) 
      increased with tegaserod and placebo, to 0.69 and 0.62, respectively at study end 
      (P = 0.366). Similarly, both groups showed improvements in the composite daily 
      symptom severity score (overall LSM change from baseline of 1.55 and 1.57, P = 
      0.934), and the Nepean Dyspepsia Index (overall LSM change of -39.0 and -37.8, P 
      = 0.537). Tegaserod was well tolerated. Diarrhea was the most common AE (8.1% 
      tegaserod, 0% placebo). There were no serious AEs or deaths. CONCLUSIONS: A 
      significant treatment effect was not demonstrated in this study using a 
      treatment-withdrawal methodology. In future studies of functional dyspepsia 
      patients with heartburn, a more rigorous parallel-group study design should be 
      considered.
FAU - Vakil, Nimish
AU  - Vakil N
FAU - Kianifard, Farid
AU  - Kianifard F
FAU - Bottoli, Ivan
AU  - Bottoli I
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Arch Drug Inf
JT  - Archives of drug information
JID - 101322852
PMC - PMC2710991
EDAT- 2009/07/30 09:00
MHDA- 2009/07/30 09:01
CRDT- 2009/07/30 09:00
PHST- 2009/07/30 09:00 [entrez]
PHST- 2009/07/30 09:00 [pubmed]
PHST- 2009/07/30 09:01 [medline]
AID - 10.1111/j.1753-5174.2008.00012.x [doi]
PST - ppublish
SO  - Arch Drug Inf. 2008 Dec;1(3):79-88. doi: 10.1111/j.1753-5174.2008.00012.x.