PMID- 17278196
OWN - NLM
STAT- MEDLINE
DCOM- 20070327
LR  - 20240321
IS  - 1007-9327 (Print)
IS  - 2219-2840 (Electronic)
IS  - 1007-9327 (Linking)
VI  - 13
IP  - 5
DP  - 2007 Feb 7
TI  - A randomized, double-blind, placebo-controlled trial assessing the efficacy and 
      safety of tegaserod in patients from China with chronic constipation.
PG  - 732-9
AB  - AIM: To evaluate the efficacy and safety of tegaserod, 6 mg twice daily (b.i.d.), 
      in men and women with chronic constipation (CC) from China. METHODS: This was a 
      multicenter, double-blind, placebo-controlled study. Following a 2-wk 
      treatment-free baseline period, patients were randomized to receive either 
      tegaserod (6 mg b.i.d.) or placebo (b.i.d.) for 4 wk. An analysis of covariance 
      with repeated measures was used to determine the overall effect of treatment for 
      the primary efficacy variable; the change from baseline in the number of complete 
      spontaneous bowel movements (CSBMs) during the 4-wk treatment period. Secondary 
      efficacy endpoints included other measures of response in terms of CSBMs, and 
      patients' daily and weekly assessment of bowel habits. Safety was also assessed, 
      based on the incidence and severity of adverse events (AEs). RESULTS: A total of 
      607 patients were randomized to receive either tegaserod (n = 304) or placebo (n 
      = 303). Tegaserod treatment resulted in a rapid and significant increase from 
      baseline in the adjusted mean number of CSBMs per week over wk 1-4 compared with 
      placebo (1.39 vs 0.91, P = 0.0002). A statistically significant difference in 
      favor of tegaserod was also observed for a mean increase > or = 1 CSBM/wk over wk 
      1-4 (47.7% vs 35.0%, tegaserod vs placebo, respectively, P = 0.0018) and for the 
      absolute number of > or = 3 CSBMs/wk over wk 1-4 (25.0% vs 14.5%, tegaserod vs 
      placebo, respectively, P = 0.0021). Improvements in other symptoms of CC were 
      also seen in the tegaserod group, including improved stool form and reduced 
      straining. In addition, more patients in the tegaserod group reported 
      satisfactory relief from their constipation symptoms. The frequency and severity 
      of AEs was comparable between tegaserod and placebo groups, with the exception of 
      a greater incidence of diarrhea in patients receiving tegaserod (3.6%) compared 
      with placebo (1.7%). CONCLUSION: Tegaserod treatment improved multiple symptoms 
      of CC and was associated with a favorable safety profile.
FAU - Lin, San-Ren
AU  - Lin SR
AD  - The 3rd Hospital, Beijing Medical University, China.
FAU - Ke, Mei-Yun
AU  - Ke MY
FAU - Luo, Jin-Yan
AU  - Luo JY
FAU - Yuan, Yao-Zong
AU  - Yuan YZ
FAU - Wang, Ji-Yao
AU  - Wang JY
FAU - diTommaso, Shelley
AU  - diTommaso S
FAU - Walter, Verena
AU  - Walter V
FAU - Huang, Jiaqing
AU  - Huang J
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - World J Gastroenterol
JT  - World journal of gastroenterology
JID - 100883448
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Indoles)
RN  - 0 (Placebos)
RN  - 458VC51857 (tegaserod)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - China
MH  - Chronic Disease
MH  - Constipation/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Gastrointestinal Agents/*administration & dosage/adverse effects
MH  - Humans
MH  - Indoles/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Treatment Outcome
PMC - PMC4066006
EDAT- 2007/02/06 09:00
MHDA- 2007/03/28 09:00
PMCR- 2007/02/07
CRDT- 2007/02/06 09:00
PHST- 2007/02/06 09:00 [pubmed]
PHST- 2007/03/28 09:00 [medline]
PHST- 2007/02/06 09:00 [entrez]
PHST- 2007/02/07 00:00 [pmc-release]
AID - 10.3748/wjg.v13.i5.732 [doi]
PST - ppublish
SO  - World J Gastroenterol. 2007 Feb 7;13(5):732-9. doi: 10.3748/wjg.v13.i5.732.