Chronic constipation is a common, persistent disorder with limited effective treatment options.
Dr Hugo-Cournez and a group of researchers from Europe undertook a study in order to investigate the efficacy, safety, and tolerability of tegaserod in the treatment of chronic constipation.
After a 2-wk baseline period, the research team randomly assigned patients to either double-blind treatment of 12 wk with tegaserod (2 or 6 mg b.i.d.) or placebo.
Response during weeks 14 (primary variable) was defined as an increase in complete spontaneous bowel movement (CSBM)/wk.
Secondary variables included response during weeks 112, patient evaluation of individual symptoms, and global assessment of bowel habits and constipation.
The researchers recruited a total of 1,264 patients were randomized to tegaserod or placebo.
| Tegaserod 6 mg b.i.d. reduced straining, abdominal bloating/distension, and abdominal pain/discomfort|
|The American Journal of Gastroenterology|
The research team found that responder rates for the primary efficacy variable were 36% for tegaserod 2 mg b.i.d., 40% for 6 mg b.i.d. and 27% for placebo.
The investigators noted that the number of participants that they needed to treat was 7 for the 6 mg b.i.d. dose compared with 11 for tegaserod 2 mg b.i.d.
The researchers found that Tegaserod 6 mg b.i.d. reduced straining, abdominal bloating/distension, and abdominal pain/discomfort during the 12-wk treatment period compared with placebo.
In addition, the team noted significant improvements in stool form and in global assessment of bowel habits and constipation.
Dr Hugo-Cournez conclude, "The most common adverse events, headache and abdominal pain, were more frequent with placebo than with tegaserod."
"Tegaserod was efficacious in relieving symptoms of chronic constipation and was well tolerated."