In IBS-C patients with severe symptoms, severity changes ranged from -2.7 to -3.4 with linaclotide versus -1.4 to -1.9 with placebo (P < .0001).
In plain wordsIn IBS-C patients with severe symptoms, linaclotide reduced abdominal symptom severity more than placebo.
- Peptide
- Linaclotide
- Outcome
- DecreaseSevere abdominal symptoms
- Study
n: not reported in source
- Comparator
- placebo
- Outcome group
- Gastrointestinal protection · Gastrointestinal
- Studied dose
- 290 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
- Severity change
- −3.4 to −2.7 score
- linaclotide
- Severity change
- −1.9 to −1.4 score
- placebo
Source sentences
In patients with severe symptoms, linaclotide reduced all abdominal symptoms; mean changes from baseline severity scores ranged from -2.7 to -3.4 for linaclotide vs -1.4 to -1.9 for placebo (P < .0001).
3 context sentences(design, population, supporting numbers)
In two phase 3 trials, patients who met modified Rome II criteria for IBS-C were randomly assigned to groups given oral, once-daily linaclotide (290 μg) or placebo for 12 weeks.
During the baseline (2 weeks prior to treatment) and treatment periods, patients rated abdominal pain, discomfort, bloating, fullness, and cramping daily (from 0 = none to 10 = very severe).
Linaclotide's effects on abdominal symptoms, global measures, and IBS-related QOL were assessed in subpopulations of patients who rated specific individual abdominal symptoms as severe (≥ 7.0) at baseline.