In IBS-C with moderate-to-severe bloating, plecanatide reduced bloating severity versus placebo (least-squares mean change -1.7 versus -1.3; P = 0.002).
In plain wordsIn IBS-C with moderate-to-severe bloating, plecanatide reduced bloating severity more than placebo.
- Peptide
- Plecanatide
- Outcome
- DecreaseBloating severity in moderate-to-severe subgroup
- Study
n = 1,104
- Comparator
- Placebo
- Outcome group
- Bowel Function · Gastrointestinal
- Studied dose
- 3 mg · 12 weeksAs given in this study (human).
Measurements
- Bloating severity change
- −1.7 LSMC
- plecanatide 3 mg, moderate-to-severe bloating
- Bloating severity change
- −1.3 LSMC
- placebo, moderate-to-severe bloating
- P value
- 0.002 P
- plecanatide versus placebo
Source sentences
In the moderate-to-severe bloating subgroup, plecanatide significantly reduced bloating severity versus placebo (least-squares mean change [LSMC]: - 1.7 vs - 1.3; P = 0.002), reduced abdominal pain (- 1.7 vs - 1.3; P = 0.006), and increased CSBM frequency (1.4 vs 0.8; P < 0.0001).
2 context sentences(design, population, supporting numbers)
Pooled phase 3 data (2 randomized, controlled IBS-C trials) from adults treated with plecanatide 3 mg or placebo for 12 weeks were analyzed.
Patients were stratified post-hoc by baseline bloating severity (11-point scale: mild [≤ 5] and moderate-to-severe [> 5]).