- Linaclotide was significantly more effective at treating opioid-induced constipation (OIC) than placebo in patients whose chronic noncancer pain syndromes were managed with opioid therapy.
Why this matters
- OIC is the most common adverse effect of chronic opioid use.
- Multicenter, randomized, double-blind, placebo-controlled, phase 2 trial.
- 254 patients with OIC with chronic noncancer pain syndromes managed with opioids received linaclotide 145 μg/day (n=87) or 290 μg/day (n=88) or placebo (n=79) for 8 weeks.
- Funding: Allergan plc; Ironwood Pharmaceuticals, Inc.
- Significantly greater increase in weekly spontaneous bowel movements with linaclotide vs placebo:
- 1.6 with placebo.
- 2.9 with 145 μg (P<.01 vs placebo>
- 3.5 with 290 μg (P<.0001 vs placebo>
- 0.9 with placebo.
- 1.7 with 145 μg (P<.001 vs placebo>
- 1.9 with 290 μg (P<.001 vs placebo>
- −0.6 with placebo.
- −1.0 for 145 μg (P=.0088 vs placebo).
- −1.1 for 290 μg (P<.0001 vs placebo>
- Small treatment population, short-term follow-up.