Lubiprostone -Effective for Pediatric Constipation Plus One

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E Elkaragy et al. JPGN; 78:800–809. Efficacy of lubiprostone for functional constipation treatment in adolescents and children: Randomized controlled trial

Methods:In this single‐blinded, randomized controlled study with 280 patients (aged 8–18) s with FC, patients were randomized either to a weight‐based lubiprostone dose (n= 140) or conventional laxatives (n= 140), for 12 weeks, followed by4 weeks posttreatment follow‐up. Patients weighing <50 and ≥50 kg were administered lubiprostone 8 mcg TID or 24 mcg BID, respectively.

Key findings:

  • Improvement in constipation was achieved in 128 (91.4%) patients in the lubiprostone group, and in 48 (34.3%) patients of the conventional therapy group (p< 0.001) and was sustained after treatment discontinuation
  • Mild self‐limited colicky abdominal pain and headache were the most prevalent side effects in the lubiprostone group

In their discussion, they note that a clinical trial by Benninga et al., which was designed to evaluate the efficacy and safety of lubiprostone in patients with FC aged 6–17 years in a placebo-controlled design, concluded that lubiprostone was not superior to placebo in terms of efficacy (18.5% vs. 14.4% response rates), in contrast to this study.11 Some of the factors that could account for the discrepancy: this trial did not enroll patients with a fecal impaction, lower enrollment of patients with prior laxative failure, and shorter duration of constipation.

My take: It is good to see pediatric data for lubiprostone! Particularly for milder constipation, it appears to be effective compared to typical laxatives.

Related blog post: Lubiprostone Study: Ineffective for Pediatric Functional Constipation

In the same issue of JPGN, a separate study showed that antegrade continence enemas may be helpful in children (n=33) with autism and soiling. One safety issue is tube dislodgement. In this study, the authors noted that three patients (9.1%) had inadvertent tube dislodgement, and all tubes were uneventfully replaced. One patient had behavioral issues that prohibited utilization of an ACE.

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