A Randomized, Multicenter, Prospective, Crossover, Open-Label Study of Factors Associated With Patient Preferences for Naloxegol or PEG 3350 for Opioid-Induced Constipation

Darren M Brenner, Yiqun Hu, Catherine Datto, Dana Creanga, Michael Camilleri, Darren M Brenner, Yiqun Hu, Catherine Datto, Dana Creanga, Michael Camilleri

Abstract

Objectives: To determine patient preference for treating opioid-induced constipation (OIC) using naloxegol or polyethylene glycol (PEG) 3350 in patients receiving opioids for noncancer pain.

Methods: This crossover study included two 2-week active treatment periods, each preceded by a 1-week washout period (NCT03060512). Individuals with baseline Bowel Function Index scores ≥30 were randomized to 1 of 2 treatment sequences (naloxegol/PEG 3350 or PEG 3350/naloxegol). Patient preference (primary end point) was measured at the end of the second treatment period.

Results: Of 276 patients randomized, 246 completed both treatment periods and reported preference (per protocol). Similar proportions of patients reported overall preference for naloxegol (50.4%) or PEG 3350 (48.0%; P = 0.92); 1.6% reported no preference. Medication characteristics influencing preference were similar for both treatments, except convenience and working quickly, which were strong influences of preference for higher proportions of patients preferring naloxegol (69.9% and 39.0%, respectively) vs those preferring PEG 3350 (29.9% and 27.4%, respectively). Patients aged <50 years or receiving laxatives within the previous 2 weeks generally preferred naloxegol. Changes from baseline in overall Bowel Function Index and Patient Global Impression of Change scores were similar between treatments, but analyses according to treatment preference revealed clinical improvement aligned with reported preference. Safety profiles were generally consistent with known medication profiles.

Conclusions: Almost equal proportions of patients with OIC reported similar preference for daily naloxegol or PEG 3350 treatment, and their preference was generally supported by clinically relevant and measurable improvements in OIC symptoms.

Figures

Figure 1.
Figure 1.
Study design. BFI, Bowel Function Index; PEG, polyethylene glycol; PGIC, Patient Global Impression of Change; V, visit.
Figure 2.
Figure 2.
Patient disposition (all enrolled patients). BFI, Bowel Function Index; PEG, polyethylene glycol. aTotal number of patients who consented.
Figure 3.
Figure 3.
Patient preference ratings for naloxegol or PEG 3350 (per-protocol population). PEG, polyethylene glycol.
Figure 4.
Figure 4.
Patient-reported influence of medication characteristics contributing to their treatment preference. OIC, opioid-induced constipation; PEG, polyethylene glycol.
Figure 5.
Figure 5.
Clinical improvements in OIC symptoms: (a) change from baseline at visits 3/5 in the BFI overall (left) and by treatment preference (right); (b) PGIC overall (left) and by treatment preference (right). BFI, Bowel Function Index; OIC, opioid-induced constipation; PEG 3350, polyethylene glycol 3350; PGIC, Patient Global Impression of Change. an = 116.

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