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.
This important study shows inexpensive therapy as good as new pharma.
I doubt this will lead to a change in clinical management. It does not add to the literature.
It is rare to see direct "head-to-head" comparisons of different agents for conditions such as opioid-induced constipation (OIC). The fact that participants were almost equally split in terms of preference for PEG 3350 and naloxegol is interesting. Despite the known pathogenesis of OIC and the pharmacological profiles of the two agents, it is important to recognize that osmotic laxatives such as PEG 3350 are often effective in management. This is supported by recent treatment guidelines.
Unimpressive results for an expensive branded medication compared with the inexpensive over-the-counter medication.