Patient preference with respect to QoL and reduction in opioid‐induced constipation (
            <scp>OIC</scp>
            ) after treatment with prolonged‐release (
            <scp>PR</scp>
            ) oxycodone/naloxone compared with previous analgesic therapy [
            <scp>PREFER</scp>
            study]

Ma, Van Dongen; Vanelderen, Pascal; Koopmans-Klein, Gineke; Megen, Y.J.B. van; Zundert, Jan Van; Huygen, Frank

doi:10.1111/ijcp.12468

Cited by 11 publications

(5 citation statements)

References 29 publications

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“…These findings are supported by PREFER, a 3‐week, open‐label study investigating patient preference for opioid therapy. Of 169 patients (62% had low back pain), OXN PR improved QoL measures, with most marked gains in individuals with OIC who were previously treated with WHO step II analgesics; greater patient preference for OXN PR compared with prior opioid analgesic therapy was also reported …”

Section: Literature Searchmentioning

confidence: 99%

Oral Prolonged‐Release Oxycodone/Naloxone for Managing Pain and Opioid‐Induced Constipation: A Review of the Evidence

et al. 2017

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Section: Literature Searchmentioning

confidence: 99%

Oral Prolonged‐Release Oxycodone/Naloxone for Managing Pain and Opioid‐Induced Constipation: A Review of the Evidence

et al. 2017

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“… 41 Furthermore, patients previously treated with non-opioids or weak opioids indicated their preference for oxycodone/naloxone treatment with respect to quality of life outcomes. 42 Direct and indirect treatment costs for oxycodone/naloxone were also ~13% lower compared to other strong opioids for chronic low back pain patients in Germany; the cost-effectiveness analysis indicates better health economic benefits for oxycodone/naloxone. 37 …”

Section: Discussionmentioning

confidence: 96%

Quality of life under oxycodone/naloxone, oxycodone, or morphine treatment for chronic low back pain in routine clinical practice

Ueberall¹,

Eberhardt²,

Mueller-Schwefe³

2016

IJGM

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ObjectiveTo compare the quality of life of patients with moderate-to-severe chronic low back pain under treatment with the WHO-step III opioids oxycodone/naloxone, oxycodone, or morphine in routine clinical practice.Study designProspective, 12-week, randomized, open-label, blinded end-point study in 88 medical centers in Germany.Patients and methodsA total of 901 patients requiring around-the-clock pain treatment with a WHO-step III opioid were randomized to either morphine, oxycodone, or oxycodone/naloxone (1:1:1). Changes from baseline to week 12 in quality of life were assessed using different validated tools (EuroQoL-5 Dimensions [EQ-5D], Short Form 12 [SF-12], quality of life impairment by pain inventory [QLIP]).ResultsEQ-5D weighted index scores significantly improved over the 12-week treatment period under all three opioids (P<0.001) with significantly greater improvements under oxycodone/naloxone (65.2% vs 49.6% for oxycodone and 48.2% for morphine, P<0.001). The proportion of patients without EQ-5D complaints was also significantly higher under oxycodone/naloxone (P<0.001). Although quality of life ratings with the QLIP inventory showed significant improvements in all the three treatment arms, improvements were significantly higher under oxycodone/naloxone than under oxycodone and morphine (P<0.001): 90.7% of all oxycodone/naloxone patients achieved ≥30% improvements in quality of life, 72.8% had ≥50%, and 33.2% ≥70% improvements. Similarly, both physical and mental SF-12 component scores showed significantly greater improvements under oxycodone/naloxone with both scores close to the German population norm after 12 weeks.ConclusionTreatment with morphine, oxycodone, or oxycodone/naloxone under routine daily practice conditions significantly improved state of health and quality of life of patients with moderate-to-severe low back pain over a 12-week treatment period. Comparison between the treatment groups showed significantly greater improvements for oxycodone/naloxone than for the other two opioids.

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“…The current trial was also the first study to compare patient preference for a prescription treatment for OIC with an OTC laxative and demonstrate alignment of preference with clinical outcomes. Protocols using preference scales similar to those in the current study have been used in previous OIC studies, as well as studies of other symptomatic conditions (e.g., migraine headaches) (11,12). In a previous study that compared the prescription OIC treatment lubiprostone with the OTC laxative senna, both treatments were associated with improvements in OIC-related symptoms and quality of life, but no significant differences were observed between lubiprostone and the OTC laxative in clinically evaluated measures (18).…”

Section: Discussionmentioning

confidence: 99%

“…The primary end point—patient-reported preference for naloxegol or PEG 3350—was assessed at the end of the second treatment period using a graded, 7-point, symmetrical scale (strong, moderate, or slight preference for naloxegol; no preference; slight, moderate, or strong preference for PEG 3350). Similar measures have been used in previous OIC studies and for other symptomatic conditions (e.g., migraine headaches) (11,12). For analysis purposes, responses were collapsed into 3 preference categories: prefer naloxegol, no preference, and prefer PEG 3350.…”

Section: Methodsmentioning

confidence: 99%

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

Brenner

Datto

et al. 2019

Am J Gastroenterol

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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.

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Patient preference with respect to QoL and reduction in opioid‐induced constipation ( OIC ) after treatment with prolonged‐release ( PR ) oxycodone/naloxone compared with previous analgesic therapy [ PREFER study]

Cited by 11 publications

References 29 publications

Oral Prolonged‐Release Oxycodone/Naloxone for Managing Pain and Opioid‐Induced Constipation: A Review of the Evidence

Oral Prolonged‐Release Oxycodone/Naloxone for Managing Pain and Opioid‐Induced Constipation: A Review of the Evidence

Quality of life under oxycodone/naloxone, oxycodone, or morphine treatment for chronic low back pain in routine clinical practice

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

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