Efficacy and tolerability of low-dose oral prolonged-release oxycodone/naloxone for chronic nononcological pain in older patients

Abstract

PurposeChronic pain is highly prevalent in older adults. Increasing evidence indicates strong opioids as a valid option for chronic pain management in geriatrics. The aim of this study was to evaluate efficacy and safety of low-dose oral prolonged-release oxycodone–naloxone (OXN-PR) in patients aged ≥70 years.MethodsThis open-label prospective study assessed older patients naïve to strong opioids presenting with moderate-to-severe chronic pain. Patients were prescribed OXN-PR at an initial dose of 10/5 mg/day for 28 days. In case of insufficient analgesia, the initial daily dose could be increased gradually. The primary efficacy measure was change in pain intensity from baseline, assessed by a ten-point Numeric Rating Scale (NRS) at day 28 (T28). Changes in cognitive state, daily functioning, quality of life, constipation, and other adverse events were assessed.ResultsOf 53 patients enrolled (mean 81.7±6.2 years [range 70–92 years]), 52 (98.1%) completed the 28-day observation. At T28, the primary end point (≥30% reduction in mean pain from baseline in the absence of bowel function deterioration) was achieved in 38 patients (71.7%). OXN-PR significantly relieved pain (NRS score –3.26; P<0.0001), as well as daily need for rescue paracetamol (from 86.8% at baseline to 40.4% at T28; P<0.001), and reduced impact of pain on daily activities (Brief Pain Inventory Short Form from 6.2±1.5 to 3.4±2.1; P<0.0001). OXN-PR was also associated with significant improvement in daily functioning (Barthel Index from 53.3±14.1 to 61.3±14.3; P<0.01). No changes were observed in cognitive status and bowel function. OXN-PR was well tolerated; only one patient (1.9%) prematurely withdrew from treatment, due to drowsiness.ConclusionFindings from this open-label prospective study suggest that low-dose OXN-PR may be effective and well tolerated for treatment of moderate-to-severe chronic pain in older patients. Besides its effectiveness, these data indicate that low-dose OXN-PR may be considered a safe analgesic option in this fragile population and warrants further investigation in randomized controlled studies.

Efficacy of Duloxetine Compared with Opioid for Postoperative Pain Control Following Total Knee Arthroplasty

“…Major barriers to opioid use are opioid-related side effects [33]. The most common side effects are constipation, dizziness, nausea, vomiting, and delirium.…”

“…Constipation is one major side effect of opioids. The use of oxycodone-naloxone can reduce the rate of constipation [33]. Duloxetine is a drug that can act on the central nervous system like opioids.…”

Pharmacological treatment of chronic non-malignant pain among elderly persons: an integrative review

“…The oxycodone-naloxone prolonged-release combination has shown analgesic efficacy in studies, with a significant reduction in the incidence of opioid-induced constipation and improvement in patient quality of life 37,39,40 . A study conducted by Guerriero et al 37 demonstrated statistically significant clinical improvements during oxycodone-naloxone treatment.…”

Developments in managing severe chronic pain: role of oxycodone&ndash;naloxone extended release

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