BackgroundWorld Health Organization step III opioids are required to relieve moderate-to-severe cancer pain; constipation is one of the most frequent opioid-induced side effects. A fixed combination, prolonged-release oxycodone/naloxone (OXN), was developed with the aim of reducing opioid-related gastrointestinal side effects. The objective of this study was to compare the efficacy and safety of prolonged-release oxycodone (OXY) alone to OXN in opioid-naïve cancer patients with moderate-to-severe pain.MethodsPropensity analysis was utilized in this observational study, which evaluated the efficacy, safety, and quality of life.ResultsOut of the 210 patients recruited, 146 were matched using propensity scores and included in the comparative analysis. In both groups, pain intensity decreased by ≈3 points after 60 days, indicating comparable analgesic efficacy. Responder rates were similar between groups. Analgesia was achieved and maintained with similarly low and stable dosages over time (12.0–20.4 mg/d for OXY and 11.5–22.0 mg/d for OXN). Bowel Function Index (BFI) and laxative use per week improved from baseline at 30 days and 60 days in OXN recipients (−16, P<0.0001 and −3.5, P=0.02, respectively); BFI worsened in the OXY group. The overall incidence of drug-related adverse events was 28.9% in the OXY group and 8.2% in the OXN group (P<0.01); nausea and vomiting were two to five times less frequent with OXN. Quality of life improved to a significantly greater extent in patients receiving OXN compared to OXY (increase in Short Form-36 physical component score of 7.1 points vs 3.2 points, respectively; P<0.001).ConclusionIn patients with chronic cancer pain, OXN provided analgesic effectiveness that is similar to OXY, with early and sustained benefits in tolerability. The relationship between responsiveness to OXN and clinical characteristics is currently being investigated.

c i a l D i s t r i b u t i o n U n a u t h o r i z e d u s e p r o h i b i t e d . A u t h o r i s e d u s e r s c a n d o w n l o a d , d i s p l a y , v i e w a n d p r i n t a s i n g l e c o p y f o r p e r s o n a l u s eCurrent Medical Research & Opinion Vol. 30, No. 4, 2014, 555-564 0300-7995 Article RT-0359. R1/866545 doi:10.1185/03007995.2013.866545 All rights reserved: reproduction in whole or part not permitted Results:Of 200 patients (mean age 65.9 years; 54% female) with NP included in the analysis; 97% completed 8 weeks' treatment. At the observation start, all patients were taking anticonvulsants and complained of constipation, and 60% were receiving opioids. Pain intensity and DN4 score decreased significantly by endpoint (NRS p50.0001; DN4 p50.0001) and need for rescue analgesics abated. Reduction in pain intensity throughout the observation was similar regardless of NP aetiology. According to PGIC, 87.8% of patients were much/extremely improved, CPSI (p50.0001) and BFI were significantly improved (p50.0001) and laxative use decreased. No differences were found between patients 565 years vs those !65 years. OXN was generally well tolerated. Study limitations:Study limitations including the retrospective observational design, the lack of a control group and the single-centre design may limit the generalizability of our findings. Conclusions:Low-dose OXN (25.0 AE 12.5 mg/day) added to anticonvulsants was highly effective in controlling noncancer NP of varied aetiology, with reduced need for rescue analgesia and improved quality of sleep, and was well tolerated, with improved bowel function and reduced laxative use. The efficacy and tolerability of OXN demonstrated in this real-world setting suggest its utility in this difficult to manage patient population. IntroductionNeuropathic pain (NP) -''pain arising as a direct consequence of a lesion or disease affecting the somatosensory system'' according to the Special Interest Group on Neuropathic Pain (NeuPSIG) 1 -may be related to cancer or of noncancer origin, can be continuous and/or episodic (paroxysmal) and is associated with dysaesthesia, hyperalgesia and allodynia [2][3][4][5] . Although treatments for NP may provide clinically meaningful reduction in pain and improvement on a broad spectrum of domains of health-related quality of life (QoL), including mood, sleep or enjoyment of life 6 , it remains difficult to manage, poses diagnostic and therapeutic challenges and presents a significant burden to individuals and society 7,8 . Pharmacological treatment for NP includes antidepressants, anticonvulsants, topical anaesthetics, and opioids, accompanied by nonpharmacological interventions such as physical therapy, psychological and interventional approaches 7,8 . Current guidelines recommend that combinations of pharmacotherapies may be more effective than monotherapy 8,9 . There are a number of limitations of current treatment, the main one being that many patients do not receive adequate pain relief due either to a lack of willingness on...

PurposeChronic pain has a high prevalence in the aging population. Strong opioids also should be considered in older people for the treatment of moderate to severe pain or for pain that impairs functioning and the quality of life. This study aimed to assess the efficacy and safety of the direct switch to low-dose strong opioids (World Health Organization-Step III drugs) in elderly, opioid-naive patients.Patients and methodsThis was a single-center, retrospective, observational study in opioid-naive patients aged ≥75 years, with moderate to severe chronic pain (>6-month duration) and constipation, who initiated treatment with prolonged-release oxycodone/naloxone (OXN-PR). Patients were re-evaluated after 15, 30, and 60 days (T60, final observation). Response to treatment was defined as an improvement in pain of ≥30% after 30 days of therapy without worsening of constipation.ResultsOne-hundred and eighty-six patients (mean ± SD age 80.7±4.7 years; 64.5% women) with severe chronic pain (mean average pain intensity 7.1±1.0 on the 11-point numerical rating scale) and constipation (mean Bowel Function Index 64.1±24.4; 89.2% of patients on laxatives) were initiated treatment with OXN-PR (mean daily dose 11.3±3.5 mg). OXN-PR reduced pain intensity rapidly and was well tolerated; 63.4% of patients responded to treatment with OXN-PR. At T60 (mean daily OXN-PR dose, 21.5±9.7 mg), the pain intensity was reduced by 66.7%. In addition, bowel function improved (mean decrease of Bowel Function Index from baseline to T60, −28.2, P<0.0001) and the use of laxatives decreased. Already after 15 days and throughout treatment, ~70% of patients perceived their status as much/extremely improved. Only 1.6% of patients discontinued treatment due to adverse events.ConclusionLow-dose OXN-PR in elderly patients naive to opioids proved to be an effective option for the treatment of moderate to severe chronic pain. Large-scale trials are needed to improve clinical guidance in the assessment and treatment of pain in older people.