Effectiveness and tolerability of low-dose oral oxycodone/naloxone added to anticonvulsant therapy for noncancer neuropathic pain: an observational analysis

Abstract

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...

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

“…Two large‐scale observational studies included a total of 1,688 patients with neuropathic pain, receiving OXN PR at mean starting doses of 24.4 mg/day and 16 mg/day, respectively (concomitant gabapentin/pregabalin was permitted) . In these “real‐life” settings, OXN PR provided clinically relevant improvements in pain, functional impairment, and BFI scores compared with prior therapy, and was reported to be well tolerated . These findings are supported by a third large‐scale observational study of OXN PR (mean starting dose 15/7.5 mg/day; 19% received concomitant anticonvulsants) in 1,051 patients with constipation (37% had received prior opioid analgesia), of whom approximately 85% had chronic, moderate‐to‐severe neuropathic pain .…”

“…While several RCTs of OXN PR have included some patients with moderate‐to‐severe neuropathic pain, the effectiveness and tolerability of OXN PR in this setting was specifically investigated in 4 studies identified in our literature search (see Table ). Two large‐scale observational studies included a total of 1,688 patients with neuropathic pain, receiving OXN PR at mean starting doses of 24.4 mg/day and 16 mg/day, respectively (concomitant gabapentin/pregabalin was permitted) . In these “real‐life” settings, OXN PR provided clinically relevant improvements in pain, functional impairment, and BFI scores compared with prior therapy, and was reported to be well tolerated .…”

Analgesic effectiveness and tolerability of oral oxycodone/naloxone and pregabalin in patients with lung cancer and neuropathic pain: an observational analysis

“…The observed improvement in QoL and patient’s satisfaction is in agreement with previous results, showing that attenuation of neuropathic pain after opioids improves mood and sleep. 48 , 49 …”

Emerging therapies for patients with symptoms of opioid-induced bowel dysfunction

“…This result suggests development of a collateral circulation due to portal vein thrombosis, and naloxone directly reaching the central nervous system and evoking withdrawal symptoms. 89 Numerous other studies have demonstrated clinical effectiveness of OXN in patients with chronic nonmalignant pain, 67 , 68 , 79 , 80 , 83 , 84 , 90 – 95 cancer-related pain, 96 – 99 and postoperative pain. 100 , 101 …”