Controlled‐Release Oxycodone and Naloxone in the Treatment of Chronic Low Back Pain: A Placebo‐Controlled, Randomized Study

Cloutier, Christian; Taliano, John; O’Mahony, William; M, Csanadi; Cohen, Geoffrey; Sutton, Ian; Sinclair, Donald M.; Awde, M; Henein, Sam; Robinson, Lawrence R.; Eisenhoffer, John; Piraino, Paula S; Harsanyi, Zoltan; Michalko, K.

doi:10.1155/2013/164609

Cited by 45 publications

(45 citation statements)

References 42 publications

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“…Of the 15 included RCTs, 8 evaluated the efficacy and tolerability of tapentadol, [28][29][30][31][32][33][34][35] and 7 investigated the efficacy and tolerability of oxycodone/naloxone. 16,18,[36][37][38][39] Most trials were in Phase III (11 trials), 2 trials were in Phase II, 30,37 and 1 trial was in Phase IV. 39 The phase of one trial was unclear.…”

Section: Search Results and Patient Characteristicsmentioning

confidence: 99%

“…39 The phase of one trial was unclear. 36 Among the 15 included studies, 2 studies used an enriched or seeded trial design. 30 …”

Section: Search Results and Patient Characteristicsmentioning

confidence: 99%

“…The study by Cloutier et al 36 and the OXN4502 trial 39 were conducted at multiple centers in Canada and the United Kingdom, respectively. The method of randomization generation and concealment of allocation were judged to be adequate in 7 trials, 28,29,[31][32][33]36,37 whereas in the remaining 8 trials these were unclear.…”

Section: Clinical Therapeuticsmentioning

confidence: 99%

“…Among the included studies, sample size ranged from 83 patients 36 to 1121 patients. 32 The mean age of enrolled participants was reported in 12 RCTs.…”

Section: Clinical Therapeuticsmentioning

confidence: 99%

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Impact of Prolonged-release Oxycodone/Naloxone on Outcomes Affecting Patients' Daily Functioning in Comparison With Extended-release Tapentadol: A Systematic Review

Thakur¹,

Dickerson²,

Bhutani³

et al. 2015

Clinical Therapeutics

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Section: Search Results and Patient Characteristicsmentioning

confidence: 99%

“…39 The phase of one trial was unclear. 36 Among the 15 included studies, 2 studies used an enriched or seeded trial design. 30 …”

Section: Search Results and Patient Characteristicsmentioning

confidence: 99%

Section: Clinical Therapeuticsmentioning

confidence: 99%

“…Among the included studies, sample size ranged from 83 patients 36 to 1121 patients. 32 The mean age of enrolled participants was reported in 12 RCTs.…”

Section: Clinical Therapeuticsmentioning

confidence: 99%

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Impact of Prolonged-release Oxycodone/Naloxone on Outcomes Affecting Patients' Daily Functioning in Comparison With Extended-release Tapentadol: A Systematic Review

Thakur¹,

Dickerson²,

Bhutani³

et al. 2015

Clinical Therapeutics

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“…Some experimental and clinical findings suggest that the positive reinforcing effects that lead to opioid abuse are diminished or even absent in individuals with severe chronic pain, making opioid addiction less likely 51,52 . Of note, withdrawal effects have never been documented in RCTs evaluating OXN PR 16,19,20,53 . Additional longterm studies with PR OXN combination in patients with NP are required to better understand the benefits and risk of this treatment.…”

Section: Discussionmentioning

confidence: 99%

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

Lazzari¹,

Sabato²,

Caldarulo³

et al. 2013

Current Medical Research and Opinion

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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...

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Opioids for Chronic Noncancer Pain

Busse

Wang

Kamaleldin

et al. 2018

JAMA

494

216

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IMPORTANCE Harms and benefits of opioids for chronic noncancer pain remain unclear. OBJECTIVE To systematically review randomized clinical trials (RCTs) of opioids for chronic noncancer pain. DATA SOURCES AND STUDY SELECTION The databases of CENTRAL, CINAHL, EMBASE, MEDLINE, AMED, and PsycINFO were searched from inception to April 2018 for RCTs of opioids for chronic noncancer pain vs any nonopioid control. DATA EXTRACTION AND SYNTHESIS Paired reviewers independently extracted data. The analyses used random-effects models and the Grading of Recommendations Assessment, Development and Evaluation to rate the quality of the evidence. MAIN OUTCOMES AND MEASURES The primary outcomes were pain intensity (score range, 0-10 cm on a visual analog scale for pain; lower is better and the minimally important difference [MID] is 1 cm), physical functioning (score range, 0-100 points on the 36-item Short Form physical component score [SF-36 PCS]; higher is better and the MID is 5 points), and incidence of vomiting. RESULTS Ninety-six RCTs including 26 169 participants (61% female; median age, 58 years [interquartile range, 51-61 years]) were included. Of the included studies, there were 25 trials of neuropathic pain, 32 trials of nociceptive pain, 33 trials of central sensitization (pain present in the absence of tissue damage), and 6 trials of mixed types of pain. Compared with placebo, opioid use was associated with reduced pain (weighted mean difference [WMD], −0.69 cm [95% CI, −0.82 to −0.56 cm] on a 10-cm visual analog scale for pain; modeled risk difference for achieving the MID, 11.9% [95% CI, 9.7% to 14.1%]), improved physical functioning (WMD, 2.04 points [95% CI, 1.41 to 2.68 points] on the 100-point SF-36 PCS; modeled risk difference for achieving the MID, 8.5% [95% CI, 5.9% to 11.2%]), and increased vomiting (5.9% with opioids vs 2.3% with placebo for trials that excluded patients with adverse events during a run-in period). Low-to moderate-quality evidence suggested similar associations of opioids with improvements in pain and physical functioning compared with nonsteroidal anti-inflammatory drugs (pain: WMD, −0.60 cm [95% CI, −1.54 to 0.34 cm]; physical functioning: WMD, −0.90 points [95% CI, −2.69 to 0.89 points]), tricyclic antidepressants (pain: WMD, −0.13 cm [95% CI, −0.99 to 0.74 cm]; physical functioning: WMD, −5.31 points [95% CI, −13.77 to 3.14 points]), and anticonvulsants (pain: WMD, −0.90 cm [95% CI, −1.65 to −0.14 cm]; physical functioning: WMD, 0.45 points [95% CI, −5.77 to 6.66 points]). CONCLUSIONS AND RELEVANCE In this meta-analysis of RCTs of patients with chronic noncancer pain, evidence from high-quality studies showed that opioid use was associated with statistically significant but small improvements in pain and physical functioning, and increased risk of vomiting compared with placebo. Comparisons of opioids with nonopioid alternatives suggested that the benefit for pain and functioning may be similar, although the evidence was from studies of only low to moderate quality.

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Controlled‐Release Oxycodone and Naloxone in the Treatment of Chronic Low Back Pain: A Placebo‐Controlled, Randomized Study

Abstract: In patients complying with treatment as per protocol, CR oxycodone⁄CR naloxone was effective for the management of chronic low back pain of moderate or severe intensity.

Cited by 45 publications

References 42 publications

Impact of Prolonged-release Oxycodone/Naloxone on Outcomes Affecting Patients' Daily Functioning in Comparison With Extended-release Tapentadol: A Systematic Review

Impact of Prolonged-release Oxycodone/Naloxone on Outcomes Affecting Patients' Daily Functioning in Comparison With Extended-release Tapentadol: A Systematic Review

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

Opioids for Chronic Noncancer Pain

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