Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study

Buynak, Robert; Shapiro, Douglas Y.; Okamoto, Akiko; Hove, Ilse Van; Rauschkolb, Christine; Steup, Achim; Lange, Bernd; Lange, Claudia; Etropolski, Mila

doi:10.1517/14656566.2010.497720

Cited by 226 publications

(278 citation statements)

References 53 publications

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“…The incidence of gastrointestinal treatment emergent adverse events, including nausea, vomiting or constipation, that led to study discontinuation was lower in the tapentadol prolonged release group (8.6%) than in the oxycodone controlled release group (21.5%). For patients completing the study, the mean total daily dose of both tapentadol prolonged release and oxycodone controlled release increased sharply during the first 4 weeks of the treatment period (dose titration), then remained approximately stable at tapentadol prolonged release 390mg and oxycodone HCl controlled release 74mg for the remainder of the study giving the same approximate dose equivalency of 5:1 as reported by Buynak et al 16 .…”

Section: Tapentadol Prolonged Release For the Management Of Chronic Lsupporting

confidence: 65%

“…In a prospective, randomized, double blind, activeand placebo-controlled, multicentre, phase III study in 981 patients with moderate to severe chronic low back pain, tapentadol prolonged release (100-250mg twice daily) and oxycodone controlled release (20-50mg twice daily) significantly reduced mean pain intensity compared with placebo over the treatment period (3-week titration followed by 12-week maintenance period) 16 . This study did not directly compare the analgesic efficacy of tapentadol prolonged release and oxycodone controlled release, but the data suggest similar efficacy and a dose equivalency of approximately 5:1 for tapentadol prolonged release to oxycodone controlled release.…”

Section: Tapentadol Prolonged Release For the Management Of Chronic Lmentioning

confidence: 99%

“…Tapentadol prolonged release 100-250mg twice daily has demonstrated efficacy and tolerability in the management of moderate to severe chronic osteoarthritis of the knee 15 , moderate to severe chronic low back pain 16 , and painful diabetic peripheral neuropathy 18 .Tapentadol 50-75mg (4-6-hourly) has demonstrated efficacy and tolerability in the management of moderate to severe postoperative (bunionectomy) pain 12,13 , of moderate to severe pain related to degenerative joint disease 14 and moderate to severe lower back pain and pain from osteoarthritis of the hip or knee 20 .…”

Section: Dosage and Administrationmentioning

confidence: 99%

“…These complementary mechanisms of action may explain the broad clinical efficacy reported in nociceptive and neuropathic pain [12][13][14][15][16][17][18] .…”

mentioning

confidence: 99%

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Role of tapentadol in pain management

Mendis¹

2014

Sri Lankan J Anaesthesiol

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This article reviews tapentadol, a novel centrally-acting opioid analgesic that exerts its analgesic effects through muopioid receptor agonism and additionally via noradrenaline reuptake inhibition and so potentially has a role in the treatment of both nociceptive and neuropathic pain. Appropriate management of acute, chronic and cancer pain remains a considerable challenge for health-care providers. The physiological and psychological effects of uncontrolled pain lead to unnecessary suffering and financial loss, not only to the individual concerned but to the family and society. Current pharmacological treatment options for the management of pain are limited by significant side effects affecting the CNS, cardiovascular system, gastrointestinal system and the respiratory system.

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Section: Tapentadol Prolonged Release For the Management Of Chronic Lsupporting

confidence: 65%

Section: Tapentadol Prolonged Release For the Management Of Chronic Lmentioning

confidence: 99%

Section: Dosage and Administrationmentioning

confidence: 99%

“…These complementary mechanisms of action may explain the broad clinical efficacy reported in nociceptive and neuropathic pain [12][13][14][15][16][17][18] .…”

mentioning

confidence: 99%

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Role of tapentadol in pain management

Mendis¹

2014

Sri Lankan J Anaesthesiol

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“…Similarly, tapentadol extended release, 100-250 mg b.i.d., effectively relieved moderate-tosevere chronic low back pain over 15 weeks with a better gastrointestinal tolerability than oxycodone HCl controlled release, 20 -50 mg b.i.d. (23). Studies of the pharmacodynamic effects of tapentadol on gastric emptying and colonic transit would be of significant interest.…”

Section: Tapentadolmentioning

confidence: 99%

Opioid Induced Constipation

Aurilio¹,

Pace²,

Pota³

et al. 2012

Constipation - Causes, Diagnosis and Treatment

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Opioids for Chronic Noncancer Pain

Busse

Wang

Kamaleldin

et al. 2018

JAMA

473

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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Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study

Abstract: Tapentadol ER (100 - 250 mg b.i.d.) effectively relieved moderate to severe chronic low back pain over 15 weeks and had better gastrointestinal tolerability than oxycodone HCl CR (20 - 50 mg b.i.d.).

Cited by 226 publications

References 53 publications

Role of tapentadol in pain management

Role of tapentadol in pain management

Opioid Induced Constipation

Opioids for Chronic Noncancer Pain

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