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Effectiveness of tapentadol prolonged release (PR) compared with oxycodone/naloxone PR for the management of severe chronic low back pain with a neuropathic component: a randomized, controlled, open‐label, phase 3b/4sStudy
dc.contributor.author | Baron, Ralf | |
dc.contributor.author | Likar, Rudolf | |
dc.contributor.author | Martín-Mola, Emilio | |
dc.contributor.author | Blanco García, Francisco J | |
dc.contributor.author | Kennes, Lieven | |
dc.contributor.author | Müller, Matthias | |
dc.contributor.author | Falke, Dietmar | |
dc.contributor.author | Steigerwald, Ilona | |
dc.date.accessioned | 2020-03-30T09:52:13Z | |
dc.date.available | 2020-03-30T09:52:13Z | |
dc.date.issued | 2015-06-12 | |
dc.identifier.citation | Baron R, Likar R, Martín-Mola E, Blanco FJ, Kennes L, Müller M, et al. Effectiveness of tapentadol prolonged release (PR) compared with oxycodone/naloxone PR for the management of severe chronic low back pain with a neuropathic component: a randomized, controlled, open‐label, phase 3b/4sStudy. Pain Pract. 2016;16(5): 580-99 | es_ES |
dc.identifier.issn | 1530-7085 | |
dc.identifier.uri | http://hdl.handle.net/2183/25268 | |
dc.description.abstract | [Abstract] OBJECTIVE: To evaluate the effectiveness of tapentadol prolonged release (PR) vs. oxycodone/naloxone PR in non-opioid-pretreated patients with severe chronic low back pain with a neuropathic pain component. METHODS: Eligible patients (average pain intensity [numerical rating scale-3 (NRS-3)] ≥6; painDETECT positive/unclear) were randomized to twice-daily tapentadol PR 50 mg or oxycodone/naloxone PR 10 mg/5 mg. After a 21-day titration (maximum twice-daily doses: tapentadol PR 250 mg, or oxycodone/naloxone PR 40 mg/20 mg plus oxycodone PR 10 mg), target doses were continued for 9 weeks. The primary effectiveness endpoint was the change in NRS-3 from baseline to final evaluation; the exact repeated confidence interval (RCI) for tapentadol PR minus oxycodone/naloxone PR was used to establish noninferiority (upper limit <1.3) and superiority (confirmatory analyses). RESULTS: For the primary effectiveness endpoint, tapentadol PR was noninferior to oxycodone/naloxone PR (97.5% RCI: [-1.820, -0.184]; P < 0.001). This exact RCI also yielded evidence of superiority for tapentadol PR vs. oxycodone/naloxone PR (significantly greater reduction in pain intensity; P = 0.003). Improvements (baseline to final evaluation) in painDETECT and Neuropathic Pain Symptom Inventory scores were significantly greater with tapentadol PR vs. oxycodone/naloxone PR (all P ≤ 0.005). CONCLUSIONS: The study was formally shown to be positive and demonstrated, in the primary effectiveness endpoint, the noninferiority for tapentadol PR vs. oxycodone/naloxone PR. The effectiveness of tapentadol PR was superior to that of oxycodone/naloxone PR by means of clinical relevance and statistical significance (confirmatory evidence of superiority). Tapentadol PR was associated with significantly greater improvements in neuropathic pain-related symptoms and global health status than oxycodone/naloxone PR and with a significantly better gastrointestinal tolerability profile. Tapentadol PR may be considered a first-line option for managing severe chronic low back pain with a neuropathic pain component. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Wiley | es_ES |
dc.relation.uri | https://doi.org/10.1111/papr.12308 | es_ES |
dc.rights | Atribución-NoComercial-SinDerivadas 3.0 España | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.subject | RCT | es_ES |
dc.subject | Chronic low back pain | es_ES |
dc.subject | Effectiveness | es_ES |
dc.subject | Neuropathic pain | es_ES |
dc.subject | Randomized controlled trial | es_ES |
dc.subject | Tapentadol prolonged release | es_ES |
dc.title | Effectiveness of tapentadol prolonged release (PR) compared with oxycodone/naloxone PR for the management of severe chronic low back pain with a neuropathic component: a randomized, controlled, open‐label, phase 3b/4sStudy | es_ES |
dc.type | info:eu-repo/semantics/article | es_ES |
dc.rights.access | info:eu-repo/semantics/openAccess | es_ES |
UDC.journalTitle | Pain Practice | es_ES |
UDC.volume | 16 | es_ES |
UDC.issue | 5 | es_ES |
UDC.startPage | 580 | es_ES |
UDC.endPage | 599 | es_ES |
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