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Baron, R; Likar, R; Martin-Mola, E; Blanco, FJ; Kennes, L; Müller, M; Falke, D; Steigerwald, I.
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/4 Study.
Pain Pract. 2016; 16(5): 580-99. Doi: 10.1111/papr.12308
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Co-authors Med Uni Graz: Likar Rudolf
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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.
Find related publications in this database (using NLM MeSH Indexing): Adult - administration & dosage; Aged - administration & dosage; Analgesics, Opioid - administration & dosage, therapeutic use; Delayed-Action Preparations - administration & dosage; Endpoint Determination - administration & dosage; Female - administration & dosage; Humans - administration & dosage; Low Back Pain - drug therapy; Male - administration & dosage; Middle Aged - administration & dosage; Naloxone - administration & dosage, therapeutic use; Narcotic Antagonists - administration & dosage, therapeutic use; Neuralgia - drug therapy; Oxycodone - administration & dosage, therapeutic use; Pain Measurement - administration & dosage; Phenols - administration & dosage, therapeutic use; Tapentadol - administration & dosage
Find related publications in this database (Keywords): effectiveness; tapentadol prolonged release; chronic low back pain; neuropathic pain; randomized controlled trial; RCT