Abstract | PURPOSE: METHODS: FINDINGS: Of the 1,154 patients in the safety population, 82.7% were aged >65 years and 57.9% were female; 50.1% had mild baseline pain intensity. Mean (SD) pain intensity scores (11-point numerical rating scale) were 3.9 (2.38) at baseline (end of preceding study) and 3.7 (2.42) at end point, indicating that pain relief was maintained during the extension study. Improvements in measures of quality of life (eg, EuroQol-5 Dimension and the 36-item Short Form Health Survey [SF-36]) health status questionnaires) achieved during the preceding studies were maintained during the open-label extension study. Tapentadol ER was associated with a safety and tolerability profile comparable to that observed in the preceding studies. The most common treatment-emergent adverse events (incidence ≥10%; n = 1154) were headache (13.1%), nausea (11.8%), and constipation (11.1%). Similar efficacy and tolerability results were shown for patients who received up to 2 years of tapentadol ER treatment. IMPLICATIONS:
Pain relief and improvements in quality of life achieved during the preceding studies were maintained throughout this extension study, during which tapentadol ER was well tolerated for the long-term treatment of chronic osteoarthritis or low back pain over up to 2 years of treatment. (ClinicalTrials.gov identifier: NCT00487435.).
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Authors | Robert Buynak, Stephen A Rappaport, Kevin Rod, Pierre Arsenault, Fabian Heisig, Christine Rauschkolb, Mila Etropolski |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 37
Issue 11
Pg. 2420-38
(Nov 01 2015)
ISSN: 1879-114X [Electronic] United States |
PMID | 26428249
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015. Published by Elsevier Inc. |
Chemical References |
- Delayed-Action Preparations
- Phenols
- Oxycodone
- Tapentadol
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Topics |
- Aged
- Chronic Disease
- Chronic Pain
(drug therapy)
- Cross-Over Studies
- Delayed-Action Preparations
- Female
- Humans
- Low Back Pain
(drug therapy)
- Male
- Middle Aged
- Osteoarthritis, Knee
(drug therapy)
- Oxycodone
(administration & dosage)
- Phenols
(administration & dosage, adverse effects, therapeutic use)
- Quality of Life
- Tapentadol
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