Abstract
Background: Chronic osteoarthritis (OA) pain leads to severe impairments in physical functioning and quality of life. Patients & methods: Data of patients with severe chronic knee and/or hip OA pain were extracted from the database of a prospective, noninterventional trial to assess the benefits of tapentadol prolonged release (PR) in elderly patients (>65 years of age; n = 1162) compared with younger patients (≤65 years of age; n = 498). Results: Tapentadol PR treatment (up to 3 months) significantly reduced pain intensity and pain-related restrictions on daily functioning and significantly improved physical and mental quality of life in both patient groups. The incidence of adverse drug reactions was low. Conclusion: Tapentadol PR is a useful strong analgesic to improve pain intensity, physical functioning and quality of life in elderly OA patients.
Author contributions
M Sohns and C Elling contributed to the conception and design. The acquisition, analysis and interpretation of data was done by all the authors. Critical revision for important intellectual content, final approval and agreement was done by all the authors.
Acknowledgments
The authors would like to thank all patients and physicians involved in the original trial as well as Jérôme Rapion for statistical analyses.
Financial & competing interests disclosure
Data extraction and effectiveness analysis were performed by factum GmbH, Offenbach Germany and were paid for by Grünenthal GmbH, Germany. In the past 3 years KU Kern has worked as a consultant and/or speaker for the following companies: Astellas, Berlin Chemie, Boehringer Ingelheim, Betapharm, Grünenthal, Hexal, Indivior, Lilly, Kyowa Kirin, MSD, Mundipharma, Ratiopharm, Roche and Sanofi. M Sohns, B Heckes and C Elling are employees of Grünenthal GmbH, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing assistance was provided by E Grosselindemann and B Brett and was paid for by Grünenthal GmbH, Germany.
Ethical conduct of research
The original trial was conducted in accordance with section 4, subsection 23, sentence 3 and section 67, subsection 6 of the Medicinal Products Act of the Federal Republic of Germany. As required by law, the trial was registered with the German Federal Institute for Drugs and Medical Devices, the German Association of Statutory Health Insurance Physicians, and the German Federal Associations of Health Insurance Funds. Approval was given by the Freiburg Ethics Commission International.