Tapentadol Prolonged Release in Patients with Chronic low back Pain: Real-World Data from the German Pain eRegistry

Abstract

Aim: Comparison of tapentadol prolonged release (PR) with other oral WHO-III PR opioid analgesics (morphine, oxycodone ± naloxone, hydromorphone) in routine medical care of chronic low back pain. Patients & methods: Noninterventional, retrospective 12-week study using anonymized clinical practice data from the German Pain eRegistry. Six effectiveness, tolerability, and safety criteria were aggregated in a primary composite end point (treatment responder). Propensity scoring matched 2331 datasets per treatment cohort. Results: All six single criteria showed significantly better outcomes for tapentadol PR (all parameters p < 0.001). There were significantly more treatment responders under tapentadol PR (65.7 vs 14.2%; p < 0.001). Conclusion: Tapentadol PR showed significantly better effectiveness and tolerability in severe chronic low back pain unsuccessfully treated with WHO-I/II analgesics compared with the other oral WHO-III PR opioids investigated.

Lay abstract

Chronic low back pain is a common condition often resulting in impaired functioning in daily life and reduced quality of life and well-being of the patient. In case treatment with less potent pain medications is unsuccessful, opioid treatment might be required. Our study compared the effectiveness and tolerability of the prolonged release formulation of the atypical opioid tapentadol with other strong opioids commonly used for chronic pain treatment in Germany (morphine, hydromorphone, oxycodone ± naloxone). Anonymized patient data from German clinical practices collected in a pain registry were used (2331 comparable patients per treatment group). Patients receiving 12 weeks of tapentadol treatment experienced significantly greater pain relief, greater improvements in daily living activities, sleep, and quality of life compared with those receiving the other strong opioids investigated. Neuropathic pain components (pain features resembling nerve pain, often described as shooting, burning or stabbing pain) were reduced to a greater extent in the tapentadol treatment group. Tapentadol was also significantly better tolerated. This study showed that tapentadol is effective and well tolerated in chronic low back pain treatment in routine medical practice in patients still in considerable pain despite treatment with less potent pain medications.

Keywords::

• chronic low back pain
• prolonged release WHO-III opioid analgesics
• real-world data
• routine medical care
• tapentadol

Author contributions

MA Überall, B Heckes, C Lefeber and M Heine contributed to the conception and design. MA Überall performed the data extraction and data analysis. All the authors were responsible for the data interpretation. All the authors critically revised for important intellectual content, approved the final manuscript version and agreed to the submission.

Financial & competing interests disclosure

The German Pain Association received payment from Grünenthal GmbH, Germany, for the use of the data. MA Überall is a physician, pain specialist, medical director of the Institute of Neurological Sciences and CEO of O. Meany-MDPM GmbH, which was responsible for data extraction and biometrical analyses. MA Überall received payment for conference representation of the data. MA Überall has received financial support and/or expenses in form of research funds, consultancy fees and/or renumerations for lecture activities from: Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Esanum, Glaxo Smith Kline, Grünenthal, Hapa Medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionogi, Spectrum Therapeutics, Strathmann, Teva, and Tilray. GHH Müller-Schwefe is a physician and pain/palliative care specialist and has received no financial support and/or expenses. All other authors 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 and editorial assistance was provided by E Grosselindemann and B Brett and was paid for by Grünenthal GmbH, Germany.

Ethical conduct of research

The study is registered in the European Union electronic Registry of Post-Authorization Studies (EUPAS 38332) through the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP^®) coordinated by the European Medicines Agency (EMA) and was conducted in accordance with the Declaration of Helsinki and relevant national and regulatory requirements; approval was granted by the independent ethics committee of the German Pain Association and the German Pain Alliance. All the patients provided written informed consent prior to participation in the registry. All analyses were carried out using only anonymized data to comply with German guidelines on protection of data privacy and with the European Union General Data Protection Regulation.

Additional information

Funding

The German Pain Association received payment from Grünenthal GmbH, Germany, for the use of the data. MA Überall is a physician, pain specialist, medical director of the Institute of Neurological Sciences and CEO of O. Meany-MDPM GmbH, which was responsible for data extraction and biometrical analyses. MA Überall received payment for conference representation of the data. MA Überall has received financial support and/or expenses in form of research funds, consultancy fees and/or renumerations for lecture activities from: Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Esanum, Glaxo Smith Kline, Grünenthal, Hapa Medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionogi, Spectrum Therapeutics, Strathmann, Teva, and Tilray. GHH Müller-Schwefe is a physician and pain/palliative care specialist and has received no financial support and/or expenses. All other authors 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 and editorial assistance was provided by E Grosselindemann and B Brett and was paid for by Grünenthal GmbH, Germany.