Abstract
Objective:
To assess patients’ perceptions regarding the low-dose 7-day buprenorphine transdermal patch for treatment of moderate non-malignant chronic pain.
Methods:
Patient-reported outcome data were collected in clinical practices in Germany in a prospective, multicenter, non-interventional observation using the German Pain Questionnaire/German Pain Diary. Questionnaires were completed by the patients without influence from the attending physician. Mean change in pain intensity (lowest, average, and highest pain intensity in the previous 24 h), changes in Hospital Anxiety and Depression Scale scores (HADS-A and HADS-D), in impairments of daily activities (modified pain disability index, mPDI), in quality of life (quality of life impairment by pain inventory, QLIP), and in overall burden of pain over a 12-week treatment period were evaluated.
Results:
Data of 891 patients were assessed (mean age 72.8 years). Buprenorphine starting doses were mainly 5 µg/h (67.1% of patients) and 10 µg/h (27.3%). At the end of week 12, the majority received either 5 µg/h (41%) or 10 µg/h (42.3%) buprenorphine. Mean average pain intensity was reduced by 5.1 points to 1.7 ± 1.3 from 6.8 ± 1.5 points at baseline (76% improvement). Amelioration was observed in HADS-A (59% from 7.8 ± 3.3 at baseline) and HADS-D (56% from 9.2 ± 3.1), in mPDI sum score (76%; from 31.1 ± 9.8), and in quality of life (165%; from 13.9 ± 10.1). Mean burden of pain continuously decreased.
Limitations:
All those inherent in open-label observations and pain studies using subjective and patient-reported outcome parameters (such as the lack of a control group).
Conclusions:
Our results indicate that the 7-day buprenorphine patch might be considered an effective treatment option for moderate non-malignant chronic pain management in daily clinical practice. The mostly elderly patient population of this patient survey experienced sustained pain relief and improvements in pain-related impairments of daily activities and quality of life, leading to a substantial reduction in overall burden of pain.
Transparency
Declaration of funding
This project was initiated by the German Pain Association (Deutsche Gesellschaft für Schmerztherapie) and the German Pain League (Deutsche Schmerzliga) and carried out by the Institute for Neurological Sciences, Algesiology and Pediatrics, Nürnberg, Germany. Grünenthal GmbH, Aachen, Germany acquired the analyzed data and provided funding for all costs associated with the development and publication of the present manuscript. Grünenthal was given the opportunity to review the present manuscript and suggest changes; however, responsibility for both the content of the manuscript and the presented data lies with the authors.
Declaration of financial/other relationships
M.A.Ü. has in the past 12 months received compensation for consulting or speaking fees from Astellas, Bene-Arzneimittel, Eisai, Grünenthal, Janssen-Cilag, Mundipharma, Nycomed, Pfizer, PharmAllergan, ProStrakan and TEVA. G.H.H.M.-S. has disclosed that he has received compensation for consulting or speaking fees from Cephalon, Eisai, Grünenthal, Janssen-Cilag, Mundipharma, Pfizer, PharmAllergan and TEVA.
CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgments
The authors wish to thank all participating patients for their contributions. Further thanks go to Elke Grosselindemann (Brett Medical Writing, Australia) and Birgit Brett (Brett Medical Writing, Germany) for writing and editorial assistance and publication coordination. All costs associated with the publication of the manuscript were met by Grünenthal.