Combination Therapy with Transdermal Buprenorphine and Pregabalin for Chronic Low Back Pain

Abstract

SUMMARY Aim: The aim of this study was to evaluate the efficacy and safety of combined transdermal buprenorphine and pregabalin in chronic low back pain. Patients & methods: A total of 45 patients with chronic low back pain were recruited into the study. For an initial 3-week period, all patients received transdermal buprenorphine 35 µg/h. After 3 weeks of only transdermal buprenorphine 35 µg/h, patients were randomized (single-blind) to receive transdermal buprenorphine 35 µg/h plus pregabalin 300 mg/day (group A) or transdermal buprenorphine 35 µg/h plus placebo (group B), and were observed for a further 3-week period. Efficacy parameters were weekly mean Visual Analog Scale (VAS) scores, the Pain Rating Index (PRI) of the Short-Form McGill Pain Questionnaire (SF-MPQ), the Present Pain Index (PPI) of the SF-MPQ and sleep interference. We also evaluated the use of rescue medication (paracetamol [acetaminophen]) and the presence of adverse events. Results: A total of 44 patients were evaluated for efficacy and safety parameters. Pain relief, as assessed by VAS, PPI and PRI, improved significantly (p < 0.05) in all patients after the first week of treatment with only transdermal buprenorphine. Following randomization, only patients in group A showed further reductions in the mean VAS, PPI and PRI scores. Moreover, patients in group A had a lower consumption of rescue medication than those in group B. There was a low incidence of mild adverse events in both group A and group B, with no serious adverse events in either group. Conclusion: Pregabalin 300 mg/day as an add-on to transdermal buprenorphine 35 µg/h led to significant pain reduction and a significant reduction of interference with sleep quality in patients with chronic low back pain.

Acknowledgements

The authors gratefully thank P Barbuto for her support in the translation of the original manuscript.

Financial & competing interests disclosure

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing assistance was utilized in the production of this manuscript. The authors thank DP Figgitt, Content Ed Net, for providing valuable editorial support in the preparation of the manuscript; funding for editorial support was provided by Grunenthal.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.