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Transdermal Buprenorphine in Non-Oncological Moderate-to-Severe Chronic Pain

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Abstract

Background: Musculoskeletal pathologies are among the most frequent causes of long-term non-oncological severe pain and consequent physical impairment. Aims of pharmacological and physical therapy are to reduce pain, promote functional recovery and improve overall quality of life. Pharmacological therapy may include the use of opioids.

Objective: To evaluate the efficacy and tolerability of transdermal buprenorphine (TDS) in the long-term management of non-oncological, chronic, moderate-to-severe musculoskeletal pain.

Study Design: An open-label, prospective, single-centre, 6-month study.

Setting: A ‘real world’ outpatient setting.

Patients: Adult patients with chronic moderate-to-severe musculoskeletal pain were enrolled consecutively.

Intervention: Patients initially received buprenorphine TDS 11.7 µg/h (onethird of 35 µg/h patch) every 72 hours. If required, patients could be uptitrated to 17.5 µg/h (one-half of 35µg/h patch), 23.4 µg/h (two-thirds of 35 µg/h patch) or 35 µg/h. Concomitant antiemetics were allowed.

Main Outcome Measures: The primary endpoint was percentage mean reduction in static and dynamic pain visual analogue scale (VAS) scores at study end (10 being worst pain, 0 being no pain). Quality of life and tolerability were also assessed.

Results: We enrolled 146 patients aged 41–94 years; their baseline mean± SD static and dynamic pain VAS scores were 6.87±1.89 and 7.70 ± 1.74, respectively. Buprenorphine TDS initial dosages were 11.7 µg/h (n=139), 17.5 µg/h (n = 4), 23.4 µg/h (n= 1) and 35 µg/h (n = 2). At 6 months, 89 patients were under treatment; 11% (n=10) were receiving 11.7µg/h, 30% (n = 27) 17.5 µg/h, 6% (n = 5) 23.4 µg/h and 53% (n = 47) 35µg/h. Patients achieved a nonsignificant reduction in pain at rest and in movement; mean ± SD static and dynamic pain VAS scores decreased to 1.56 ± 2.05 and 3.54 ± 2.02, respectively. The quality of life improved as shown by significant (p< 0.01) increases from baseline in all items relating to physical and mental health on the Short-Form 36 health survey. Patients experienced recovery of daily and social activities according to the significant (p<0.01) increase in Karnofsky Performance Status sub-item scores. Twenty-three patients discontinued treatment because of adverse events, which were mainly gastrointestinal or CNS-related.

Conclusions: Low-dose buprenorphine TDS had good analgesic efficacy, and quality of life improved as early as 1 month after treatment initiation. Our results suggest that buprenorphine TDS is a well tolerated long-term analgesic for patients experiencing chronic musculoskeletal pain of moderateto-severe intensity.

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Acknowledgements

The authors have no conflicts of interest relating to the contents of this paper; no external funding was received to conduct the study. We thank Tracy Harrison of inScience Communications, a Wolters Kluwer business, who provided English-language and editorial assistance in the preparation of this article. This assistance was funded by Molteni Farmaceutici, Inc, Italy.

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Authors and Affiliations

  1. Emergency Care, Critical Care Medicine, Pain Medicine and Anaesthesiology, Department at Tor Vergata Polyclinic, University of Rome - Tor Vergata, Rome, Italy

    Antonio Gatti, Mario Dauri, Francesca Leonardis, Giuseppe Longo, Massimo Mammucari & Alessandro Fabrizio Sabato

  2. Anaesthesiology and Pain Therapy Department, University of Aquila, Italy

    Franco Marinangeli

  3. Anaesthesiology, Tor Vergata Polyclinic, University of Rome-Tor Vergata, Rome, Italy

    Franco Marinangeli

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  1. Antonio Gatti
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Correspondence to Antonio Gatti.

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Gatti, A., Dauri, M., Leonardis, F. et al. Transdermal Buprenorphine in Non-Oncological Moderate-to-Severe Chronic Pain. Clin. Drug Investig. 30 (Suppl 2), 31–38 (2010). https://doi.org/10.2165/1158409-S0-000000000-00000

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