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Efficacy and Safety of Sublingual Fentanyl Orally Disintegrating Tablets in Patients with Breakthrough Pain: Multicentre Prospective Study

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Abstract

Background and Objectives

The aim of this study was to evaluate the effectiveness and safety of sublingual fentanyl oral disintegrating tablets (sublingual fentanyl ODT) for the treatment of breakthrough pain (BTP), cancer or non-cancer related, in terms of relief of pain intensity, adverse events (AEs) and patient satisfaction, and to further examine the clinical and epidemiological profile of patients with BTP in a clinical setting.

Methods

A multicentre, prospective, open-label study was conducted in 19 pain units from Catalonia hospitals (Spain) over a 1-month period. Opioid-tolerant adult patients experiencing episodes of BTP intensity >5 on a visual analogue scale (VAS) during the 12–24 h before screening or AEs related to their previous rescue medication for BTP received sublingual fentanyl ODT in the course of routine clinical practice and completed a 30-day study period consisting of five assessment points: days 0 (baseline), 3, 7, 15 and 30. The efficacy was assessed by collecting pain intensity and pain relief data at baseline and at each assessment. AEs were recorded by investigators throughout the study during clinic visits and telephone follow-ups. For all patients, titration was begun with an initial dose of 100 μg. No more than two doses were allowed to treat an episode and patients might wait at least 4 h before treating another BTP episode with sublingual fentanyl ODT. The dose was increased by 100 μg multiples up to 400 μg as needed; and by 200 μg multiples up from 400 to 800 μg, the maximum titration step.

Results

A total of 182 patients were enrolled and 177 (97.2 %) completed the study: 37 had breakthrough cancer pain (BTcP) and 145 had breakthrough non-cancer pain (BTncP). The mean pain intensity showed a statistically significant improvement at the first assessment point and at all assessments thereafter (p < 0.0001). At the end of the study, the time lag between administration and first effect of sublingual fentanyl ODT was ≤10 min in 69.0 % (60 % BTcP and 71.2 % BTncP). The number of daily BTP episodes decreased in both groups, but it was statistically significant in BTcP. 114 patients (62.64 %) experienced AEs during the study. AEs recorded included nausea, vomiting, somnolence and constipation, and seven (4.49 %) were considered severe. No death or discontinuation was considered related to AEs.

Conclusion

Sublingual fentanyl ODT provided rapid and consistent relief from BTP, both in cancer and non-cancer patients. It was well-tolerated and well-accepted by patients in routine clinical practice.

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Acknowledgments

Assistance with writing and preparation of this manuscript was provided by Maria José Sánchez, librarian at Hospital Universitari Sagrat Cor, Barcelona. No external funding was received to conduct the study. Data in this article were previously presented as poster at the XII Annual Meeting of the Spanish Society of Pain and XII Atlantic Islands Pain Forum 2011. The authors have no potential conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Department of Anesthesiology, Hospital Plató, c/ Plató 21, 08006, Barcelona, Spain

    Jordi Guitart, Juan M. Vázquez & Jordi Folch

  2. Pain Unit, Department of Anesthesiology, Hospital de Sant Boi, Barcelona, Spain

    Isabel Vargas

  3. Pain Unit, Department of Anesthesiology, Hospital Universitari Capio Sagrat Cor, Barcelona, Spain

    Vicente De Sanctis

  4. Pain Unit, Department of Anesthesiology, Hospital Residència Sant Camil, Barcelona, Spain

    Julia Ferreras & Francisco Rodelas

  5. Department of Anesthesiology, Pius Hospital de Valls, Tarragona, Spain

    Jose Fuentes

  6. Department of Anesthesiology, Hospital Comarcal d’Inca, Palma de Mallorca, Spain

    Rafael Salazar

  7. Pain Unit, Department of Anesthesiology, Hospital Mateu Orfila, Menorca, Spain

    Jordi Moya

  8. Pain Unit, Department of Anesthesiology, Hospital Son Dureta, Palma de Mallorca, Spain

    Hermann Ribera

  9. Pain Unit, Department of Anesthesiology, Fundació Hospital Sant Bernabé, Barcelona, Spain

    Albert Tomás

  10. Department of Anesthesiology, Hospital de l’Esperança, Barcelona, Spain

    María Arilla

  11. Department of Anesthesiology, Hospital General de l’Hospitalet, Barcelona, Spain

    Joan Coma

  12. Pain Unit, Department of Anesthesiology, Hospital Comarcal de l’Alt Penedés, Barcelona, Spain

    Teresa Aberasturi

  13. Pain Unit, Department of Anesthesiology, Hospital Municipal de Badalona, Barcelona, Spain

    Dolores Sintes

  14. Pain Unit, Department of Anesthesiology, Consorci Sanitari Terrassa, Barcelona, Spain

    Ester Lombán

Authors
  1. Jordi Guitart
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  2. Isabel Vargas
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Correspondence to Jordi Guitart.

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Guitart, J., Vargas, I., De Sanctis, V. et al. Efficacy and Safety of Sublingual Fentanyl Orally Disintegrating Tablets in Patients with Breakthrough Pain: Multicentre Prospective Study. Clin Drug Investig 33, 675–683 (2013). https://doi.org/10.1007/s40261-013-0111-z

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  • DOI: https://doi.org/10.1007/s40261-013-0111-z

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