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Abstract
Objective: To describe the characteristics of patients treated with the capsaicin 8% patch, prescribing conditions, long-term effects of repeat treatment on pain intensity and perception, quality of life, and impact on concomitant medication.
Methods: A national, longitudinal, prospective, non-interventional, post-marketing open study was conducted in 50 French pain centers. Adult volunteer non-diabetic patients with peripheral neuropathic pain receiving capsaicin 8% patch treatment were consecutively enrolled. Treatment could be repeated over a 12-month period, with 6 months’ follow-up after last application.
Results: A total of 684 patients (age: 53.0 ± 14.9 years, mean ± standard deviation; post-traumatic/surgical peripheral neuropathic pain: 76.3%; pain intensity: 6.2 ± 1.7; pain duration: 3.0 years, median) were treated with 1 to 5 patches at 3/4 month intervals; 70.3% were naive to capsaicin 8% patch treatment at inclusion. Six months after last application, treatment was considered as successful for 21.8% (95% confidence interval: 17.5%–26.7%) of patients by a stringent criterion combining improvement according to the patient’s global impression of change (PGIC) and at least 30% improvement on a numerical pain rating scale (NPRS). Clinically relevant improvement in health-related quality of life was observed at end-of-study. No unexpected safety concerns were observed with capsaicin 8% patch repeat treatment.
Conclusions: The data of this post-marketing study meets the request by the French authorities for additional data on conditions of use in everyday practice. They confirmed the tolerance and long-term effect of capsaicin 8% patch in patients with peripheral neuropathic pain in real-world conditions.
Acknowledgments
The authors would like to thank Dr Didier Bouhassira, a member of the Scientific Committee, for supporting protocol preparation, analysis of the results and review of the manuscript, Caroline Defawe who was employed by Astellas Pharma France at the time of the study, the Contract Research Organisation RCTs (Lyon, France) for providing support in the conduct of the study, and Christian Kempf and Fabienne Péretz (Abelia Science, Saint-Georges-sur-Baulche, France) for writing the manuscript. Assistance was funded by Astellas Pharma France (RCTs and Christian Kempf) and then by Grünenthal GmBH (Fabienne Péretz).
The authors also recognize and thank the investigators of the QAPSA study, for successfully conducting the study: Drs Navez and Créac’h, Centre Hospitalier Universitaire de St Etienne; Dr Alchaar, Centre Hospitalier Universitaire de Nice; Dr Plantevin, Centre Hospitalier de Macon; Dr Challi, Centre Hospitalier de Béthune; Drs Planchet-Barraud, Saadallah and Dousset, Hôpital Saint-Joseph, Marseille; Drs Rostaing and Guérin, Hôpital Saint-Antoine, Paris; Dr Pluchon, Centre Hospitalier de la Roche-sur-Yon; Dr Picard, Centre Hospitalier Universitaire de Clermont-Ferrand; Pr Viel and Dr Bredeau, Centre Hospitalier Universitaire de Nîmes; Drs Tiberghien, Piccand and Lajoie, Centre Hospitalier Universitaire de Besançon; Dr Dousset, Hopital de la Timone à Marseille; Dr Attal, Hôpital Ambroise Paré, Boulogne-Billancourt; Dr Allano, Clinique mutualiste de Lorient; Dr Basset, Centre Hospitalier de Chambéry; Dr Barmaki, Clinique mutualiste de Lyon; Dr Quinio, Centre Hospitalier Universitaire de Brest – Hôpital de la CavaBlanche; Dr Kong A Siou, Centre Hospitalier Universitaire de Montpellier; Dr Cantagrel, Centre Hospitalier Universitaire de Toulouse; Dr Rouby-Landrieux, Centre Hospitalier Régional d’Orléans; Dr Racine, Hôpital Avicenne, Bobigny; Dr Noury, Centre Hospitalier du Haut-Anjou, Château-Gontier; Dr Durand, Centre Hospitalier Universitaire de Nantes; Dr Vannier, Centre Hospitalier Universitaire de Tours; Dr Pouplin, Centre Hospitalier Universitaire de Rouen; Drs Hodaj and Maindet-Dominici, Centre Hospitalier Universitaire de Grenoble; Dr Delorme, Centre Hospitalier de Bayeux; Dr Minello, Centre Georges François Leclerc, Dijon; Dr Feuillet, Centre Hospitalier de Saint-Lô; Drs Douay and Serra, Centre Hospitalier Universitaire d’Amiens; Dr Grandhaye, Centre Hospitalier d’Epinal; Dr Hoffmann, Centre Hospitalier de Saint-Brieuc; Dr Collin, Hôpital de la Pitié Salpêtrière, Paris; Dr Michel-Dhaine, Centre Hospitalier Intercommunal Meulan Muraux; Dr Pottier, Clinique de l’Europe, Rouen; Pr Serrie, Hôpital Lariboisière, Paris; Dr Louazon-Busnel, Clinique de la Sagesse, Rennes; Dr Caillet, Centre Hospitalier Universitaire de Lyon; Dr Sorel, Centre Hospitalier de Nemours; Dr Misery, Centre Hospitalier Universitaire de Brest – Hôpital Morvan; Dr Nègre, Hôpital Bicêtre, Kremlin Bicêtre; Dr Soriot, Centre Hospitalier d’Abbeville; Dr Guez, Centre Hospitalier de Voiron; Dr Baude, Clinique mutualiste de Lyon.
Transparency
Declaration of funding
The QAPSA study was supported by Astellas Pharma France and subsequently by Grünenthal GmBH.
Author contributions
The authors were involved in the conception and design of the study, analysis and interpretation of the data, and critical revision for intellectual content of the manuscript.
Declaration of financial/other relationships
The authors received fees from Astellas Pharma France during the conduct of the study. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.