Prospective, non-interventional study on the tolerability and analgesic effectiveness over 12 weeks after a single application of capsaicin 8% cutaneous patch in 1044 patients with peripheral neuropathic pain: first results of the QUEPP study

Abstract

Background:

Reversible defunctionalisation of nociceptors by the TRPV1 agonist capsaicin in high concentration is an emerging new concept for the treatment of peripheral neuropathic pain.

Objectives:

The capsaicin 8% cutaneous patch with a long-lasting effect for up to 3 months after a single application is available in Germany by prescription since October 2010. The aim of this study was to monitor its usage and therapeutic performance in clinical practice.

Methods:

Patients had a single patch application with up to 4 patches and were followed up after 7–14 days, 4, 8, and 12 weeks. Average pain intensity (NPRS-11), pain attacks, neuropathy symptoms, sleep parameters, quality of life, working capacity and concomitant neuropathic pain medication were assessed during at least two visits.

Results:

A total of 509 females (48.8%; effectiveness population N = 1044) and 531 males (50.9%) were included; the mean age was 61.2 ± 14.4 (SD) years. Postherpetic neuralgia was the most frequent diagnosis (31.9%), followed by postsurgical neuralgia (22.8%), post-traumatic neuropathy (12.4%), polyneuropathy (14.3%), and mixed pain syndromes (16.6%). Thirty and 50% responder rates were 42.7% and 23.7%, respectively, with a mean relative reduction of pain intensity during weeks 1–12 of 24.7% (1.1 SEM) and significant improvements in pain attacks, sleep duration and sleep quality, while the consumption of opioids and antiepileptics decreased significantly. In 106 patients (10.0%; safety population n = 1063) 146 adverse drug reactions (ADRs) were reported, mainly application site reactions (erythema, pain). A total of 27 serious ADRs were documented in 17 patients (1.6%).

Conclusions:

Analgesic treatment of peripheral neuropathic pain with the capsaicin 8% cutaneous patch is safe and effective.

Limitations:

The study did not include a control group; therefore, a comparison of the results with that of therapeutic alternatives is not justified.

Keywords::

• Capsaicin
• Effectiveness
• Non-interventional study
• Peripheral neuropathic pain
• Safety

Transparency

Declaration of funding

This study was funded by Astellas Pharma GmbH, Munich, Germany.

Declaration of financial/other relationships

C.M. has received honoraria as consultant for Astellas, Bioresearch, and Mundipharma and has participated in speakers bureaus of Allergan, Astellas, Grunenthal, Janssen, and Pfizer. M-L.H. is an employee of Astellas Pharma GmbH.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed relevant financial relationships.

Acknowledgements

Franz Gerstheimer (medwiss-extern GbR, Aachen) provided medical writing assistance funded by Astellas Pharma GmbH.

Notes

*Qutenza is a registered trade name of Astellas Pharma Europe BV, The Netherlands