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.

• Authors: C Maihofner, M-L Heskamp
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 29 Issue 6 Pg. 673-83 (Jun 2013) ISSN: 1473-4877 [Electronic] England
• PMID: 23551064 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Capsaicin

Topics

• Administration, Cutaneous
• Analgesics (administration & dosage, adverse effects, therapeutic use)
• Capsaicin (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Neuralgia (drug therapy)
• Pain Management
• Peripheral Nervous System Diseases (drug therapy)
• Transdermal Patch
• Treatment Outcome