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Capsaicin 8% Patch Repeat Treatment in Non-diabetic Peripheral Neuropathic Pain: A 52-week, Open-label, Single-arm, Safety Study.

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Date

2016-12-21

Authors

Gálvez, Rafael
Navez, Marie-Louise
Moyle, Graeme
Maihöfner, Christian
Stoker, Malcolm
Ernault, Etienne
Nurmikko, Turo J
Attal, Nadine

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Lippincott, Williams & Wilkins
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Abstract

OBJECTIVES To investigate long-term safety and tolerability of capsaicin 8% patch repeat treatment in non-diabetic patients with peripheral neuropathic pain (NP). METHODS Prospective, open-label, observational study in patients with post-herpetic neuralgia, post-traumatic or post-surgical nerve injury, HIV-associated distal sensory polyneuropathy, or other peripheral NP, and average daily pain score ≥4, received ≤6 capsaicin 8% patch treatments over 52 weeks according to clinical need (retreatment at 9-12 wk intervals). Sensory testing and analgesic effectiveness were assessed using "bedside tests" and Brief Pain Inventory (question 5). RESULTS Overall, 306 patients received treatment. Treatment-emergent adverse events (TEAE) and drug-related TEAEs were reported by 252 (82.4%) and 207 (67.6%) patients. Application site pain was the most common drug-related TEAE (n=112, 36.6%); no drug-related serious TEAEs were reported. Sensory category shift analyses from baseline to end of study (EoS) in patients attending at least two sensory visits (n=278 for all tests except warm, n=277) found sensory deterioration/loss in at least one modality in 50.4% (n=140); deterioration/loss in one, two, three, four or five modalities occurred in 26.6% (n=74), 14.0% (n=39), 5.8% (n=16), 2.5% (n=7) and 1.4% (n=4). Newly emergent hyperaesthesia or allodynia was apparent in 1.1-3.6% (depending on modality) by EoS. Between 25.2 and 32.0% of patients reported improvement in a sensory modality by EoS. Average daily pain was 6.6 and 4.7 at baseline and Month 12. CONCLUSIONS Generally, capsaicin 8% patch repeat treatment over 52 weeks was well tolerated, with variable alteration in sensory function and minimal chance of complete sensory loss.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0.

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Journal Article;

MeSH Terms

Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Peripheral Nervous System Agents::Sensory System Agents::Analgesics
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amides::Polyunsaturated Alkamides::Capsaicin
Medical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::HIV Infections
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Diseases::Nervous System Diseases::Neurologic Manifestations::Sensation Disorders::Somatosensory Disorders::Hyperalgesia
Medical Subject Headings::Diseases::Nervous System Diseases::Neurologic Manifestations::Sensation Disorders::Somatosensory Disorders::Hyperesthesia
Medical Subject Headings::Diseases::Nervous System Diseases::Neurologic Manifestations::Pain::Neuralgia
Medical Subject Headings::Diseases::Nervous System Diseases::Neurologic Manifestations::Pain::Neuralgia::Neuralgia, Postherpetic
Medical Subject Headings::Diseases::Nervous System Diseases::Neuromuscular Diseases::Peripheral Nervous System Diseases::Polyneuropathies
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Prospective Studies
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Retreatment

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Keywords

Analgésicos, Capsaicina, Infecciones por VIH, Humanos, Hiperalgesia, Hiperestesia, Neuralgia, Neuralgia posherpética, Polineuropatías, Estudios prospectivos, Retratamiento

Citation

Gálvez R, Navez ML, Moyle G, Maihöfner C, Stoker M, Ernault E, et al. Capsaicin 8% Patch Repeat Treatment in Non-diabetic Peripheral Neuropathic Pain: A 52-week, Open-label, Single-arm, Safety Study. Clin J Pain. 2016