RT Journal Article
T1 Capsaicin 8% Patch Repeat Treatment in Non-diabetic Peripheral Neuropathic Pain: A 52-week, Open-label, Single-arm, Safety Study.
A1 Gálvez, Rafael
A1 Navez, Marie-Louise
A1 Moyle, Graeme
A1 Maihöfner, Christian
A1 Stoker, Malcolm
A1 Ernault, Etienne
A1 Nurmikko, Turo J
A1 Attal, Nadine
K1 Analgésicos
K1 Capsaicina
K1 Infecciones por VIH
K1 Humanos
K1 Hiperalgesia
K1 Hiperestesia
K1 Neuralgia
K1 Neuralgia posherpética
K1 Polineuropatías
K1 Estudios prospectivos
K1 Retratamiento
AB OBJECTIVESTo investigate long-term safety and tolerability of capsaicin 8% patch repeat treatment in non-diabetic patients with peripheral neuropathic pain (NP).METHODSProspective, 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).RESULTSOverall, 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.CONCLUSIONSGenerally, 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.
PB Lippincott, Williams & Wilkins
SN 0749-8047
YR 2016
FD 2016-12-21
LK http://hdl.handle.net/10668/2600
UL http://hdl.handle.net/10668/2600
LA en
NO 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
NO Journal Article;
DS RISalud
RD Apr 10, 2025