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Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients.
Br J Anaesth. 2014 Feb; 112(2):337-47.BJ

Abstract

BACKGROUND

Treprostinil sodium improves haemodynamics and symptoms in pulmonary arterial hypertension (PAH) patients, but its subcutaneous (s.c.) administration can produce severe local site pain, and lead to discontinuation of vital treatment. Treprostinil is a prostacyclin analogue which stimulates prostacyclin receptors in skin nociceptor terminals, resulting in pain and cutaneous hypersensitivity, for which current pain remedies have limited effect. Capsaicin 8% patch relieves neuropathic pain for 3 months after a single 60 min cutaneous application; we investigated whether its pre-application can reduce s.c. trepostinil-induced pain.

METHODS

A single-centre, double-blind, randomized, placebo-controlled, crossover study was conducted to assess the safety and efficacy of a single capsaicin 8% patch pre-application for s.c. treprostinil pain in 11 PAH patients, relative to control patch with low-dose capsaicin 0.075% cream.

RESULTS

The primary efficacy endpoint, mean difference between the two treatment arms in an 11-point numerical pain rating scale from baseline to 2 weeks after patch applications, was significantly lower on the capsaicin 8% patch treatment arm [P=0.01, mean difference=-1.47 units, 95% credible interval (CI): -2. 59 to -0.38] in the patients who completed the study per protocol, although intention-to-treat analysis did not show significant difference (P=0.28). Heat pain thresholds were decreased (P=0.027, mean difference=5.43°C, 95% CI: 0.71-10.21) and laser Doppler flux increased (P=0.016, mean difference=370 units, 95% CI: 612 to 127.9) at the application site immediately after capsaicin 8% patch, confirming activity.

CONCLUSIONS

Further investigation of the efficacy of capsaicin 8% patch in this indication is warranted.

Authors+Show Affiliations

The National Institute for Health Research (NIHR) Wellcome Trust Imperial Clinical Research Facility, Imperial Centre for Translational and Experimental Medicine, Imperial College London, Du Cane Road, London W12 0HS, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24062200

Citation

Libri, V, et al. "Capsaicin 8% Patch for Treprostinil Subcutaneous Infusion Site Pain in Pulmonary Hypertension Patients." British Journal of Anaesthesia, vol. 112, no. 2, 2014, pp. 337-47.
Libri V, Gibbs JS, Pinato DJ, et al. Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. Br J Anaesth. 2014;112(2):337-47.
Libri, V., Gibbs, J. S., Pinato, D. J., Iddamalgoda, T., Khengar, R. H., Gin-Sing, W., Huson, L., & Anand, P. (2014). Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. British Journal of Anaesthesia, 112(2), 337-47. https://doi.org/10.1093/bja/aet308
Libri V, et al. Capsaicin 8% Patch for Treprostinil Subcutaneous Infusion Site Pain in Pulmonary Hypertension Patients. Br J Anaesth. 2014;112(2):337-47. PubMed PMID: 24062200.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. AU - Libri,V, AU - Gibbs,J S R, AU - Pinato,D J, AU - Iddamalgoda,T, AU - Khengar,R H, AU - Gin-Sing,W, AU - Huson,L, AU - Anand,P, Y1 - 2013/09/22/ PY - 2013/9/25/entrez PY - 2013/9/26/pubmed PY - 2014/3/14/medline KW - capsaicin 8% KW - clinical trial KW - pain KW - pulmonary arterial hypertension KW - treprostinil SP - 337 EP - 47 JF - British journal of anaesthesia JO - Br J Anaesth VL - 112 IS - 2 N2 - BACKGROUND: Treprostinil sodium improves haemodynamics and symptoms in pulmonary arterial hypertension (PAH) patients, but its subcutaneous (s.c.) administration can produce severe local site pain, and lead to discontinuation of vital treatment. Treprostinil is a prostacyclin analogue which stimulates prostacyclin receptors in skin nociceptor terminals, resulting in pain and cutaneous hypersensitivity, for which current pain remedies have limited effect. Capsaicin 8% patch relieves neuropathic pain for 3 months after a single 60 min cutaneous application; we investigated whether its pre-application can reduce s.c. trepostinil-induced pain. METHODS: A single-centre, double-blind, randomized, placebo-controlled, crossover study was conducted to assess the safety and efficacy of a single capsaicin 8% patch pre-application for s.c. treprostinil pain in 11 PAH patients, relative to control patch with low-dose capsaicin 0.075% cream. RESULTS: The primary efficacy endpoint, mean difference between the two treatment arms in an 11-point numerical pain rating scale from baseline to 2 weeks after patch applications, was significantly lower on the capsaicin 8% patch treatment arm [P=0.01, mean difference=-1.47 units, 95% credible interval (CI): -2. 59 to -0.38] in the patients who completed the study per protocol, although intention-to-treat analysis did not show significant difference (P=0.28). Heat pain thresholds were decreased (P=0.027, mean difference=5.43°C, 95% CI: 0.71-10.21) and laser Doppler flux increased (P=0.016, mean difference=370 units, 95% CI: 612 to 127.9) at the application site immediately after capsaicin 8% patch, confirming activity. CONCLUSIONS: Further investigation of the efficacy of capsaicin 8% patch in this indication is warranted. SN - 1471-6771 UR - https://www.unboundmedicine.com/medline/citation/24062200/Capsaicin_8_patch_for_treprostinil_subcutaneous_infusion_site_pain_in_pulmonary_hypertension_patients_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0007-0912(17)31924-4 DB - PRIME DP - Unbound Medicine ER -