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Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients.

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.

journal_name

Br J Anaesth

journal_title

British journal of anaesthesia

authors

Libri V,Gibbs JS,Pinato DJ,Iddamalgoda T,Khengar RH,Gin-Sing W,Huson L,Anand P

doi

10.1093/bja/aet308

subject

Has Abstract

pub_date

2014-02-01 00:00:00

pages

337-47

issue

eissn

0007-0912

issn

1471-6771

pii

S0007-0912(17)31924-4

journal_volume

112

pub_type

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Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients.