Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain

Autor: C. Chambers, A.K. Abdulahad, A. Bosilkov, Maija Haanpää, W.T. McBride, Turo Nurmikko, Giorgio Cruccu, E. Ernault, A. Docu Axelarad
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: European Journal of Pain (London, England)
Popis: Background Clinical trials have not yet compared the efficacy of capsaicin 8% patch with current standard therapy in peripheral neuropathic pain (PNP). Objectives Head-to-head efficacy and safety trial comparing the capsaicin patch with pregabalin in PNP. Methods Open-label, randomized, multicentre, non-inferiority trial. Patients with PNP, aged 18–80 years, were randomly assigned to either the capsaicin 8% patch (n = 282) or an optimised dose of oral pregabalin (n = 277), and assessed for a ≥30% mean decrease in Numeric Pain Rating Scale (NPRS) score from baseline to Week 8. Secondary endpoints included optimal therapeutic effect (OTE), time-to-onset of pain relief and treatment satisfaction. Results The capsaicin 8% patch was non-inferior to pregabalin in achievement of a ≥30% mean decrease in NPRS score from baseline to Week 8 (55.7% vs. 54.5%, respectively; Odds ratio: 1.03 [95% CI: 0.72, 1.50]). The proportion of patients achieving OTE at Week 8 was 52.1% for the capsaicin 8% patch versus 44.8% for pregabalin (difference: 7.3%; 95% CI: −0.9%, 15.6%). The median time-to-onset of pain relief was significantly shorter for capsaicin 8% patch versus pregabalin (7.5 vs. 36.0 days; Hazard ratio: 1.68 [95% CI: 1.35, 2.08]; p
Databáze: OpenAIRE