title: Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain.
abstract: BACKGROUND
  Clinical trials have not yet compared the efficacy of capsaicin 8% patch with current standard therapy in peripheral neuropathic pain (PNP).
  
  
  OBJECTIVE
  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 < 0.0001). Treatment satisfaction was also significantly greater with the capsaicin 8% patch versus pregabalin. TEAEs were mild-to-moderate in severity, and resulted in treatment discontinuation only with pregabalin (n = 24). Systemic adverse drug reactions ranged from 0 to 1.1% with capsaicin 8% patch and 2.5 to 18.4% with pregabalin.
  
  
  CONCLUSIONS
  The capsaicin 8% patch provided non-inferior pain relief to an optimized dose of pregabalin in PNP, with a faster onset of action, fewer systemic side effects and greater treatment satisfaction.
authors.affiliation: Helsinki University Central Hospital, Finland.
authors.forename: M
authors.initials: M
authors.lastname: Haanpää
authors.affiliation: Department of Neurology and Psychiatry, Sapienza University, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Cruccu
authors.affiliation: The Walton Centre NHS Foundation Trust, Liverpool, UK.
authors.forename: T J
authors.initials: TJ
authors.lastname: Nurmikko
authors.affiliation: Belfast Health and Social Care Trust, Belfast, Northern Ireland.
authors.forename: W T
authors.initials: WT
authors.lastname: McBride
authors.affiliation: Ovidius University, General Medicine, Constanta, Romania.
authors.forename: A
authors.initials: A
authors.lastname: Docu Axelarad
authors.affiliation: Centre for Mental Health, Russe, Bulgaria.
authors.forename: A
authors.initials: A
authors.lastname: Bosilkov
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, UK.
authors.forename: C
authors.initials: C
authors.lastname: Chambers
authors.affiliation: Astellas Pharma Europe B.V., Leiden, The Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Ernault
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, UK.
authors.forename: A K
authors.initials: AK
authors.lastname: Abdulahad
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002211:Capsaicin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement / Q000187:drug effects; D000069583:Pregabalin / Q000008:administration & dosage / Q000627:therapeutic use*; D057968:Transdermal Patch; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000069583:Pregabalin; D002211:Capsaicin