title: Efficacy of Qutenza® (capsaicin) 8% patch for neuropathic pain: a meta-analysis of the Qutenza Clinical Trials Database.
abstract: Qutenza® is a capsaicin patch used to treat peripheral neuropathic pain, including postherpetic neuralgia (PHN) and human immunodeficiency virus-associated neuropathy (HIV-AN). The Qutenza Clinical Trials Database has been assembled to more fully characterize the effects of Qutenza. We conducted a within-subject meta-analysis of Qutenza studies to further define the medication's efficacy profile across studies. The meta-analysis combined individual patient data from randomized, controlled studies of Qutenza in peripheral neuropathic pain (1458 subjects treated with approved doses of Qutenza or control patches; 1120 with PHN and 338 with HIV-AN). These 7 studies had similar designs and were performed with the high-dose 8% capsaicin Qutenza patch and a 0.04% low-dose control patch. The difference between treatment groups for the primary efficacy end point of percentage change from baseline to weeks 2 to 12 on pain intensity score was calculated. Response was defined as a ≥ 30% decrease in mean pain intensity score during weeks 2 to 12. The overall between-group difference in percentage change from baseline in pain intensity was 8.0% (95% confidence interval 4.6, 11.5; P<.001), which statistically significantly favored Qutenza over low-dose control. Qutenza superiority was demonstrated for both PHN and HIV-AN patients for the primary end point and the end point proportion of 30% pain reduction response, and for PHN patients for the end point of proportion of 50% pain reduction response. These results confirm that Qutenza is effective for the treatment of both PHN and HIV-AN compared to low-dose control patch.
authors.affiliation: Analgesic Solutions, Natick, MA, USA FocusBiocomm, Boulder, CO, USA Biobridges, Wellesley, MA, USA Astellas Pharma Global Development, Leiderdorp, The Netherlands.
authors.forename: Joy
authors.initials: J
authors.lastname: Mou
authors.forename: Florence
authors.initials: F
authors.lastname: Paillard
authors.forename: Barry
authors.initials: B
authors.lastname: Turnbull
authors.forename: Jeremiah
authors.initials: J
authors.lastname: Trudeau
authors.forename: Malcolm
authors.initials: M
authors.lastname: Stoker
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002211:Capsaicin / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D016208:Databases, Factual / Q000706:statistics & numerical data; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009437:Neuralgia / Q000188:drug therapy*; D018689:Sensory System Agents / Q000008:administration & dosage*; D057968:Transdermal Patch
chemical_list: D018689:Sensory System Agents; D002211:Capsaicin
keywords: Capsaicin; Neuropathic pain; Patch