title: Short- and intermediate-term efficacy of buprenorphine TDS in chronic painful neuropathies.
abstract: Buprenorphine is a potent opioid available as a transdermal delivery system (TDS) formulation. This open-label study investigated its safety, tolerability, and efficacy in 30 patients with chronic painful neuropathy. Subjects with visual analogue scale (VAS) score > or = 5 under stable analgesic treatment were entered. The starting dosage of 35 microg/h was increased up to 70.0 microg/h in case of unsatisfactory pain control as assessed by fortnightly visits. The primary endpoint was the number of patients achieving at least 30% pain relief at day 42 visit. Treatment was safe over the study period. Nine patients dropped out for side effects, mostly nausea and daily sleepiness. Buprenorphine TDS was well tolerated in 21 patients. Thirteen patients achieved > 30% of pain relief at day 42 visit. Five patients needed to increase the dosage to 52.5 microg/h. Eight patients did not meet the primary outcome, but none allowed increasing the dosage to 70 microg/h, and four patients withdrew consent to continue the study before day 42 visit because of a 'fear to become addicted,' although 40% had obtained VAS reduction. In our study, which needs to be confirmed by a controlled trial, buprenorphine TDS induced clinically meaningful pain relief in about 40% of patients with chronic painful neuropathy, suggesting its use as a third-line treatment.
authors.affiliation: Neuromuscular Diseases Unit, Fondazione IRCCS National Neurological Institute Carlo Besta, Milan, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Penza
authors.forename: Angela
authors.initials: A
authors.lastname: Campanella
authors.forename: Alfredo
authors.initials: A
authors.lastname: Martini
authors.forename: Giorgia
authors.initials: G
authors.lastname: Melli
authors.forename: Raffaella
authors.initials: R
authors.lastname: Lombardi
authors.forename: Francesca
authors.initials: F
authors.lastname: Camozzi
authors.forename: Grazia
authors.initials: G
authors.lastname: Devigili
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lauria
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D010523:Peripheral Nervous System Diseases / Q000150:complications / Q000188:drug therapy*; D013995:Time
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine