title: A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 μg/h or 20 μg/h in patients with osteoarthritis pain.
abstract: OBJECTIVE
  The objective of this study was to evaluate continued pain control and tolerability of converting patients from Vicodin (hydrocodone/acetaminophen; HCD/APAP) to the buprenorphine transdermal system (BTDS).
  
  
  METHODS
  Adult patients with pain from osteoarthritis receiving a stable dosage of HCD/APAP (i.e., 15 - 30 mg hydrocodone/day) were switched to an equivalent or near-equivalent dosage of open-label Vicodin for 7 days. Patients maintaining acceptable analgesia were stratified based on their Vicodin dosage and randomized to receive either titratable BTDS 10 μg/h or fixed-dose BTDS 20 μg/h. The primary efficacy variable was completion of the 14-day double-blind phase. Tolerability was assessed.
  
  
  RESULTS
  A total of 84.3% of patients met the primary end point, completion of the 14-day double-blind phase (167/198 patients, 95% CI 79.3 - 89.4). Adverse events were consistent with those associated with the use of opioid analgesics and transdermal patches.
  
  
  CONCLUSIONS
  There was a similar analgesic and tolerability profile when patients treated with Vicodin for osteoarthritis pain were switched to 7-day BTDS treatment.
authors.affiliation: Purdue Pharma LP, One Stamford Forum, Stamford, CT 06901-3431, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Ripa
authors.forename: Bill H
authors.initials: BH
authors.lastname: McCarberg
authors.forename: Catherine
authors.initials: C
authors.lastname: Munera
authors.forename: Warren
authors.initials: W
authors.lastname: Wen
authors.forename: Craig J
authors.initials: CJ
authors.lastname: Landau
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000279:Administration, Cutaneous; D000284:Administration, Oral; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D018771:Arthralgia / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D057915:Drug Substitution; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement; D013997:Time Factors; D057968:Transdermal Patch; D016896:Treatment Outcome; D014481:United States
chemical_list: D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; C083640:acetaminophen, hydrocodone drug combination; D000082:Acetaminophen; D002047:Buprenorphine; D006853:Hydrocodone