title: Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care.
abstract: BACKGROUND
  Buprenorphine is well known in the treatment of opioid dependence. Despite a high safety profile and good tolerance buprenorphine has been subject to misuse and diversion. To reduce misuse the antagonist naloxone was added and the 4:1 combination of buprenorphine-naloxone was launched in Germany in March 2007. On the basis of the results from international clinical trials a non-interventional study was conducted to gather data on safety, effectiveness, retention and acceptability of buprenorphine-naloxone in the treatment of opioid dependent patients in routine care.
  
  
  METHODS
  A nationwide multicentre 12-month prospective, non-interventional, post-marketing, surveillance study was carried out with 12 assessment points in N=384 opioid dependent patients currently in maintenance treatment from N=69 general practitioners, clinics and outpatient clinics in Germany.
  
  
  RESULTS
  N=337 data sets were eligible for analysis. The rates of patients with serious and non-serious adverse events were low with 1.2% and 17.5%, respectively. No deaths occurred during the observational period and only one hospitalization was documented. Concomitant drug use decreased for all illicit substances. Mental health and quality of life measured with standardized self-assessment questionnaires improved significantly. The 12-month retention rate was 57.1%. Of the n=181 patients still in treatment at the end of the observation period, 96.7% continued treatment with buprenorphine-naloxone.
  
  
  CONCLUSIONS
  The findings of the non-interventional study indicate high effectiveness and safety of buprenorphine-naloxone in the treatment of opioid dependence. The medication was well accepted by opioid dependent patients in long-term substitution treatment with substantial reductions of concomitant drug use and measurable improvement in quality of life.
authors.affiliation: Certum Consulting-Scientific Research, Oberbergkirchen, Germany. sma@certum-consulting.com
authors.forename: S M
authors.initials: SM
authors.lastname: Apelt
authors.forename: N
authors.initials: N
authors.lastname: Scherbaum
authors.forename: J
authors.initials: J
authors.lastname: Gölz
authors.forename: M
authors.initials: M
authors.lastname: Backmund
authors.forename: M
authors.initials: M
authors.lastname: Soyka
mesh_terms: D000328:Adult; D002047:Buprenorphine / Q000627:therapeutic use*; D016206:Databases, Bibliographic / Q000706:statistics & numerical data; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D019370:Observation; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012647:Self-Assessment; D011795:Surveys and Questionnaires
chemical_list: D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine