title: 3-year prevalence of alcohol-related disorders in German patients treated with high-potency opioids.
abstract: OBJECTIVE
  In November 2010, the European Medicines Agency's Committee for Medicinal Products for Human Use completed a review of the safety and effectiveness of modified-release oral high-potency opioids (HPO). The reason for this referral procedure was the concern that some of these controlled-release systems may be unstable when co-ingested with alcohol and that the active substance would be released too quickly. The aim of this study was to estimate the prevalence of alcohol-related disorders (ARD) in German patients treated with HPO approved for pain therapy.
  
  
  METHODS
  The source of data was the German Pharmacoepidemiological Research Database including more than 14 million members of four statutory health insurances. The age and sex standardized 3-year prevalence of ARD in patients treated with any type of HPO and in patients receiving modified-release oral HPO was compared with the prevalence of ARD in the general population excluding HPO-treated patients.
  
  
  RESULTS
  The age and sex standardized prevalence of ARD was significantly higher in patients treated with any type of HPO (5.5%, 95%confidence interval [CI]: 5.2%-5.9%) or with modified-release HPO (5.4%, 95%CI: 4.8%-5.9%) than in persons belonging to the general population (2.2%, 95%CI: 2.2-2.2%).
  
  
  CONCLUSIONS
  Interactions with alcohol in patients receiving modified-release HPO may be of relevance in a substantial number of patients. Physicians should be aware of this potentially dangerous interaction.
authors.affiliation: BIPS - Institute for Epidemiology and Prevention Research, Bremen, Germany.
authors.forename: Kathrin
authors.initials: K
authors.lastname: Jobski
authors.forename: Ulrike
authors.initials: U
authors.lastname: Schmid
authors.forename: Sigrid
authors.initials: S
authors.lastname: Behr
authors.forename: Frank
authors.initials: F
authors.lastname: Andersohn
authors.forename: Edeltraut
authors.initials: E
authors.lastname: Garbe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019973:Alcohol-Related Disorders / Q000150:complications* / Q000453:epidemiology*; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000075202:Contraindications; D062313:Databases, Pharmaceutical; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000150:complications* / Q000188:drug therapy*; D015995:Prevalence
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations