Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD)

AIMS: The study estimated serious adverse event (SAE) rates among entrants to pharmacotherapies for opioid dependence, during treatment and after leaving treatment. DESIGN: A longitudinal study based on data from 12 trials included in the Australian National Evaluation of Pharmacotherapies for Opioi...

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Publicado en:Addiction Vol. 99; no. 4; pp. 450 - 461
Autores principales: Digiusto E, Shakeshaft A, Ritter A, O'Brien S, Mattick RP
Formato: research tables/charts Journal Article
Publicado: Wiley-Blackwell Apr2004
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Apr2004
      vid: 99
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        106749112
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        2004099423
        10.1111/j.1360-0443.2004.00654.x
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        atl: Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD)
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          Digiusto E
          Shakeshaft A
          Ritter A
          O'Brien S
          Mattick RP
        affil: National Centre in HIV Social Research UNSW, Sydney, Australia; Erol@accsoft.com.au
      sug:
        subj:
          Drug Therapy Adverse Effects
          Narcotics
          Substance Dependence Drug Therapy
          Adult
          Australia
          Buprenorphine
          Confidence Intervals
          Death
          Detoxification, Alternative Therapy
          Female
          Funding Source
          Heroin
          Male
          Methadone
          Naltrexone Adverse Effects
          Overdose
          Prospective Studies
          Human
          Adult: 19-44 years
          Female
          Male
      ab: AIMS: The study estimated serious adverse event (SAE) rates among entrants to pharmacotherapies for opioid dependence, during treatment and after leaving treatment. DESIGN: A longitudinal study based on data from 12 trials included in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). PARTICIPANTS AND SETTINGS: A total of 1244 heroin users and methadone patients treated in hospital, community and GP settings. Intervention Six trials included detoxification; all included treatment with methadone, buprenorphine, levo-alpha-acetyl-methadol (LAAM) or naltrexone. FINDINGS: During 394 person-years of observation, 79 SAEs of 28 types were recorded. Naltrexone participants experienced 39 overdoses per 100 person-years after leaving treatment (44% occurred within 2 weeks after stopping naltrexone). This was eight times the rate recorded among participants who left agonist treatment. Rates of all other SAEs were similar during treatment versus out of treatment, for both naltrexone-treated and agonist-treated participants. Five deaths occurred, all among participants who had left treatment, at a rate of six per 100 person-years. Total SAE rates during naltrexone and agonist treatments were similar (20, 14 per 100 person-years, respectively). Total SAE and death rates observed among participants who had left treatment were three and 19 times the corresponding rates during treatment. CONCLUSIONS: Individuals who leave pharmacotherapies for opioid dependence experience higher overdose and death rates compared with those in treatment. This may be due partly to a participant self-selection effect rather than entirely to pharmacotherapy being protective. Clinicians should alert naltrexone treatment patients in particular about heroin overdose risks. Duty of care may extend beyond cessation of dosing.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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