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

摘要: 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 based on data from 12 trials included in the Australian National Evaluation of Pharmacotherapies Opioid Dependence (NEPOD). Participants settings total 1.244 heroin users methadone patients treated hospital, community GP settings. Intervention Six detoxification; all with methadone, buprenorphine, levo-alpha-acetyl-methadol (LAAM) or naltrexone. Findings During 394 person-years observation, 79 SAEs 28 types were recorded. Naltrexone participants experienced 39 overdoses per 100 (44% occurred within 2 weeks stopping naltrexone). This was eight times rate recorded who left agonist Rates other similar versus out treatment, both naltrexone-treated agonist-treated participants. Five deaths occurred, had at a six person-years. Total SAE naltrexone treatments (20, 14 person-years, respectively). death observed three 19 corresponding Conclusions Individuals leave dependence experience higher overdose compared those may be due partly participant self-selection effect rather than entirely pharmacotherapy being protective. Clinicians should alert particular about risks. Duty care extend beyond cessation dosing.