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The Risk of Ischemic Cardio- and Cerebrovascular Events Associated with Oxycodone–Naloxone and Other Extended-Release High-Potency Opioids: A Nested Case–Control Study

Author

Listed:
  • Kathrin Jobski

    (Leibniz Institute for Prevention Research and Epidemiology-BIPS
    Carl von Ossietzky University Oldenburg)

  • Bianca Kollhorst

    (Leibniz Institute for Prevention Research and Epidemiology-BIPS)

  • Edeltraut Garbe

    (Leibniz Institute for Prevention Research and Epidemiology-BIPS
    University of Bremen)

  • Tania Schink

    (Leibniz Institute for Prevention Research and Epidemiology-BIPS)

Abstract

Introduction In Germany, an extended-release (ER) combination of the high-potency opioid (HPO) oxycodone and the antagonist naloxone was approved in 2006. In recent years, the cardio- and cerebrovascular safety of opioid antagonists and of opioids themselves has been discussed. Objectives The objective of this study was to estimate the risk of major ischemic cardio- and cerebrovascular events in patients receiving ER oxycodone–naloxone compared with those receiving other ER HPOs. Methods We used the German Pharmacoepidemiological Research Database (GePaRD) to conduct a nested case–control study (2006–2011) within a cohort of ER HPO users. Cases were defined as patients hospitalized for acute myocardial infarction (MI) or ischemic stroke (IS). For each case, up to ten controls were selected by risk-set sampling. Using conditional logistic regression, confounder-adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were obtained for the risk of MI/IS associated with (1) current HPO treatment, (2) recent discontinuation, or (3) recent switch of HPO therapy compared with past treatment. Results In 309,936 ER HPO users, 12,384 MI/IS events were detected, resulting in a crude incidence rate of 19.48 (95% CI 19.14–19.82) per 1000 person years. A small but significantly elevated aOR was found for morphine (1.12; 95% CI 1.04–1.22) but not for oxycodone–naloxone. Recent discontinuation and recent switch of any ER HPO also had a significant impact on the outcome (aOR 1.12; 95% CI 1.04–1.21 and 1.25; 95% CI 1.03–1.52, respectively). Conclusions Our study does not indicate an association between oxycodone–naloxone and ischemic cardio- or cerebrovascular events. However, our findings do suggest that every change in ER HPO therapy should be conducted with caution.

Suggested Citation

  • Kathrin Jobski & Bianca Kollhorst & Edeltraut Garbe & Tania Schink, 2017. "The Risk of Ischemic Cardio- and Cerebrovascular Events Associated with Oxycodone–Naloxone and Other Extended-Release High-Potency Opioids: A Nested Case–Control Study," Drug Safety, Springer, vol. 40(6), pages 505-515, June.
    • Handle: RePEc:spr:drugsa:v:40:y:2017:i:6:d:10.1007_s40264-017-0511-8
    DOI: 10.1007/s40264-017-0511-8
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    Cited by:

    1. Wiebke Schäfer & Christina Princk & Bianca Kollhorst & Tania Schink, 2019. "Antidepressants and the Risk of Hemorrhagic Stroke in the Elderly: a Nested Case–Control Study," Drug Safety, Springer, vol. 42(9), pages 1081-1089, September.
    2. Oluwabunmi Ogungbe & Luma Akil & Hafiz A. Ahmad, 2019. "Exploring Unconventional Risk-Factors for Cardiovascular Diseases: Has Opioid Therapy Been Overlooked?," IJERPH, MDPI, vol. 16(14), pages 1-10, July.

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