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Fung KW, Baye F, Kapusnik-Uner J, et al. Using Medicare Data to Assess the Proarrhythmic Risk of Non-Cardiac Treatment Drugs that Prolong the QT Interval in Older Adults: An Observational Cohort Study. Drugs Real World Outcomes. 2021;8(2):173-185doi: 10.1007/s40801-021-00230-1.
Fung, K. W., Baye, F., Kapusnik-Uner, J., & McDonald, C. J. (2021). Using Medicare Data to Assess the Proarrhythmic Risk of Non-Cardiac Treatment Drugs that Prolong the QT Interval in Older Adults: An Observational Cohort Study. Drugs - real world outcomes, 8(2), 173-185. https://doi.org/10.1007/s40801-021-00230-1
Fung, Kin Wah, et al. "Using Medicare Data to Assess the Proarrhythmic Risk of Non-Cardiac Treatment Drugs that Prolong the QT Interval in Older Adults: An Observational Cohort Study." Drugs - real world outcomes vol. 8,2 (2021): 173-185. doi: https://doi.org/10.1007/s40801-021-00230-1
Fung KW, Baye F, Kapusnik-Uner J, McDonald CJ. Using Medicare Data to Assess the Proarrhythmic Risk of Non-Cardiac Treatment Drugs that Prolong the QT Interval in Older Adults: An Observational Cohort Study. Drugs Real World Outcomes. 2021 Jun;8(2):173-185. doi: 10.1007/s40801-021-00230-1. Epub 2021 Feb 10. PMID: 33569737; PMCID: PMC7875170.
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Drugs Real World Outcomes. 2021 Jun;8(2):173-185. doi: 10.1007/s40801-021-00230-1. Epub 2021 Feb 10.

Using Medicare Data to Assess the Proarrhythmic Risk of Non-Cardiac Treatment Drugs that Prolong the QT Interval in Older Adults: An Observational Cohort Study.

Drugs - real world outcomes

Kin Wah Fung, Fitsum Baye, Joan Kapusnik-Uner, Clement J McDonald

Affiliations

  1. Lister Hill National Center for Biomedical Communications, National Library of Medicine, U.S. National Institutes of Health, 8600 Rockville Pike, Bethesda, MD, 20894, USA. [email protected].
  2. Lister Hill National Center for Biomedical Communications, National Library of Medicine, U.S. National Institutes of Health, 8600 Rockville Pike, Bethesda, MD, 20894, USA.
  3. First Databank. Inc., San Francisco, CA, USA.
  4. University of California, San Francisco, CA, USA.

PMID: 33569737 PMCID: PMC7875170 DOI: 10.1007/s40801-021-00230-1

Abstract

INTRODUCTION: Serious cardiac arrhythmias caused by QT-prolonging drugs are difficult to predict based on physiological measurement and pre-approval clinical trials. Post-marketing surveillance and monitoring are important to generate safety data.

OBJECTIVES: To assess whether an observational study using Medicare claims data can detect the arrhythmogenic risk of QT-prolonging drugs.

METHODS: We identified 17 QT-prolonging drugs with known risk of torsades des pointes (TdP) that were not used to treat cardiac arrhythmias. Amoxicillin and four serotonin-norepinephrine reuptake inhibitors (SNRIs) were used as controls. De-identified claims data of 1.2 million Medicare beneficiaries were accessed. Two separate Cox regressions were done for short-term and chronic-use drugs. The primary outcome was a composite of ventricular arrhythmias and/or sudden death, identified by ICD diagnostic codes. We explored the independent effect of each study drug on the outcomes. Other covariates included patient demographics, comorbidities, and known risk factors for drug-induced cardiac arrhythmia.

RESULTS: We were able to detect increased risk in 14 of 17 study drugs (82.3%), and none of the control drugs. Among the fluoroquinolones, ciprofloxacin was the safest. Azithromycin and clarithromycin were relatively safe compared to erythromycin. Compared to SNRIs, both citalopram and escitalopram had increased risk, more so with escitalopram than citalopram. Comorbidities associated with increased risk included ischemic heart disease, electrolyte imbalance, bradycardia, acute myocardial infarction, heart failure, and chronic kidney and liver disease.

CONCLUSION: Medicare data can be utilized for post-marketing surveillance and monitoring of the proarrhythmic risk of QT-prolonging drugs in older adults.

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