Acute Kidney Injury in Statin Initiators: Patterns of Initiation and Applications in Observational Drug Safety Research Public Deposited

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  • March 21, 2019
  • Layton, James Bradley
    • Affiliation: Gillings School of Global Public Health, Department of Epidemiology
  • Recent reports have suggested an increase in acute kidney injury (AKI) among users of statins, but non-experimental studies of statins face difficult, methodological challenges in estimating valid effect measure estimates. Conflictingly, some studies suggest a renal-protective effect of statins when used prior to heart surgery. To address these uncertainties, we assembled a large cohort of statin initiators and non-initiators using insurance claims from employer-based commercial and Medicare supplementary insurance plans. We investigated other medications initiated at the same time as the statin, and found that large numbers of statin users concurrently initiated other cardiovascular drugs, which may be a proxy of more severe disease risk, better medical care, better access to medical care, or increased health consciousness and behavior, all of which may be important confounding factors. We investigated the effect of statin initiation prior to heart surgery on post-surgical renal failure in a statin naïve cohort, considering concurrent medication initiation as covariates. We found a mild protective effect of statin initiation on post-surgical AKI: RR = 0.80, 95% CI 0.67, 0.96. This effect differed by age: ≥65 years, RR=0.90 (95% CI: 0.71, 1.14); <65 years, RR=0.69 (95% CI: 0.52, 0.91), although AKI was much more common in the older age group (8.1 vs. 3.9%). In the general population, statins were not associated with an increased risk of AKI, nor were higher-intensity statins at greater risk than lower-intensity statins, or were individual statin formulations shown to be at higher risk than others, with the exception of higher-potency simvastatin, which demonstrated a slightly higher risk of AKI. Overall, there is no need for renal concern among typical statin initiators, and there may be small renal-protective effects, as well.
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  • In Copyright
  • Brookhart, M. Alan
  • Doctor of Philosophy
Graduation year
  • 2012

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