TY - JOUR
T1 - The FDA metformin label change and racial and sex disparities in metformin prescription among patients with CKD
AU - Shin, Jung Im
AU - Sang, Yingying
AU - Chang, Alex R.
AU - Dunning, Stephan C.
AU - Coresh, Josef
AU - Inker, Lesley A.
AU - Selvin, Elizabeth
AU - Ballew, Shoshana H.
AU - Grams, Morgan E.
N1 - Funding Information:
The project described was supported by National Institute of Diabetes and Digestive and Kidney Diseases grants R01DK115534 (principal investigators: M. Grams and L. Inker) and K01DK121825 (principal investigator: J.-I. Shin). J. Coresh reports grants from the National Institutes of Health and grants from the National Kidney Foundation during the conduct of the study. L. Inker reports grants from the National Institute of Diabetes and Digestive and Kidney Diseases during the conduct of the study. E. Selvin reports grants from the National Institutes of Health during the conduct of the study. J.-I. Shin reports grants from the National Institutes of Health during the conduct of the study.
Funding Information:
J. Coresh reports grants from the National Kidney Foundation and the National Institutes of Health, outside the submitted work. M. Grams reports grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases, grants from the National Kidney Foundation, and nonfinancial support from DCI, outside the submitted work. L. Inker reports grants from Reata Pharmaceuticals, grants from Omeros Corporation, grants from Retrophin, grants from Otsuka, and other from Tricida, outside the submitted work. J.-I. Shin reports grants from Merck, outside the submitted work.
Publisher Copyright:
Copyright © 2020 by the American Society of Nephrology
PY - 2020/8
Y1 - 2020/8
N2 - Background In 2016, the Food and Drug Administration (FDA) changed labeling regarding metformin contraindications in patients with diabetes and CKD from using serum creatinine–based thresholds to using eGFR-based thresholds. Because race and sex affect serum creatinine levels independently of GFR, the earlier creatinine-based contraindication may have inadvertently caused racial and sex disparities in metformin prescription among patients with low eGFR. Methods In an analysis of 15,946 Black and White primary care patients with diabetes and eGFR$30 ml/min per 1.73 m2 in a large health system (the primary cohort), we assessed the association of race and sex with metformin prescription across eGFR level before and after the FDA label change. For a replication cohort, we meta-analyzed data from 36 cohorts with 1,051,723 patients from OptumLabs Data Warehouse. Results In the primary cohort, before the label change, Black patients with eGFR of 30–44 ml/min per 1.73 m2 were prescribed metformin less often than White counterparts (adjusted prevalence ratio [aPR], 0.65; 95% confidence interval [95% CI], 0.52 to 0.82); this disparity was significantly attenuated after the label change (aPR, 0.90; 95% CI, 0.74 to 1.09; P value for interaction by period 50.04). Results were consistent in the replication cohorts. Men with eGFR of 30–44 ml/min per 1.73 m2 received metformin prescriptions less often than women counterparts before the label change; this was nonsignificantly attenuated after the label change, but we found significant attenuation in the replication cohorts (aPRpre-label change, 0.76; 95% CI, 0.73 to 0.79; aPRpost-label change, 0.85; 95% CI, 0.83 to 0.88; P value for interaction by period,0.001). Conclusions The metformin label change to an eGFR-based contraindication may have reduced racial and sex disparities in metformin prescription in moderate kidney dysfunction.
AB - Background In 2016, the Food and Drug Administration (FDA) changed labeling regarding metformin contraindications in patients with diabetes and CKD from using serum creatinine–based thresholds to using eGFR-based thresholds. Because race and sex affect serum creatinine levels independently of GFR, the earlier creatinine-based contraindication may have inadvertently caused racial and sex disparities in metformin prescription among patients with low eGFR. Methods In an analysis of 15,946 Black and White primary care patients with diabetes and eGFR$30 ml/min per 1.73 m2 in a large health system (the primary cohort), we assessed the association of race and sex with metformin prescription across eGFR level before and after the FDA label change. For a replication cohort, we meta-analyzed data from 36 cohorts with 1,051,723 patients from OptumLabs Data Warehouse. Results In the primary cohort, before the label change, Black patients with eGFR of 30–44 ml/min per 1.73 m2 were prescribed metformin less often than White counterparts (adjusted prevalence ratio [aPR], 0.65; 95% confidence interval [95% CI], 0.52 to 0.82); this disparity was significantly attenuated after the label change (aPR, 0.90; 95% CI, 0.74 to 1.09; P value for interaction by period 50.04). Results were consistent in the replication cohorts. Men with eGFR of 30–44 ml/min per 1.73 m2 received metformin prescriptions less often than women counterparts before the label change; this was nonsignificantly attenuated after the label change, but we found significant attenuation in the replication cohorts (aPRpre-label change, 0.76; 95% CI, 0.73 to 0.79; aPRpost-label change, 0.85; 95% CI, 0.83 to 0.88; P value for interaction by period,0.001). Conclusions The metformin label change to an eGFR-based contraindication may have reduced racial and sex disparities in metformin prescription in moderate kidney dysfunction.
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U2 - 10.1681/ASN.2019101119
DO - 10.1681/ASN.2019101119
M3 - Article
C2 - 32660971
AN - SCOPUS:85089127433
VL - 31
SP - 1847
EP - 1858
JO - Journal of the American Society of Nephrology : JASN
JF - Journal of the American Society of Nephrology : JASN
SN - 1046-6673
IS - 8
ER -