The FDA Metformin Label Change and Racial and Sex Disparities in Metformin Prescription among Patients with CKD.

ABSTRACT:

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

SUBMITTER: Shin JI 

PROVIDER: S-EPMC7460896 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature