CERSI Collaborators: Peter Noseworthy, MD (Mayo Clinic) (PI), Nihar Desai, MD, MPH (Yale), Karl Nath, MD (Mayo Clinic), Che Ngufor, PhD (Mayo Clinic), Joseph Ross, MD, MHS (Yale), Nilay Shah, PhD (Formerly of Mayo Clinic), Konstantinos Siontis, MD (Mayo Clinic), Xiaoxi Yao, PhD (Mayo Clinic)
FDA Collaborators: David Graham, MD, MPH, David Martin, MD, MPH (no longer at FDA), Rima Izem, PhD (Formerly of FDA), Joo-Yeon Lee, PhD, Mary Ross Southworth, PharmD, Aliza Thompson, MD
CERSI In-Kind Collaborators: University of Michigan- Brahmajee Nallamothu, MD, MPH, and Rajiv Saran, MD, MS, MBBS
Project Start Date: December 2017
Project End Date: March 2023
Regulatory Science Challenge
The FDA has long relied on electronic healthcare data (e.g., data from administrative claims and electronic health records) to examine the safety of drugs once they are on the market. Linking multiple types of electronic health record data to insurance claims may help support examination of a drug’s performance after approval through more comprehensive measurement of medication use, patient demographic and clinical history, and outcomes of interest.
Project Description and Findings
Atrial fibrillation is a disorder in which the heart beats irregularly and blood flow through the heart is abnormal. Atrial fibrillation can lead to strokes. Anticoagulants (blood thinners) can reduce the risk of stroke in patients with atrial fibrillation. Bleeding is a side effect of anticoagulants. The decision to use an anticoagulant to prevent stoke in patients with atrial fibrillation can be complicated by the presence of chronic kidney disease, as poor kidney function increases the risks of both stroke and bleeding and may change the risk-benefit balance of different treatment options. Investigators utilized insurance claims linked to structured data elements from the electronic health record, including laboratory data, to assess the effectiveness and safety of different oral anticoagulant drugs (non–vitamin K antagonist oral anticoagulants [NOAC] apixaban, dabigatran, and rivaroxaban, as well as warfarin) in patients with different levels of kidney function.
This study found that, in routine clinical practice, NOACs were used less frequently than warfarin in patients with reduced kidney function. However, as compared to warfarin, these treatments appear to have similar or better effectiveness and safety across the range of kidney function.
Yao X, Inselman JW, Ross JS, Izem R, Graham DJ, Martin DB, Thompson AM, Ross Southworth M, Siontis KC, Ngufor CG, Nath KA, Desai NR, Nallamothu BK, Saran R, Shah ND, Noseworthy PA. Comparative effectiveness and safety of oral anticoagulants across kidney function in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2020 Oct 5.
Ngufor C, Yao,X, Inselman JW, Ross JS, Dhruva SS, Graham DJ, Lee JY, Siontis KC, Desai NR, Polley E, Shah ND, Noseworthy PA. Identifying treatment heterogeneity in atrial fibrillation using a novel causal machine learning method. Am Heart J 2023 Jun: 260.