Abstract | BACKGROUND: METHODS: We analyzed Optum de-Identified electronic health record (EHR) data from 11/2010-12/2019. We included adults with NVAF and T2D newly initiated on rivaroxaban or warfarin with ≥12 months of prior EHR activity. Patients with another indication for anticoagulation, valve disease, history of end-stage renal disease, major adverse limb events (MALE), diabetic retinopathy or pregnancy were excluded. We evaluated the incidence rate of developing a composite outcome of >40% decrease in estimated glomerular filtration incidence rate (eGFR) from baseline, eGFR < 15 mL/minute/1.73 m2, need for dialysis or kidney transplant, MALE, diabetic retinopathy or death. Overlap weighting was used to balance baseline characteristics between cohorts while preserving sample size. Hazard ratios with 95% confidence intervals were calculated using propensity score-overlap weighted Cox regression. RESULTS: We included 24,912 rivaroxaban and 58,270 warfarin users. The mean ± standard deviation (SD) CHA2DS2VASc score was 4.3 ± 1.5 and modified HASBLED score was 1.5 ± 0.8. Thirty percent of rivaroxaban patients were started on 15 mg once daily, with the rest prescribed 20 mg once daily. Warfarin patients had a mean time in therapeutic range of 47 ± 28%. Patients were followed for a mean of 2.89 ± 1.95 years. Rivaroxaban was associated with a reduced hazard of the composite outcome (HR = 0.93, 95%CI = 0.91-0.95; absolute risk reduction = 1.97 events per 1000 patient-years; number needed-to-treat = 51) versus warfarin. Rivaroxaban was also associated with significant reductions in the relative hazard of > 40% decrease in eGFR from baseline (HR = 0.96), need for dialysis or renal transplant (HR = 0.81), and limb revascularization or major amputation (HR = 0.85). Death occurred at a lower incidence rate with rivaroxaban (HR = 0.92, 95%CI = 0.89-0.95). CONCLUSIONS:
Rivaroxaban was associated with reduced incidence rates of kidney and limb complications, and death in NVAF patients with type 2 diabetes compared to warfarin. ClinicalTrials.gov Identifier: NCT04509193.
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Authors | Olivia S Costa, Bridget O'Donnell, Burcu Vardar, Khaled Abdelgawwad, Christopher W Brescia, Nitesh Sood, Craig I Coleman |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 37
Issue 9
Pg. 1493-1500
(09 2021)
ISSN: 1473-4877 [Electronic] England |
PMID | 34166150
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Warfarin
- Rivaroxaban
- Dabigatran
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Topics |
- Anticoagulants
(adverse effects, therapeutic use)
- Atrial Fibrillation
(drug therapy)
- Dabigatran
- Diabetes Mellitus, Type 2
(complications, drug therapy)
- Electronic Health Records
- Eye Diseases
(chemically induced)
- Humans
- Kidney
- Kidney Diseases
(chemically induced)
- Retrospective Studies
- Rivaroxaban
(adverse effects)
- Stroke
- Treatment Outcome
- Warfarin
(adverse effects)
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