Cardiovascular, Kidney Failure, and All-Cause Mortality Events in Patients with Focal Segmental Glomerulosclerosis in a U.S. Real-World Database

Juan Carlos Q Velez; Kamlesh M Thakker; Mark E Bensink; Edgar V Lerma; Richard Lieblich; C Martin Bunke; Wu Gong; Kaijun Wang; Andrew R Rava; Diana T Amari; David Oliveri; Michael V Murphy; David M W Cork

doi:10.34067/KID.0000000000000469

Cardiovascular, Kidney Failure, and All-Cause Mortality Events in Patients with Focal Segmental Glomerulosclerosis in a U.S. Real-World Database

Kidney360. 2024 May 15. doi: 10.34067/KID.0000000000000469. Online ahead of print.

Authors

Juan Carlos Q Velez^{1

2}, Kamlesh M Thakker³, Mark E Bensink⁴, Edgar V Lerma⁵, Richard Lieblich⁶, C Martin Bunke⁷, Wu Gong⁴, Kaijun Wang⁴, Andrew R Rava⁸, Diana T Amari⁸, David Oliveri⁸, Michael V Murphy⁸, David M W Cork⁹

Affiliations

¹ Department of Nephrology, Ochsner Health, New Orleans, LA, USA.
² Ochsner Clinical School, The University of Queensland, Brisbane, QLD, Australia.
³ Notting Hill Consulting LLC, Celebration, FL, USA.
⁴ Travere Therapeutics, Inc., San Diego, CA, USA.
⁵ University of Illinois Chicago/ Advocate Christ Medical Center, Oak Lawn, IL, USA.
⁶ VJA Consulting, Walnut Creek, CA, USA.
⁷ CM Bunke Consulting, Mt. Pleasant, SC, USA.
⁸ Genesis Research Group, Hoboken, NJ, USA.
⁹ Genesis Research Group, Newcastle upon Tyne, UK.

PMID: 38748483
DOI: 10.34067/KID.0000000000000469

Abstract

Background: Focal segmental glomerulosclerosis (FSGS) leads to proteinuria and progressive decline in glomerular filtration rate which correlates with kidney failure and increased cardiovascular risk. The purpose of this study was to estimate the effects of proteinuria on kidney failure status/all-cause mortality and cardiovascular disease events/all-cause mortality, as well as the relationship between progression to kidney failure and occurrence of cardiovascular disease/mortality events among adult patients (≥18 years old) with FSGS.

Methods: This was an observational, retrospective cohort study utilizing Optum® de-identified Market Clarity Data and proprietary Natural Language Processing (NLP) data. The study period was from January 1, 2007 through March 31, 2021, with patients in the overall cohort being identified from July 1, 2007 through March 31, 2021. The index date was the first FSGS ICD-10 diagnosis code or FSGS-related NLP term within the identification period.

Results: Elevated proteinuria >1.5 g/g and ≥3.5 g/g increased risk for kidney failure/all-cause mortality (adjusted hazard ratio [95% CI]: 2.34 [1.99-2.74] and 2.44 [2.09-2.84], respectively) and cardiovascular disease/all-cause mortality (adjusted hazard ratio [95% CI]: 2.11 [1.38-3.22] and 2.27 [1.44-3.58], respectively). Progression to kidney failure was also associated with a higher risk of cardiovascular disease/all-cause mortality (adjusted hazard ratio [95% CI]: 3.04 [2.66-3.48].

Conclusions: A significant proportion of FSGS patients experience kidney failure and cardiovascular disease events. Elevated proteinuria and progression to kidney failure were associated with a higher risk of cardiovascular disease/all-cause mortality events, and, elevated pre-kidney failure proteinuria was associated with progression to kidney failure/all-cause mortality events. Treatments that meaningfully reduce proteinuria and slow the decline in glomerular filtration rate have the potential to reduce the risk of cardiovascular disease, kidney failure and early mortality in patients with FSGS.

Grants and funding

Travere Therapeutics Inc.