Increased risk of adverse events among patients with vs. without systemic autoimmune rheumatic disease prescribed sodium-glucose cotransporter 2 inhibitors: a retrospective cohort study
- 25-10-2024
- ORIGINAL ARTICLE
Published in:
- Authors
- Emily G. Oakes
- Jack Ellrodt
- Hongshu Guan
- Jeong Yee
- May Y. Choi
- Karen H. Costenbader
- Published in
- Clinical Rheumatology | Issue 12/2024
Abstract
Background
Systemic autoimmune rheumatic disease (SARD) patients have been excluded from sodium-glucose cotransporter 2 inhibitor (SGLT2i) trials given putative risks, but this risk magnitude is unknown. We aimed to quantify SGLT2i adverse event risks among patients with vs. without SARD.
Methods
In a retrospective cohort study, patients with SARD at Mass General Brigham, a multihospital system in Boston, Massachusetts, prescribed SGLT2i were age-, self-reported race-, and sex-matched to patients prescribed the same SGLT2i between 1/1/2016 and 12/10/2021. Cumulative incidence and Cox models, overall and sex-stratified, estimated patient-reported adverse event risks from prescription date, censoring for discontinuation, death, or study end (12/12/2022).
Results
Four hundred sixty-eight SARD and 420 matched non-SARD patients were compared: mean age 64 years (SD 11.3), 61% female, and 70% White. SARD patients had shorter SGLT2i use duration (8.4 vs. 12.7 months; p < 0.0001) and time to adverse event (0.59 vs. 0.85 years; p 0.04). Yeast infections (9.8% vs. 6.2%; p 0.047) and muscular symptoms (3.4% vs. 1.0%, p 0.01) were more prevalent among those with SARD. Adjusting for baseline demographics, adverse event risk was higher (MV HR 1.68; 95% CI 1.28, 2.21), in patients with vs. without SARD. Risk was higher in women than men overall and in women with SARD vs. without (adjusted HR 1.86; 95% CI 1.36, 2.54).
Conclusion
Patients with vs. without SARD had 68% higher adverse event risk with SGLT2i use. Women with vs. without SARD had > 85% higher adverse event risks, although most were not serious. Trials of safety and efficacy of SGLT2i among SARD patients are warranted.
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Key Points
•To our knowledge, this is the first study to compare adverse events associated with SGLT2i utilization in patients with vs. without SARD, despite RCT exclusion and documented SGLT2i use in the population.
•In our comparison of 468 patients with SARD and 420 patients without, we identified a greater than 65% increase in risk of adverse event outcomes among patients with SARD.
•Furthermore, we found that this risk disproportionately affected female patients, with a 4.4-fold increased risk among women with SARD compared to men without.
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- Title
- Increased risk of adverse events among patients with vs. without systemic autoimmune rheumatic disease prescribed sodium-glucose cotransporter 2 inhibitors: a retrospective cohort study
- Authors
-
Emily G. Oakes
Jack Ellrodt
Hongshu Guan
Jeong Yee
May Y. Choi
Karen H. Costenbader
- Publication date
- 25-10-2024
- Publisher
- Springer International Publishing
- Published in
-
Clinical Rheumatology / Issue 12/2024
Print ISSN: 0770-3198
Electronic ISSN: 1434-9949 - DOI
- https://doi.org/10.1007/s10067-024-07206-w
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