Comprehensive analysis of sparsentan-related adverse events: latest insights from VigiAccess and FAERS

Trachtman H, Komers R, Inrig J (2024) Sparsentan: the first and only non-immunosuppressive therapy for the reduction of proteinuria in IgA nephropathy. Expert Rev Clin Immunol 20:571–576. https://doi.org/10.1080/1744666X.2024.2319132

Article  CAS  PubMed  Google Scholar 

Kohan DE, Bedard PW, Jenkinson C et al (2024) Mechanism of protective actions of sparsentan in the kidney: lessons from studies in models of chronic kidney disease. Clin Sci (Lond) 138:645–662. https://doi.org/10.1042/CS20240249

Article  CAS  PubMed  Google Scholar 

Nagasawa H, Suzuki H, Ueda S, Suzuki Y (2024) Dual blockade of endothelin A and angiotensin II type 1 receptors with sparsentan as a novel treatment strategy to alleviate IgA nephropathy. Expert Opin Investig Drugs 33:1143–1152. https://doi.org/10.1080/13543784.2024.2414902

Article  CAS  PubMed  Google Scholar 

Heerspink HJL, Radhakrishnan J, Alpers CE et al (2023) Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet 401:1584–1594. https://doi.org/10.1016/S0140-6736(23)00569-X

Article  CAS  PubMed  Google Scholar 

Komers R, Diva U, Inrig JK et al (2020) Study design of the phase 3 sparsentan versus irbesartan (DUPLEX) study in patients with focal segmental glomerulosclerosis. Kidney Int Rep 5:494–502. https://doi.org/10.1016/j.ekir.2019.12.017

Article  PubMed  PubMed Central  Google Scholar 

Rovin BH, Barratt J, Heerspink HJL et al (2023) Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet 402:2077–2090. https://doi.org/10.1016/S0140-6736(23)02302-4

Article  CAS  PubMed  Google Scholar 

Wang M (2024) Renoprotective effects of sparsentan: clinical trial evidence in IgA nephropathy and FSGS. Nat Rev Nephrol 20:6. https://doi.org/10.1038/s41581-023-00795-w

Article  CAS  PubMed  Google Scholar 

Zhang Y, Zhang H (2024) Current understanding and new insights in the treatment of IgA nephropathy. Nephrology (Carlton) 29(Suppl 2):75–79. https://doi.org/10.1111/nep.14340

Article  CAS  PubMed  Google Scholar 

Campbell KN, Griffin S, Trachtman H et al (2023) Practical considerations for the use of sparsentan in the treatment of patients with IgAN in clinical practice. Int J Nephrol Renovasc Dis 16:281–291. https://doi.org/10.2147/IJNRD.S430377

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kant S, Kronbichler A, Sharma P, Geetha D (2022) Advances in understanding of pathogenesis and treatment of immune-mediated kidney disease: a review. Am J Kidney Dis 79:582–600. https://doi.org/10.1053/j.ajkd.2021.07.019

Article  CAS  PubMed  Google Scholar 

Tang SCW, Wei C, Aldworth C et al (2024) Clinical and humanistic burden of IgAN in adult patients: a global real-world survey. Kidney360. https://doi.org/10.34067/KID.0000000613

Article  PubMed  PubMed Central  Google Scholar 

van De Ven NS, Pozniak AL, Levi JA et al (2020) Analysis of pharmacovigilance databases for dolutegravir safety in pregnancy. Clin Infect Dis 70:2599–2606. https://doi.org/10.1093/cid/ciz684

Article  CAS  PubMed  Google Scholar 

Huang Y, Xu M, Ma X et al (2024) Characterizing ADRs of Enfortumab vedotin and Erdafitinib in bladder cancer treatment: a descriptive analysis from WHO-VigiAccess. Front Pharmacol 15:1503154. https://doi.org/10.3389/fphar.2024.1503154

Article  CAS  PubMed  PubMed Central  Google Scholar 

Keshishi D, Makunts T, Abagyan R (2021) Common osteoporosis drug associated with increased rates of depression and anxiety. Sci Rep 11:23956. https://doi.org/10.1038/s41598-021-03214-x

Article  CAS  PubMed  PubMed Central  Google Scholar 

He M, Yang T, Zhou J et al (2024) A real-world study of antifibrotic drugs-related adverse events based on the United States food and drug administration adverse event reporting system and VigiAccess databases. Front Pharmacol 15:1310286. https://doi.org/10.3389/fphar.2024.1310286

Article  CAS  PubMed  PubMed Central  Google Scholar 

Rothman KJ, Lanes S, Sacks ST (2004) The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf 13:519–523. https://doi.org/10.1002/pds.1001

Article  PubMed  Google Scholar 

Chen S, Fang W, Zhao L, Xu H (2024) Safety assessment of cenobamate: real-world adverse event analysis from the FAERS database. Front Pharmacol 15:1369384. https://doi.org/10.3389/fphar.2024.1369384

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jiang Y, Zhou L, Shen Y et al (2024) Safety assessment of Brexpiprazole: real-world adverse event analysis from the FAERS database. J Affect Disord 346:223–229. https://doi.org/10.1016/j.jad.2023.11.025

Article  CAS  PubMed  Google Scholar 

Selvaskandan H, Barratt J, Cheung CK (2024) Novel treatment paradigms: primary IgA nephropathy. Kidney Int Rep 9:203–213. https://doi.org/10.1016/j.ekir.2023.11.026

Article  PubMed  Google Scholar 

Rheault MN, Alpers CE, Barratt J et al (2023) Sparsentan versus irbesartan in focal segmental glomerulosclerosis. N Engl J Med 389:2436–2445. https://doi.org/10.1056/NEJMoa2308550

Article  CAS  PubMed  Google Scholar 

Liu ID, Willis NS, Craig JC, Hodson EM (2019) Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev 2019:CD003594. https://doi.org/10.1002/14651858.CD003594.pub6

Article  PubMed  PubMed Central  Google Scholar 

Chavez E, Rodriguez J, Drexler Y, Fornoni A (2022) Novel therapies for Alport syndrome. Front Med (Lausanne) 9:848389. https://doi.org/10.3389/fmed.2022.848389

Article  PubMed  Google Scholar 

El Karoui K, Fervenza FC, De Vriese AS (2024) Treatment of IgA nephropathy: a rapidly evolving field. J Am Soc Nephrol 35:103–116. https://doi.org/10.1681/ASN.0000000000000242

Article  PubMed  Google Scholar 

Barr B, Barbour S (2024) New therapies for immunoglobulin A nephropathy: what’s the standard of care in 2023? Curr Opin Nephrol Hypertens 33:311–317. https://doi.org/10.1097/MNH.0000000000000979

Article  PubMed  Google Scholar 

Liang Q, Liao X, Huang Y et al (2024) Safety study on adverse events of zanubrutinib based on WHO-VigiAccess and FAERS databases. Expert Opin Drug Saf. https://doi.org/10.1080/14740338.2024.2416917

Article  PubMed  Google Scholar 

Huang Y, Gao H, Lin Y et al (2024) Real-world pharmacovigilance study of FDA adverse event reporting system events for finerenone. Expert Opin Drug Saf. https://doi.org/10.1080/14740338.2024.2412218

Article  PubMed  Google Scholar 

Chiu AW, Bredenkamp N (2024) Sparsentan: a first-in-class dual endothelin and angiotensin II receptor antagonist. Ann Pharmacother 58:645–656. https://doi.org/10.1177/10600280231198925

Article  PubMed  Google Scholar 

Groothof D, Gans ROB, Bakker SJL (2024) Sparsentan and kidney protection: improved medullary oxygenation? Lancet 404:1808. https://doi.org/10.1016/S0140-6736(24)01168-1

Article  PubMed  Google Scholar 

Chung EYM, Badve SV, Heerspink HJL, Wong MG (2023) Endothelin receptor antagonists in kidney protection for diabetic kidney disease and beyond? Nephrology (Carlton) 28:97–108. https://doi.org/10.1111/nep.14130

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