PMID- 37741921 OWN - NLM STAT- MEDLINE DCOM- 20240311 LR - 20240413 IS - 1573-2584 (Electronic) IS - 0301-1623 (Print) IS - 0301-1623 (Linking) VI - 56 IP - 4 DP - 2024 Apr TI - Repurposing fexofenadine as a promising candidate for diabetic kidney disease: randomized clinical trial. PG - 1395-1402 LID - 10.1007/s11255-023-03804-w [doi] AB - PURPOSE: Diabetic kidney disease (DKD) is a devastating complication of diabetes mellitus. Inflammation and histamine are potentially involved in the disease progression. This study aimed to evaluate the role of fexofenadine in patients with DKD. METHODS: From January 2020 to February 2022, out of 123 patients screened for eligibility, 61 patients completed the study. Patients were randomized into two groups, the fexofenadine group (n = 30): received ramipril plus fexofenadine, and the control group (n = 31): received ramipril only for six months. Changes in urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR) were considered primary outcomes. Measurements of urinary cyclophilin A, monocyte chemoattractant protein-1 (MCP-1), 8-hydroxy-2' deoxyguanosine (8-OHdG), and podocalyxin (PCX) were considered secondary outcomes. The study was prospectively registered on clinicaltrial.gov on January 13, 2020, with identification code NCT04224428. RESULTS: At the end of the study, fexofenadine reduced UACR by 16% (95% CI, - 23.4% to - 9.3%) versus a noticeable rise of 11% (95% CI, 4.1% to 17.8%) in UACR in the control group, (p < 0.001). No significant difference in eGFR was revealed between the two groups. However, the control group showed a significant decrease of - 3.5% (95% CI, - 6.6% to - 0.3%) in eGFR, compared to its baseline value. This reduction was not reported in the fexofenadine group. Fexofenadine use was associated with a significant decline in MCP-1, 8-OHdG, and PCX compared to baseline values. CONCLUSION: Fexofenadine is a possible promising adjuvant therapy in patients with DKD. Further large-scale trials are needed to confirm our preliminary results. CI - (c) 2023. The Author(s). FAU - El-Fatatry, Basma Mahrous AU - El-Fatatry BM AUID- ORCID: 0000-0002-7266-168X AD - Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Al-Guiesh Street, Tanta, 31527, Egypt. Basma.mahrous.clinical@gmail.com. FAU - El-Haggar, Sahar Mohamed AU - El-Haggar SM AD - Department of Clinical Pharmacy, Faculty of Pharmacy, Professor of Clinical Pharmacy, Tanta University, Al-Geish Street, Tanta, Egypt. FAU - Ibrahim, Osama Mohamed AU - Ibrahim OM AD - Department of Clinical Pharmacy, Faculty of Pharmacy, Professor of Clinical Pharmacy, Tanta University, Al-Geish Street, Tanta, Egypt. FAU - Shalaby, Khaled Hamed AU - Shalaby KH AD - Department of Internal Medicine, Faculty of Medicine, Lecturer of Internal Medicine, Tanta University, Al-Geish Street, Tanta, Egypt. LA - eng SI - ClinicalTrials.gov/NCT04224428 PT - Journal Article PT - Randomized Controlled Trial DEP - 20230923 PL - Netherlands TA - Int Urol Nephrol JT - International urology and nephrology JID - 0262521 RN - E6582LOH6V (fexofenadine) RN - L35JN3I7SJ (Ramipril) RN - 7BA5G9Y06Q (Terfenadine) SB - IM MH - Humans MH - *Diabetic Nephropathies/etiology/complications MH - Ramipril/therapeutic use MH - *Diabetes Mellitus, Type 2/complications MH - Kidney Function Tests MH - Glomerular Filtration Rate MH - Albuminuria/complications MH - Terfenadine/*analogs & derivatives PMC - PMC10923951 OTO - NOTNLM OT - Albuminuria OT - Antihistamines OT - Diabetic kidney disease OT - Fexofenadine COIS- The authors declare that they have no conflict of interest. EDAT- 2023/09/24 00:42 MHDA- 2024/03/11 06:44 PMCR- 2023/09/23 CRDT- 2023/09/23 23:24 PHST- 2023/05/08 00:00 [received] PHST- 2023/09/13 00:00 [accepted] PHST- 2024/03/11 06:44 [medline] PHST- 2023/09/24 00:42 [pubmed] PHST- 2023/09/23 23:24 [entrez] PHST- 2023/09/23 00:00 [pmc-release] AID - 10.1007/s11255-023-03804-w [pii] AID - 3804 [pii] AID - 10.1007/s11255-023-03804-w [doi] PST - ppublish SO - Int Urol Nephrol. 2024 Apr;56(4):1395-1402. doi: 10.1007/s11255-023-03804-w. Epub 2023 Sep 23.