PMID- 36288823
OWN - NLM
STAT- MEDLINE
DCOM- 20231012
LR  - 20231012
IS  - 2056-5933 (Electronic)
IS  - 2056-5933 (Linking)
VI  - 8
IP  - 2
DP  - 2022 Oct
TI  - Safety and efficacy of the SGLT2 inhibitor dapagliflozin in patients with 
      systemic lupus erythematosus: a phase I/II trial.
LID - 10.1136/rmdopen-2022-002686 [doi]
LID - e002686
AB  - OBJECTIVE: Sodium-glucose cotransporter-2 inhibitors have been identified 
      profound renal/cardiac protective effects in different diseases. Here, we 
      assessed the safety and efficacy of dapagliflozin among adult patients with 
      systemic lupus erythematosus (SLE). METHODS: We conducted a single-arm, 
      open-label, investigator-initiated phase I/II trial of dapagliflozin in Chinese 
      patients with SLE with/without lupus nephritis (LN). Patients received oral 
      dapagliflozin at a daily dose of 10 mg added to the standard of care for 6 
      months. The primary end point was the safety profile. The secondary efficacy end 
      points were composite assessments of disease activity. RESULTS: A total of 38 
      eligible patients were enrolled. Overall, 19 (50%) adverse events (AEs) were 
      recorded, including 8 (21%) AEs leading to drug discontinuation, of which 4 
      (10.5%) were attributed to dapagliflozin. Two serious AEs (one of major lupus 
      flare and one of fungal pneumonia) were recorded. Lower urinary tract infection 
      was observed in one (2.63%) patient. The secondary end points revealed no 
      improvement of SLE Disease Activity Index scores or proteinuria (among 17 
      patients with LN); the cumulative lupus flare rate was 18%, and a reduction of 
      ~30% in the prednisone dose was captured. Net changes in body mass index (-0.50 
      kg/m(2)), systolic blood pressure (-3.94 mm Hg) and haemoglobin levels 
      (+8.26 g/L) were detected. The overall estimated glomerular filtration rate 
      (eGFR) was stable, and there was an improvement in the eGFR slope among patients 
      with LN with a baseline eGFR <90 mL/min/1.73 m(2). CONCLUSION: Dapagliflozin had 
      an acceptable safety profile in adult patients with SLE. Its possible 
      renal/cardiac protective effects and long-term safety issues in patients with 
      SLE, patients with LN in particular, call for further exploration. TRIAL 
      REGISTRATION NUMBER: ChiCTR1800015030.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published 
      by BMJ.
FAU - Wang, Huijing
AU  - Wang H
AUID- ORCID: 0000-0002-4647-6130
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Li, Ting
AU  - Li T
AUID- ORCID: 0000-0001-6800-6650
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Sun, Fangfang
AU  - Sun F
AUID- ORCID: 0000-0003-2570-4576
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Liu, Zhe
AU  - Liu Z
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Zhang, Danting
AU  - Zhang D
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Teng, Xiangyu
AU  - Teng X
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China.
FAU - Morel, Laurence
AU  - Morel L
AD  - Department of Microbiology, Immunology, and Molecular Genetics, University of 
      Texas Health San Antonio, San Antonio, Texas, USA.
FAU - Wang, Xiaodong
AU  - Wang X
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China ye_shuang2000@163.com wangxiaodong@renji.com.
FAU - Ye, Shuang
AU  - Ye S
AD  - Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong 
      University, Shanghai, China ye_shuang2000@163.com wangxiaodong@renji.com.
LA  - eng
SI  - ChiCTR/ChiCTR1800015030
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - RMD Open
JT  - RMD open
JID - 101662038
RN  - 0 (Hemoglobins)
RN  - VB0R961HZT (Prednisone)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Hemoglobins
MH  - *Lupus Erythematosus, Systemic/complications/drug therapy
MH  - *Lupus Nephritis/complications/drug therapy
MH  - Prednisone
MH  - *Sodium-Glucose Transporter 2 Inhibitors/adverse effects
MH  - Symptom Flare Up
MH  - Treatment Outcome
PMC - PMC9615980
OTO - NOTNLM
OT  - lupus erythematosus, systemic
OT  - lupus nephritis
OT  - outcome and process assessment, health care
COIS- Competing interests: None declared.
EDAT- 2022/10/27 06:00
MHDA- 2022/10/29 06:00
PMCR- 2022/10/26
CRDT- 2022/10/26 20:42
PHST- 2022/08/22 00:00 [received]
PHST- 2022/10/06 00:00 [accepted]
PHST- 2022/10/26 20:42 [entrez]
PHST- 2022/10/27 06:00 [pubmed]
PHST- 2022/10/29 06:00 [medline]
PHST- 2022/10/26 00:00 [pmc-release]
AID - rmdopen-2022-002686 [pii]
AID - 10.1136/rmdopen-2022-002686 [doi]
PST - ppublish
SO  - RMD Open. 2022 Oct;8(2):e002686. doi: 10.1136/rmdopen-2022-002686.