PMID- 30684076
OWN - NLM
STAT- MEDLINE
DCOM- 20200722
LR  - 20221207
IS  - 1573-2568 (Electronic)
IS  - 0163-2116 (Linking)
VI  - 65
IP  - 2
DP  - 2020 Feb
TI  - Empagliflozin for the Treatment of Nonalcoholic Steatohepatitis in Patients with 
      Type 2 Diabetes Mellitus.
PG  - 623-631
LID - 10.1007/s10620-019-5477-1 [doi]
AB  - BACKGROUND AND AIMS: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a 
      novel class of drugs that lower glucose by inducing renal glycosuria. We aimed to 
      explore whether SGLT2 inhibitor added to the usual care for patients with type 2 
      diabetes mellitus (T2DM) and biopsy-proven nonalcoholic steatohepatitis (NASH) 
      will benefit NASH histology. METHODS: In this investigator-initiated, single-arm, 
      open-label, pilot study, nine biopsy-proven NASH patients with T2DM were given 
      empagliflozin 25 mg daily for 24 weeks. Liver biopsy was repeated at the end of 
      treatment. The histological outcomes were compared with the placebo group of a 
      previous 48-week clinical trial. RESULTS: There was a significant reduction in 
      body mass index (median change, Delta = -0.7 kg per m(2), p = 0.011), waist 
      circumference (Delta = -3 cm, p = 0.033), systolic blood pressure (Delta = -9 mmHg, 
      p = 0.024), diastolic blood pressure (Delta = -6 mmHg, p = 0.033), fasting blood 
      glucose (Delta = -1.7 mmol/L, p = 0.008), total cholesterol (Delta = -0.5 mmol/L, 
      p = 0.011), gamma glutamyl transpeptidase (Delta = -19 U/L, p = 0.013), volumetric 
      liver fat fraction (Delta = -7.8%, p = 0.017), steatosis (Delta = -1, p = 0.014), 
      ballooning (Delta = -1, p = 0.034), and fibrosis (Delta = 0, p = 0.046). All histological 
      components either remained unchanged or improved, except in one patient who had 
      worsening ballooning. Empagliflozin resulted in significantly greater 
      improvements in steatosis (67% vs. 26%, p = 0.025), ballooning (78% vs. 34%, 
      p = 0.024), and fibrosis (44% vs. 6%, p = 0.008) compared with historical 
      placebo. CONCLUSION: This pilot study provides primary histological evidence that 
      empagliflozin may be useful for the treatment of NASH. This preliminary finding 
      should prompt larger clinical trials to assess the effectiveness of empagliflozin 
      and other SGLT2 inhibitors for the treatment of NASH in T2DM patients. Trial 
      registry number ClincialTrials.gov number, NCT02964715.
FAU - Lai, Lee-Lee
AU  - Lai LL
AD  - Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of 
      Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.
FAU - Vethakkan, Shireene Ratna
AU  - Vethakkan SR
AD  - Endocrine Unit, Department of Medicine, Faculty of Medicine, University of 
      Malaya, 50603, Kuala Lumpur, Malaysia. shireene.vethakkan@gmail.com.
FAU - Nik Mustapha, Nik Raihan
AU  - Nik Mustapha NR
AD  - Department of Pathology, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.
FAU - Mahadeva, Sanjiv
AU  - Mahadeva S
AD  - Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of 
      Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.
FAU - Chan, Wah-Kheong
AU  - Chan WK
AD  - Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of 
      Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia. 
      wahkheong2003@hotmail.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02964715
GR  - BK006-2016/University of Malaya Special Research Fund/International
GR  - BKS067-2017/University of Malaya Special Research Fund/International
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20190125
PL  - United States
TA  - Dig Dis Sci
JT  - Digestive diseases and sciences
JID - 7902782
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 97C5T2UQ7J (Cholesterol)
RN  - EC 2.3.2.2 (gamma-Glutamyltransferase)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
CIN - Dig Dis Sci. 2020 Feb;65(2):342-344. PMID: 30847693
MH  - Benzhydryl Compounds/*therapeutic use
MH  - Biopsy
MH  - Blood Glucose/metabolism
MH  - Blood Pressure
MH  - Body Mass Index
MH  - Cholesterol/metabolism
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy/metabolism
MH  - Female
MH  - Glucosides/*therapeutic use
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/therapeutic use
MH  - Liver/pathology
MH  - Male
MH  - Middle Aged
MH  - Non-alcoholic Fatty Liver Disease/complications/*drug 
      therapy/metabolism/pathology
MH  - Pilot Projects
MH  - Sodium-Glucose Transporter 2 Inhibitors/*therapeutic use
MH  - Treatment Outcome
MH  - Waist Circumference
MH  - gamma-Glutamyltransferase/metabolism
OTO - NOTNLM
OT  - Jardiance
OT  - NAFLD
OT  - NASH
OT  - SGLT2
OT  - Sodium-glucose cotransporter-2
EDAT- 2019/01/27 06:00
MHDA- 2020/07/23 06:00
CRDT- 2019/01/27 06:00
PHST- 2018/11/01 00:00 [received]
PHST- 2019/01/17 00:00 [accepted]
PHST- 2019/01/27 06:00 [pubmed]
PHST- 2020/07/23 06:00 [medline]
PHST- 2019/01/27 06:00 [entrez]
AID - 10.1007/s10620-019-5477-1 [pii]
AID - 10.1007/s10620-019-5477-1 [doi]
PST - ppublish
SO  - Dig Dis Sci. 2020 Feb;65(2):623-631. doi: 10.1007/s10620-019-5477-1. Epub 2019 
      Jan 25.