Dapagliflozin as an oral antihyperglycemic agent in the management of diabetes mellitus in patients with liver cirrhosis

doi:10.5493/wjem.v14.i4.95272

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World Journal of Experimental Medicine

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World J Exp Med. Dec 20, 2024; 14(4): 95272
Published online Dec 20, 2024. doi: 10.5493/wjem.v14.i4.95272

Table 1 Comparison of demographic data among the study groups

Parameter	Dapagliflozin group, n = 200	Insulin group, n = 100	Test of sig.
Parameter	Dapagliflozin group, n = 200	Insulin group, n = 100	*t/χ²*	P value
Age in years
mean ± SD	56.84 ± 7.48	56.96 ± 9.29	0.121	0.904
Range	42–76	33–80	0.121	0.904
Sex
Male	96 (48)	44 (44)	0.258	0.611
Female	104 (52)	56 (56)	0.258	0.611
Smoking
Yes	59 (29.5)	38 (38)	2.202	0.137
No	141 (70.5)	62 (62)	2.202	0.137
Contact with canal water
Yes	119 (59.5)	59 (59)	0.007	0.933
No	81 (40.5)	41 (41)	0.007	0.933
Comorbidities¹
Cardiac ischemia	16 (8)	11 (11)	0.733	0.392
HTN	32 (16)	21 (21)	1.146	0.284
Dyslipidemia	16 (8)	11 (11)	0.733	0.392
None	160 (80)	73 (73)	1.883	0.170
Child classification
A	56 (28)	24 (24)	4.599	0.100
B	81 (40.5)	32 (32)
C	63 (31.5)	44 (44)
Causes of cirrhosis
Unknown	33 (16.5)	14 (14)	0.321	0.956
HBV	2 (1)	1 (1)
HCV	151 (75.5)	78 (78)
Bilharziasis	14 (7)	7 (7)
Treatment of HCV Infection
No	49 (24.5)	22 (22)	0.329	0.849
Interferon	5 (2.5)	2 (2)
DAAs	146 (73)	76 (76)
Diuretic dose change
No change	150 (75)	18 (18)	55.162	< 0.0001¹
Decreased dose	0 (0)	12 (12)
Stopped	0 (0)	8 (8)
Increased	50 (25)	41 (41)

¹Some patients have more than 1 comorbidity.

Data are n (%) unless otherwise indicated. DAAs: Direct-acting antivirals; HCV: Hepatitis C virus; HTN: Hypertension; SD: Standard deviation.

Table 2 Comparison of body mass index, blood pressure and laboratory investigations before and after dapagliflozin treatment

Parameter	Dapagliflozin before, n = 200		Dapagliflozin after, n = 200		Test of sig.
Parameter	Mean	SD	Mean	SD	t	P value
Body weight in kg	90.58	17.14	83.18	13.22	4.836	0.0001
BMI in kg/m²	31.74	5.24	29.20	4.41	5.251	0.0001
SBP in mmHg	110.18	12.01	109.48	11.62	0.592	0.554
DBP in mmHg	72.30	8.92	71.58	8.66	0.825	0.410
HbA1c as %	9.64	1.74	6.88	1.12	18.906	0.0001
Fasting blood sugar in mg/dL	225.83	92.09	142.98	55.16	10.916	0.0001
Triglycerides in mg/dL	180.46	82.07	167.40	66.19	1.752	0.081
Cholesterol in mg/dL	205.36	58.85	199.02	56.94	1.096	0.274
Creatinine in mg/dL	0.87	0.35	0.86	0.44	0.176	0.860
MELD	11.07	5.09	10.88	5.17	0.37	0.711
MELD-Na	14.40	6.82	14.31	7.06	0.13	0.897
eGFR value in mL/min/1.73 m²	125.93	59.37	116.12	49.50	1.788	0.075
Uric acid in mg/dL	5.07	1.05	4.89	0.85	1.908	0.057
AST in IU/L	49.06	68.16	44.36	61.00	0.727	0.467
ALT in IU/L	30.74	23.73	30.69	24.57	0.021	0.983
GGT in IU/L	78.64	126.52	77.84	185.29	0.05	0.960
Serum Na in mmol/L	133.48	4.77	133.05	5.64	0.832	0.406
Serum K in mg/dL	4.22	0.50	4.10	0.37	2.554	0.011

ALT: Alanine transaminase; AST: Aspartate aminotransferase; BMI: Body mass index; DBP: Diastolic blood pressure; eGFR: Estimated glomerular filtration rate; GGT: gamma-glutamyl transferase; HbA1c: Hemoglobin A1c; K: Potassium; MELD: Model for end-stage liver disease; MELD-Na: Model for end-stage liver disease-sodium; NA: Sodium; SBP: Systolic blood pressure.

Table 3 Comparison of clinical and laboratory investigations at baseline and 3 months later in control group

Parameter	Baseline, n = 100		3 months later, n = 100		Test of sig.
Parameter	Baseline, n = 100		3 months later, n = 100		t	P value
	Mean	SD	Mean	SD
Body weight in kg	95.86	19.13	84.60	14.21	4.725	0.0001
BMI in kg/m²	33.45	6.08	29.54	5.29	4.86	0.0001
SBP in mmHg	112.00	15.04	111.20	12.97	0.403	0.688
DBP in mmHg	70.80	10.22	70.80	9.18	0.0001	0.999
HbA1c as %	10.22	2.03	7.47	1.11	11.9	0.0001
Fasting blood sugar in mg/dL	299.26	77.57	174.74	63.29	12.438	0.0001
Triglycerides in mg/dL	240.04	78.18	221.62	51.48	1.968	0.050
Cholesterol in mg/dL	230.20	77.26	223.64	79.44	0.592	0.555
Creatinine in mg/dL	0.98	0.44	0.99	0.57	-0.144	0.886
MELD	12.46	5.11	12.32	5.60	0.185	0.854
MELD-Na	17.46	6.72	16.70	7.08	0.778	0.437
eGFR value in mL/min/1.73 m²	119.29	68.19	101.53	46.25	2.141	0.034
Uric acid in mg/dL	4.96	0.80	4.96	0.80	0.0001	0.999
AST in IU/L	74.56	90.09	67.58	81.21	0.575	0.566
ALT in IU/L	40.40	30.79	41.72	31.73	-0.299	0.766
GGT in IU/L	131.98	199.44	131.31	269.69	0.02	0.984
Serum Na in mmol/L	131.42	5.81	131.36	6.78	0.067	0.946
Serum K in mg/dL	4.33	0.62	4.19	0.45	1.857	0.065

Table 4 Comparison of clinical and laboratory investigations changes on follow-up in both groups

Parameter	Dapagliflozin, n = 200		Control group, n = 100		Test of sig.
Parameter	Dapagliflozin, n = 200		Control group, n = 100		t	P value
	Mean	SD	Mean	SD
Body weight in kg	11.26	12.12	7.40	21.56	-1.982	0.048
BMI in kg/m²	3.92	4.35	2.54	6.91	-2.103	0.036
SBP in mmHg	0.70	16.77	0.80	15.68	-0.051	0.959
DBP in mmHg	0.73	11.81	0.00	12.55	0.481	0.631
HbA1c as %	2.77	2.03	2.75	1.67	0.072	0.943
Fasting blood sugar in mg/dL	124.52	66.17	82.86	104.24	-4.206	0.000
Triglycerides in mg/dL	13.06	95.16	18.42	54.61	-0.619	0.537
Cholesterol in mg/dL	6.35	74.66	6.56	41.71	-0.032	0.975
Creatinine in mg/dL	0.01	0.55	-0.01	0.32	0.345	0.730
MELD	0.19	5.76	0.14	3.20	0.097	0.923
MELD-Na	0.09	8.48	0.76	3.09	-0.993	0.321
eGFR value in mL/min/1.73 m²	10.96	63.42	19.79	57.57	-1.21	0.228
Uric acid in mg/dL	0.18	1.02	0.00	1.14	1.349	0.179
AST in IU/L	4.71	89.72	6.98	37.89	-0.308	0.758
ALT in IU/L	0.05	32.30	-1.32	23.08	0.422	0.673
GGT in IU/L	0.79	218.46	0.67	167.59	0.005	0.996
Serum Na in mmol/L	0.44	7.50	0.06	4.03	0.563	0.574
Serum K in mg/dL	0.11	0.63	0.14	0.61	-0.379	0.705

Table 5 Comparison of complications rate in the studied groups

Parameter	Dapagliflozin, n = 200	Control group, n = 100	Test of sig.
Parameter	Dapagliflozin, n = 200	Control group, n = 100	χ²	P value
UTI	0 (0)	19 (19)	40.569	0.0001
Proteinuria	0 (0)	0 (0)
Frequent micturition	20 (10)	0 (0)	10.714	0.001
Vertigo	20 (10)	0 (0)	10.714	0.001
Hepatic encephalopathy	0 (0)	6 (6)	6.091	0.014
Variceal bleeding	0 (0)	13 (13)	13.437	0.002
HCC	0 (0)	0 (0)
Pyelonephritis	0 (0)	0 (0)
Hypoglycemia	0 (0)	5 (5)	10.169	0.0001
Genital infection	8 (4)	4 (4)	0.098	0.755
Syncope	0 (0)	0 (0)
Hypotension	12 (6)	5 (5)	0.125	0.724
Dehydration	12 (6)	5 (5)	0.125	0.724
Abdominal discomfort	0 (0)	0 (0)
Back pain	0 (0)	0 (0)
Dizziness	0 (0)	0 (0)
Rash	0 (0)	0 (0)
Phlebitis	0 (0)	0 (0)

Data are n (%). HCC: Hepatocellular carcinoma; UTI: Urinary tract infection.

Citation: Seif El-Din Z, Afify M, Zayed E, Elsabaawy D, Tharwa ES, Elsharawy A, Abdelsameea E, Rady MA. Dapagliflozin as an oral antihyperglycemic agent in the management of diabetes mellitus in patients with liver cirrhosis. World J Exp Med 2024; 14(4): 95272
URL: https://www.wjgnet.com/2220-315x/full/v14/i4/95272.htm
DOI: https://dx.doi.org/10.5493/wjem.v14.i4.95272