Efficacy and Safety of Empagliflozin in Patients with Type 2 Diabetes Mellitus Fasting During Ramadan: A Real-World Study from Bangladesh

Figures & data

Figure 1 Patient disposition.

Table 1 Demographic and Baseline Characteristics

Characteristic of Patients		Group 1 [Empagliflozin Group] (n = 274)	Group 2 [Non-Empagliflozin Group] (n= 219)	P value
Age (Yrs) [Mean ± SD]		49.0±11.8	49.7±10.5	0.492
Male/Female (n)		134/140	95/124	0.224
Weight (kg) [Mean ± SD]		70.7±11.3	66.4±9.5	0.001
BMI (kg/m^2) [Mean ± SD]		27.3±4.2	26.1±3.62	0.009
BP (mm Hg) [Mean ± SD]	Systolic	132.7±12.9	128.4±15.9	0.001
	Diastolic	81.4±7.1	79.7±6.9	0.027
HbA1c (%) [Mean ±SD]		8.4±1.45	8.1±1.46	0.019
Duration of DM (Yrs) [Mean ±SD]		7.8±5.9	6.3±4.8	0.003

Notes: ANOVA and Chi-square analysis were done; p-values <0.05 was considered as statistically significant.

Abbreviations: BP, blood pressure; BMI, body mass index; DM, diabetes mellitus; SD, standard deviation.

Table 2 Mean Change in Efficacy Parameters in Studied Population

Efficacy Parameters		Group 1 [Empagliflozin Group] (n=274)		Change	Group 2 [Non-Empagliflozin Group] (n=219)		Change	p value
		Before Mean ± SD	After Mean ± SD		Before Mean ±SD	After Mean ±SD
HbA1c (%)		8.4±1.45	7.91±1.2	0.49	8.1±1.46	8.0±1.54	0.1	<0.001
Weight (Kg)		70.7±11.3	69.3±10.9	−1.4	66.4±9.5	66.31± 9.15	−0.09	<0.001
BMI (kg/m^2)		27.3±4.2	26.8±4.1	0.5	26.1±3.62	25.9 ± 3.95	0.2	0.197
BP (mmHg)	Systolic	132.7±12.9	122.6±16.1	10/3	128.4±15.9	125.6 ± 9.2	3/0	<0.001
	Diastolic	81.4±7.1	78.6±8.4		79.7±6.9	79.5 ±6.1		<0.001

Notes: Paired Samples t-test was done to analyze the changes in clinical and biochemical parameters before and after Ramadan. ANOVA was used to calculate the significance change among groups; p-values <0.05 was considered as statistically significant.

Abbreviations: BP, blood pressure; BMI, body mass index; SD, standard deviation.

Table 3 Participants Having Good Glycemic Control (HbA1c <7%)

Participants	Group 1 [Empagliflozin Group] (n=274)			Group 2 [Non-Empagliflozin Group] (n=219)
	Before Ramadan	After Ramadan	P value	Before Ramadan	After Ramadan	P value
Number of patients having good Glycemic Control	29	71	0.031	56	60	0.729
Percentage of patients having good Glycemic Control	10.58%	25.91%		25.33%	27.39%

Notes: Chi-square test was done; p-values <0.05 was considered as statistically significant.

Table 4 Changes in Safety Parameters in Studied Population

Safety Parameter	Group 1 [Empagliflozin Group] (n=274)		Change	Group 2 [Non-Empagliflozin Group] (n=219)		Change	P value
	Pre-Ramadan	During Ramadan		Pre-Ramadan	During Ramadan
Hypoglycemia;N(%)	1(0.3)	2(0.7)	1	0	1(0.4)	1	0.267
UTI;N(%)	0	6 (2.1%)	6	0	4(1.8%)	4	0.818
Volume depletion; N(%)	0	7 (2.6%)	7	0	4(1.8%)	4	0.551

Notes: Chi-square test was used to calculate the significance change among groups; p-values <0.05 was considered as statistically significant.

Table 5 Changes in Laboratory Parameters

Bio-Chemical Parameters	Group 1 [Empagliflozin Group] (n-274)		Change	Group 2 [Non-Empagliflozin Group] (n=219)		Change	P value
	Pre-Ramadan	Post-Ramadan		Pre-Ramadan	Post-Ramadan
Na (mmol/L)	139.5±3.07	138.9±8.4	−0.6	139.6±3.54	140.1±2.75	0.5	0.678
K (mmol/L)	4.0±0.52	4.1±2.44	0.1	4.2±2.8	4.0±0.45	0.2	0.891
Cl (mmol/L)	105.6±56.4	100.9±4.9	5.7	101.5±3.27	101.3±6.26	0.12	0.082
HCO3 (mmol/L)	26.2±10.2	26.3±10.1	−0.1	24.7±2.00	24.4±1.63	0.3	0.134
Creatinine (mg/dl/)	1.0±0.27	1.1±0.9	0.1	1.0±0.26	1.0±0.23	0	0.342
eGFR (mL/min)	79.3±21.2	79.5±19.1	0.2	84.4±22.9	82.7±20.4	1.7	0.550

Notes: Paired Samples t-test was done to analyze the changes in clinical and biochemical parameters before and after Ramadan. ANOVA was used to calculate the significance change among groups; p-values <0.05 was considered as statistically significant.

Abbreviations: Na, sodium; K, potassium; Cl, chloride; HCO₃, bicarbonate.