Efficacy of Dapagliflozin in Southern Europe Across the Spectrum of Characteristics of Type 2 Diabetes: An International Real-World Analysis

Figures & data

Table 1 Demographic and Clinical Characteristics of Study Participants at Baseline (N = 1438)

Characteristic	N	Overall
Follow-up time, months	1438	5.6 (1.51)
Duration, years	1410	12.4 (8.34)
Duration ≥ 10 years		813 (56.54%)
Gender, male	1438	860 (59.81%)
Age, years	1438	60.6 (9.66)
Age ≥ 65 years		524 (36.44%)
Weight, kg	1377	92.4 (18.26)
Height, cm	1389	166.5 (9.59)
BMI, kg/m^2	1348	33.3 (5.87)
BMI ≥ 30 kg/m^2		933 (64.88%)
Waist, cm	427	110.2 (14.02)
SBP, mm Hg	1119	138.9 (17.9)
DBP, mm Hg	1116	80.5 (10.64)
FPG, mg/dl	1269	173.4 (57.86)
HbA1c, mmol/mol	1364	71.2 (52.91)
HbA1c, %		8.7 (4.84)
TC, mg/dl	1095	176.2 (41.18)
TC, mmol/l		4.6 (1.07)
HDL, mg/dl	1022	45.0 (13.72)
HDL, mmol/l		1.2 (0.35)
TG, mg/dl	1090	176.8 (134.69)
TG, mmol/l		2 (1.52)
LDL, mg/dl	968	96.8 (33.69)
LDL, mmol/l		2.5 (0.87)
sGOT, U/l	828	26 (15.88)
sGPT, U/l	915	32.4 (20.4)
Creatinine, mg/dl	1082	0.8 (0.28)
eGFR, mL/min/1.73 m^2	1041	85.7 (20.66)
eGFR ≥90 mL/min/m^2		502 (34.91%)
Metf, N (%)	1403	1311 (93.44%)
Insulin, N (%)	1077	667 (61.93%)
SU or repaglinide, N (%)	994	158 (15.9%)
GLP-1RA, N (%)	932	97 (10.41%)
Pioglitazone, N (%)	861	25 (2.9%)
Acarbose, N (%)	840	1 (0.12%)
ACEi / ARBs, N (%)	1042	808 (77.54%)
Beta-blockers, N (%)	800	295 (36.88%)
CCB, N (%)	749	192 (25.63%)
Statin, N (%)	912	640 (70.18%)
Fibrates/omega-3 fatty acids, N (%)	786	175 (22.26%)
APA, N (%)	840	431 (51.31%)
Retino, N (%)	1177	218 (18.52%)
Stroke, N (%)	1402	44 (3.14%)
AMI, N (%)	1251	145 (11.59%)
HF, N (%)	1253	37 (2.95%)
PAD, N (%)	954	74 (7.76%)
CVD, N (%)	426	140 (32.86%)

Note: Results are expressed as mean with standard deviation or as number of subjects with percentage.

Table 2 Glycemic and Laboratory Data in the Entire Population at Baseline and Follow-Up

	N	Baseline	Follow-Up	Beta (95% CI)	p-value
HbA1c, mmol/mol	1341	71.5 (53.3)	58.9 (13.2)	−12.5 (−15.38: −9.66)	<0.0001
HbA1c, %		8.7 (4.9)	7.5 (1.2)	−1.2 (−1.41: −0.88)	<0.0001
FPG, mg/dl	1186	173.8 (58.3)	139.6 (42.6)	−34.2 (−37.51: −30.85)	<0.0001
Weight, kg	1346	92.4 (18.3)	89.6 (17.8)	−2.9 (−3.11: −2.63)	<0.0001
SBP, mmHg	1047	138.7 (17.8)	134.9 (16.3)	−3.8 (−4.79: −2.76)	<0.0001
DBP, mmHg	1044	80.5 (10.6)	78.6 (9.4)	−1.9 (−2.53: −1.28)	<0.0001
TC, mg/dl	942	176.7 (42.0)	170.0 (38.2)	−6.7 (−8.92: −4.42)	<0.0001
HDL, mg/dl	849	45.0 (14.1)	46.4 (12.9)	1.4 (0.82: 1.94)	<0.0001
TG, mg/dl	930	180.8 (142.6)	159.2 (105.7)	−21.6 (−30.12: −13.03)	<0.0001
LDLc, mg/dl	777	97.02 (33.8)	93.0 (31.4)	−4.0 (−5.99: −1.98)	0.0014
eGFR, mL/min/m^2	918	84.77 (21.1)	86.3 (17.9)	1.6 (0.47: 2.65)	0.0423

Notes: Baseline: mean with standard deviation at baseline; follow-up: mean with standard deviation at follow-up; Beta; beta coefficient of the mixed-effect model controlling for country effect; p-value: likelihood ratio, p-value adjusted with the Holm method.

Figure 1 Heatmap representing p-values calculated through a mixed effect model. In particular, each mixed effect model was constructed by regressing one dependent variable (HbA_1c, FPG, weight, SBK, DBP, TC, HDL, TG, UAER, eGFR, and LDLc) on one independent variable (age, gender, BMI, HbA_1c, eGFR, duration, insulin, CVD, and HF), controlling for the country effect. Bar color: p-values ranging from <0.0001 (light gray) to 0.9999 (dark gray) and NA values are reported as white boxes.

Figure 2 Forest plots showing changes in HbA_1c (A) and body weight (B) in subgroups of patients by baseline characteristics.