Table 3.

Baseline Versus 24-Week Comparisons and Intergroup Analysis of 24-Hour Holter-ECG findings, Time-Domain Heart Rate Variability, and Heart Rate Turbulence Parameters Between Dapagliflozin and Control Groups

	Dapagliflozin Group (n = 42)			Control Group (n = 38)			Adjusted Difference Between Groups
Baseline	24 Weeks	P	Baseline	24 Weeks	P	Mean (95% CI)	P
24-hour Holter-ECG findings
PVBs per hour, n	15.9 ± 20.7	11.3 ± 17.6	<.001	15.1 ± 21.1	14.4 ± 20.1	.519	−3.89 (−7.61, −0.16)	.041
PVBs percent	0.329 ± 0.424	0.233 ± 0.351	<.001	0.315 ± 0.426	0.304 ± 0.423	.280	−0.084 (−0.158, −0.011)	.025
Mean heart rate, beats/minute	81.6 ± 6.0	82.4 ± 6.2	.414	81.0 ± 5.4	81.6 ± 5.9	.417	0.083 (−2.244, 2.409)	.944
Mean RR interval, ms	746.1 ± 64.4	748.9 ± 65.2	.785	749.7 ± 65.7	751.0 ± 66.8	.933	1.45 (−34.24, 37.14)	.936
Heart rate variability parameters
SDNN, ms	102.1 ± 25.1	113.1 ± 29.5	<.001	100.3 ± 24.1	102.6 ± 23.4	.067	8.79 (2.76, 14.82)	.005
SDANN, ms	85.1 ± 22.4	92.3 ± 27.4	.006	82.9 ± 23.7	84.1 ± 23.3	.380	6.11 (0.41, 11.81)	.036
SDNN index, ms	31.2 ± 15.4	35.9 ± 17.4	.003	31.0 ± 13.2	31.5 ± 12.6	.141	4.16 (1.01, 7.32)	.010
RMSSD, ms	41.6 ± 28.3	49.9 ± 28.4	.001	39.2 ± 27.6	40.6 ± 26.2	.099	6.95 (1.19, 12.70)	.019
pNN50, %	4.02 ± 3.33	5.8 ± 4.59	<.001	4.13 ± 2.96	4.34 ± 2.67	.174	1.58 (0.57, 2.58)	.003
Heart rate turbulence parameters
Turbulence onset	−0.0454 ± 0.0995	−0.0673 ± 0.1044	<.001	−0.0486 ± 0.0876	−0.0458 ± 0.0903	.104	−0.025 (−0.039, −0.010)	.001
Turbulence slope, ms/RR	3.64 ± 4.77	5.22 ± 5.56	<.001	3.97 ± 4.61	4.21 ± 5.14	.129	1.348 (0.705, 1.991)	<.001
HRTc 0, n (%)	12 (28.6)	22 (52.4)	.001	14 (36.8)	16 (42.1)	.223	N/A	<.001
HRTc 1, n (%)	19 (45.2)	13 (31)		15 (39.5)	14 (36.8)
HRTc 2, n (%)	11 (26.2)	7 (16.6)	9 (23.7)	8 (21.1)
Clinical and laboratory findings
HbA1c, %	7.81 ± 1.37	7.41 ± 1.17	<.001	7.94 ± 1.31	7.5 ± 1.08	<0.001	−0.037 (−0.197, 0.122)	.645
Body weight, kg	83.3 ± 13.8	81.0 ± 12.3	<.001	81.7 ± 12.1	82.3 ± 11.9	0.195	−2.92 (−4.18, −1.65)	<.001
Body mass index, kg/m2	29.6 ± 4.7	28.9 ± 4.3	<.001	29.4 ± 5.0	29.6 ± 5.2	0.212	−1.03 (−1.50, −0.56)	<.001
Systolic BP, mm Hg	128.5 ± 19.9	122.7 ± 18.2	<.001	129.3 ± 22.0	127.9 ± 18.5	0.394	−5.7 (−7.8, −0.7)	.020
Diastolic BP, mm Hg	77.9 ± 11.8	75.0 ± 11.4	<.001	79.3 ± 14.6	78.8 ± 10.7	0.805	−2.9 (−4.7, −1.0)	.086
Resting heart rate, beats/minute	75.2 ± 11.4	76.1 ± 10.2	.569	73.7 ± 10.6	72.9 ± 9.5	0.760	1.6 (−3.8, 7.1)	.349

Data presented as mean ± standard deviation. Statistically significant P-values are given in bold.

BP, blood pressure; HRTc, heart rate turbulence category; n, numbers; N/A, not available; pNN50, percentage of successive normal to normal (NN) intervals that differ by more than 50 milliseconds; PVBs, premature ventricular beats; RMSSD, root mean square of successive RR interval difference; SDANN, standard deviation (SD) of the average NN intervals for each 5-minute segment of the 24-hour recording; SDNN, SD of NN intervals; SDNN index, mean of the 5-minute SD of the NN interval calculated over 24 hours; ECG, electrocardiogram.