Table 2.
HRV parameters’ changes following empagliflozin exposure or placebo (baseline–24 weeks), assessed using Holter ECG
| Parameter | Empagliflozin (n = 46) | Placebo (n = 50) | Adjusted difference Between groups (95% CI) | P | |||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 24 weeks | P | Baseline | 24 weeks | P | ||||
| HRV | |||||||||
| Average NN, msec | 882.4 (130.1) | 889.0 (131.1) | 0.43 | 866.7 (128.6) | 884.7(99.2) | 0.15 | −11.6 | (− 57.1, 33.9) | 0.61 |
| SDNN, msec | 101.1 (37.4) | 112.8 (46.1) | < 0.01 | 102.5 (36.9) | 113.2 (33.6) | < 0.01 | 0.9 | (− 10.1, 12.0) | 0.87 |
| SDANN, msec | 81.0 (27.0) | 92.7 (28.9) | 0.02 | 82.2 (28.8) | 91.4 (24.2) | 0.06 | 2.5 | (− 9.5, 14.5) | 0.68 |
| r-MSSD, msec | 34.2 (54.8) | 40.7 (67.6) | 0.01 | 39.2 (54.4) | 41.5 (56.0) | 0.35 | 4.2 | (− 2.0, 10.4) | 0.19 |
| pNN50, % | 8.6 (18.4) | 8.7 (17.7) | 0.92 | 9.3 (18.9) | 10.2 (18.8) | 0.38 | −0.8 | (− 3.4, 1.8) | 0.55 |
| HF, msec2 | 1057.3 (4700.3) | 1623.2 (6923.6) | 0.04 | 1136.9 (4240.3) | 1200.1 (4280.8) | 0.76 | 499.4 | (− 195.4, 1194.2) | 0.16 |
| LF, msec2 | 748.6 (2321.6) | 1082.0 (3584.3) | 0.05 | 818.4 (2160.3) | 914.2 (2161.6) | 0.60 | 235.6 | (− 151.6, 622.7) | 0.23 |
| LF/HF ratio | 2.77 (2.21) | 2.37 (1.55) | 0.01 | 2.09 (1.31) | 2.09 (1.20) | 0.43 | −0.40 | (− 0.94, 0.13) | 0.14 |
Data are expressed as mean (SD) and analyzed using ANCOVA adjusting for allocation factors
CI, Confidence interval; HRV, heart rate variability; SDNN, Standard deviation of normal RR intervals; SDANN, Standard deviation of all 5 min mean normal RR intervals; r-MSSD, Square root of the mean of the sum of the squares of differences between adjacent RR intervals; pNN50, Percentage of adjacent RR intervals differing by > 50 ms; HF, high-frequency power; LF, low-frequency power