Table 5.
ECG data of 151 women before and after 9 cycles of 4 mg drospirenone
| Parameter | Visit | Drospirenone | Desogestrel | LS Mean Difference 90% CI |
|
|---|---|---|---|---|---|
| Summary (mean) | Visit 1b | n | 151 | 56 | |
| Heart rate (bpm) | Mean (SD) | 72.9 (9.4) | 72.6 (10.1) | 0.31 [−2.17; 2.80] | |
| Median | 73.0 | 71.5 | |||
| Min/ Max | 51/106 | 49/102 | |||
| Visit 5/EDV | n | 138 | 58 | ||
| Mean (SD) | 70.7 (10.7) | 72.7 (12.3) | −1.97 [−4.86; 0.92] | ||
| Median | 71.0 | 70.5 | |||
| Min/ Max | 50/102 | 49/104 | |||
| Change from V1b | n | 132 | 54 | ||
| Mean (SD) | −2.5 (10.3) | 0.3 (11.7) | −2.81 [−5.67; 0.05] | ||
| Median | −3.0 | 0.0 | |||
| Min/ Max | −34/18 | −28/32 | |||
| Summary (mean) | Visit 1b | n | 151 | 56 | |
| RR Duration | Mean (SD) | 830.8 (109.1) | 836.5 (117.2) | −5.66 [−34.43; 23.11] | |
| (ms) | Median | 821.0 | 832.5 | ||
| Min/ Max | 564/1162 | 586/1223 | |||
| Visit 5/EDV | n | 138 | 58 | ||
| Mean (SD) | 861.7 (133.4) | 842.0 (139.3) | 19.68 [−15.27; 54.64 | ||
| Median | 835.0 | 843.0 | |||
| Min/ Max | 586/1200 | 572/1218 | |||
| Change from V1b | n | 132 | 54 | ||
| Mean (SD) | 35.5 (121.8) | 2.3 (125.9) | 33.19 [0.33; 66.04] | ||
| Median | 29.5 | 0.5 | |||
| Min/ Max | −198/391 | − 306/260 | |||
| Summary (mean) | Visit 1b | n | 151 | 56 | |
| PR duration (ms) | Mean (SD) | 150.0 (26.0) | 150.2 (18.7) | −0.22 [−6.50; 6.06] | |
| Median | 147.0 | 150.0 | |||
| Min/ Max | 91/305 | 115/207 | |||
| Visit 5/EDV | n | 138 | 58 | ||
| Mean (SD) | 151.1 (21.4) | 150.8 (17.8) | 0.35 [−4.93; 5.63] | ||
| Median | 149.5 | 152.5 | |||
| Min/ Max | 105/242 | 111/198 | |||
| Change from V1b | n | 132 | 54 | ||
| Mean (SD) | −0.6 (17.6) | − 0.2 (11.6) | |||
| Median | 0.0 | 0.0 | −0.41 [−4.72; 3.90] | ||
| Min/ Max | −117/73 | −41/35 | |||
| Summary (mean) | Visit 1b | n | 151 | 56 | |
| QRS duration | Mean (SD) | 90.9 (8.1) | 89.6 (8.3) | 1.31 [−0.79; 3.42] | |
| (ms) | Median | 90.0 | 89.0 | ||
| Min/ Max | 74/118 | 70/107 | |||
| Visit 5/EDV | n | 138 | 58 | ||
| Mean (SD) | 92.0 (8.4) | 88.4 (8.6) | 3.58 [1.40; 5.77] | ||
| Median | 92.0 | 87.5 | |||
| Min/ Max | 71/115 | 68/106 | |||
| Change from V1b | n | 132 | 54 | ||
| Mean (SD) | 1.5 (5.4) | −1.1 (5.0) | 2.55 [1.13; 3.97] | ||
| Median | 1.0 | 0.0 | |||
| Min/ Max | −13/20 | − 12/8 | |||
| Summary (mean) | Visit 1b | n | 151 | 56 | |
| QT duration (ms) | Mean (SD) | 383.3 (22.1) | 385.3 (19.9) | −1.96 [−7.52; 3.60] | |
| Median | 382.0 | 384.5 | |||
| Min/ Max | 332/437 | 335/438 | |||
| Visit 5/EDV | n | 138 | 58 | ||
| Mean (SD) | 390.8 (23.0) | 384.3 (27.1) | 6.50 [0.22; 12.78] | ||
| Median | 389.0 | 387.0 | |||
| Min/ Max | 330/454 | 317/442 | |||
| Change from V1b | n | 132 | 54 | ||
| Mean (SD) | 8.0 (22.0) | −0.9 (20.5) | 8.90 [3.13; 14.68] | ||
| Median | 6.0 | 3.5 | |||
| Min/ Max | −43/70 | −49/51 | |||
| Summary (mean) | Visit 1b | n | 151 | 56 | |
| QTcB - Bazett’s | Mean (SD) | 421.5 (17.3) | 422.8 (20.5) | −1.33 [−6.05; 3.38] | |
| Correction Formula | Median | 420.0 | 420.5 | ||
| (ms) | Min/ Max | 377/473 | 382/466 | ||
| Visit 5/EDV | n | 138 | 58 | ||
| Mean (SD) | 422.7 (19.2) | 420.6 (17.5) | 2.14 [−2.70; 6.98] | ||
| Median | 423.0 | 418.5 | |||
| Min/ Max | 373/483 | 392/463 | |||
| Change from V1b | n | 132 | 54 | ||
| Mean (SD) | 0.7 (15.8) | −1.5 (20.7) | 2.19 [−2.44; 6.82] | ||
| Median | −1.0 | −5.0 | |||
| Min/ Max | −44/40 | −41/61 | |||
| Summary (mean) | Visit 1b | n | 151 | 56 | |
| QTcF - Fridericia’s | Mean (SD) | 408.0 (14.7) | 409.5 (15.1) | −1.56 [−5.40; 2.27] | |
| Correction Formula | Median | 407.0 | 410.0 | ||
| (ms) | Min/ Max | 374/461 | 370/436 | ||
| Visit 5/EDV | n | 138 | 58 | ||
| Mean (SD) | 411.4 (14.5) | 407.7 (14.8) | 3.69 [−0.09; 7.47] | ||
| Median | 410.5 | 407.0 | |||
| Min/ Max | 371/458 | 381/450 | |||
| Change from V1b | n | 132 | 54 | ||
| Mean (SD) | 3.2 (12.3) | −1.3 (14.5) | 4.55 [1.09; 8.02] | ||
| Median | 4.0 | −2.0 | |||
| Min/ Max | −28/48 | −30/43 |