Table 1.
Baseline patients characteristics—Studies 1 and 2
| Statistics | Study 1 | Study 2 | ||
|---|---|---|---|---|
| DRSP 4 mg (n = 713) | DRSP 4 mg (n = 858) | Desogestrel 0.075 mg (n = 332) | ||
| Age (years) | Mean (SD) | 28.7 (7.1) | 28.9 (7.1) | 28.9 (7.1) |
| Age group | ||||
| ≤35 years | n (%) | 569 (79.8%) | 682 (79.5) | 259 (78.0) |
| >35 years | n (%) | 144 (20.2%) | 176 (20.5) | 73 (22.0) |
| Ethnicity | ||||
| Caucasian | n (%) | 710 (99.6%) | 856 (99.8) | 331 (99.7) |
| BMI (kg/m2) | Mean (SD) | 23.0 (3.8) | 22.96 (3.537) | 22.82 (3.905) |
| Min/Max | 16/38 | 16.6/41.0 | 15.9/38.0 | |
| BMI group | ||||
| <30 kg/m2 | n (%) | 672 (94.2%) | 828 (96.5) | 316 (95.2) |
| ≥30 kg/m2 | n (%) | 41 (5.8%) | 30 (3.5) | 16 (4.8) |
| BP group | ||||
| SBP <130 and DBP <85 mmHg | n (%) | 571 (80.1%) | 727 (84.7) | 290 (87.3) |
| SBP ≥130 and DBP ≥85 mmHg | n (%) | 142 (19.9%) | 131 (15.3) | 42 (12.7) |
| Subject status | ||||
| Switcher | n (%) | 391 (54.8%) | ||
| Direct switcher | n (%) | — | 628 (73.2) | 259 (78.0) |
| Indirect Switcher | n (%) | — | 39 (4.5) | 14 (4.2) |
| Starter | n (%) | 309 (43.3%) | 191 (22.3) | 59 (17.8) |
| Unknown | n (%) | 13 (1.8%) | — | — |
| VTE risk factor | ||||
| Presence of at least one risk factor | n (%) | 110 (15.4%) | 142 (16.5) | 59 (17.8) |
| Previous delivery | ||||
| Yes | n (%) | 305 (42.8%) | 395 (46.0) | 150 (45.2) |
| Regular menstrual bleeding during the last 6 cycles | ||||
| Yes | n (%) | 680 (95.4%) | 786 (91.6) | 305 (91.9) |
| Prior treatment with sex hormones and modulators of the genital system | ||||
| Yes | n (%) | 455 (63.8%) | 469 (54.7) | 195 (58.7) |
Abbreviations: BMI, body mass index: BP, blood pressure; DBP, diastolic blood pressure; DRSP, drospirenone; SBP, systolic blood pressure; VTE venous thromboembolic events.