Table 1.
Patient demographics and CV‐related baseline characteristics (SAF)
| Combination n=725 | Solifenacin 5 mg n=728 | Solifenacin 10 mg n=719 | |
|---|---|---|---|
| Sex, n (%) | |||
| Female | 603 (83.2) | 604 (83.0) | 600 (83.4) |
| Male | 122 (16.8) | 124 (17.0) | 119 (16.6) |
| Race, n (%) | |||
| White | 688 (94.9) | 679 (93.3) | 680 (94.6) |
| Black/African American | 20 (2.8) | 24 (3.3) | 27 (3.8) |
| Asian | 13 (1.8) | 21 (2.9) | 10 (1.4) |
| Other | 4 (0.6) | 4 (0.5) | 2 (0.3) |
| Mean (SD) age, year | 58.2 (13.1) | 56.9 (13.5) | 57.3 (13.3) |
| ≥65 year, n (%) | 231 (31.9) | 226 (31.0) | 224 (31.2) |
| ≥75 year, n (%) | 73 (10.1) | 66 (9.1) | 55 (7.6) |
| BMI (kg/m2) | |||
| Mean (SD) | 28.9 (5.9) | 29.1 (6.2) | 28.9 (6.0) |
| Previous OAB medication (prior to screening), n (%) | 485 (66.9) | 503 (69.1) | 491 (68.3) |
| CV history (system organ class, preferred term) affecting ≥1% of patients in any treatment group, n (%) | |||
| Vascular disorders | 308 (42.5) | 294 (40.4) | 283 (39.4) |
| Hypertension | 270 (37.2) | 262 (36.0) | 262 (36.4) |
| Varicose vein | 35 (4.8) | 21 (2.9) | 19 (2.6) |
| Essential hypertension | 2 (0.3) | 10 (1.4) | 3 (0.4) |
| Venous insufficiency | 4 (0.6) | 7 (1.0) | 4 (0.6) |
| Cardiac disorders | 62 (8.6) | 59 (8.1) | 61 (8.5) |
| Myocardial ischaemia | 14 (1.9) | 12 (1.6) | 14 (1.9) |
| Coronary artery disease | 14 (1.9) | 15 (2.1) | 6 (0.8) |
| Myocardial infarction | 7 (1.0) | 5 (0.7) | 9 (1.3) |
| Arrhythmia | 7 (1.0) | 2 (0.3) | 5 (0.7) |
| Metabolism and nutrition disorders | 191 (26.3) | 211 (29.0) | 199 (27.7) |
| Hypercholesterolaemia | 67 (9.2) | 95 (13.0) | 74 (10.3) |
| Diabetes mellitus | 45 (6.2) | 66 (9.1) | 51 (7.1) |
| Obesity | 43 (5.9) | 37 (5.1) | 37 (5.1) |
| Type 2 diabetes mellitus | 23 (3.2) | 43 (5.9) | 30 (4.2) |
| Hyperlipidaemia | 23 (3.2) | 26 (3.6) | 35 (4.9) |
| Dyslipidaemia | 12 (1.7) | 9 (1.2) | 13 (1.8) |
| Vitamin D deficiency | 8 (1.1) | 6 (0.8) | 10 (1.4) |
| Gout | 8 (1.1) | 5 (0.7) | 5 (0.7) |
| Hyperuricaemia | 2 (0.3) | 7 (1.0) | 5 (0.7) |
| CV‐related concomitant medication use during double blind treatment period, n (%) | |||
| Antihypertensivesa | 22 (3.0) | 17 (2.3) | 9 (1.3) |
| β‐blocking agents | 90 (12.4) | 95 (13.0) | 101 (14.0) |
| Calcium channel blockers | 53 (7.3) | 49 (6.7) | 48 (6.7) |
| Agents acting on renin‐angiotensin system | 205 (28.3) | 196 (26.9) | 194 (27.0) |
| Lipid‐modifying agents | 119 (16.4) | 152 (20.9) | 130 (18.1) |
| Antithrombotic agents | 97 (13.4) | 95 (13.0) | 81 (11.3) |
| Drugs used in diabetes | 62 (8.6) | 95 (13.0) | 75 (10.4) |
| Cardiac therapy | 57 (7.9) | 74 (10.2) | 51 (7.1) |
| Vital signs, mean (SD) | n=724 | n=728 | n=719 |
| SBP mm Hg | 126.73 (13.83) | 125.63 (14.24) | 125.88 (14.64) |
| DBP mm Hg | 76.43 (8.31) | 76.15 (8.63) | 75.70 (8.41) |
| Pulse rate bpm | 71.35 (9.62) | 71.33 (9.47) | 71.17 (9.20) [n=718] |
| ECG parameters (Central reader) n (%) | n=721 | n=727 | n=719 |
| QTcF >450 mseconds | 31 (4.3) | 24 (3.3) | 17 (2.4) |
| QTcF >480 mseconds | 1 (0.1) | 1 (0.1) | 0 |
| QTcF >500 mseconds | 0 | 0 | 0 |
BMI, body mass index; CV, cardiovascular; DBP, diastolic blood pressure; ECG, electrocardiogram; OAB, overactive bladder; QTcF, QT interval corrected using Fridericia's formula; SBP, systolic blood pressure; SE, standard error.
a
Alpha adrenoceptor antagonists, imidazoline receptor agonists, tadalafil, magnesium sulphate, pyrimidine derivatives, hydrazinophthalazine derivatives, methyldopa, rauwolfia alkaloids.