Table 1. Baseline demographics.
| Variables | DUT-TAM FDC (n = 86,057) | AB/5ARI free combination (n = 55,610) | p-value |
|---|---|---|---|
| Prescriber specialty at index date, % | |||
| Urologist | 79.8 | 83.0 | < 0.001 |
| GP | 15.4 | 14.7 | < 0.001 |
| Others | 4.8 | 2.3 | < 0.001 |
| Age (mean, SD) | 76.4 (9.3) | 76.6 (9.3) | 0.017 |
| Age group, % | |||
| ≤ 60 | 6.0 | 5.7 | 0.037 |
| 61 – 70 | 18.8 | 18.9 | 0.789 |
| 71 – 80 | 40.3 | 39.9 | 0.175 |
| > 80 | 34.9 | 35.4 | 0.028 |
| Index year, % | |||
| 2011 | 9.6 | 7.8 | < 0.001 |
| 2012 | 20.1 | 17.6 | < 0.001 |
| 2013 | 18.4 | 16.4 | < 0.001 |
| 2014 | 18.9 | 16.6 | < 0.001 |
| 2015 | 17.4 | 19.1 | < 0.001 |
| 2016 | 15.6 | 22.5 | < 0.001 |
| Prior treatment in BPH, % | |||
| AB | 66.5 | 66.1 | 0.131 |
| 5ARI | 18.7 | 11.9 | < 0.001 |
| Therapy naïve | 28.2 | 25.9 | < 0.001 |
| Duration of prior AB treatment, % | |||
| Naïve | 33.5 | 33.9 | 0.131 |
| Up to 12 months | 25.9 | 26.9 | < 0.001 |
| 12 – 24 months | 10.9 | 10.7 | 0.177 |
| > 24 months | 29.7 | 28.6 | < 0.001 |
| Max. ATC classes besides index therapy on a single day within 12 months prior to index date, % | |||
| 0 | 1.8 | 2.2 | < 0.001 |
| 1 – 3 | 51.7 | 51.6 | 0.673 |
| 4 – 5 | 28.8 | 28.2 | 0.021 |
| 6 – 8 | 14.4 | 14.3 | 0.790 |
| > 8 | 3.3 | 3.7 | < 0.001 |
5ARI = 5-α reductase inhibitor; AB = α-blocker; ATC = anatomical therapeutic chemical; BPH = benign prostatic hyperplasia; DUT-TAM = dutasteride-tamsulosin; FDC = fixed-dose combination; GP = general practitioner; SD = standard deviation.