Table 3.
Risk of specific AEs with free combination therapy compared with dutasteride or tamsulosin monotherapy
| Free combination therapy versus dutasteride monotherapy | Free combination therapy versus tamsulosin monotherapy | ||||
|---|---|---|---|---|---|
| Free combination of dutasteride plus tamsulosin therapy (n = 1529) | Dutasteride monotherapy (n = 6600) | Adjusted RR (95% CI)* | Tamsulosin monotherapy (n = 6566) | Adjusted RR (95% CI)* | |
| Specific AE, n (%) | |||||
| Constipation | 401 (26.2) | 1271 (19.1) | 1.31 (1.17, 1.45) | 1595 (24.3) | 1.05 (0.94, 1.16) |
| Depressed mood | 219 (14.3) | 794 (11.9) | 1.05 (0.90, 1.22) | 1025 (15.6) | 0.91 (0.78, 1.05) |
| Urticaria | 216 (14.1) | 828 (12.4) | 1.02 (0.87, 1.18) | 1024 (15.6) | 0.89 (0.76,1.03) |
| Dizziness | 202 (13.2) | 833 (12.5) | 1.01 (0.87, 1.19) | 889 (13.5) | 0.98 (0.84, 1.14) |
| Arrhythmia | 188 (12.3) | 608 (9.1) | 1.33 (1.13, 1.57) | 638 (9.7) | 1.24 (1.05, 1.46) |
| Vertigo | 176 (11.5) | 643 (9.7) | 1.20 (1.01, 1.42) | 735 (11.2) | 1.05 (0.89, 1.24) |
| Diarrhea | 166 (10.9) | 702 (10.5) | 0.99 (0.83, 1.17) | 765 (11.7) | 0.94 (0.80, 1.12) |
| Pruritus | 146 (9.5) | 624 (9.4) | 0.98 (0.81, 1.18) | 757 (11.5) | 0.83 (0.69, 1.00) |
| Cardiac failure | 137 (9.0) | 400 (6.0) | 1.37 (1.12, 1.68) | 442 (6.7) | 1.23 (1.01, 1.49) |
| Vomiting | 117 (7.7) | 374 (5.6) | 1.29 (1.03, 1.62) | 513 (7.8) | 0.99 (0.80, 1.22) |
| Rhinitis | 103 (6.7) | 422 (6.3) | 1.11 (0.89, 1.39) | 454 (6.9) | 0.97 (0.78, 1.22) |
| Dyspnea | 74 (4.8) | 266 (4.0) | 1.10 (0.84, 1.44) | 288 (4.4) | 1.00 (0.77, 1.30) |
| Asthenia | 51 (3.3) | 196 (2.9) | 1.06 (0.77, 1.47) | 204 (3.1) | 1.06 (0.75, 1.50) |
| Localized edema | 30 (2.0) | 130 (2.0) | 0.84 (0.55, 1.29) | 149 (2.3) | 0.80 (0.52, 1.21) |
| Impotence | 21 (1.4) | 88 (1.3) | 1.15 (0.69, 1.93) | 108 (1.6) | 1.09 (0.66, 1.79) |
| Epistaxis | 19 (1.2) | 84 (1.3) | 1.10 (0.65, 1.87) | 87 (1.3) | 1.08 (0.60, 1.95) |
| Syncope orthostatic | 13 (0.9) | 62 (0.9) | 0.83 (0.45, 1.53) | 70 (1.1) | 0.74 (0.41, 1.34) |
| Hypotension | 11 (0.7) | 35 (0.5) | 1.34 (0.67, 2.70) | 34 (0.5) | 1.24 (0.62, 2.46) |
| Rash | 9 (0.6) | 22 (0.3) | 1.45 (0.65, 3.26) | 23 (0.4) | 1.33 (0.57, 3.09) |
| Alopecia | 5 (0.3) | 34 (0.5) | 0.87 (0.33, 2.28) | 28 (0.4) | 1.09 (0.41, 2.91) |
| Breast disorder | 5 (0.3) | 25 (0.4) | 1.12 (0.39, 3.19) | 18 (0.3) | 1.53 (0.47, 4.99) |
| Dry mouth | 5 (0.3) | 17 (0.3) | 0.98 (0.34, 2.83) | 23 (0.4) | 0.83 (0.30, 2.31) |
| Visual impairment | 2 (0.1) | 16 (0.2) | 0.44 (0.10, 1.97) | 17 (0.3) | 0.41 (0.10, 1.79) |
| Other specified disorders of male genital organ | 1 (0.1) | 8 (0.1) | 0.92 (0.12, 7.37) | 10 (0.2) | 0.54 (0.07, 4.25) |
| Vision blurred | 0 (0.0) | 5 (0.1) | – | 7 (0.1) | – |
| Angioedema | 0 (0.0) | 4 (0.1) | – | 2 (0.0) | – |
| Erythema multiforme | 0 (0.0) | 2 (0.0) | – | 4 (0.1) | – |
| Premature ejaculation | 0 (0.0) | 2 (0.0) | – | 1 (0.0) | – |
| Breast cancer | 0 (0.0) | 1 (0.0) | – | 1 (0.0) | – |
| Hypertrichosis | 0 (0.0) | 1 (0.0) | – | 0 (0.0) | – |
| Loss of libido | 0 (0.0) | 1 (0.0) | – | 0 (0.0) | – |
| Dermatitis exfoliative | 0 (0.0) | 0 (0.0) | – | 3 (0.0) | – |
| Priapism | 0 (0.0) | 0 (0.0) | – | 1 (0.0) | – |
AE, adverse event; CI, confidence interval; RR, risk ratio.*RRs of any or specific AEs among patients receiving free combination therapy compared to each monotherapy were estimated using log-binomial regression models adjusted for inverse probability of treatment weights. A robust variance estimator was used to derive the 95% CIs