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Table 3 Risk of specific AEs with free combination therapy compared with dutasteride or tamsulosin monotherapy

From: Free combination of dutasteride plus tamsulosin for the treatment of benign prostatic hyperplasia in South Korea: analysis of drug utilization and adverse events using the National Health Insurance Review and Assessment Service database

   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)
  1. 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