Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction
Article first published online: 13 AUG 2013
© 2013 The Authors. BJU International © 2013 BJU International
Volume 112, Issue 7, pages 990–997, November 2013
How to Cite
Brock, G., Broderick, G., Roehrborn, C. G., Xu, L., Wong, D. and Viktrup, L. (2013), Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction. BJU International, 112: 990–997. doi: 10.1111/bju.12251
- Issue published online: 11 OCT 2013
- Article first published online: 13 AUG 2013
- Accepted manuscript online: 23 MAY 2013 06:48AM EST
- lower urinary tract symptoms;
- prostatic hyperplasia;
- erectile dysfunction;
- phosphodiesterase type 5 inhibitors;
- To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH-LUTS) in men without erectile dysfunction (ED).
- To compare these with effects in men with ED.
Patients and Methods
- After a 4-week washout period and 4-week placebo run-in period, 1089 men without ED (n = 338) and with ED (n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs.
- In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH-LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality-of-life (IPSS-QoL) subscores.
- Safety was assessed using treatment-emergent adverse events.
- The treatment-by-ED-status interaction was used to assess efficacy differences between the with/without ED subgroups.
- Men without ED were similar in BPH-LUTS severity/previous therapy to men with ED.
- Tadalafil significantly reduced BPH-LUTS from baseline when compared with placebo in men without ED (IPSS −5.4 vs −3.3, P < 0.01; IPSS voiding subscore −3.5 vs −2.0, P < 0.01; IPSS storage subscore −1.9 vs −1.3, P < 0.05).
- Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED (IPSS-QoL −1.0 vs −0.7, BII −1.4 vs −1.0; both P < 0.05).
- Between-ED-subgroup interactions were not significant (all P > 0.68).
- Tadalafil was safe and well tolerated.
- Tadalafil 5 mg once daily improved BPH-LUTS in men without ED by a magnitude similar to that observed in men with ED.
- The adverse event profile in men without ED was consistent with that observed in men with ED.