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Objectives:

* 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.

Results:

* 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.

Conclusion:

* 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.

(C) 2013 John Wiley & Sons, Ltd