Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction
Correspondence: Gerald Brock, St Joseph's Health Care London, University of Western Ontario, London, Canada.
- 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.