Comparison of efficacy for erectile function and lower urinary tract symptoms of tadalafil 20 mg on-demand and 5 mg once daily in patients with erectile dysfunction
Abstract
Aim: To compare the improvement in erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) as well as safety of tadalafil dosed at 20 mg on-demand and 5 mg once daily among ED patients. Materials and methods: A total of 194 ED patients visited between March 2010 and June 2011 were recruited. Out of 194 individuals, 168 (86.6%) met inclusion criteria after completing the two-week screening period (V0). The Patients were randomly allocated into two groups: (i) 20 mg of tadalafil as needed (Group 1: n = 84, 50.0%) and (ii) 5 mg of tadalafil once daily (Group 2: n = 84, 50.0%). Blood pressure (BP), heart rate (HR) and the five-item version of the International Index of Erectile Function (IIEF-5) were assessed immediately before initiation of treatment (V1) and after four (V2) and twelve weeks of treatment (V3). In men with an IPSS of ≥ 8 at V1, IPSS, maximal flow rate (Qmax) and post-void residual volume (PVR) were also assessed. Results: Of the 168 patients, 134 (79.8%; Group 1: n = 68, 81.0%; Group 2: n = 66, 78.6%) patients completed the trial. IIEF-5 improved in both groups, and the mean change was larger in Group 2 at V3 (4.9 ± 4.2 vs. 6.5 ± 4.5; p = 0.032) Similarly, though IPSS (with ≥ 8, n = 88, 65.7%; Group 1: n = 44, 64.7%; Group 2: n = 44, 66.7%) improved in both groups, the mean change was larger in Group 2 at V3 (-2.8 ± 4.3 vs. -4.8 ± 4.1; p = 0.026). Qmax and PVR did not differ significantly in either group. Conclusions: Once daily tadalafil was more…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 194 participants or records.
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