The available evidence does not strongly support the use of tadalafil doses >5 mg for treating BPH, due to the lack of data directly comparing between doses. While one urodynamic study suggested higher doses (e.g., 20 mg) were not associated with adverse effects, most meta-analyses found significant benefits only with the 5 mg dose, particularly for Qmax. Primarily literature observed a trend towards greater effects with higher doses, but robust efficacy and safety comparisons to confirm a be...
A 2015 systematic review and meta-analysis evaluated the clinical efficacy of phosphodiesterase type 5 inhibitors (PDE5-Is), including tadalafil, in the management of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), both with and without concurrent erectile dysfunction (ED). The analysis incorporated data from 16 randomized, double-blind, placebo-controlled trials to assess the various primary outcomes. Tadalafil 2.5 mg, 5 mg, 10 mg, and 20 mg were only assessed together for the outcome of maximum urinary flow rate (Qmax) in LUTS/BPH, which was found to not be statistically significant (effect estimate 0.22; mean difference -0.04 to 0.49; p= 0.10). There did not appear to be any further assessments for tadalafil doses > 5 mg. In contrast, the 5 mg dose of tadalafil alone significantly improved the Qmax (mean difference 0.33; p= 0.03). [1]
Additionally, a 2013 meta-analysis synthesized data from eight randomized, double-blind, placebo-controll...
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A search of the published medical literature revealed
3 studies investigating the researchable question:
What evidence is there for use of doses over 5 mg of tadalafil for treatment of BPH?
Level of evidence
C - Multiple studies with limitations or conflicting results
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[1] Zhang LT, Park JK. Are phosphodiesterase type 5 inhibitors effective for the management of lower urinary symptoms suggestive of benign prostatic hyperplasia?. World J Nephrol. 2015;4(1):138-147. doi:10.5527/wjn.v4.i1.138
[2] Dong Y, Hao L, Shi Z, Wang G, Zhang Z, Han C. Efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a meta-analysis. Urol Int. 2013;91(1):10-18. doi:10.1159/000351405