OBJECTIVE: To assess the efficacy and safety of tadalafil, a phosphodiesterase 5 (PDE5) inhibitor efficacious for erectile dysfunction and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH), in population subgroups, using pooled data from 4 international, randomized, placebo-controlled studies in men with LUTS/BPH.
METHODS: The safety database included 1500 men randomized to tadalafil 5 mg once daily or placebo for 12 weeks. Changes in total International Prostate Symptom Score (IPSS), IPSS-quality of life index, and BPH impact index were examined overall, and changes in IPSS or adverse events (AEs) were examined across subgroups of interest. Treatment-group differences were assessed using analysis of covariance.
RESULTS: Results of pooled data confirmed that tadalafil (N = 752) resulted in significant improvements from baseline vs placebo (N = 746) in IPSS (mean difference -2.3; P < .001), and also in BPH impact index and IPSS-quality of life index (both P < .001). Subgroup analyses demonstrated that IPSS improvements were significant regardless of baseline LUTS severity (IPSS < 20/≥20), age (≤ 65/>65 years), recent previous use of α-blockers or PDE5 inhibitors, total testosterone level (< 300/≥300 ng/dL), or prostate-specific antigen predicted prostate volume (≤ 40/>40 mL). Rates of treatment emergent AEs were comparable between subgroups of baseline age (≤ 65/>65 years), previous PDE5 inhibitor use, and the presence or absence of pre-existing diabetes, hypertension, or cardiovascular disease (including hypertension), but somewhat higher for recent previous α-blocker use.
CONCLUSION: In these pooled data analyses, tadalafil 5 mg improved LUTS/BPH across subgroups of age, LUTS severity, testosterone levels, and prostate volume. Rates of AEs were similar across the subgroups assessed.
Written by:
Porst H, Oelke M, Goldfischer ER, Cox D, Watts S, Dey D, Viktrup L. Are you the author?
Department of Urology, Hannover Medical School, Hannover, Germany.
Reference: Urology. 2013 Sep;82(3):667-73.
doi: 10.1016/j.urology.2013.05.005
PubMed Abstract
PMID: 23876588
