Effects of tadalafil on endothelial, angiogenic, metabolic, and microRNA biomarker profiles in sexually active men with BPH and erectile dysfunction: a randomized controlled trial
Abstract
Benign prostatic hyperplasia (BPH) is increasingly linked to endothelial dysfunction, angiogenic activation, chronic inflammation, and metabolic dysregulation. This randomized controlled trial evaluated the dose-dependent effects of tadalafil on circulating endothelial, angiogenic, metabolic, and microRNA biomarkers implicated in BPH. A total of 306 sexually active men with BPH/LUTS and erectile dysfunction were randomized equally to placebo, tadalafil 2.5 mg, or tadalafil 5 mg daily for 12 weeks. Baseline demographic, clinical, biochemical, and molecular characteristics were comparable across groups. Tadalafil produced significant, dose-dependent improvements across multiple mechanistic domains. Both doses reduced circulating ANGPTL2, E-selectin, MMP-7, and PECAM-1, while increasing eNOS levels (p < 0.0001). Lipid metabolism improved, with favorable shifts in the Atherogenic Index of Plasma (AIP), decreasing from 0.65 in the placebo group to 0.62 with 2.5 mg and 0.50 with 5 mg tadalafil (p < 0.0001). Tadalafil also modulated microRNA expression, increasing hsa-miRNA-486-3p and decreasing hsa-miRNA-181a-5p in a dose-dependent manner (p < 0.0001). Clinical outcomes paralleled biomarker changes. Both tadalafil doses improved IPSS scores, with the greatest symptom relief at 5 mg. Biomarker-symptom correlations were strong, including ANGPTL2 (r = 0.6806-0.766), PECAM-1 (r = 0.892-0.896), eNOS (r = -0.655 to -0.824), hsa-miRNA-486-3p (r = -0.707 to -0.880), and HDL (r = -0.833 to…
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: 306 participants or records.
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