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<p>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&#xa0;mg, or tadalafil 5&#xa0;mg daily for 12&#xa0;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 (<i>p</i> &lt; 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&#xa0;mg and 0.50 with 5&#xa0;mg tadalafil (<i>p</i> &lt; 0.0001). Tadalafil also modulated microRNA expression, increasing hsa-miRNA-486-3p and decreasing hsa-miRNA-181a-5p in a dose-dependent manner (<i>p</i> &lt; 0.0001). Clinical outcomes paralleled biomarker changes. Both tadalafil doses improved IPSS scores, with the greatest symptom relief at 5&#xa0;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 –0.855). Tadalafil was well tolerated, with no treatment-related discontinuations. Tadalafil was associated with dose-dependent changes in endothelial, angiogenic, metabolic, and microRNA biomarkers. Because the study enrolled sexually active men with BPH/LUTS and erectile dysfunction, findings may not be generalizable to all men with BPH.</p>

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Effects of tadalafil on endothelial, angiogenic, metabolic, and microRNA biomarker profiles in sexually active men with BPH and erectile dysfunction: a randomized controlled trial

  • 期刊论文

  • 发表日期：

    2026年8月1日

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  • Ahmed Abomandour,
  • Ehab A. M. El-Shoura,
  • Basem A. Fathi,
  • Hosny Ahmed Elewa,
  • Ahmed M. Abd-Eldayem,
  • Zeinab Alkasaby Zalat

摘要

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 –0.855). Tadalafil was well tolerated, with no treatment-related discontinuations. Tadalafil was associated with dose-dependent changes in endothelial, angiogenic, metabolic, and microRNA biomarkers. Because the study enrolled sexually active men with BPH/LUTS and erectile dysfunction, findings may not be generalizable to all men with BPH.