Tadalafil for the treatment of benign prostatic hyperplasia

References

• Toque HA, Teixeira CE, Priviero FBM, et al. Vardenafil, but not sildenafil or tadalafil, has calcium-channel blocking activity in rabbit isolated pulmonary artery and human washed platelets. Br J Pharmacol. 2008;154:787–796.
   PubMed Web of Science ®Google Scholar
• Toque HA, Teixeira CE, Lorenzetti R, et al. Pharmacological characterization of a novel phosphodiesterase type 5 (PDE5) inhibitor lodenafil carbonate on human and rabbit corpus cavernosum. Eur J Pharmacol. 2008;591:189–195.
   PubMed Web of Science ®Google Scholar
• Toque HA, Priviero FBM, Teixeira CE, et al. Comparative relaxing effects of sildenafil, vardenafil, and tadalafil in human corpus cavernosum: contribution of endogenous nitric oxide release. Urology. 2009;74:216–221.
   PubMed Web of Science ®Google Scholar
• Venneri MA, Giannetta E, Panio G, et al. Chronic inhibition of PDE5 limits pro-inflammatory monocyte-macrophage polarization in streptozotocin-induced diabetic mice. PLoS One. 2015;10.
   PubMed Web of Science ®Google Scholar
• Mokry J, Urbanova A, Medvedova I, et al. Effects of tadalafil (PDE5 inhibitor) and roflumilast (PDE4 inhibitor) on airway reactivity and markers of inflammation in ovalbumin-induced airway hyperresponsiveness in guinea pigs. J Physiol Pharmacol. 2017;68:721–730.
   PubMed Web of Science ®Google Scholar
• Islam BN, Sharman SK, Hou Y, et al. Sildenafil suppresses inflammation-driven colorectal cancer in mice. Cancer Prev Res. 2017;10:377–388.
   Web of Science ®Google Scholar
• El-Naa MM, Othman M, Younes S. Sildenafil potentiates the antitumor activity of cisplatin by induction of apoptosis and inhibition of proliferation and angiogenesis. Drug Des Devel Ther. 2016;10:3661.
   PubMedGoogle Scholar
• Webb DJ, Freestone S, Allen MJ, et al. Sildenafil citrate and blood-pressure–lowering drugs: results of drug interaction studies with an organic nitrate and a calcium antagonist. Am J Cardiol. 1999;83:21–28.
   PubMed Web of Science ®Google Scholar
• Webb DJ, Muirhead GJ, Wulff M, et al. Sildenafil citrate potentiates the hypotensive effects of nitric oxide donor drugs in male patients with stable angina. J Am Coll Cardiol. 2000;36:25–31.
   PubMed Web of Science ®Google Scholar
• Mendes GD, Mendes FD, Ilha JO, et al. A phase I clinical trial of lodenafil carbonate, a new phosphodiesterase type 5 (PDE5) inhibitor, in healthy male volunteers. Int J Clin Pharmacol Ther. 2012;50:896–906.
   PubMed Web of Science ®Google Scholar
• Salem EA, Kendirci M, Hellstrom WJ. Udenafil, a long-acting PDE5 inhibitor for erectile dysfunction. Curr Opin Investig Drugs. 2000;2006(7):661–669.
   Google Scholar
• Gu N, Kim J, Lim KS, et al. Assessment of the effect of mirodenafil on the hemodynamics of healthy male Korean volunteers administered tamsulosin: a randomized, double-blind, placebo-controlled, 2-period crossover study. Clin Ther. 2012;34:1929–1939.
   PubMed Web of Science ®Google Scholar
• Chung JH, Kang DH, Oh CY, et al. Safety and efficacy of once daily administration of 50 mg mirodenafil in patients with erectile dysfunction: a multicenter, double-blind, placebo controlled trial. J Urol. 2013;189:1006–1013.
   PubMed Web of Science ®Google Scholar
• Matsukawa Y, Takai S, Majima T, et al. Objective impacts of tadalafil on storage and voiding function in male patients with benign prostatic hyperplasia: 1-year outcomes from a prospective urodynamic study. World J Urol. 2018 Aug 18. doi: 10.1007/s00345-018-2453-x. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Huang YY, Li Z, Cai YH, et al. The molecular basis for the selectivity of tadalafil toward phosphodiesterase 5 and 6: a modeling study. J Chem Inf Model. 2013;53:3044–3053.
   PubMed Web of Science ®Google Scholar
• Daugan A, Grondin P, Ruault C, et al. The discovery of tadalafil: a novel and highly selective PDE5 inhibitor. 1: 5, 6, 11, 11a-tetrahydro-1 H-imidazo [1 ‘, 5 ‘: 1, 6] pyrido [3, 4-b] indole-1, 3 (2 H)-dione analogues. J Med Chem. 2003;46:4525–4532.
   PubMed Web of Science ®Google Scholar
• Sung B, Hwang K, Jeon Y, et al. Structure of the catalytic domain of human phosphodiesterase 5 with bound drug molecules. Nature. 2003;425:98–102.
   PubMed Web of Science ®Google Scholar
• de Oliveira IP, Lescano CH, De Nucci G. Q817G mutation in phosphodiesterase type 5 (PDE-5): conformational analysis and dissociation profile of the inhibitor tadalafil. Chem Biol Drug Des. 2018. DOI:10.1111/cbdd.13426
   Web of Science ®Google Scholar
• Zoraghi R, Francis SH, Corbin JD. Critical amino acids in phosphodiesterase-5 catalytic site that provide for high-affinity interaction with cyclic guanosine monophosphate and inhibitors. Biochemistry. 2007;46:13554–13563.
   PubMed Web of Science ®Google Scholar
• Corbin JD, Francis SH. Conformational conversion of PDE5 by incubation with sildenafil or metal ion is accompanied by stimulation of allosteric cGMP binding. Cell Signal. 2011;23:1578–1583.
   PubMed Web of Science ®Google Scholar
• Granovsky AE, Natochin M, McEntaffer RL, et al. Probing domain functions of chimeric PDE6α′/PDE5 cGMP-phosphodiesterase. J Biol Chem. 1998;273:24485–24490.
   PubMed Web of Science ®Google Scholar
• Wunder F, Tersteegen A, Rebmann A, et al. Characterization of the first potent and selective PDE9 inhibitor using a cGMP reporter cell line. Mol Pharmacol. 2005;68:1775–1781.
   PubMed Web of Science ®Google Scholar
• Zhang W, Zang N, Jiang Y, et al. Upregulation of phosphodiesterase type 5 in the hyperplastic prostate. Sci Rep. 2015;5:17888.
   PubMed Web of Science ®Google Scholar
• Fibbi B, Morelli A, Vignozzi L, et al. Characterization of phosphodiesterase type 5 expression and functional activity in the human male lower urinary tract. J Sex Med. 2010;7:59–69.
   PubMed Web of Science ®Google Scholar
• Müller D, Mukhopadhyay AK, Davidoff MS, et al. Cyclic GMP signaling in rat urinary bladder, prostate and epididymis: tissue-specific changes with aging and in response to leydig cell depletion. Reproduction. 2011;142:333–343.
   PubMed Web of Science ®Google Scholar
• Lin C-S, Lau A, Tu R, et al. Expression of three isoforms of cGMP-binding cGMP-specific phosphodiesterase (PDE5) in human penile cavernosum. Biochem Biophys Res Commun. 2000;268:628–635.
   PubMed Web of Science ®Google Scholar
• Mónica FZ, Rojas-Moscoso J, Porto M, et al. Immunohistochemical and functional characterization of nitric oxide signaling pathway in isolated aorta from Crotalus durissus terrificus. Comp Biochem Physiol Part C Toxicol Pharmacol. 2012;155:433–439.
   PubMed Web of Science ®Google Scholar
• Wilson LS, Elbatarny HS, Crawley SW, et al. Compartmentation and compartment-specific regulation of PDE5 by protein kinase G allows selective cGMP-mediated regulation of platelet functions. Proc Natl Acad Sci. 2008;105:13650–13655.
   PubMed Web of Science ®Google Scholar
• Houdart F, Girard-Nau N, Morin F, et al. The regulatory subunit of PDE6 interacts with PACSIN in photoreceptors. Mol Vis. 2005;11:1061–1070.
   PubMed Web of Science ®Google Scholar
• Cahill KB, Quade JH, Carleton KL, et al. Identification of amino acid residues responsible for the selectivity of tadalafil binding to two closely related phosphodiesterases, PDE5 and PDE6. J Biol Chem. 2012;287:41406–41416.
   PubMed Web of Science ®Google Scholar
• Porst H. IC351 (tadalafil, Cialis): update on clinical experience. Int J Impot Res. 2002;14:S57–S64.
   PubMed Web of Science ®Google Scholar
• Nivison-Smith L, Zhu Y, Whatham A, et al. Sildenafil alters retinal function in mouse carriers of Retinitis pigmentosa. Exp Eye Res. 2014;128:43–56.
   PubMed Web of Science ®Google Scholar
• Weeks JL, Zoraghi R, Beasley A, et al. High biochemical selectivity of tadalafil, sildenafil and vardenafil for human phosphodiesterase 5A1 (PDE5) over PDE11A4 suggests the absence of PDE11A4 cross-reaction in patients. Int J Impot Res. 2005;17:5–9.
   PubMed Web of Science ®Google Scholar
• Forgue ST, Patterson BE, Bedding AW, et al. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006;61:280–288.
   PubMed Web of Science ®Google Scholar
• Gupta M, Kovar A, Meibohm B. The clinical pharmacokinetics of phosphodiesterase-5 inhibitors for erectile dysfunction. J Clin Pharmacol. 2005;19:987–1003.
   PubMed Web of Science ®Google Scholar
• Kloner RA, Hutter AM, Emmick JT, et al. Time course of the interaction between tadalafil and nitrates. J Am Coll Cardiol. 2003;42:1855–1860.
   PubMed Web of Science ®Google Scholar
• Mónica FZ, Antunes E. Stimulators and activators of soluble guanylate cyclase for urogenital disorders. Nat Rev Urol. 2018;15:42–54.
   PubMed Web of Science ®Google Scholar
• Rahnama’i MS, Ückert S, Hohnen R, et al. The role of phosphodiesterases in bladder pathophysiology. Nat Rev Urol. 2013;414–424.
   PubMed Web of Science ®Google Scholar
• Bertollotto GM, de Oliveira MG, Alexandre EC, et al. Inhibition of multidrug resistance proteins by MK 571 enhances bladder, prostate, and urethra relaxation through cAMP or cGMP accumulation. J Pharmacol Exp Ther. 2018;367:138–146.
   PubMed Web of Science ®Google Scholar
• Rius M, Thon WF, Keppler D, et al. Prostanoid transport by multidrug resistance protein 4 (MRP4/ABCC4) localized in tissues of the human urogenital tract. J Urol. 2005;174:2409–2414.
   PubMed Web of Science ®Google Scholar
• Kedia GT, Ückert S, Jonas U, et al. The nitric oxide pathway in the human prostate: clinical implications in men with lower urinary tract symptoms. World J Urol. 2008;26:603–609.
   PubMed Web of Science ®Google Scholar
• Leiria LO, Silva FH, Davel APC, et al. The soluble guanylyl cyclase activator BAY 60-2770 ameliorates overactive bladder in obese mice. J Urol. 2014;191:539–547.
   PubMed Web of Science ®Google Scholar
• Calmasini FB, Silva FH, Alexandre EC, et al. Implication of Rho-kinase and soluble guanylyl cyclase enzymes in prostate smooth muscle dysfunction in middle-aged rats. Neurourol Urodyn. 2017;36:589–596.
   PubMed Web of Science ®Google Scholar
• Alexandre EC, Leiria LO, Silva FH, et al. Soluble guanylyl cyclase (sGC) degradation and impairment of nitric oxide-mediated responses in urethra from obese mice: reversal by the sGC activator BAY 60-2770. J Pharmacol Exp Ther. 2014;349:2–9.
   PubMed Web of Science ®Google Scholar
• Silva FH, Lanaro C, Leiria LO, et al. Oxidative stress associated with middle aging leads to sympathetic hyperactivity and downregulation of soluble guanylyl cyclase in corpus cavernosum. AJP Heart Circ Physiol. 2014;307:H1393–H1400.
   PubMed Web of Science ®Google Scholar
• Musicki B, Burnett AL. Constitutive NOS uncoupling and NADPH oxidase upregulation in the penis of type 2 diabetic men with erectile dysfunction. Andrology. 2017;5:294–298.
   PubMed Web of Science ®Google Scholar
• Tinel H, Stelte-Ludwig B, Hütter J, et al. Pre-clinical evidence for the use of phosphodiesterase-5 inhibitors for treating benign prostatic hyperplasia and lower urinary tract symptoms. BJU Int. 2006;98:1259–1263.
   PubMed Web of Science ®Google Scholar
• Filippi S, Morelli A, Sandner P, et al. Characterization and functional role of androgen-dependent PDE5 activity in the bladder. Endocrinology. 2007;148:1019–1029.
   PubMed Web of Science ®Google Scholar
• Ückert S, Küthe A, Jonas U, et al. Characterization and functional relevance of cyclic nucleotide phosphodiesterase isoenzymes of the human prostate. J Urol. 2001;166:2484–2490.
   PubMed Web of Science ®Google Scholar
• Morelli A, Sarchielli E, Comeglio P, et al. Phosphodiesterase type 5 expression in human and rat lower urinary tract tissues and the effect of tadalafil on prostate gland oxygenation in spontaneously hypertensive rats. J Sex Med. 2011;8:2746–2760.
   PubMed Web of Science ®Google Scholar
• Zarifpour M, Nomiya M, Sawada N, et al. Protective effect of tadalafil on the functional and structural changes of the rat ventral prostate caused by chronic pelvic ischemia. Prostate. 2015;75:233–241.
   PubMed Web of Science ®Google Scholar
• Fusco F, D’Emmanuele Di Villa Bianca R, Mitidieri E, et al. Sildenafil effect on the human bladder involves the L-cysteine/hydrogen sulfide pathway: a novel mechanism of action of phosphodiesterase type 5 inhibitors. Eur Urol. 2012;62:1174–1180.
   PubMed Web of Science ®Google Scholar
• Behr-Roussel D, Oger S, Caisey S, et al. Vardenafil decreases bladder afferent nerve activity in unanesthetized, decerebrate, spinal cord-injured rats. Eur Urol. 2011;59:272–279.
   PubMed Web of Science ®Google Scholar
• Adolfsson PI, Ahlstrand C, Varenhorst E, et al. Lysophosphatidic acid stimulates proliferation of cultured smooth muscle cells from human BPH tissue: sildenafil and papaverin generate inhibition. Prostate. 2002;51:50–58.
   PubMed Web of Science ®Google Scholar
• Zenzmaier C, Sampson N, Pernkopf D, et al. Attenuated proliferation and trans-differentiation of prostatic stromal cells indicate suitability of phosphodiesterase type 5 inhibitors for prevention and treatment of benign prostatic hyperplasia. Endocrinology. 2010;151:3975–3984.
   PubMed Web of Science ®Google Scholar
• Vignozzi L, Gacci M, Cellai I, et al. PDE5 inhibitors blunt inflammation in human BPH: a potential mechanism of action for PDE5 inhibitors in LUTS. Prostate. 2013;73:1391–1402.
   PubMed Web of Science ®Google Scholar
• Kurita M, Yamaguchi H, Okamoto K, et al. Chronic pelvic pain and prostate inflammation in rat experimental autoimmune prostatitis: effect of a single treatment with phosphodiesterase 5 inhibitors on chronic pelvic pain. Prostate. 2018;78:1157–1165.
   PubMed Web of Science ®Google Scholar
• Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the international continence society. Neurourol Urodyn. 2002;21:167–178.
   PubMed Web of Science ®Google Scholar
• Hammarsten J, Peeker R. Urological aspects of the metabolic syndrome. Nat Rev Urol. 2011;483–494.
   PubMed Web of Science ®Google Scholar
• Daneshgari F, Liu G, Hanna-Mitchell AT. Path of translational discovery of urological complications of obesity and diabetes. Am J Physiol - Ren Physiol. 2017;312:F887–F896.
   PubMed Web of Science ®Google Scholar
• Lu T, Lin W-J, Izumi K, et al. Targeting androgen receptor to suppress macrophage-induced EMT and benign prostatic hyperplasia (BPH) development. Mol Endocrinol. 2012;26:1707–1715.
   PubMed Web of Science ®Google Scholar
• Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. 2012;367:248–257.
   PubMed Web of Science ®Google Scholar
• McVary KT, Roehrborn CG, Kaminetsky JC, et al. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2007;177:1401–1407.
   PubMed Web of Science ®Google Scholar
• Bechara A, Romano S, Casabé A, et al. Comparative efficacy assessment of tamsulosin vs. tamsulosin plus tadalafil in the treatment of LUTS/BPH. Pilot study. J Sex Med. 2008;5:2170–2178.
   PubMed Web of Science ®Google Scholar
• Porst H, McVary KT, Montorsi F, et al. Effects of once-daily tadalafil on erectile function in men with erectile dysfunction and signs and symptoms of benign prostatic hyperplasia. Eur Urol. 2009;56:727–736.
   PubMed Web of Science ®Google Scholar
• Roehrborn CG, McVary KT, Elion-Mboussa A, et al. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008;180:1228–1234.
   PubMed Web of Science ®Google Scholar
• Egerdie RB, Auerbach S, Roehrborn CG, et al. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study. J Sex Med. 2012;9:271–281.
   PubMed Web of Science ®Google Scholar
• Mujoo K, Sharin VG, Martin E, et al. Role of soluble guanylyl cyclase-cyclic GMP signaling in tumor cell proliferation. Nitric Oxide - Biol Chem. 2010;22:43–50.
   PubMed Web of Science ®Google Scholar
• Sotolongo A, Mónica FZ, Kots A, et al. Epigenetic regulation of soluble guanylate cyclase (sGC) β1 in breast cancer cells. FASEB J. 2016;30:3171–3180.
   PubMed Web of Science ®Google Scholar
• Zhu H, Li J, Zheng F, et al. Restoring sGC expression and function blocks the aggressive course of glioma. Mol Pharmacol. 2011. DOI:10.1124/mol.111.073585.
   Web of Science ®Google Scholar
• Lin JE, Li P, Snook AE, et al. The hormone receptor GUCY2C suppresses intestinal tumor formation by inhibiting AKT signaling. Gastroenterology. 2010;138:241–254.
   PubMed Web of Science ®Google Scholar
• Rappaport JA, Waldman SA. The guanylate cyclase C—cGMP signaling axis opposes intestinal epithelial injury and neoplasia. Front Oncol. 2018;8:299.
   PubMed Web of Science ®Google Scholar
• Liu N, Mei L, Fan X, et al. Phosphodiesterase 5/protein kinase G signal governs stemness of prostate cancer stem cells through Hippo pathway. Cancer Lett. 2016;378:38–50.
   PubMed Web of Science ®Google Scholar