Tadalafil: A Phosphodiesterase-5 Inhibitor for Benign Prostatic Hyperplasia

• Published in: Pharmacotherapy 2013-06, Vol.33 (6), p.639-649
• Main Authors: Cantrell, Matthew A., Baye, Jordan, Vouri, Scott Martin
• Format: Article
• Language: English
• Subjects: benign prostatic hyperplasia; Biological and medical sciences; Carbolines - adverse effects; Carbolines - pharmacology; Carbolines - therapeutic use; Drug Approval; Drug therapy; Erectile Dysfunction - drug therapy; Gynecology. Andrology. Obstetrics; Half-Life; Humans; Kinases; lower urinary tract symptoms; Lower Urinary Tract Symptoms - drug therapy; Lower Urinary Tract Symptoms - etiology; Male; Male genital diseases; Medical sciences; Nephrology. Urinary tract diseases; new FDA indication; overflow incontinence; PDE-5 inhibitors; Pharmacology. Drug treatments; Phosphodiesterase 5 Inhibitors - adverse effects; Phosphodiesterase 5 Inhibitors - pharmacology; Phosphodiesterase 5 Inhibitors - therapeutic use; Prostate; Prostatic Hyperplasia - drug therapy; Prostatic Hyperplasia - physiopathology; Tadalafil; Tumors; Tumors of the urinary system; United States; United States Food and Drug Administration; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; urology
• ISSN: 0277-0008; 1875-9114
• DOI: 10.1002/phar.1243

Tadalafil is a phosphodisesterase (PDE)‐5 inhibitor recently approved by the United States Food and Drug Administration for lower urinary tracts symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). The mechanism for improved LUTS is thought to be related to three principal theories: alterations in nitric oxide levels, Rho‐associated protein kinase deactivation, and reductions in pelvic atherosclerosis. The efficacy of PDE‐5 inhibitors for the treatment of LUTS associated with BPH has been demonstrated in several randomized placebo‐controlled trials. Tadalafil is thought to be superior based on an extended half‐life; however, other PDE‐5 inhibitors have positive results in BPH and have not been proved to be inferior to tadalafil. Before administration, concomitant use of medications such as nonselective α‐adrenergic antagonists, nitrates, and cytochrome P450 inhibitors should be assessed for possible drug interactions. Potential adverse drug events seen in Food and Drug Administration–approved tadalafil include back pain, dyspepsia, headache, and dizziness. Given the efficacy and safety data currently available, the PDE‐5 inhibitor tadalafil represents a reasonable alternative for selected male patients with LUTS associated with BPH, especially with concomitant erectile dysfunction.