Tadalafil for the treatment of benign prostatic hyperplasia

ABSTRACT

Introduction: In men, lower urinary tract symptoms (LUTS) are primarily attributed to benign prostatic hyperplasia (BPH). Therapeutic options are targeted to relax prostate smooth muscle and/or reduce prostate enlargement.

Areas covered: This article reviews the major preclinical and clinical data on PDE5 inhibitors with a specific focus on tadalafil. It includes details of the role of the nitric oxide (NO)-cyclic guanosine monophosphate (cGMP) – PDE5 pathway in the LUT organs (bladder and prostate) in addition to the available data on tadalafil in patients with LUTS secondary to BPH with or without erectile dysfunction (ED).

Expert opinion: Preclinical and clinical data have clearly demonstrated that PDE5 inhibitors induce bladder and prostate relaxation, which contributes to the improvement seen in storage symptoms in both animal models of bladder and prostate hypercontractility. Tadalafil is effective both as a monotherapy and add-on therapy in patients with LUTS secondary to BPH. Furthermore, as LUTS-BPH and ED are urological disorders that commonly coexist in aging men, tadalafil is more advantageous than α1-adrenoceptors and should be used as the first option. Tadalafil is a safe and tolerable therapy and unlike α1- adrenoceptors and 5-alpha reductase inhibitors, which can cause sexual dysfunctions, tadalafil improves sexual function.

KEYWORDS:

• Tadalafil
• benign prostatic hyperplasia
• lower urinary tract
• prostate
• bladder
• phosphodiesterase type 5
• erectile dysfunction
• cyclic GMP

Box 1. Drug summary.

Acknowledgments

The authors acknowledge Charles Serpellone Nash for his language revision.

Declaration of interest

G De Nucci is the CSO of Galeno Clinical Research Ltd (a contract research organization) which conducts clinical trials. Over the past three years, Galeno Clinical Research Ltd has conducted two phase I trials and two phase II trials, as well as one phase III trial for Biolab Farmaceutica. Professor De Nucci has received speaker’s fees from EMS Farmaceutica. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This manuscript has not been funded.