Tadalafil 5 mg Once Daily 12-Week Monotherapy Effective and Safe in Men with LUTS/BPH
Introduction
A significant proportion of men with benign prostatic hyperplasia (BPH) experience lower tract urinary symptoms (LUTS) that can negatively impact their quality of life (QoL). Tadalafil has been approved for the treatment of BPH in many countries and has been widely used for nearly 10 years. However, there is lack of evidence-based studies of the efficacy and safety of tadalafil in treating LUTS/BPH. The results of the latest and high-quality synthesis of current worldwide evidence on the efficacy of tadalafil in treating LUTS/BPH have been presented here.
Aim
The clinical efficacy and safety of tadalafil monotherapy (5 mg once daily for 12 weeks) has been assessed in men with LUTS/BPH.
Method
Study Design
- Qualitative and quantitative synthesis of randomized controlled trials (RCTs).
Treatment Strategy
- A comprehensive literature search was conducted using PubMed, Cochrane Central Register of Controlled Trials, Embase, and Web of Science databases.
- A total of 15 RCTs met the eligibility criteria.
- The quality of the included RCTs was evaluated independently by two authors, who, extracted data according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach.
- The urodynamic parameters, QoL and safety outcomes were assessed.
Endpoints
- Total International Prostate Symptom Score (IPSS)
- IPSS storage subscore
- IPSS voiding subscore
- IPSS QoL
- BPH Impact Index (BII)
- Maximum flow rate (Qmax)
- Postvoid residual (PVR)
- Adverse events (AEs)
- Serious AEs (SAEs)
Results
- The total IPSS was significantly lower and better with 5 mg once daily tadalafil for 12 weeks as compared placebo (mean difference [MD]: -1.97; p<0.00001).
- Significant improvements from baseline were demonstrated by the tadalafil monotherapy in other efficacy endpoints such as IPSS voiding subscore (MD: -1.30; p<0.00001), the IPSS storage subscore (MD: -0.70; p<0.00001), the IPSS QoL (MD: -0.29; p<0.00001), and BII (MD: -0.58; p<0.00001).
- Interestingly, younger age, high body mass index (BMI) and high baseline IPSS were associated with better IPSS.
- The differences with respect to Qmax and PVR were insignificant among the tadalafil and placebo groups.
- The incidence of AEs such as headache, dyspepsia and back pain were significantly higher in the tadalafil group as compared to placebo.
- However, there were no significant difference in SAEs between the two groups.
Conclusion
- Oral monotherapy with once daily 5 mg tadalafil was found to be effective, well tolerated and safe in men experiencing lower tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Front Med. 2021 Oct 12;8:744012. Doi: 10.3389/fmed.2021.744012.
