Daily Tadalafil More Effective than On-Demand Tadalafil in Long-Term Treatment of Erectile Dysfunction

Introduction

Few clinical studies have demonstrated improvement in the International Index of Erectile Function – Erectile Function (IIEF-EF) with tadalafil given over 12 weeks in men with erectile dysfunction (ED). However, there are conflicting reports on the advantages and disadvantages between long term treatment with daily and on-demand tadalafil. One study showed that daily tadalafil did not bring about significant changes in the IIEF-EF scores as compared to on-demand tadalafil after 12 weeks of treatment.

Aim

The efficacy and safety of daily tadalafil was compared with on-demand tadalafil after 24 weeks of long-term treatment in men with ED.

Method

Study Design

• Meta-analysis of randomized clinical trials (RCTs)
• RCTs were identified using MEDLINE, EMBASE and Cochrane databases
• RCTs comparing the effects of daily vs on demand tadalafil over 24 weeks were included
• Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses

Endpoints

Primary Endpoints

• IIEF-EF scores

Secondary Endpoints

• Sexual encounter profile question 2 (SEP2)
• SEP question 3 (SEP3)
• Any treatment-emergent adverse event (AE)
• Discontinuation due to AEs, myalgia, back pain, headache, dyspepsia, and nasopharyngitis

Results

• A total of 4 studies with 1035 patients were included
• Tadalafil daily and tadalafil on-demand groups comprised of 521 and 514 men with ED respectively
• The improvement in the IIEF-EF scores was better in the tadalafil daily group (mean difference (MD) 1.24; p = 0.04)
• Similarly, the tadalafil daily group had a significant improvement in the SEP2 (MD 10.08; p < 0.00001) and SEP3 (MD 8.19; p = 0.009)
• The incidence of any treatment-emergent AE was higher in the on-demand tadalafil group (odds ratio 0.73; p = 0.02)
• There were no significant differences in the rates of discontinuation due to AEs, myalgia, back pain, headache, dyspepsia, and nasopharyngitis between the 2 groups  

Conclusion

• Tadalafil daily was associated with better efficacy than on-demand tadalafil in men with erectile dysfunction after at least 24 weeks of treatment
• Daily tadalafil was also safe and well tolerated, with a lower incidence of treatment-emergent adverse events as compared to on-demand tadalafil

Sex Med. 2019 Sep;7(3):282-291. Doi: 10.1016/j.esxm.2019.06.006.