(244) Population Pharmacokinetic and Economic Analysis of On-Demand Sildenafil vs. Daily Tadalafil for Erectile Dysfunction in High-Income Countries
Abstract
Erectile dysfunction (ED) risk is strongly associated with increasing age and the prevalence of non-communicable chronic diseases, such as diabetes, hypertension, dyslipidemia, and cardiovascular disease. The global prevalence of ED in 2019 varied from 37.2% to 48.6% with 16%–45% affected in Europe and 52% affected in the United States of America, impacting men’s overall well-being, interpersonal relationships, and self-esteem. Sildenafil (100 mg and 50 mg), typically administered as on-demand doses, and tadalafil (5 mg), commonly prescribed in daily doses, represent two of the widely utilized medications approved by the European Medicines Agency and US Food and Drug Administration. Mulhall JP et al. (2018) reported that the median frequency of sexual activity ranged from 4 to 10 times/month, with ED medication taken 3–8 times/month. Thus, a daily-dosing regimen might lead to unnecessary pharmacological exposure and increased treatment expenses, especially when considering the out-of-pocket (OoP) expenditure.
The objective of the study was to evaluate the pharmacokinetic (PK) and cost-utility outcomes of on-demand sildenafil vs. daily dosing of tadalafil.
A population-based PK model for on-demand sildenafil (50 mg and 100 mg) and daily-dose tadalafil (5 mg) was developed to assess interindividual variability in PKs and overall management of ED in high-income countries. Data from published literature and advanced modeling techniques were used to simulate a hypothetical cohort…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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