Clinical Briefs By Louis Kuritzky

By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is an advisor for Endo, Kowa, Pricara, and Takeda.

Once-daily Tadalafil for ED: Efficacy and Safety

By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville

Source: Seftel AD, et al. Int J Impot Res 2013;25:91-98.

The utilization of pde5 inhibition (PDE5-i) for restoration of sexual function in men suffering erectile dysfunction (ED) is well established, beginning with the introduction of sildenafil (Viagra) in 1998. In the earliest years of PDE5-i treatment, regimens were typically targeted to PRN use. Almost a decade later, consideration of lower-dose, daily use of tadalafil became popular.

In this retrospective analysis, Seftel et al report on the safety and efficacy of once-daily tadalafil (TAD-QD) in doses ranging from 2.5-10.0 mg/day. The rationale for their study was to specifically define whether age impacts the efficacy of TAD-QD, since older men (age > 50 years, by their definition) might be more refractory to PDE5-i than younger men (age < 50 years). Additionally, they wished to examine the tolerability profile of TAD-QD in men with mild-moderate ED, who comprise the largest segment of men taking PDE5-i. The dataset used in this analysis included 522 men, predominantly Caucasian (> 75%), most of whom had long-standing ED and about half of whom had comorbidities of hypertension and/or diabetes.

TAD-QD more than doubled the rates of successful intercourse (from 33.4% pretreatment to 76.8% on treatment), with no discernible difference in younger men vs older men. TAD-QD was also well tolerated, with the most common adverse events — headache, dyspepsia, and myalgias — consistent with what has been seen in prior literature.

The authors conclude that TAD-QD provides substantial improvements in ED, independent of age, in men with mild-moderate ED, and is well tolerated.