Efficacy of Continuous Dosing of Tadalafil Once Daily vs Tadalafil On Demand in Clinical Subgroups of Men with Erectile Dysfunction: A Descriptive Comparison Using the Integrated Tadalafil Databases

Abstract

Introduction Various factors play a role in the development of erectile dysfunction (ED). Aim To provide a descriptive comparison of erectile function response for tadalafil on-demand (PRN) and once-daily (OAD) dosing regimens in patients with common comorbid conditions, treatments, or risk factors that can be considered when treating ED. Methods In total, 17 PRN and 4 OAD placebo-controlled studies were included in the integrated database in these pooled analyses. Data were analyzed from patients treated with placebo, tadalafil 10 mg (low dose), and 20 mg (high dose) for the PRN studies and placebo, tadalafil 2.5 mg (low dose), and 5 mg (high dose) for the OAD studies. Main Outcome Measures The effects of tadalafil were measured using the International Index of Erectile Function administered from baseline to week 12. A descriptive comparison of the efficacy of tadalafil PRN vs OAD was examined in the clinical populations. Results Baseline characteristics of 4,354 men were comparable between the PRN and OAD groups, with differences seen only in the variables of race, body mass index (BMI) of at least 30 kg/m2, and alcohol use. Tadalafil was efficacious at improving erectile function for all clinical populations, except for the low-dose OAD group, which demonstrated a weaker effect vs placebo than the high-dose OAD group, and the low- and high-dose PRN groups vs placebo for patients with BMI of at least 30 kg/m2 for patients without a cardiovascular disorder, smokers, patients with ED duration shorter than 1 year, and patients without previous phosphodiesterase type 5 inhibitor use. Tadalafil was efficacious for patients with or without diabetes mellitus, arterial hypertension, hyperlipidemia, and alcohol use at baseline. Conclusion Tadalafil OAD and PRN regimens showed efficacy in patients with ED. No clinical populations of patients with ED seemed to benefit overwhelmingly from one dose regimen over the other.

The central mechanism of tadalafil vs Chaihu-Shugan-San capsule for psychogenic erectile dysfunction: a magnetic resonance imaging study protocol of a randomized placebo-controlled trial

“…Due to the lack of reference on the expected effect size of using CHSGS to treat erectile dysfunction evaluated in this study, we did not estimate the sample size based on a power calculation. According to previous studies, International Index of Erectile Function 5 (IIEF-5) scores of ED patients increased 6.0-7.1 after tadalafil [13,15]. Therefore, we predicted ascension of IIEF-5 score by 6.5 points after oral tadalafil or CHSGS capsule, a reduction by 2.5 points after placebo.…”

“…According to the current guidelines, tadalafil [9][10][11][12][13][14][15][16] is the first-line oral pharmacotherapy for ED. It could take action from various species in vivo and in vitro by increasing the intracellular concentrations of cGMP by amplifying the endogenous NO-cGMP pathway [9,17].…”

Should All Men with Type 2 Diabetes Be Routinely Prescribed a Phosphodiesterase Type 5 Inhibitor?

“…Five meta-analyses have compared on-demand vs. daily tadalafil and the findings are reported in Table 2. Brock et al [39] compared only RCTs and concluded equal efficacy but these trials were usually of 12-week duration where on-demand patients were provided with unlimited medication such that total dose of tadalafil was usually significantly higher than 5 mg daily dosing. Bansal et al [40] reviewed 6 head to head studies of up to 12 weeks and concluded that daily tadalafil resulted in a 1.82 higher ED score then 20mg on-demand.…”

Management of Erectile Dysfunction in Cardiovascular Patients With Comorbidities: Review of the Trials on Continuing Therapy With Phosphodiesterase-5 Medications

“…Курсовая терапия ежедневного приема ингибиторов ФДЭ-5 представляет высокий интерес в лечении пациентов, у которых прием этих препаратов "по требованию" неэффективен или малоэффективен. Как показывает статистика, количество таких пациентов достигает 30-40% [17]. Постоянный прием ингибиторов ФДЭ-5 может рассматриваться в качестве дополнительной возможности улучшить ЭФ в группе "тяжелых для лечения" пациентов: больных сахарным диабетом и пациентов, перенесших радикальную простатэктомию [18].…”