Continuation and effectiveness of tadalafil once daily during a 6‐month observational study in erectile dysfunction: the EDATE study

Abstract

Aims: This was the first observational study evaluating treatment continuation, effectiveness and tolerability of tadalafil 5 mg once daily (TAD-OaD) in patients who chose and paid for treatment of erectile dysfunction (ED) in routine clinical practice. Methods: Men ≥ 18 years with ED, treated previously with phosphodiesterase type 5 (PDE5)-inhibitor on-demand (PRN) or treatment-na€ ıve, were enrolled at 59 sites. For patients prescribed TAD-OaD at baseline (T1), change in erectile function (IIEF-EF and GAQ) was documented after 1-3 (T2) and 4-6 (T3) months. The primary outcome was the probability to switch/discontinue from TAD-OaD, estimated by Kaplan-Meier (KM) product-limit method. Changes in IIEF-EF were evaluated using a mixed model for repeated measures adjusting for patient baseline characteristics. Results: Of 975 men enrolled (median age 56.8 years, 33.7% with previous PDE5-inhibitor use), 778 were prescribed TAD-OaD, 135 TAD-PRN and 62 sildenafil or vardenafil PRN. During the 6-month longitudinal observation, 107 patients (13.8% of 778) switched or discontinued TAD-OaD-treatment. KM-rates (95%CI) for continuing TAD-OaD at 2, 4 and 6 months were 94.0% (92.3, 95.7), 88.3% (85.9, 90.6) and 86.3% (83.7, 88.9), respectively. The 25th percentile of time to switch/discontinuation of TAD-OaD was estimated as 31.1 weeks (lower 95%CI 30.3 weeks). At T3, IIEF-EF scores had increased by 7.1 (LSmean; 95%CI 5.8, 8.5) points; 91.3% of patients reported improved erections. The most frequently reported AE was headache (10 patients; 1.3%); no new/unexpected safety signals were observed. Conclusion: Under routine conditions, and when patients were involved in treatment decision-making, more than 86% of men starting/ switching to tadalafil once daily (OaD) at baseline continued tadalafil OaD treatment for ≥ 6 months. What's knownPDE5 inhibitor on-demand treatment for erectile dysfunction (ED) is frequently discontinued; adherence may vary depending on the initial regimen. What's newUnder routine conditions, and when patients were involved in treatment decision-making, more than 86% of men starting/switching to tadalafil once daily (OaD) at baseline continued tadalafil OaD treatment for 6 months.

Tadalafil 5 mg once daily for the treatment of erectile dysfunction during a 6-month observational study (EDATE): impact of patient characteristics and comorbidities

“…EDATE was a prospective, longitudinal, observational study conducted in 59 centres across Germany, France, Italy, and Greece, enrolling patients from November 2011 through June 2012 [ 20 ]. Adult male patients who met the investigator’s criteria for ED and presented within the normal course of care were eligible to participate if they had decided, in consultation with their physician, to either initiate PDE5 inhibitor treatment for the first time (treatment-naïve) or switch from any previous PDE5 inhibitor taken on-demand.…”

“…The primary results on the time to treatment discontinuation of tadalafil OaD in men who had initiated or switched to tadalafil OaD at baseline have already been published [ 20 ]. The current article includes secondary outcome results on the impact of patients characteristics and comorbidities on time to treatment discontinuation, and on mean changes from baseline to end of observation in the International Index of Erectile Function (IIEF) domain scores [ 21 ], and Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) total score [ 22 ].…”

“…A sample size of 250 patients initiating or switching to tadalafil OaD at baseline was planned, based on the primary outcome (continuation rate on tadalafil OaD, estimated to be 50 − 80 % after 6 months of treatment) [ 20 ]. Consecutive enrollment was planned to be stopped as soon as either 3,000 patients were enrolled overall, or 600 patients were enrolled in the tadalafil OaD cohort.…”

“…The EDATE study was the first multinational, observational study in patients with ED, with or without previous exposure to PDE5 inhibitors, that documented the effectiveness and tolerability of tadalafil 5 mg OaD under routine conditions. The study highlighted that more than 85 % of men who choose to be treated with tadalafil OaD maintained the treatment in the next 6 months [ 20 ]. In this article, we present results of secondary analyses for the impact of patient characteristics and relevant comorbidities on treatment continuation rates as well as treatment effectiveness and satisfaction in patients with ED who had started with or switched to tadalafil OaD and were followed for a period of 6 months.…”

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

“…The BSSM guidelines 2018, report that on-demand PDE5 inhibitors are only successful in 50% of men with T2DM [17] despite unlimited medication in clinical trials. Buvat et al [38] reported that 89% of patients switched to daily tadalafil were still taking medication after 12 months. The BSSM guidelines suggest that up to 50% of patients who fail with on-demand therapy respond to daily dosing [17].…”