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Abstract and Introduction
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-naïve, 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.
Introduction
The efficacy and safety of oral phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil citrate (sildenafil), tadalafil and vardenafil HCl (vardenafil) for treatment of erectile dysfunction (ED) – have been well-documented in randomised, placebo-controlled studies and systematic meta-analyses. However, high treatment discontinuation rates of 50–60% have been reported for short-acting PDE5-inhibitors used on-demand (pro re nata, PRN) in naturalistic settings. Men starting PDE5-inhibitors face multiple obstacles that may lead to early dissatisfaction and subsequent treatment discontinuation. One major factor affecting effectiveness of PDE5-inhibitors in clinical practice is inadequate patient instruction during the initial prescription process. Hatzichristou and coworkers have found that the response rate to sildenafil may be maximised after appropriate dose-titration and instruction on administration. A potential restraint of short-acting PDE5-inhibitors is the required temporal association between drug intake and timing of sexual intercourse. In contrast to the short-acting PDE5-inhibitors sildenafil or vardenafil, tadalafil has a long half-life (17.5 h) and has been shown to improve erectile function (EF) up to 36 h postdose (PRN administration).
The greater flexibility and uncoupling of drug intake and sexual activity leads to improvements in time concerns, sexual self-confidence and spontaneity.
The long half-life of tadalafil allowed the development of a once daily (OaD) dosing strategy. The resulting OaD regimen (tadalafil 5 mg/day) was well-tolerated and significantly improved ED in randomised controlled trials (RCTs). Furthermore, the OaD regimen improved the sexual quality of life of couples to a level comparable to that experienced prior to onset of ED in controlled studies.
However, no prospective data on the use of tadalafil OaD treatment in routine practice, and no information on continuation rates of patients treated with tadalafil OaD in naturalistic settings are available so far. This observational study in men with ED, with or without previous exposure to PDE5-inhibitors, assessed their reasons for choosing or switching to different PDE5-inhibitors, documented effectiveness and tolerability of tadalafil 5 mg OaD under routine conditions and observed as primary outcome the time to treatment switch or discontinuation in those men initiating tadalafil 5 mg OaD at baseline.
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