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

Abstract

BackgroundTo explore the impact of patient-characteristics and relevant comorbidities on treatment continuation rates, effectiveness, and satisfaction in patients with erectile dysfunction (ED) who started or switched to tadalafil 5 mg once daily (TAD-OaD) at baseline.MethodsIn the EDATE observational study, phosphodiesterase-type-5 (PDE5)-inhibitor pretreated or naïve ED patients who started or switched to TAD-OaD were prospectively followed for 6 months. Time to discontinuation of TAD-OaD was estimated using the Kaplan-Meier product-limit method at Months 2, 4, and 6 in subgroups stratified by age (18 − 65 years and >65 years), PDE5-inhibitor pretreatment, ED-severity (mild, moderate, severe), and presence or absence of relevant comorbidities (BPH, diabetes, CVD, hypertension, dyslipidemia). LSmean change from baseline in International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores and associated 95 % CIs were assessed using a mixed-model for repeated measures. Visit, ED etiology, and subgroups were included as fixed-effects.ResultsOverall, 778 patients received prescriptions for initiating or switching to TAD-OaD at baseline. At Month 2, >90 % of patients remained on TAD-OaD, except those aged >65 years (86.7 %) and patients with severe ED (89.0 %). More than 80 % of patients in all subgroups, except those aged >65 years (75.0 %), continued TAD-OaD at Month 6. There was a significant LSmean negative effect on IIEF- EF domain-score improvement for BPH (LSmean effect [95 % CI]: −2.77 [−4.98, −0.55], p = 0.014), previous PDE5-inhibitor treatment (−2.13 [−3.33,-0.94], p < 0.001), and mild vs moderate ED (-2.00 [−3.54,-0.46], p = 0.011); the latter possibly linked with a bigger treatment-effect in those with more severe ED at baseline. The LSmean effect on change in IIEF-EF was significantly positive for diabetes (2.28 [0.64,3.92], p = 0.007), most likely because those with diabetes had more severe ED at baseline. For all other parameters, no statistically significant LSmean effects in IIEF-EF changes were observed. No comorbidity or baseline-characteristic except age (18 − 65 years vs >65 years: 11.25 [2.96,19.54], p = 0.008) affected changes in EDITS.ConclusionsUnder routine clinical conditions, treatment continuation rate or satisfaction does not seem to be significantly affected by the presence of comorbidities in men who choose ED-treatment with TAD-OaD. The magnitude of treatment effectiveness was affected by certain baseline characteristics and comorbid conditions.Trial RegistrationThe study (H6D-EW-LVIU) is registered in the German VfA Registry of Non-Interventional Studies (Verband Forschender Arzneimittelhersteller) since 06 December 2011; available at: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_741.Electronic supplementary materialThe online version of this article (doi:10.1186/s12894-015-0107-5) contains supplementary material, which is available to authorized users.

Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis

“…They do not correct the underlying penile pathophysiology, such as vascular lesions secondary to diabetes mellitus, structural lesions secondary to trauma, or neurologic injury secondary to prostatectomy, that is responsible for the ED [1]. A novel method to prevent the deterioration of erectile function due to these pathophysiologic processes is desperately needed.…”

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].…”

“…The cell molecular mechanisms involved have been reviewed in detail elsewhere [18]. The fact that CNS mechanisms play an important role for erection and penile as drugs targets for ED has been accepted [11,13,18].…”

Men’s Power-Pressure Wave Erectile Regeneration-Therapy: an Early Assessment

“…Though effective, these drugs have limitations and are associated with significant non-compliance, side effects and do not reverse the underlying pathology [1][2][3]. Non-invasive low intensity shockwave therapy (LISWT) has been shown to significantly improve erectile function in men previously PDE5i dependent.…”