Onset of Efficacy of Tadalafil Once Daily in Men With Erectile Dysfunction: A Randomized, Double-Blind, Placebo Controlled Trial

Seftel, Allen D.; Goldfischer, Evan R.; Kim, Edward D.; Dula, Eugene; Zeigler, Haoyue; Burns, Patrick R.

doi:10.1016/j.juro.2010.09.035

Cited by 17 publications

(8 citation statements)

References 7 publications

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“…Therefore, composites of several doseunits should only be made after non-destructive techniques show there are no differences. Further, the drug substance may be hidden where normally not expected and active ingredients may be masked by difficult matrices [95,97]. The best screening practice appears to be a combination of visual inspection, multiple analysis techniques, and an open mind.…”

Section: Discussionmentioning

confidence: 99%

Towards a decade of detecting new analogues of sildenafil, tadalafil and vardenafil in food supplements: A history, analytical aspects and health risks

Venhuis

Kaste

2012

Journal of Pharmaceutical and Biomedical Analysis

158

116

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Section: Discussionmentioning

confidence: 99%

Towards a decade of detecting new analogues of sildenafil, tadalafil and vardenafil in food supplements: A history, analytical aspects and health risks

Venhuis

Kaste

2012

Journal of Pharmaceutical and Biomedical Analysis

158

116

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“…Pharmacokinetic studies have proven that with daily dosing of tadalafil after 5 days, a steady state of plasma concentrations is reached equal to 1.6 times a single dose [25]. In this context, a recent clinical study was able to show that from day 2, tadalafil OAD resulted in significant efficacy that increased over the next 5 days ([88], Figure 9).…”

Section: Daily Dosing Of Pde5 Inhibitorsmentioning

confidence: 99%

“… Cumulative dose response with tadalafil OAD 2.5 and 5 mg in a prospective study [88]. OAD = once a day …”

Section: Daily Dosing Of Pde5 Inhibitorsmentioning

confidence: 99%

SOP Conservative (Medical and Mechanical) Treatment of Erectile Dysfunction

Porst¹,

Burnett

Brock

et al. 2013

The Journal of Sexual Medicine

173

128

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Introduction Erectile dysfunction (ED) is the most frequently treated male sexual dysfunction worldwide. ED is a chronic condition that exerts a negative impact on male self-esteem and nearly all life domains including interpersonal, family, and business relationships. Aim The aim of this study is to provide an updated overview on currently used and available conservative treatment options for ED with a special focus on their efficacy, tolerability, safety, merits, and limitations including the role of combination therapies for monotherapy failures. Methods The methods used were PubMed and MEDLINE searches using the following keywords: ED, phosphodiesterase type 5 (PDE5) inhibitors, oral drug therapy, intracavernosal injection therapy, transurethral therapy, topical therapy, and vacuum-erection therapy/constriction devices. Additionally, expert opinions by the authors of this article are included. Results Level 1 evidence exists that changes in sedentary lifestyle with weight loss and optimal treatment of concomitant diseases/risk factors (e.g., diabetes, hypertension, and dyslipidemia) can either improve ED or add to the efficacy of ED-specific therapies, e.g., PDE5 inhibitors. Level 1 evidence also exists that treatment of hypogonadism with total testosterone < 300 ng/dL (10.4 nmol/L) can either improve ED or add to the efficacy of PDE5 inhibitors. There is level 1 evidence regarding the efficacy and safety of the following monotherapies in a spectrum-wide range of ED populations: PDE5 inhibitors, intracavernosal injection therapy with prostaglandin E1 (PGE1, synonymous alprostadil) or vasoactive intestinal peptide (VIP)/phentolamine, and transurethral PGE1 therapy. There is level 2 evidence regarding the efficacy and safety of the following ED treatments: vacuum-erection therapy in a wide range of ED populations, oral L-arginine (3–5 g), topical PGE1 in special ED populations, intracavernosal injection therapy with papaverine/phentolamine (bimix), or papaverine/phentolamine/PGE1 (trimix) combination mixtures. There is level 3 evidence regarding the efficacy and safety of oral yohimbine in nonorganic ED. There is level 3 evidence that combination therapies of PDE5 inhibitors + either transurethral or intracavernosal injection therapy generate better efficacy rates than either monotherapy alone. There is level 4 evidence showing enhanced efficacy with the combination of vacuum-erection therapy + either PDE5 inhibitor or transurethral PGE1 or intracavernosal injection therapy. There is level 5 evidence (expert opinion) that combination therapy of PDE5 inhibitors + L-arginine or daily dosing of tadalafil + short-acting PDE5 inhibitors pro re nata may rescue PDE5 inhibitor monotherapy failures. There is level 5 evidence (expert opinion) that adding either PDE5 inhibitors or transurethral PGE1 may improve outcome of penile prosthetic surgery regarding soft (cold) glans syndrome. There is level 5 evidence (expert opinion) that the combination of PDE5 inhibitors and dapoxetine is effective and safe in patients suffering from both ED and premature ejaculation.

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“…106 The onset of efficacy of tadalafil 5 mg once daily was reported within a few days of initiating therapy. 107 There is strong evidence that tadalafil is efficacious (based on IIEF, SEP2, and SEP3 scores) in the treatment of ED in the broad population. There are 14 level 1 studies for on-demand use 22,108e120 and four level 1 studies for daily use, 121e124 with consistent outcomes.…”

Section: Tadalafilmentioning

confidence: 99%

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

Hatzimouratidis

Salonia

Adaikan

et al. 2016

The Journal of Sexual Medicine

178

199

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Introduction Treatment of erectile dysfunction is based on pharmacotherapy for most patients. Aim To review the current data on pharmacotherapy for erectile dysfunction based on efficacy, psychosocial outcomes, and safety outcomes. Methods A review of the literature was undertaken by the committee members. All related articles were critically analyzed and discussed. Main Outcome Measures Levels of evidence (LEs) and grades of recommendations (GRs) are provided based on a thorough analysis of the literature and committee consensus. Results Ten recommendations are provided. (i) Phosphodiesterase type 5 (PDE5) inhibitors are effective, safe, and well-tolerated therapies for the treatment of men with erectile dysfunction (LE = 1, GR = A). (ii) There are no significant differences in efficacy, safety, and tolerability among PDE5 inhibitors (LE = 1, GR = A). (iii) PDE5 inhibitors are first-line therapy for most men with erectile dysfunction who do not have a specific contraindication to their use (LE = 3, GR = C). (iv) Intracavernosal injection therapy with alprostadil is an effective and well-tolerated treatment for men with erectile dysfunction (LE = 1, GR = A). (v) Intracavernosal injection therapy with alprostadil should be offered to patients as second-line therapy for erectile dysfunction (LE = 3, GR = C). (vi) Intraurethral and topical alprostadil are effective and well-tolerated treatments for men with erectile dysfunction (LE = 1, GR = A). (vii) Intraurethral and topical alprostadil should be considered second-line therapy for erectile dysfunction if available (LE = 3, GR = C). (viii) Dose titration of PDE5 inhibitors to the maximum tolerated dose is strongly recommended because it increases efficacy and satisfaction from treatment (LE = 2, GR = A). (ix) Treatment selection and follow-up should address the psychosocial profile and the needs and expectations of a patient for his sexual life. Shared decision making with the patient (and his partner) is strongly recommended (LE = 2, GR = A). (x) Counterfeit medicines are potentially dangerous. It is strongly recommended that physicians educate their patients to avoid taking any medication from unauthorized sources (LE = 2, GR = A). The first seven recommendations are the same as those from the Third International Consultation for Sexual Medicine and the last three are new recommendations. Conclusion PDE5 inhibitors remain a first-line treatment option because of their excellent efficacy and safety profile. This class of drugs is continually developed with new molecules and new formulations. Intracavernosal injections continue to be an established treatment modality, and intraurethral and topical alprostadil provide an alternative, less invasive treatment option.

show abstract

Onset of Efficacy of Tadalafil Once Daily in Men With Erectile Dysfunction: A Randomized, Double-Blind, Placebo Controlled Trial

Abstract: This prospective trial shows the onset of efficacy of tadalafil 2.5 and 5 mg once daily within a few days of initiating therapy.

Cited by 17 publications

References 7 publications

Towards a decade of detecting new analogues of sildenafil, tadalafil and vardenafil in food supplements: A history, analytical aspects and health risks

Towards a decade of detecting new analogues of sildenafil, tadalafil and vardenafil in food supplements: A history, analytical aspects and health risks

SOP Conservative (Medical and Mechanical) Treatment of Erectile Dysfunction

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

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