Comparable Efficacy of Once-Daily Versus On-Demand Vardenafil in Men with Mild-to-Moderate Erectile Dysfunction: Findings of the RESTORE Study

Zumbé, J.; Porst, Hartmut; Sommer, Frank; Grohmann, Walter; Beneke, Manfred; Ulbrich, Ernst

doi:10.1016/j.eururo.2008.03.056

Cited by 52 publications

(27 citation statements)

References 18 publications

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“…Zumb e et al compared and showed no significant difference in erectile function improvement between once daily and on-demand vardenafil in the treatment of mild-tomoderate ED. 14 Park et al study showed that once daily and on-demand udenafil (a selective PDE5I, approved in 13 countries) did not demonstrate a significant difference, and the treatment efficacy was not maintained after treatment of ED patients with DM. 15 Therefore, further studies are needed to determine whether the dosage frequency influence the treatment outcomes of PDE5Is.…”

Section: Resultsmentioning

confidence: 96%

Association Between Dosage Frequency and the Treatment Outcomes of Sildenafil in Young and Middle-aged Men With Erectile Dysfunction: A Chinese, Multicenter, Observational Study

Yang

Jiang

Hong

et al. 2015

Urology

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Section: Resultsmentioning

confidence: 96%

Association Between Dosage Frequency and the Treatment Outcomes of Sildenafil in Young and Middle-aged Men With Erectile Dysfunction: A Chinese, Multicenter, Observational Study

Yang

Jiang

Hong

et al. 2015

Urology

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“…As-needed vardenafil showed greater efficacy than placebo (45% v. 24% SEP3) Zumbe et al 75 Placebo-controlled, 48 Prospective study 22 PGE1 or Trimix 2-3/wk + sildenafil daily Facilitated early sexual intercourse, increased patient satisfaction, earlier return of natural erections, no control group ICSI = intracavernosal self-injection; IIEF-EF= International Index of Erectile Function, erectile function domain; MUSE = medicated urethral system for erection; PDE5 = phosphodiestrerase type 5; PGE1 = prostaglandin E1; SEP3 = Sexual Encounter Profile, question 3; VCD = vacuum constriction device.…”

Section: Resultsmentioning

confidence: 99%

“…Two studies have recently been published to address the question of whether chronic PDE5 inhibitor use is superior to on-demand dosing. In the RESTORE study, Zumbe and colleagues 75 designed a randomized, placebo-controlled, double-blind, multicentre study in a mixed population of patients with mild to moderate ED to directly compare once daily vardenafil 10 mg plus ondemand placebo for 12 (n = 76) or 24 weeks (n = 79), or once daily placebo plus on-demand vardenafil 10 mg for 24 weeks (n = 77). After the treatment phase of the study, all study groups were compared after a 4-week washout period with placebo.…”

Section: Phosphodiesterase Type 5 Inhibitorsmentioning

confidence: 99%

Penile rehabilitation following treatment for prostate cancer: an analysis of the current state of the art

Al-Shaiji

Domes

Brock

2013

CUAJ

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Despite recent advances in surgical technique using laparoscopic and robotic approaches for the management of early organconfined prostate cancer, most contemporary reports demonstrate significant rates of erectile dysfunction comparable to standard open approaches. Controversy remains related to many of the preand postoperative management strategies, including agents to enhance nerve recovery, erectogenic drugs, antioxidants, vasoactive injectables, vacuum erection devices and nerve grafting procedures. Additionally, the optimal timing of these interventions and their duration, dose, frequency and outcome thresholds remain ill-defined. In our paper, we provide a comprehensive literature review involving both the basic and clinical data surrounding rehabilitative approaches. RésuméMalgré des avancées récentes dans les techniques chirurgicales utilisant la laparoscopie et la robotique pour la prise en charge du cancer de la prostate au stade précoce, la majorité des rapports récents font état de taux significatifs de dysfonction érectile se comparant aux taux associés aux approches ouvertes standard. Bon nombre des stratégies de traitement préopératoires et postopératoires, comme les agents favorisant la récupération nerveuse, les médicaments érec-togènes, les antioxydants, les agents vasoactifs injectables, les pompes péniennes et les greffes de nerfs, font toujours l'objet de controverses. Par ailleurs, le moment optimal pour effectuer ces interventions, la durée de ces dernières, la dose, la fréquence et le seuil d'évaluation des résultats demeurent encore bien mal défi-nis. Cet article de synthèse présente une revue approfondie de la littérature comprenant les données de recherche fondamentale et les données cliniques concernant les approches de réadaptation.going surgery and are thus expressing concern about preservation of erectile function after the procedure, a fact that is true for older men as well. Since Walsh and Donker 4 published their landmark article describing the etiology and prevention of impotence following retropubic RP in 1982, the nerve-sparing technique they described is widely employed and believed to improve postoperative erectile function. 5 Furthermore, there continue to be modifications to the nervesparing technique in an attempt to minimize nerve compromise and improve postoperative potency, as reported by Chuang and coauthors 6 and Masterson and colleagues. 7 However, optimal sexual functioning often requires 18 to 42 months to return, even among men in whom bilateral nerve sparing was performed, with reported recovery rates varying from 16% to 86%. 8,9 Sexual dysfunction has been reported to be an independent determinant of a poorer general health-related quality of life at 2 years after primary treatment for prostate cancer. 10 Recent advances in the understanding of the pathophysiology of postprostatectomy erectile dysfunction (PED) have stimulated great attention directed toward the concept of penile rehabilitation, in which prophylactic measures are instituted to prom...

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“…36,37 However, this is not a consistent finding as other studies have shown that on-demand dosing could have no greater clinical benefits than once-daily dosing. 38,39 As an example, Zumbe et al 17 showed a comparable efficacy of once-daily dose of PDE5 inhibitors with on-demand on erectile function. However, in a recent clinical study Montorsi et al 40 proposed that on-demand vardenafil treatment is the best option for the treatment of ED in men after bilateral Sildenafil citrate and mononuclear cells J García-Cardoso et al nerve-sparing radical prostatectomy with respect to daily administration.…”

Section: Sildenafil Citrate and Mononuclear Cells J García-cardoso Et Almentioning

confidence: 99%

“…Patients were excluded from the study based on the exclusion criteria typically used in studies with PDE5 inhibitors for ED treatment. 17 Patients received sildenafil citrate (Viagra) 100 mg on-demand during 12 weeks. Concomitant use of other therapies for ED was not allowed.…”

Section: Study Protocolmentioning

confidence: 99%

Increased cyclic guanosine monophosphate production and endothelial nitric oxide synthase level in mononuclear cells from sildenafil citrate-treated patients with erectile dysfunction

et al. 2009

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Mononuclear cells express enzymes involved in the NO/cyclic guanosine monophosphate (cGMP) generating system, as well as PDE5. The objective of the study was to determine the effect of sildenafil citrate administration on the level of proteins involved in the NO/cGMP generating system in mononuclear cells from patients with ED. Twenty-one patients with ED (International Index of Erectile Function-Erectile Function Domain (IIEF-EFD) 17.9±0.8) were enrolled and 100 mg sildenafil citrate on-demand was administered during 12 weeks. All patients showed cardiovascular risk factors. After sildenafil citrate administration, IIEF-EFD score was improved (26 ± 1.2 Po0.05). In the mononuclear cells, the protein level of endothelial NO synthase (eNOS) was higher after sildenafil citrate treatment. It was accompanied by reduction in the circulating plasma levels of both high-sensitive C-reactive protein and soluble intercellular adhesive molecule-1. The protein level of soluble guanylate cyclase and PDE5 did not change in the mononuclear cells after sildenafil citrate treatment. However, in the mononuclear cells exogenous NO induced a higher cGMP production after 12-weeks sildenafil citrate administration. In conclusion, in mononuclear cells from patients with ED sildenafil citrate administration increased the level of eNOS protein and increased cGMP production in response to NO. Moreover, sildenafil citrate administration reduced the plasma circulating levels of two biomarkers associated with inflammation.

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Comparable Efficacy of Once-Daily Versus On-Demand Vardenafil in Men with Mild-to-Moderate Erectile Dysfunction: Findings of the RESTORE Study

Cited by 52 publications

References 18 publications

Association Between Dosage Frequency and the Treatment Outcomes of Sildenafil in Young and Middle-aged Men With Erectile Dysfunction: A Chinese, Multicenter, Observational Study

Association Between Dosage Frequency and the Treatment Outcomes of Sildenafil in Young and Middle-aged Men With Erectile Dysfunction: A Chinese, Multicenter, Observational Study

Penile rehabilitation following treatment for prostate cancer: an analysis of the current state of the art

Increased cyclic guanosine monophosphate production and endothelial nitric oxide synthase level in mononuclear cells from sildenafil citrate-treated patients with erectile dysfunction

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