Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial

Hellstrom, Wayne J.G.; Gittelman, Marc; Karlin, Gary S.; Segerson, Thomas P.; Thibonnier, Marc; Taylor, Terry; Padma‐Nathan, Harin

doi:10.1016/s0090-4295(03)00115-8

Cited by 131 publications

(85 citation statements)

References 16 publications

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“…112 Further analysis showed the effects of vardenafil were similar in the organic, psychogenic and mixed groups, and regardless of baseline severity. 113,114 Similar results were obtained in a 6 month trials of 5, 10 or 20 mg vardenafil or placebo in 805 ED patients, mostly of organic aetiology, 115 a 6 month trial of 5, 10 or 20 mg vardenafil in 1650 men in a broad of men with ED, 116 and in flexible-dose studies starting with 10 mg vardenafil. 117,118 A 12-month extension to a 12-month trial of 566 men with ED of 10 and 20 mg vardenafil, showed that vardenafil had long-term efficacy, reliability and tolerability.…”

Section: Clinical Trials With Vardenafilsupporting

confidence: 66%

“…One point of difference is that no alterations of colour vision were reported in the early studies with vardenafil. 112,113,116,117 whereas transient visual disturbances were reported in the early studies with sildenafil. There are no clinical trials directly comparing sildenafil and vardenafil, and such trials should be undertaken to determine if there are any differences between the drugs.…”

Section: Clinical Trials With Vardenafilmentioning

confidence: 99%

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Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

Doggrell

2006

Int J Impot Res

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Erectile dysfunction (ED) affects up to 50% of men between the ages of 40 and 70 years of age. Sildenafil, vardenafil and tadalafil have all been shown to be similarly effective in the treatment of men with ED of vary etiologies, to have similar adverse effects profiles, and to improve quality-oflife by similar amounts. As these phosphodiesterase 5 (PDE5) inhibitors all increase the hypotensive effects of nitrates, they are not suitable for use in patients taking nitrates for the treatment of ischaemic heart disease. All three inhibitors must be used with caution in patients taking a 1 -adrenoceptors antagonists for benign prostatic hyperplasia. Although nonarteritic anterior ischaemic neuropathy has been reported in some users of the PDE5 inhibitors, there is no conclusive evidence that PDE5 inhibitors cause this rare effect. Tadalafil has a longer half-life than sildenafil or vardenafil, and a longer duration of action than sildenafil and vardenafil. Most preference studies have shown tadalafil to be preferred, but there are serious limitations to some of these studies. One approach to treatment is to give each patient a short-and long-acting agent, and for individuals to decide their preference.

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Section: Clinical Trials With Vardenafilsupporting

confidence: 66%

Section: Clinical Trials With Vardenafilmentioning

confidence: 99%

Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

Doggrell

2006

Int J Impot Res

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“…[87][88][89] Vardenafil (Levitra s ) and tadalafil (Cialis s ) are newer PDE-5 inhibitors that appear to be as effective as sildenafil. [90][91][92][93][94] All PDE-5 inhibitors are contraindicated with concomitant nitrate or any NO donator use (nitroprusside, molsidomine, etc). 95 Although these newer agents may not have additional cardiac risks compared with sildenafil, there is less clinical information related to the safety of these drugs available in patients with heart disease.…”

Section: Oral Phosphodiesterase Inhibitorsmentioning

confidence: 99%

Why do patients with heart failure suffer from erectile dysfunction? A critical review and suggestions on how to approach this problem

et al. 2005

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Chronic heart failure (HF) is an increasingly common cardiovascular disorder. The goal of healthcare providers is to optimize quality of life in this population, including sexual health. Up to 75% of patients with HF report erectile dysfunction (ED). As HF is a condition with distinct physiologic sequelae, some unique organic and psychological factors contributing to ED in this patient population have been identified, along with risk factors common to the development of coronary artery disease, HF and ED. This review describes contributing factors to ED in the setting of HF and highlights treatment considerations for this distinct patient population.

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“…6,7 Two further PDE5 inhibitors (tadalafil Cialis s , vardenafil Levitra s ) have recently been launched. Clinical trials have demonstrated that both agents are also effective in a wide range of patient subtypes; 8,9 however, they too are less effective in diabetic and postradical prostatectomy patients. 10,11 Therefore new therapeutic options, which do not require endogenous NO, are being developed.…”

Section: Introductionmentioning

confidence: 99%

NCX-911, a novel nitric oxide-releasing PDE5 inhibitor relaxes rabbit corpus cavernosum in the absence of endogenous nitric oxide

et al. 2004

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Phosphodiesterase type 5 (PDE5) inhibitors have reduced efficacy in treating erectile dysfunction (ED) in conditions where there is a lack of endogenous nitric oxide (NO). Therefore, NO-releasing PDE5 inhibitors have been developed. Here we report the effect of such a compound, NCX-911, on the tone and nitrergic relaxations of rabbit corpus cavernosum in the absence or presence of a NO synthase inhibitor, N G -nitro-L-arginine methyl ester (L-NAME; 500 lM). NCX-911 was found to be as potent as sildenafil at inducing relaxation of rabbit cavernosum (EC 50 values 997.87195.7 and 1000.57140.8 nM, respectively). The potency of NCX-911 was not altered, but that of sildenafil decreased five-fold in the presence of L-NAME (EC 50 values 1281.27268.3 and 4959.17882.1, nM respectively, Po0.001 for sildenafil). Both compounds potentiated nitrergic relaxations with similar potencies. These results suggest that NO-releasing PDE5 inhibitors could potentially be more useful than PDE5 inhibitors in the treatment of ED in conditions where there is a lack of endogenous NO.

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Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial

Cited by 131 publications

References 16 publications

Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

Do vardenafil and tadalafil have advantages over sildenafil in the treatment of erectile dysfunction?

Why do patients with heart failure suffer from erectile dysfunction? A critical review and suggestions on how to approach this problem

NCX-911, a novel nitric oxide-releasing PDE5 inhibitor relaxes rabbit corpus cavernosum in the absence of endogenous nitric oxide

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