How effective are PDE-5 inhibitors?

Efficacy is a deciding factor in the selection of a therapy, also by erectile dysfunction. With PDE-5 inhibitors, efficacy can only be determined using subjective information from the patient. Various methods have been developed to quantify this information. If one attempts to compare Sildenafil, Tadalafil ( Cialis ) and Vardenafil ( Levitra ) using currently available data, it is necessary to bear in mind that groups of patients with differing severity of erectile dysfunction and various placebo response rates were examined. In addition, patients for whom Sildenafil Citrate ( Viagra ) did not work were excluded from important studies with Tadalafil ( Cialis ) and Vardenafil. Taking into consideration these factors, the new drugs show no advantages over Sildenafil. Moreover, detailed data for the counselling of certain patient groups is at present only available for Sildenafil, and there is, in addition, a high degree of patient satisfaction with this drug. The "gold standard" for the therapy of erectile dysfunction is Sildenafil Citrate ( Viagra ) and the effectiveness of all new drugs must be compared to it.

Safety and efficacy of Vardenafil ( Levitra ) in patients with erectile dysfunction: result of a bridging study in Japan.

AIM: Vardenafil ( Levitra ) is a selective and highly potent phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED), with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED. The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED. METHODS: This was a prospective, double blind, randomized clinical trial designed to evaluate the efficacy and safety of Vardenafil ( Levitra ). Following a 4-week treatment-free observation period, 283 eligible patients were randomized to 12 weeks treatment with Vardenafil ( Levitra ) 5 mg, 10 mg, 20 mg, or placebo. Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function (IIEF). RESULTS: All three Vardenafil ( Levitra ) doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF questionnaire, either at 12 weeks or at the 'last observation carried forward' (LOCF, P < 0.0001). Q3 scores were improved to 4.06 with Vardenafil ( Levitra ) 5 mg, 4.53 with Vardenafil ( Levitra ) 10 mg, and 4.64 with Vardenafil ( Levitra ) 20 mg, versus 3.17 with placebo. Comparable scores for Q4 were 3.47, 4.15 and 4.31 versus 2.31 for placebo. Up to 86% of patients achieved improved erections as assessed by the global assessment question (GAQ). Reported adverse event rates were 35.3%, 45.3% and 54.5% with Vardenafil ( Levitra ) 5 mg, 10 mg and 20 mg, respectively, versus 21.1% in the placebo group. No serious adverse drug reactions were reported. The most common treatment-emergent adverse events were transient headache, flushing and rhinitis, which were mostly mild. CONCLUSION: Vardenafil ( Levitra ) is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED. The results of our trial show that up to nearly 90% of patients achieve improved erections with the administration of Vardenafil ( Levitra ).

Vardenafil.

Vardenafil hydrochloride is a potent and highly selective inhibitor of phosphodiesterase Type 5 that increases blood flow to the penis during sexual stimulation and helps restore the ability to achieve and sustain an erection in men with erectile dysfunction. Vardenafil ( Levitra ) was developed specifically to be an effective and safe oral medication for the treatment of erectile dysfunction, with potential advances over existing therapies. This review summarises key findings during the rapid and aggressive development of this compound, from in vitro assays to Phase III trials with both broad and special populations. Emphasis is placed on the presentation of data that demonstrates the clinical effectiveness and safety of this agent which is anticipated to be available in 2003.

Sustained efficacy and tolerability with Vardenafil ( Levitra ) over 2 years of treatment in men with erectile dysfunction.

This randomised, double-blind study assessed the long-term efficacy and tolerability of Vardenafil ( Levitra ) 10 and 20 mg in men with erectile dysfunction (ED). A total of 566 men who completed an initial 12-month treatment period entered a 12-month extension. In these men, both doses of Vardenafil ( Levitra ) produced improvement in scores for the 'erectile function' Domain of the International Index of Erectile Function, evident from week 4 and maintained through 2 years. Sexual Encounter Profile diary responses indicated that following treatment, penetration was achieved on 92-94% of attempts and erections that lasted long enough for successful intercourse were achieved on 87-89% of attempts. In response to the General Assessment Question, 90-92% of patients reported improved erections with Vardenafil ( Levitra ). Most treatment-emergent events were mild and transient with no cardiovascular safety concerns. These results support the long-term efficacy, reliability and tolerability of Vardenafil ( Levitra ) 10 and 20 mg in men with ED.