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  • Literatuur
    ADIS NEW DRUG PROFILE

    Douglas Ormrod, Stephanie E. Easthope and David P. Figgitt
    Drugs Aging 2002; 19(3) 217-227

    Vardenafil selectively inhibits phosphodiesterase type 5 (PDE5), an enzyme which hydrolyses cyclic guanosine monophosphate in the cavernosum tissue of the penis. Inhi-bition of PDE5 results in increased arterial blood flowleading to enlargement of the corpus cavernosum. Because of the in-creased tumescence, veins are compressed between the cor-pus cavernosumand the tunica albuginea, resulting in an erec-tion. Vardenafil has a high bioavailabilty and is rapidly absorbed. An erection of >60% rigidity was maintained for approxi-mately twice as long following visual stimulation in patients treated with vardenafil 10 or 20mg than in recipients of pla-cebo. In a large, placebo-controlled trial in patients with mild to severe erectile dysfunction (ED), vardenafil 5, 10 or 20mg taken as needed over a 12-week period significantly improved the scores in questions 3 and 4 of the International Index of Erectile Function (IIEF). The rate of successful attempts at intercourse with ejaculation was also significantly higher with vardenafil (71 to 75%) than in the placebo group (39.5%), and significantly more patients treated with vardenafil than placebo responded ‘yes’ to a Global Assessment Question (GAQ) asking if treatment had improved erections. In a 26-week trial in 736 men with ED of varied aetiologies and severity patients receiving vardenafil 5, 10 or 20mg ex-perienced significantly improved erections with 85% of var-denafil 20mg recipients reporting improved erectile function
    (assessed using the GAQ) compared with 28% of placebo recipients. Treatment with vardenafil also significantly im-proved scores in response to questions 3 and 4 of the IIEF compared with placebo. A12-week trial in 452 men with ED associated with diabetes mellitus demonstrated that treatment with vardenafil 20mg compared with placebo significantly improved IIEF erectile function domain scores and the rate of positive responders to the erectile improvement GAQ. Similar results were reported in a placebo-controlled trial of vardenafil 10 to 20mg involv-ing 440 patients with ED after radical prostectomy. Adverse events associated with vardenafil were those com-monly associated with PDE5 inhibitors: headache, flushing, dyspepsia and rhinitis. These were mostly dose-dependent and mild to moderate in intensity.

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