Efficacy, safety and treatment satisfaction with tadalafil (Cialis?) in Czech and Slovak men with erectile dysfunction
Abstract
Cl: Cialis? (tadalafil) je inhibitor fosfodiesterzy 5. typu podporujc erekci prostednictvm relaxace hladk svaloviny v kavernznch tlesech. V rmci multicentrick, randomizovan, dvojit zaslepen, paraleln a placebem kontrolovan studie byla provedena analza souboru podskupiny eskch a slovenskch mu s lehkou a zvanou erektiln dysfunkc (ED), s clem vyhodnotit v tto subpopulaci innost, bezpenost a spokojenost s lbou Cialisem podvanm v reimu podle poteby. Metodika: Po 4tdenn fzi studie bez lby a stratifikaci do 3 skupin dle zvanosti stanoven vchozm skre domny erektiln funkce (EF) v dotaznku International Index of Erectile Function (IIEF) byli pacienti randomizovni k podvn Cialisu v dvce 20 mg nebo placeba po dobu 12 tdn. Pacienti si mohli vybrat as uit dvky ped sexuln aktivitou, bez zvislosti na pjmu stravy. Sledovan parametry innosti zahrnovaly zmnu skre oproti vchozmu stavu v domnch dotaznku International Index of Erectile Function, odpovdi na otzky z denk Sexual Encounter Profile (SEP) a odpovdi na dotaznk Global Assessment Questions (GAQ) pedloen na konci studie. Spokojenost s lbou byla vyhodnocena prostednictvm dotaznku Erectile Dysfunction Inventory of Treatment Satisfaction - EDITS (pouze v esk republice, kde byl k dispozici validovan peklad dotaznku). Analyzovan podskupina pacient pochzejc z prvn studie, kter poskytla daje o innosti, bezpenosti a spokojenosti s lbou tadalafilem v populaci mu s erektiln dysfunkc [1] z vchodn Evropy, disponovala dostatenou statistickou silou k…
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