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Generic levitra (Vardenafil), a novel selective phosphodiesterase type 5 inhibitor, was evaluated in its first large scale at home trial. A total of 601 men with mild to severe erectile dysfunction (ED) were enrolled in this multi centre, randomized, double blind, placebo controlled trial of 12 weeks of treatment with either placebo or 5, 10 and 20 mg of vardenafil. Primary endpoints were Q3 (vaginal penetration) and Q4 (maintenance of erection) of the International Index of Erectile Function (IIEF). In the intent to treat population (n=580), the changes from baseline for 5, 10 and 20 mg Generic levitra (1.2, 1.3 and 1.5, respectively) were all improved (P<0.001) over placebo (0.2) for Q3 and were similarly improved for Q4 (1.4, 1.5 and 1.7) compared to placebo (0.5) (P<0.001). All Generic levitra doses improved all IIEF domains compared to placebo (P<0.001). The percentage of successful intercourses was between 71 and 75% for the three Generic levitra doses. For the 20 mg dose, 80% of the patients experienced improved erections (GAQ) compared to 30% for placebo. Most frequent treatment emergent adverse events were headache (7 15%), flushing (10 11%) and up to 7% for dyspepsia or rhinitis. Generic levitra treatment resulted in a high efficacy and low adverse event profile in a population with mixed ED etiologies.
GENERIC NAME: vardenafil
BRAND NAME: Levitra
DRUG CLASS AND MECHANISM: Generic levitra (Vardenafil) is an oral drug that is used to treat impotence (the inability to attain or maintain a penile erection.). It is a phosphodiesterase inhibitor that is similar to sildenafil (Viagra).
Penile erection is caused by the engorgement of the penis with blood. This engorgement occurs when the blood vessels delivering blood to the penis increase in size and increase the delivery of blood to the penis. At the same time, the blood vessels carrying blood away from the penis decrease in size and decrease the removal of blood from the penis. Sexual stimulation that leads to the engorgement and erection causes the production and release of nitric oxide in the penis. Nitric oxide then activates the enzyme, guanylate cyclase to produce cyclic guanosine monophosphate (cGMP). The cGMP is primarily responsible for increasing and decreasing the size of the blood vessels carrying blood to and from the penis, respectively. Generic levitra prevents an enzyme called phosphodiesterase-5 from destroying cGMP so that cGMP persists longer. The longer cGMP persists, the more prolonged the engorgement of the penis. Generic levitra was approved by the FDA in August, 2003.
PRESCRIPTION: Yes
PREPARATIONS: Tablets: 2.5, 5, 10 and 20 mg
STORAGE: Generic levitra should be stored at room temperature between 15-30