الفهرس 
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Abstract
Avanafil is a relatively newly founded drug to treat ED. It belongs to the second generation of PDE5 inhibitors. It is assumed to have many advantages over the first generation group of these drugs being more selective on PDE5 and so have less side effects and have a faster onset of action (±30 minutes).
This drug is now available in many countries including Egypt. We aimed by this work to study the post-marketing efficacy and tolerability of this drug in treatment of ED and to evaluate its probable adverse events.
To approach our goal we designed a double-blind, placebo-controlled, crossed-over study that included 26 patients randomly selected from the Andrology Unit, Dermatology Department, Menoufia University- C/O ED of organic and psychogenic causes. Their ages ranged from 26 - 61 years (X 47.58 ± 10.35). All were in stable marriage for periods varied from 1 – 40 years (X 21.92 ± 12.27). The onset of ED ranged from 4-90 months (X 31.50 ± 23.86). No drug (systemic or local) for treatment of their ED for 2 weeks prior to inclusion in this study.
The patients were informed in the initial phase (phase I) for 2 weeks, about the nature of the study and all patients were subjected to full history taking, general examination, local examination, measurement of HBA1c, serum prolactin, total and free testosterone, ICI and penile duplex (for some cases) and evaluation of severity of ED by IIEF-EF domain score. This score identifies ED as severe when it is (1-10), moderate (11-16), mild to moderate (17-21) and mild (22-25) and no ED (>25). Then the patients entered phase II (6 weeks) where they intake the drug avanafil 100 mg or placebo 30 minutes pre-coital on-demand and instructed to do sexual intercourse twice/week. In phase III (2 weeks) no drug was taken (washout phase). In phase IV the patients received the other drug vice versa which he received in stage II for (6 weeks). Follow up visits were at 3rd & 6th weeks after treatment in phase II and IV during which the degree of erection, ability to penetrate the partner, onset of action, AEs and IIEF-EF domain score was applied again by the endpoint the 3rd & 6th week- in phases (II) & (IV) and reported by the investigators.
The results showed that:
1. Nine patients (45%) have organic and 11 (55%) have psychogenic ED.
2. Five patients (25%) were diabetic with HBA1c >7 (i.e. uncontrolled DM), 3 patients out of these diabetic patients were found to have venous leakage proved by penile duplex study, two patients showed hyperprolactinemia, one patient had low free and total testosterone levels and one patient had neurogenic ED.
3. IIEF-EF scoring showed that 40% had severe, 20% moderate, 15% mild to moderate and 25% mild ED.
4. Avanafil 100 mg markedly improved the IIEF-EF scoring and 9 patients (45%) became normal (no ED), 8 patients (40%) showed different grades of improvement in the severity of ED, while 3 patients (15%) showed no improvement of their score
5. Compared to baseline and placebo, avanafil showed significant improvement of ED.
6. The onset of action of avanafil starts after 30 minutes in most of cases (85%).
7. Avanafil is highly tolerable drug and has no serious AEs. The most common AEs reported are nasal congestion, headache, facial flushing, tingling of hands and/or feet, heart burn and diarrhea.