Table 2.
Outcome of the Individual Studies
| Reference | Intervention with Avanafil | Change in IIEF-EF, Mean ± SD/Median (IQR) | Change in SEP-2 (Successful Vaginal Penetration), n | Change in SEP-3 (Successful Intercourse), n | Adverse Events, n | ||||
|---|---|---|---|---|---|---|---|---|---|
| TEAE | SAE | Headache | Flushing | ||||||
| Belkoff et al, 201316 | A 100mg | 8.6 | 67/147 | N/A | 135/711 | 6 | 19/711 | 10/711 | |
| A 100/200mg | 10.8 | 196/535 | 183/514 | 5 | 27/514 | 17/514 | |||
| Elkamshoushi et al, 202117 | A 50mg | Pre: 9 (7–14) | Post: 13 (10–17) | N/A | N/A | N/A | N/A | N/A | N/A |
| Placebo | Pre: 11.5 (10–13) | Post: 12 (10–13) | |||||||
| Goldsteina et al, 201218 | A 50mg | 5.5 ± 0.6 | 45/154 | 44/154 | 52/160 | 1/160 | 7/160 | 6/160 | |
| A 100mg | 8.3 ± 0.6 | 42/157 | 68/157 | 68/161 | 3/161 | 12/161 | 10/161 | ||
| A 200mg | 9.4 ± 0.6 | 45/156 | 70/156 | 63/162 | 3/162 | 15/162 | 6/162 | ||
| Placebo | 2.9 ± 0.6 | 11/155 | 22/155 | 42/161 | 2/161 | 2/161 | 0 | ||
| Goldsteinb et al, 201219 | A 100mg | 4.5 ± 0.6 | 27/126 | 33/126 | 45/127 | 3/127 | 5/127 | 2/127 | |
| A 200mg | 5.4 ± 0.6 | 28/126 | 40/126 | 42/131 | 4/131 | 15/131 | 5/131 | ||
| Placebo | 1.8 ± 0.6 | 8/127 | 14/127 | 31/130 | 1/130 | 2/130 | 0 | ||
| Hellstrom et al, 201220 | A 50mg | 19.0 ± 4.0 | N/A | N/A | 4/27 | 0 | 1/27 | 4/27 | |
| A 100mg | 18.0 ± 4.3 | 3/27 | 0 | 0 | 2/27 | ||||
| A 200mg | 19.4 ± 3.8 | 4/28 | 0 | 1/28 | 2/28 | ||||
| Hellstrom et al, 201521 | A 100mg | 18.1 ± 0.8 | 27/139 | 50/139 | 30/146 | 4/146 | 2/146 | N/A | |
| A 200mg | 19.1 ± 0.8 | 30/139 | 52/139 | 40/146 | 2/146 | 13/146 | |||
| Placebo | 13.9 ± 0.8 | 7/136 | 22/136 | 30/143 | 2/143 | 1/143 | |||
| Jiang et al, 202122 | A 100mg | 8.2 ± 5.9 | 15/64 | 28/64 | 35/68 | 0 | 3/68 | 2/68 | |
| A 200mg | 8.1 ± 6.8 | 16/69 | 27/69 | 31/71 | 0 | 4/71 | 0 | ||
| Placebo | 4.8 ± 7.2 | 4/65 | 15/65 | 28/67 | 0 | 0 | 1/67 | ||
| Kumar et al, 202223 | A 100mg/200mg | 2.1 | 14/108 | 19/108 | 13/111 | 0 | 9/111 | 0 | |
| S 50mg/100mg | 0.7 | 10/103 | 14/103 | 13/109 | 0 | 10/109 | 1/109 | ||
| Mulhall et al, 201324 | A 100mg | 3.6 ± 1.2 | 29/94 | 26/94 | 38/99 | 0 | 8/99 | 5/99 | |
| A 200mg | 5.2 ± 1.1 | 37/96 | 36/96 | 45/99 | 0 | 12/99 | 10/99 | ||
| Placebo | 0.1 ± 0.4 | 7/96 | 14/96 | 23/100 | 0 | 1/100 | 0 | ||
| Park et al, 201725 | A 50mg | 4.9 (95% CI 3.1–6.7) | 8/40 | 9/40 | 3/40 | 0 | 1/40 | 1/40 | |
| A 100mg | 6.8 (95% CI 5.0–8.6) | 9/40 | 18/40 | 4/40 | 0 | 0 | 2/40 | ||
| A 200mg | 9.1 (95% CI 7.3–11.0) | 11/39 | 21/39 | 5/40 | 0 | 2/40 | 3/40 | ||
| Placebo | 3.2 (95% CI 1.4–5.1) | 4/39 | 13/39 | 4/39 | 0 | 1/39 | 1/39 | ||
| Zhao et al, 201227 | A 100mg | 8.5 | 18/68 | 37/68 | 25/70 | 0 | 3/70 | 8/70 | |
| A 200mg | 8.8 | 19/66 | 37/66 | 22/69 | 0 | 7/69 | 9/69 | ||
| Placebo | 3.5 | 10/66 | 17/66 | 3/68 | 0 | 0 | 2/68 | ||
Abbreviations: A, Avanafil; S, Sildenafil; IIEF-EF, International Index of Erectile Function; SEP, sexual encounter profile; SD, standard deviation; IQR, interquartile range; ED, erectile dysfunction; N/A, not available; TEAE, treatment-emergent adverse event; SAE, serious adverse event.