Table 7.
Number of | Percent with | ||||||
Outcome | Dose (mg) | Trials | Patients | Vardenafil | Placebo | Relative benefit or risk (95% CI) | NNT/NNTp/NNH(95%CI) |
Efficacy | |||||||
Improved erections | 5 | 3 | 833 | 62 | 27 | 2.3 (1.9 to 2.7) | 2.9 (2.4 to 3.5) |
10 | 5 | 1401 | 68 | 21 | 3.3 (2.9 to 3.9) | 2.1 (1.9 to 2.3) | |
20 | 7 | 2147 | 73 | 22 | 3.4 (3.0 to 3.8) | 2.0 (1.8 to 2.1) | |
10/20 | 7 | 2856 | 71 | 22 | 3.3 (3.0 to 3.8) | 2.0 (1.9 to 2.2) | |
Withdrawal | |||||||
All-cause | 10 | 3 | 812 | 4.2 | 2.5 | 1.7 (0.8 to 3.7) | not calculated |
20 | 5 | 1623 | 18 | 32 | 0.6 (0.5 to 0.7) | 6.9 (5.4 to 9.7) | |
10/20 | 5 | 2061 | 20 | 32 | 0.6 (0.5 to 0.6) | 7.7 (6.0 to 11) | |
Lack of efficacy | 5 | 2 | 505 | 11 | 18 | 0.6 (0.4 to 0.9) | 14 (7.5 to 85) |
10 | 4 | 1084 | 4 | 15 | 0.3 (0.2 to 0.4) | 9.3 (7.1 to 14) | |
20 | 6 | 1831 | 4 | 13 | 0.3 (0.2 to 0.4) | 11 (8.7 to 15) | |
10/20 | 6 | 2320 | 4 | 12 | 0.3 (0.2 to 0.4) | 11 (9.0 to 16) | |
Adverse event | 5 | 3 | 812 | 4.2 | 2.5 | 1.7 (0.8 to 3.7) | not calculated |
10 | 5 | 1395 | 2.8 | 1.9 | 1.5 (0.7 to 3.0) | not calculated | |
20 | 7 | 2161 | 3.6 | 1.8 | 2.1 (1.2 to 5.3) | 54 (31 to 210) | |
10/20 | 7 | 2868 | 3.3 | 1.8 | 1.8 (1.1 to 3.0) | 65 (37 to 250) | |
Adverse events | |||||||
All cause | 10/20 | insufficient data | |||||
Severe | 10/20 | 3 | 1096 | 2.7 | 2.2 | 1.2 (0.5 to 2.8) | not calculated |
Serious | 10/20 | 5 | 1984 | 2.2 | 3.2 | 0.7 (0.4 to 1.2) | not calculated |
Headache | 10/20 | 6 | 2411 | 15 | 4.1 | 3.4 (2.4 to 4.8) | 9.6 (7.9 to 12) |
Dyspepsia | 10/20 | 5 | 1972 | 3.8 | 0.3 | 7.3 (2.4 to 22) | 31 (22 to 48) |
Flushing | 10/20 | 5 | 1984 | 13 | 0.8 | 13 (6.3 to 27) | 8.0 (6.9 to 9.6) |
Rhinitis | 10/20 | 5 | 2212 | 7.9 | 3.6 | 2.2 (1.5 to 3.4) | 23 (16 to 42) |
NNT is given in standard font, NNTp in bold, and NNH in bold italic. No NNT/NNTp/NNH was calculated unless there was a statistically significant difference