Table 5

Specific adverse events (treatment related) in comparisons with placebo




Number (%) with outcome






Dosing (mg)
Number of trials
Adverse event
Sildenafil
Placebo
Relative risk (95% CI)
NNH (95% CI)

25
3
Dyspepsia
4/312 (1.2)
1/426 (0.2)
4.4 (0.6 to 34)


Headache
31/312 (10)
14/426 (3.2)
3.1 (1.6 to 6.1)
15 (9.6 to 34)


Vasodilation
30/312 (9.6)
4/426 (1.0)
11 (3.8 to 29)
12 (8.3 to 19)
50
5
Dyspepsia
24/511 (4.7)
4/607 (0.7)
6.4 (2.4 to 17)
24 (17 to 47)


Headache
77/511 (15)
21/607 (0.3)
4.5 (2.8 to 7.3)
8.6 (6.6 to 12)


Vasodilation
94/511 (18)
11/607 (1.8)
9.7 (5.4 to 18)
6.0 (5.0 to 7.7)
100
5
Dyspepsia
60/506 (12)
4/607 (0.7)
15 (5.8 to 40)
8.9 (7.1 to 12)


Headache
115/506 (23)
21/607 (0.3)
6.8 (4.3 to 11)
5.2 (4.3 to 6.5)


Vasodilation
90/506 (17)
11/607 (1.8)
9.2 (5.0 to 17)
6.3 (5.1 to 8.0)
200
2
Dyspepsia
35/191 (18)
3/181 (1.7)
11 (3.5 to 35)
6.0 (4.5 to 9.2)


Headache
62/191 (32)
7/181 (3.9)
8.4 (4.0 to 18)
3.5 (2.8 to 4.7)


Vasodilation
43/191 (22)
7/181 (3.9)
5.9 (2.7 to 13)
5.4 (4.0 to 8.3)
Dose optimised
5
Dyspepsia
24/517 (4.6)
7/524 (1.3)
3.4 (1.5 to 7.9)
31 (19 to 82)


Headache
63/517 (12)
10/524 (1.9)
6.3 (3.2 to 12)
9.8 (7.5 to 14)


Vasodilation
65/517 (13)
4/524 (0.8)
16 (6.0 to 44)
8.5 (6.7 to 11)

Moore et al. BMC Urology 2002 2:6   doi:10.1186/1471-2490-2-6