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(titrated to 100 or 25 mg), 51.3 percent and 32.9 percent of patients experienced one or more
adverse events in sildenafil and placebo arms, respectively (p values were not reported). 125 In
another study, the corresponding proportions were 59.7 percent for the sildenafil treatment group
versus 29.6 percent for the placebo arm, respectively (p = 0.079). 126
The most commonly observed all-cause adverse events across the trials were headache,
flushing, and dyspepsia. Other adverse events were myalgia, rhinitis, cardiovascular events, flulike
symptoms, nausea, respiratory events, diarrhea, vomiting, dizziness, chest pain, urinary tract
infections, depression, and anxiety. Overall, these events were less frequent for participants
taking placebo compared with those taking sildenafil. These effects were usually of a mild to
moderate or transient nature not requiring discontinuation of the therapy.
The occurrence of specific adverse events involving visual disturbances, including blurry
79-84,86,88,90,91,94,95,97,98,107,109,115, 122,125,126,131,135,
vision and chromatopsia, were reported in 33 trials. 137,138,142,146,147,151,156,164,165,167 The percentage of patients experiencing visual side effects across
the trials ranged from 1 percent 88,137,165 to 57 percent 164 for participants taking sildenafil, and
from 0 percent 80,87,88,94,95,98,101,107,109,122,125,126,135,138,147,165,167,171 to 61.9 percent 164 for participants
taking placebo.
79,83,84,87-89,94,96,97,101,102,107,109,125,126, 137,143,166
Cardiovascular events were reported in 18 studies.
These events were numerically more frequent in participants treated with sildenafil, ranging from
3 percent 94 to 29 percent, 97 compared with the range of 0 percent 101 to 12 percent 97 for placebotreated
participants.
A few studies reported the need for dose reduction as a result of adverse events. 80,84,87,115,151
The reasons for dose reduction were headache, 80,87,151 flushing, 87 chest tightness, 87 nasal
stuffiness, 87 and visual disturbance. 80
78-80,82, 85,98,104,
Twenty-four trials reported the absence of withdrawals due to adverse events. 105,107,110,112,128,131,133,134,138,146,149,156,167,168,171 The rate of WDE (presented as the proportion of
patients who withdrew) in sildenafil treatment groups was under 5 percent in 18 trials, 81,83,84,88,90,
91,96,109,115,125,135,137,142,151,156,160,175 and up to 8 to 12.5 percent in four trials. 96,99,101,126 In the
majority of these trials, the rate for withdrawals due to adverse events in placebo-treated
participants ranged between 2 and 8.5 percent. The specific events leading to withdrawals were
headache, 88,101,109,137,142,151 nausea, vomiting, gastrointestinal symptoms, 86,88,137 visual
disturbances, 88,165 cardiovascular events, 87,89,99,101,165,166 urinary tract infection, 166 chest pain, 101
and cerebrovascular events. 160 These events were reported for participants treated with sildenafil,
with the exception of one case of myocardial infarction 89 and one case of urinary tract
infection 166 in placebo-treated participants.
The occurrence/absence of serious adverse events was reported in 51 trials. In 29 trials, no
78,80,81,85,90,91,98,99,101,105,108,110-112, 124,125,128,131,133,134,
patient experienced any serious adverse event. 138,146,149,156,157,167,168,173 Thus, the occurrence of serious adverse events was reported in 22 trials
(Table 10). 82-84,87-90,93,95-97,107,109,123,126,135,143,147,151,160,166,171 In general, the quality of reporting
serious adverse events was poor, and some studies did not provide a full description of events. 82,
95,107,109,126,135,147,151,160,166 In total, 95 participants had at least one serious adverse event while
83,84,87,88,90,93,97,107,109, 126,135,143,147,
taking sildenafil or placebo, of which 32 were taking sildenafil 151,160,166 and 36 were taking placebo. 82,84,87,89,97,107,109,123,126,135,143,147,151,160,166,171 For the
remaining 27 participants in two trials, 95,96 the treatment group designation was not reported.
Cardiovascular events were the most frequent category of serious adverse events. These included
myocardial infarctions, which occurred in one participant taking sildenafil, 83 two participants
taking placebo, 89,126 and one participant whose group designation was unknown. 96 Severe angina
33