In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with Revatio (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day, as tolerated) and epoprostenol, and 131 patients were treated with placebo and epoprostenol. The duration of treatment was 16 weeks. The overall frequency of discontinuations in sildenafil/epoprostenol treated patients due to adverse events was 5.2% compared to 10.7% in the placebo/epoprostenol treated patients. Newly reported adverse reactions, which occurred more frequently in the sildenafil/epoprostenol group, were ocular hyperaemia, vision blurred, nasal congestion, night sweats, back pain and dry mouth. The known adverse reactions headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/epoprostenol treated patients compared to placebo/epoprostenol treated patients. Of the subjects who completed the initial study, 242 entered a long-term extension study. Doses up to 80 mg TID (4 times the maximum recommended dose of 20 mg three times a day) were administered and after 3 years 68% of 133 patients on study treatment were receiving Revatio 80 mg TID.
In the two placebo-controlled studies adverse events were generally mild to moderate in severity. The most commonly reported adverse reactions that occurred (greater or equal to 10%) on Revatio compared to placebo were headache, flushing, dyspepsia, diarrhoea and pain in extremity.
Tabulated list of adverse reactions: Adverse reactions which occurred in > 1% of Revatio-treated patients and were more frequent (> 1% difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table as follows by class and frequency grouping (very common (≥ 1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Reports from post-marketing experience are included in italics. (See table.)
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In a study to assess the effects of different dose levels of sildenafil on mortality in adults with PAH, the group who received the lower dose 5 mg three times a day (4 times lower than the recommended dose) showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events and severe adverse events than the 20 mg three times a day (recommended dose) and 80 mg three times a day (4 times the maximum recommended dose) groups (see Pharmacology under Actions).
The most commonly reported adverse reactions that occurred (≥ 5%) in the Revatio combined data set were headache and dizziness.
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