Sildenafil Citrate Therapy for Pulmonary Arterial Hypertension

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Abstract
The Sildenafil Use in Pulmonary Hypertension (SUPER) trial (Nov. 17 issue)1 has led to the approval of sildenafil for the treatment of pulmonary arterial hypertension by the Food and Drug Administration and its European counterpart, the European Medicines Agency. Although the availability of a new treatment is embraced, the agencies have created a major problem by restricting the sildenafil dose to 20 mg three times a day. The SUPER trial involved three doses — 20 mg, 40 mg, and 80 mg three times a day. Although all doses had similar effects with regard to the distance walked in six minutes, there was a trend toward improved hemodynamics with increasing doses of sildenafil, apparently without causing an increase in side effects. Impressive results were reported from the open-label extension of the SUPER trial, in which the majority of patients received 80 mg three times a day. The long-term efficacy of the approved dose of 20 mg three times a day remains unknown, and this dose may prove insufficient when patients are treated over extended periods of time, especially when they are receiving concomitant bosentan therapy.2,3 Although probably intended to protect patients, the decision to limit the sildenafil dose to 20 mg three times a day may cause substantial harm by preventing the use of appropriate doses.