October 21, 2008Annals of Internal Medicine
Addition of Sildenafil to Long-Term Intravenous Epoprostenol Therapy in Patients with Pulmonary Arterial Hypertension
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Discussion
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Implication
Randomized double-blind trial shows adding sildenafil to epoprostenol improves exercise capacity and hemodynamics in pulmonary arterial hypertension, highlighting benefits of combination therapy.
Key Points
- To determine whether adding oral sildenafil to long-term intravenous epoprostenol therapy improves exercise capacity and clinical outcomes in patients with pulmonary arterial hypertension.
- Multinational, 16-week, double-blind, placebo-controlled, parallel-group study conducted at 41 centers across 11 countries involving 267 patients receiving long-term intravenous epoprostenol.
- Participants were randomly assigned to receive placebo or oral sildenafil (20 mg three times daily, titrated to 40 mg and 80 mg three times daily as tolerated at 4-week intervals).
- Sildenafil treatment produced a placebo-adjusted increase of 28.8 meters (95% CI, 13.9 to 43.8 meters) in 6-minute walk distance, with greater improvements in patients with baseline distance ≥325 meters.
- Addition of sildenafil reduced mean pulmonary arterial pressure by -3.8 mm Hg (95% CI, -5.6 to -2.1 mm Hg), increased cardiac output by 0.9 L/min (95% CI, 0.5 to 1.2 L/min), and lowered the proportion of patients experiencing clinical worsening by week 16 (0.062 vs. 0.195; P = 0.002).
- Headache (57% vs. 34%; difference, 23 percentage points [95% CI, 12 to 35]) and dyspepsia (16% vs. 2%; difference, 13 percentage points [95% CI, 7 to 20]) were more frequent in the sildenafil group.
Cite This Study
Gérald Simonneau (2008) studied this question.