American Thoracic Society: Inhaled Iloprost in Class IV Pulmonary Hypertension
Speaker: Horst Olschewski, MD, Professor and Chair, Division of Pulmonary Medicine, Medical University Clinic, Medical University, Graz, Austria.
In a subset analysis of patients with New York Heart Association (NYHA) class IV pulmonary hypertension (PH), treatment with iloprost (Ventavis®, CoTherix, Inc.), a prostacyclin that offers a noninvasive inhaled dosing approach, resulted in a significant improvement in the clinically relevant measures of efficacy.
Initially, a large, placebo-controlled, randomized phase 3 trial enrolled 203 adult patients with NYHA class III and IV PH. These patients were randomly assigned to treatment with inhaled iloprost 2.5 or 5 mcg, given six to nine times a day, or placebo, for 12 weeks. Each primary clinical endpoint—a composite of an improvement in NYHA functional class, an increase in the distance walked in six minutes of at least 10%, and no clinical deterioration or death—was achieved in the treated patients versus those taking placebo.
The subgroup analysis included 83 patients with NYHA class IV PH, prospectively categorized by idiopathic pulmonary arterial hypertension (PAH), associated PAH, and chronic thromboembolic PH (CTPH) who participated in the phase 3 clinical trial. Thirty-eight of those individuals had primary PH (PPH). The mean baseline six-minute walking distance among NYHA class IV patients was 278 meters; for class III patients, it was 355 meters. Among these 83 patients, 17% of patients (7 of 41) taking iloprost but only 2% of the placebo patients (1 of 42) achieved the composite response. cheap cialis canadian pharmacy
For the six-minute walking distance, NYHA class IV patients receiving iloprost showed a statistically significant increase of 27 meters from the baseline; the placebo patients showed a reduction of 9.5 meters. This placebo-corrected improvement of 37 meters for iloprost-treated class IV patients was comparable to the 36 meters for iloprost-treated class III patients and the 36-meter improvement for all classes in the large-scale clinical trial.
Among the subset of NYHA class IV patients with PPH, 32% of the iloprost patients (6/19) and 5% of the placebo patients (1/19) met the composite response primary endpoint. The placebo-corrected improvement was 59 meters in the six-minute walking distance exercise.
Sildenafil for Pulmonary Hypertension in Pulmonary Fibrosis
Speaker: Heinrike Wilkens, MD, Professor of Medicine, Medi-zinische Klinikund Poliklinik, Linere Medizin V, University of Saarland Clinic, Hamburg, Saaland, Germany.
Long-term treatment with sildenafil (Pfizer), a drug well known for its vasodilatory capabilities, has shown benefit for patients with severe lung fibrosis and secondary pulmonary hypertension (PH).
Because interstitial lung diseases are often complicated by PH, and because it has been suggested that sildenafil citrate (now called Revatio® when used for this indication) might provide preferential pulmonary vasodilation in patients with pulmonary fibrosis and PH, a study was designed to assess the effects of at least three months in 10 patients with severe interstitial lung disease and secondary PH. Three of these patients were on the high-urgency waiting list for lung transplantation.
The patients received their first dose of sildenafil during vasoreactivity testing. After that, all patients received canadian sildenafil titrated to a dose of 50 mg three times daily. The researchers recorded the effects on gas exchange, dyspnea scores, and the six-minute walking test each month.
All patients showed a hemodynamic response, with a significant decrease in pulmonary vascular resistance. During a median follow-up period of 8.4 months (range, 4-18 months), the patients achieved significant improvements in gas exchange, dyspnea, and quality of life within the first month. These responses were maintained throughout follow-up.