A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary arterial hypertension (PAH)
N. Skoro-Sajer, E. Harja, I. M. Lang, M. P. Kneussl, W. Gin Sing, J. S. R. Gibbs (Vienna, Austria; London, United Kingdom)
Source: Annual Congress 2003 - Pulmonary hypertension
Session: Pulmonary hypertension
Session type: Oral Presentation
Number: 3537
Disease area: Pulmonary vascular diseases
Abstract INTRODUCTION: Continuous subcutaneous infusion of treprostinil is an effective treatment of PAH and does not require a permanent central venous catheter. An initial study indicated that infusion site pain, a common treprostinil side effect, was dose-dependent. HYPOTHESIS: Rapid-escalation treprostinil dosing regimens are as safe and effective as slow-escalation dosing regimens. METHODS: 23 patients (pts) received treprostinil for 24.3±10.2 months to treat primary and secondary PAH. Group one (11 pts; 7 female, 4 male) received a slow-escalation regimen (starting dose 2 ng/kg/min, weekly dose increments 1.25-2.5 ng/kg/min). Group two (12 pts; 10 female, 2 male) was exposed to rapid- dose escalation (starting dose 2.5 ng/kg/min, weekly dose increments 2 x 2.5 ng/kg/min). Follow-up occurred after 12 weeks. Dose up-titration, six-minute walk test (6WT), shuttle walk test (SWT), NYHA classification, blood pressure (BP), heart rate (HR), respiration rate (RR), baseline haemodynamic data and adverse events were monitored. RESULTS: Treprostinil dose after 12 weeks was 12.9 ng/kg/min in group one and 20.3 in group two (p<0.01). In both groups, NYHA classification changed from 3.2 at baseline to 3.0 at follow-up (p<0.05). Hemodynamic parameters, adverse events and changes in HR, RR, BP, 6 WT, and SWT were similar for both groups. CONCLUSION: The rapid-dosing regimen is safe, effective and may be associated with even better clinical outcomes than the slow-dosing regimen.
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N. Skoro-Sajer, E. Harja, I. M. Lang, M. P. Kneussl, W. Gin Sing, J. S. R. Gibbs (Vienna, Austria; London, United Kingdom). A clinical comparison of slow- and rapid-escalation treprostinil dosing regimens in patients with pulmonary arterial hypertension (PAH). Eur Respir J 2003; 22: Suppl. 45, 3537
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