Key result
Administration of IV treprostinil at low infusion rates using a miniaturized pump for 12 weeks resulted in no catheter occlusions, though pump complications occurred in 5 of 12 patients.
Why the study?
Does low-flow intravenous treprostinil via a miniaturized pump prevent catheter occlusions in adult patients with pulmonary arterial hypertension?
Does low-flow intravenous treprostinil via a miniaturized pump prevent catheter occlusions in adult patients with pulmonary arterial hypertension?
Intravenous treprostinil can be administered at low infusion rates via a miniaturized pump without catheter occlusions, though pump complications and adverse events warrant further study.
Low-rate IV treprostinil via miniaturized pump was associated with no occlusions in PAH; hypothesis-generating and requires randomized trials before practice change.
PURPOSE: Treprostinil is approved for the treatment of pulmonary arterial hypertension (PAH) via continuous intravenous (IV) infusion. Treprostinil's anti-platelet aggregation characteristics and stability at room temperature may allow for low infusion rates (0.1-0.2 mL/hr) using a miniaturized infusion pump. METHODS: A 12-week, multi-center, open-label study in 12 adult PAH patients, evaluated the feasibility and safety of low-flow IV treprostinil administration via the 407C miniaturized pump. Patients receiving IV treprostinil at a stable dose were transitioned from their current CADD-Legacy pump to the 407C and were assessed for adverse events including catheter occlusions, pump alarms, and efficacy (six minute walk distance (6MWD), Borg Dyspnea Score (BDS), NYHA functional class, and PAH signs/symptoms). All patients were also maintained on therapeutic doses of warfarin, heparin or low molecular weight heparin throughout the study. RESULTS: Baseline mean (+/-SD) 6MWD was 477 +/- 76 m (n = 9) with mean BDS of 2.1 +/- 1.2 (n = 9). Week 12 mean 6MWD and BDS were 500 +/- 92 m and 2.3 +/- 1.7, respectively (n = 9). Four patients discontinued the study prematurely (3 AEs and 1 consent withdrawn). Adverse events included headache, flushing, and nausea. Pump complications occurred in 5 of 12 patients, and although no catheter occlusions occurred in any patient during the 12-week study, further study is needed regarding pump complications. CONCLUSION: This study demonstrates that treprostinil can be administered intravenously at infusion rates as low as 0.1 mL/hr for 12 weeks without catheter occlusions. Further studies are warranted because the potential for adverse events is of some concern.
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Tapson et al. (2006) studied Pulmonary arterial hypertension (PAH) (n=12). Low-flow IV treprostinil via the 407C miniaturized pump was evaluated on Feasibility and safety (adverse events including catheter occlusions, pump alarms) and efficacy. Administration of IV treprostinil at low infusion rates using a miniaturized pump for 12 weeks resulted in no catheter occlusions, though pump complications occurred in 5 of 12 patients.
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