Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this 8-week study is to compare the effects of switching from therapy with
      epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing
      to Remodulin will have on patient satisfaction with their treatment and impact on quality of
      life.
    

Detailed description: 
      Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial
      pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a
      variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an
      increase in right ventricular afterload, impairing right ventricular function and ultimately
      leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to
      ameliorate symptoms of PAH and to improve health related quality of life (HRQOL).

      Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent
      pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in
      vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon
      bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable
      than epoprostenol and may offer potential safety and convenience advantages compared to
      intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or
      patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is
      stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin
      remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is
      less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line
      clog. In an open-label study in Europe, patients who were using a type of portable medication
      pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no
      serious side effects. This study will examine effects of switching from therapy with
      epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment
      satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with
      pulmonary hypertension using the CADD legacy pump.

      Participation in this study will last approximately 10 weeks. Study procedures include
      routine blood tests, medical history, physical exams, disease evaluation, exercise tests and
      patient questionnaires. Participants will have 4 visits during the study and will spend at
      least 1 night in the hospital.
    

Intervention name(s): treprostinil sodium
Intervention type(s): Drug
Intervention description(s): rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump
Other intervention name(s): Remodulin; Flolan
Intervention MeSH terms: Treprostinil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary hypertension; PAH; Remodulin; treprostinil; Quality of Life; Rapid Switch