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.
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
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.
- Be between 18 years and 70 years of age
- Be male or if female, be physiologically incapable of childbearing or practicing an
acceptable method of birth control (women of childbearing potential must have a
negative pregnancy test).
- Have a current World Health Organization (WHO) functional classification of II-III
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
Group 1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary
hypertension associated with lung disease (Mild interstitial lung disease associated
with predominant features of right heart failure as seen in Group 1 PAH patients);
Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension
- In the opinion of the investigator, be hemodynamically stable with no signs or
symptoms of disease progression
- Be receiving intravenous epoprostenol therapy for at least three months and a stable
dose for at least one month prior to Baseline.
- Have a central intravenous catheter in place.
- Have a baseline six-minute walk distance of at least 150 meters.
- Be optimally treated with conventional pulmonary hypertension therapy and clinically
stable for at least one month prior to baseline assessments.
- Be mentally and physically capable of learning to administer Remodulin using an
intravenous infusion pump.
- Be a nursing or pregnant woman
- Have had a new type of chronic therapy (including but not limited to oxygen, a
different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for
pulmonary hypertension added within the last month.
- Have any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3
- Have an on-going central venous line infection within the past 30 days.
- Have evidence of predominant left-sided heart disease
- Have any other disease that is associated with pulmonary hypertension (e.g. sickle
cell anemia, schistosomiasis).
- Have a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other
disease, which is thought to limit ambulation, or be connected to a machine, which is
- Have uncontrolled systemic hypertension as evidenced by a systolic blood pressure
greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.
- Be receiving an investigational drug, have in place an investigational device, or
have participated in an investigational drug study within the past 30 days.
- Have the presence of any physiological or psychological condition that
contraindicates the administration of Remodulin.