For patients with pulmonary hypertension as a consequence of the scleroderma spectrum of diseases

      The purpose of this study (trial #VA1A4001) is to determine the safety and impact of adding a continuous infusion of Flolan (R) to conventional therapy for patients with pulmonary hypertension associated with the scleroderma spectrum of diseases as compared to administering conventional therapy alone. The impact of Flolan (R) will be determined by measuring exercise ability, blood pressure in the lungs and other symptoms of pulmonary hypertension. All participants in this study must have pulmonary hypertension as a consequence of scleroderma spectrum of diseases. Side effects of Flolan (R) can include headache, dizziness , nausea/vomiting, and jaw pain.

      It is important to study the safety and efficacy of epoprostenol sodium (Flolan (R) ) in this patient group because, based on the experience with patients with PPH, there is a high likelihood that participants who begin therapy with epoprostenol sodium and appear to be benefiting will need to continue treatment for a prolonged period, possibly years. Abrupt withdrawal and interruption in drug delivery may result in symptoms of rebound pulmonary hypertension.

      In some other conditions, therapy with epoprostenol sodium has not been shown to be beneficial or has been seriously detrimental. Use of epoprostenol sodium is contraindicated in patients with congestive heart failure due to severe left ventricular systolic dysfunction.

      The inclusion/exclusion criteria, patient commitment, duration likelihood, treatment/test methods, and possible outcomes of this study are all formidable and numerous and should be thoroughly investigated and completely understood before one even considers participation. Health care professionals with questions about Flolan(R) should contact the Glaxo Wellcome Drug Information Department at 800-334-0089. Patients or other individuals seeking additional information should discuss this study with their physician or contact one of the clinical trial sites. Locations are available from the Glaxo Wellcome Drug Information department.

  l    EDITOR NOTE: The information on this page is provided without implied recommendation, solely as a service to those who may be interested. As with all research projects, interested parties should thoroughly question and have a complete understanding before considering participation.