FLOLAN - TRACLEER

Flolan (epoprostenol)

Flolan Is used to treat people who have been diagnosed with Primary Pulmonary Hypertension also known as PPH. Flolan first approved in October 1995 by the FDA for use in cases of symptomatic PPH, Flolan was first available for use in the United States in January 1996. It must be continuously infused into the heart as prostacyclin lasts only for several minutes in the circulation. Flolan recipients must have a permanent central venous catheter implanted which is attached to an external portable infusion pump. The patient receives extensive training in the proper procedures for changing the catheter, cleaning the infusion site and measuring their Flolan dosages. Flolan or Epoprostenol is a form of the molecule prostaglandin, a naturally occurring substance in the body that causes blood vessels to dilate or open up in the lungs and throughout the body. Flolan is used to ease the symptoms of PPH by keeping blood vessels dialated to relieve the high blood pressure between the lungs and the heart. Flolan may also aid in the prevention of blood clots.

Since the Flolan only stays in the body 3-5 minutes, it must be given on a continuous basis without interruption. Flolan requires skilled handling and must be kept at a controlled temperature and be protected from light. Flolan  costs about $100,000 annually, but it appears to be worth every penny as it has been found to increase life expectancy of PPH patients by up to 5 years.

Tracleer (Bosentan)

Tracleer tablets is currently prescribed  to PPH patients to improve the exercise and function level. Tracleer (Bosentan) was approved by the FDA on November 20, 2001, as the first treatment for PPH in a pill form. According to the FDA, Tracleer blocks the action of endothelin (a substance produced in the human body) which narrows blood vessels and elevates blood pressure. Although endothelin is present in healthy people, high concentrations of the hormone have been found in the plasma and lungs of patients with PPH, suggesting that endothelin may be capable of causing the disease. Designed to improve the exercise ability of patients with PPH, Tracleer became available in the US in December 2001.

In its FDA hearing, Actelion presented data from two successful Phase III pivotal studies that showed improved exercise capacity of patients. The first trial was a double-blind, placebo-controlled study involving 32 patients at six centers (five in the U.S. and one in France). At 12 weeks, patients in the Tracleer group demonstrated a 20% increase in exercise ability compared to placebo in the standardized six-minute walk test (p=0.018). Tracleer patients improved their timed walk distance by a mean of 72 meters, and there was a 40% net difference in cardiac output in favor of Tracleer compared to placebo.

According to the FDA, the use of Tracleer by persons with pulmonary hypertension may present two significant risks-liver toxicity and Tracleer's potential damage to a fetus. Consequently, Tracleer will not be available in commercial pharmacies, but will be available only through a direct distribution program from the drug's manufacturer. Unlike Flolan, that must be given intravenously and in a continuous manner, Tracleer can be taken in pill form.Tracleer does not cure PPH, nor does it slow it's progression. Tracleer does however, give  most patients a better quality of life than they would otherwise have without it and not as dependant upon intravenous therapy. The cost of Tracleer, a twice-daily pill is estimated at about $30,000 per year per patient.

PPH DRUG THERAPY see below:

TRACLEER

FLOLAN - TRACLEER

FLOLAN

BOSENTAN

REMODULIN

PROSTACYCLIN