Flolan or epoprostenol is a man-made form of a naturally occurring molecule in the human body called prostaglandin which helps the body open blood vessels. This synthetic substance contained in Flolan is called Prostacyclin.
Doctors use Flolan (Prostacyclin) to treat patients with Primary Pulmonary Hypertension (PPH). Flolan is helping many severely ill patients who do not respond to treatment with calcium channel blockers such as Nifedipine. Flolan imitates the natural prostaglandin produced by the body to keep blood vessels healthy by removing the build up of lipids, lowering blood pressure. People respond to increased doses of Flolan which dilate, or open up, blood vessels in the lungs and throughout the body. This Flolan-Prostacyclin also appears to prevent blood clots from forming. Flolan has been studied in clinical trials, and is an FDA approved drug treatment for PPH.
Flolan is administered intravenously directly into the bloodstream through a surgically implanted catheter by a portable, battery-operated pump. The pump is worn attached to a belt around the waist or carried in a small shoulder pack. Since the drug lasts only 3-5 minutes it must constantly be infused: it is slowly and continuously pumped into the body through the permanent catheter placed in a vein in the neck or chest. The pump is filled daily with the mixed Flolan solution.
More Information about the Delivery and the Pump System >>
Flolan is a lifetime therapy which requires uninterrupted infusion because of its short effect-3 to 5 minute effect. The drug is very expensive, at around $100,000 or more per year and is used only after a positive diagnosis of PPH. Because of the complexity of administering Flolan, patients use special health care services to learn about administering the treatment. Companies that distribute Flolan offer home health care services including infusion and nursing.
There is no set dose, the dose that is used is based on the amount of relief it provides the patient of their PPH symptoms and the patient's ability to handle Flolan side effects. The dose will increase during a patient's therapy in order to remain effective; no maximum dose has been demonstrated. The drug requires special handling including a constant controlled temperature and protection from light.
The downside and side effects of Flolan Treatment
Side effects can include jaw pain, headache, flushing, nausea, diarrhea, and vomiting. Interruption of Flolan can be life-threatening, even a brief interruption can result in a sudden reoccurrence of symptoms.
The indwelling central I.V. line, the catheter through which the pump delivers the Flolan needs a high degree of maintenance and infections can be serious. Other treatments such as UT-15 and Beraprost may soon offer a potential alternative more >>
Flolan and Prostacyclin Treatment
Is prostacyclin treatment effective?
There have been three controlled studies comparing prostacyclin with conventional treatment which report the impact of this drug on clinical outcomes. Two reported randomized trials. The first showed an improvement in haemodynamic variables and symptoms, but was too short to examine survival. The second study showed that the addition of prostacyclin improved walking distance, quality of life and survival to twelve weeks. This second study is published only in abstract, making thorough appraisal impossible. A third paper investigated 44 patients at a British hospital; in 25 the decision to purchase prostacyclin treatment was made by the patients' health provider, and in 19 the decision was not to purchase, so the treatment decision was not randomized. A group of historical controls from the Mayo Clinic comprised patients studied before the drug was available. In terms of prognosis at outset the historical controls were in a more favorable position than the British patients, while the untreated British controls may have had a slightly better outlook than the treated patients.
The British patients (together) had a relative risk of death of 0.56 (95% confidence interval 0.31 to 1.00) compared with historical untreated controls from the Mayo Clinic. Among the British cohort, prostacyclin doubled the time on the waiting list for heart-lung transplantation or to death (from 8 to 17 months). Deaths differed little between groups (9/25 compared with 9/19); prostacyclin apparently increased the chances of transplantation but the numbers were very small (7/25 compared with 3/19) and the difference was not significant.
The total number of patients on prostacyclin in all these studies was 149, and the results can only be regarded as preliminary. It is not clear how the patients who were treated differed from those who were not, but such differences may explain differences in outcome.
There is an obvious need for a much larger, adequately reported randomized controlled trial of prostacyclin, since random allocation is the only way to exclude differences between groups of patients. Postponing transplantation is not necessarily desirable since it leaves the patient symptomatic for longer and defers rather than removes the need for transplantation surgery, thus only helping match supply and demand of donor organs in the short term.
* FLOLAN is a registered trademark of GW USA Inc., a wholly owed subsidiary of GlaxoSmithKline Plc. This website is not owned, operated or endorsed by SmithKline Beecham Corporation or its parent GlaxoSmithKline Plc
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