What is Stayveer - Bosentan used for and what is it used for?
Stayveer is a medicine that contains the active substance bosentan . It is indicated in the treatment of patients with pulmonary arterial hypertension (PAH) in class III in order to improve exercise capacity and symptoms. PAH is a pathological condition in which the pressure in the pulmonary arteries is high. The "class" indicates the severity of the illness: the "class III" involves a strong limitation of physical activity. The PAH can be:
- primary (without any identified or family cause);
- caused by scleroderma (or progressive systemic sclerosis, a condition characterized by abnormal growth of the connective tissue supporting the skin and other organs);
- caused by congenital heart defects (present from birth) with shunts (airway malformations) that cause abnormal blood flow between the heart and lungs.
- Improvements have also been observed in patients with PAH class II. The "class II" involves a slight limitation of physical activity. Stayveer can also be used in adults with progressive systemic sclerosis, in which the poor blood circulation caused by the disease has caused the appearance of "digital ulcers" (inflammation of the fingers and toes). The aim of Stayveer is to reduce the number of new digital ulcers.
This medicine is the same as Tracleer, already authorized in the European Union (EU). The company that makes Tracleer has agreed that its scientific data can be used for Stayveer ("informed consent").
How is Stayveer - Bosentan used?
Stayveer can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH or progressive systemic sclerosis. Stayveer is available as tablets (62.5 mg and 125 mg), which must be swallowed with water. The tablets should be taken in the morning and in the evening. In adults, the starting dose is 62.5 mg twice a day for four weeks, subsequently increased to the usual dose of 125 mg twice a day. In children with PAH, the dose to be used should be calculated based on body weight and usually starts with 2 mg per kilogram twice a day. For more information, see the package leaflet. The doctor will evaluate the patient's response to Stayveer and determine the need to continue with further treatment after eight weeks in patients with PAH who have not reported improvements as well as on a regular basis in patients with progressive systemic sclerosis with ongoing digital ulcers. If the doctor decides to stop treatment with Stayveer, the dose should be reduced gradually. Patients treated with Stayveer must be given a special memorandum summarizing the main information on the safety of the medicine.
How does Stayveer - Bosentan work?
The active substance in Stayveer, bosentan, inhibits a naturally occurring hormone called endothelin-1 (ET-1), which causes narrowing of blood vessels. Therefore Stayveer determines an expansion of the blood vessels. PAH is a debilitating disease in which a severe narrowing of the blood vessels in the lungs occurs. It causes very high blood pressure in the vessels that carry blood from the right side of the heart to the lungs. This pressure reduces the amount of oxygen that the blood can carry into the lungs, making physical activity more difficult. By dilating these blood vessels, the blood pressure is reduced and the symptoms improve. In patients with progressive systemic sclerosis and ongoing digital ulcers, bosentan improves blood circulation in the fingers and toes, preventing the development of new digital ulcers.
What benefit has Stayveer - Bosentan shown during the studies?
In PAH, Stayveer has been studied in four main studies: two studies involving a total of 245 adults with PAH in class III or IV, primary or caused by scleroderma, a study conducted on 54 adults with PAH in class III associated with congenital heart defects, as well as a study of 185 patients with PAH in class II. Studies compared Stayveer with placebo (a substance with no effect on the body), both added to standard therapy. The main measure of effectiveness was the distance patients could walk in six minutes (a way to measure exercise capacity); however, the study on class II disease also examined the change in blood flow resistance in pulmonary blood vessels (an indicator of vessel constriction). In PAH class III or IV, primary or caused by scleroderma, the two studies revealed that patients treated with Stayveer were able to cover longer distances than patients treated with placebo after 16 weeks of treatment (44 meters more in the study larger in size); however, the number of patients with PAH in class IV was too small to support the use of the medicine in this group. Similar results also emerged in patients with congenital heart defects. In subjects with class II PAH, Stayveer induced a reduction in blood vessel resistance by 23% compared to placebo after six months of treatment, but the distance patients could walk in six minutes was similar in the two groups. A study was also conducted on 19 children and adolescents aged between 3 and 15 years, in which improvements were observed in the parameters related to the heart and arteries. In the case of progressive systemic sclerosis with digital ulcers, two studies compared Stayveer with placebo in a total of 312 adults. The main measure of effectiveness was based on the number of new digital ulcers that had developed during the studies. One of the studies also looked at the effects of Stayveer on the recovery of 190 patients, measuring the time needed to achieve complete healing of a given digital ulcer in each patient. Stayveer was more effective than placebo in reducing the formation of new digital ulcers. In the first study, patients taking Stayveer reported an average of 1.4 new digital ulcers after 16 weeks compared to 2.7 ulcers in placebo-treated patients. Similar results were observed in the second study after 24 weeks of treatment, however Stayveer had no effect on the healing of digital ulcers.
What is the risk associated with Stayveer - Bosentan?
In PAH, the most common side effects of Stayveer (which may affect more than 1 in 10 people) are headache and abnormal liver function tests. In patients with digital ulcers the most common side effects of Stayveer (which may affect more than 1 in 10 people) are abnormal liver function tests, edema and fluid retention. Given the risk of developing liver problems, your doctor will measure liver enzyme levels before treatment and every month during Stayveer treatment. For the full list of all side effects reported with Stayveer, see the Package Leaflet. Stayveer should not be used in patients who have liver problems, in women who are pregnant or of child-bearing age who do not use reliable contraceptive methods or in patients treated with cyclosporin A (a medicine that acts on the immune system). For the full list of limitations, see the package leaflet.
Why has Stayveer - Bosentan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Stayveer's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Stayveer - Bosentan?
A risk management plan has been developed to ensure that Stayveer is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Stayveer, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that makes Stayveer will provide an information kit for prescribers and an information leaflet for patients in each Member State, to explain the safety of Stayveer (with particular regard to its effects on the liver and during pregnancy) and his interactions. The company also undertakes to carefully monitor the distribution of the medicine in each Member State and to gather information on its use in patients with progressive systemic sclerosis with ongoing digital ulcers.
More information on Stayveer - Bosentan
On 24 June 2013, the European Commission granted a marketing authorization valid throughout the European Union for Stayveer. For more information about treatment with Stayveer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 06-2013.
