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Bosentan monohydrate, usually called bosentan, is a chemically synthesised small-molecule medicine. It belongs to a class of drugs known as endothelin receptor antagonists.[2] The substance is classified under the ATC code C02KX01, which places it among medicines that act on the cardiovascular system. Bosentan is already authorised as a medicine in the Netherlands, where marketing authorisation records are held by Abdi Farma GmbH and Accord Healthcare B.V.[1] It is sold under product names including Bosentan Abdi and Bosentan Accord, and the original brand name Tracleer is also associated with this substance.[2][4]
Bosentan works by blocking the action of a natural substance in the body called endothelin. Endothelin normally makes blood vessels tighten. By blocking endothelin receptors, bosentan helps blood vessels relax and widen, which lowers blood pressure inside the lungs and reduces strain on the heart.[2] This mechanism is the reason bosentan is used in pulmonary arterial hypertension, a condition where the blood vessels in the lungs are too narrow.
Bosentan is given by mouth as film-coated tablets.[1] In the registered trial, the tablets are available in two strengths: 62.5 mg and 125 mg. The trial uses a total daily dose of 250 mg, given as 125 mg twice daily.[1] A dispersible tablet form for oral suspension, containing 32 mg of bosentan, has also been described in product information from the United States.[3] This form is intended for people who have difficulty swallowing tablets.
One registered clinical trial is currently listed for bosentan in the EU Clinical Trials Information System. The trial, known as EDIT-CAS, is a Phase 4 randomised controlled study.[1] Phase 4 means the medicine is already authorised and the study is looking at an additional use or gathering more information in a new group of patients. The trial is in the authorised status, meaning it has received approval to begin or continue.
The study plans to enrol 100 participants with coronary vasomotor dysfunction, specifically coronary artery spasm. Participants have previously shown epicardial vasospasm during an acetylcholine reactivity test and still have angina-like complaints.[1] The trial compares bosentan against a placebo. The main measure of success is whether bosentan prevents epicardial vasospasm during a repeat spasm provocation test at 10 weeks, using criteria called COVADIS.[1]
Because this trial is still ongoing or recently authorised, no results are yet available in the registry. The design shows that researchers want to know whether a medicine that relaxes blood vessels in the lungs can also help relax the heart's own arteries when they go into spasm.
The supplementary sources provided do not contain a detailed list of side effects for bosentan. A long-term study in adults with pulmonary arterial hypertension associated with congenital heart disease examined the safety and tolerability of bosentan, but the available excerpt does not report specific adverse events.[5] The United States product information for the dispersible tablet notes that the formulation contains aspartame, which is a source of phenylalanine, and is therefore labelled for attention in people with phenylketonuria.[3]
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