What is Angiox?
Angiox is a powder that is made up into a solution for injection or an infusion (drip into a vein). Angiox contains the active substance bivalirudin.
What is Angiox used for?
Angiox is used to treat adults with "acute coronary syndromes" (ACS, reduced blood flow to the heart), such as unstable angina (a type of chest pain that varies depending on the severity) or myocardial infarction ( heart attack) without "elevation of the ST segment" (abnormal reading of the electrocardiogram or ECG). it is used together with aspirin and clopidogrel (medicines that prevent the formation of blood clots) in patients about to be treated against ACS, such as angioplasty, bypass operation or other medicines. Angioplasty or "percutaneous coronary intervention" (PCI) is an operation designed to unblock the blood vessels of the heart.
Angiox is also used to prevent the formation of clots in patients about to undergo PCI.
The medicine can only be obtained with a prescription .
How is Angiox used?
Angiox is given intravenously (into the vein). It should be administered by a doctor experienced in the emergency care of patients with heart problems or in performing heart procedures.
The dose of Angiox and the duration of treatment depend on why Angiox is used. The first dose is by injection and is immediately followed by an infusion.
For ACS, the duration of the infusion depends on how you intend to treat ACS: in patients who must be treated with other medicines, it can last up to 72 hours.
To prevent clot formation in patients undergoing PCI, a higher dose of Angiox is used and the infusion can last up to four hours after the procedure. The infusion doses must be reduced in patients with kidney problems and who must undergo PCI.
For further information, please refer to the summary of product characteristics (also included with the EPAR).
How does Angiox work?
The formation of blood clots can be problematic if the blood circulation is disturbed in some way. Angiox is an anticoagulant, meaning it prevents the formation of blood clots. The active substance in Angiox, bivalirudin, is a synthetic substance derived from hirudin, an anticoagulant substance produced by leeches. It is able to block, specifically, one of the substances involved in the coagulation process, the thrombin. Thrombin is essential for the blood coagulation process. Using Angiox during ACS and PCI greatly reduces the risk of clot formation. This allows you to maintain blood flow in patients suffering from angina or who are suffering from a heart attack and to improve the effectiveness of PCI.
What studies have been carried out on Angiox?
Angiox has been studied in over 20, 000 patients. For the treatment of ACS, the main study involved about 14, 000 patients comparing the efficacy of Angiox, taken alone or with a glycoprotein IIb / IIIa inhibitor (GPI, another medicine to prevent clot formation), with the standard treatment represented by the combination of heparin (another anticoagulant) and a GPI. All patients were also given aspirin, with or without clopidogrel.
In PCI Angiox was compared with heparin in over 6, 000 patients. During PCI, patients often had a stent inserted (a tube that remains in the artery to prevent it from closing) and received other anticoagulant drugs such as abciximab and aspirin.
In all the studies, four main measures were carried out: the number of patients who died, heart attack patients, patients who needed urgent revascularization (restoration of blood flow to the heart) and patients with major bleeding.
What benefit has Angiox shown during the studies?
Angiox has proved as effective as comparator treatments. When used to treat ACS, Angiox with or without a GPI was as effective as the standard treatment in preventing the global number of new events (deaths, heart attacks or revascularization) after 30 days and after a year. Angiox was very effective in patients also taking aspirin and clopidogrel. Patients who received Angiox without GPI also had a lower bleeding rate after 30 days and one year.
In patients undergoing PCI, Angiox was as effective as heparin in all measures except for major bleeding, in which it proved to be better than heparin.
What is the risk associated with Angiox?
The most common side effect with Angiox (seen in more than 1 patient in 10) is the decrease in bleeding. For the full list of all side effects reported with Angiox, see the Package Leaflet.
Angiox should not be used in people who may be hypersensitive (allergic) to bivalirudin, other hirudins or any of the other substances. It must not be used in patients who have had recent bleeding, in patients with severe hypertension, serious problems with their kidneys or with a heart infection. For the full list of usage restrictions, see the package leaflet.
Why has Angiox been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Angiox is an acceptable substitute for heparin in the treatment of ACS and during PCI. The Committee concluded that the benefits of Angiox outweigh its risks in the treatment of adult patients with ACS, for whom urgent or early intervention is expected, with aspirin and clopidogrel, as well as an anticoagulant in patients undergoing PCI surgery. The Committee therefore recommended that Angiox be given marketing authorization.
More information on Angiox:
On 20 September 2004, the European Commission issued a marketing authorization for Angiox, valid throughout the European Union, to The Medicines Company UK Ltd. The marketing authorization was renewed on 20 September 2009.
For the full EPAR of Angiox, click here.
Last update of this summary: 09-2009.
