Bivalirudin
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| Non-proprietary name | Bivalirudin | |||||||||||||||
| Molecular formula | C 98 H 138 N 24 O 33 | |||||||||||||||
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| Molar mass | 2180.29 g · mol -1 | |||||||||||||||
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| As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions . | ||||||||||||||||
Bivalirudin (trade name Angiox ; manufacturer The Medicines Company ) is a prescription drug from the group of anticoagulants . It is used to prevent blood clots in adults undergoing percutaneous coronary intervention (PCI) such as balloon dilatation , atherectomy, and stenting .
Chemically speaking, bivalirudin is a peptide. It is a derivative of the hirudin obtained from leeches
Clinical information
application areas
Bivalirudin is used to prevent blood clots in adults. In those patients who are undergoing percutaneous coronary intervention (PCI). In this nonsurgical procedure, the blood vessels that supply the heart muscle are freed from a blockage. Use includes patients who have had " ST elevation " (STEMI, an abnormal reading on the electrocardiogram or EKG) patients who have had myocardial infarction . Bivalirudin is also used in adults with unstable angina (varying degrees of chest pain) or non-ST elevation myocardial infarction (NSTEMI) who are undergoing treatment such as PCI, bypass surgery, or are taking other medicines. Bivalirudin is used with ASA and clopidogrel (other medicines used to prevent blood clots).
With regard to PCI, bivalirudin has been compared with another type of anticoagulant, a heparin , in a total of nearly 10,000 adults . Heparin was compared with a glycoprotein IIb / IIIa inhibitor (GPI, another medicine used to prevent blood clots), and some patients who received bivalirudin may also be given a GPI. Almost 4,000 of these patients had to undergo PCI to treat ST elevation myocardial infarction. In patients with unstable angina or myocardial infarction without ST elevation who were waiting for further treatment, almost 14,000 adults took part in the main study, in which Angiox - alone or together with a GPI - was compared with the combination of heparin and a GPI. In all three studies, patients received additional drugs to prevent blood clots, such as aspirin and clopidogrel. The main measure of effectiveness was the reduction in the number of patients who had an "ischemic event" (a problem with decreased blood flow), including death, who had a heart attack by day 30, who had a heart attack, urgent revascularization (restoring blood flow to the heart) needed or who had a stroke. The studies also looked at the number of patients who developed severe bleeding.
Bivalirudin should be administered by a doctor experienced in acute coronary treatment or in the field of percutaneous coronary intervention.
Contraindications
Angiox is contraindicated in patients with:
- known hypersensitivity to the active ingredient or to any other ingredient or to hirudins
- active bleeding or increased risk of bleeding due to a disruption of the hemostatic system and / or irreversible coagulation disorders.
- severe uncontrolled hypertension and subacute bacterial endocarditis.
- severe kidney damage (GFR <30 ml / min) and in dialysis-dependent patients
Angiox is not intended for intramuscular use.
Drug interactions
Interaction studies were with platelet inhibitors , including acetylsalicylic acid , ticlopidine , clopidogrel , abciximab , eptifibatide and tirofiban performed. The results indicate no pharmacodynamic interactions with these drugs. Please note that there is an increased risk of bleeding when combining anticoagulant drugs.
unwanted effects
Very common (≥ 10%): light bleeding anywhere; Common (1/100 to 1/10): decreased hemoglobin, access site bleeding, puncture site hematoma, ecchymosis , severe bleeding anywhere, including reports with fatal outcome.
Mechanism of action
Blood clots can be problematic if they occur in the blood vessels, blocking the flow of blood to vital organs such as the heart and brain. Angiox is an anticoagulant; that is, it prevents the blood from clotting. The active ingredient in Angiox, bivalirudin, is a synthetic substance originally derived from hirudin, the anticoagulant substance made by leeches. It specifically blocks one of the substances involved in the clotting process called thrombin. Thrombin plays a central role in the blood coagulation process. Using Angiox will significantly reduce the risk of blood clots forming. This, in turn, can increase the effectiveness of PCI and help maintain blood flow to the heart in patients with angina or myocardial infarction.
Studies
- ACUITY: Gregg W. Stone et al. a .: Bivalirudin for Patients with Acute Coronary Syndromes . In: New England Journal of Medicine . tape 355 , no. 21 , 2006, p. 2203-2216 , doi : 10.1056 / NEJMoa062437 , PMID 17124018 .
- HORIZONS-AMI-1: Roxana Mehran u. a .: Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomized controlled trial . In: The Lancet . tape 374 , no. 9696 , October 2009, p. 1149-1159 , doi : 10.1016 / S0140-6736 (09) 61484-7 .
- HORIZONS-AMI-3: Gregg W. Stone u. a .: Heparin plus a glycoprotein IIb / IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomized controlled trial . In: The Lancet . tape 377 , no. 9784 , June 2011, p. 2193-2204 , doi : 10.1016 / S0140-6736 (11) 60764-2 .
- ISAR-REACT-4: Adnan Kastrati u. a .: Abciximab and Heparin versus Bivalirudin for Non-ST-Elevation Myocardial Infarction . In: New England Journal of Medicine . tape 365 , no. 21 , 2011, p. 1980-1989 , doi : 10.1056 / NEJMoa1109596 , PMID 22077909 .
- Euromax: Philippe Gabriel Steg u. a .: Bivalirudin Started during Emergency Transport for Primary PCI . In: New England Journal of Medicine . tape 369 , no. 23 , 2013, p. 2207-2217 , doi : 10.1056 / NEJMoa1311096 , PMID 24171490 .
Trade names
- Angiox, The Medicines Company (in the EU, Russia and Switzerland)
- Angiomax (in Argentina, Australia, Canada, Chile, India, Israel, New Zealand, Peru, USA and Venezuela)
See also
literature
Web links
Individual evidence
- ↑ This substance has either not yet been classified with regard to its hazardousness or a reliable and citable source has not yet been found.
- ↑ European public assessment report (EPAR) for Angiox - Bivalirudin , website of the European Health Authority (EMA), accessed on March 24, 2014.
- ↑ a b c Summary of the EPAR for the public (German) , website of the European Health Authority (EMA), accessed on March 24, 2014 (PDF; 80 kB)
- ↑ A. Lincoff, JA Bittl, RA Harrington et al. a .: Bivalirudin and provisional glycoprotein iib / iiia blockade compared with heparin and planned glycoprotein iib / iiia blockade during percutaneous coronary intervention: Replace-2 randomized trial . In: JAMA . tape 289 , no. 7 , February 19, 2003, p. 853-863 , doi : 10.1001 / jama.289.7.853 .
- ↑ Gregg W. Stone et al. a .: Bivalirudin during Primary PCI in Acute Myocardial Infarction . In: New England Journal of Medicine . tape 358 , no. 21 , 2008, p. 2218-2230 , doi : 10.1056 / NEJMoa0708191 , PMID 18499566 .
- ↑ Analysis of EUROMAX and HORIZONS-AMI Trials of The Medicines Company's Angiomax® (Bivalirudin) Presented at ACC.14 PM by MDCO on March 30, 2014, accessed on April 1, 2014.
- ↑ a b c d Angiox Fachinformation , Rote Liste, Fachinfo-Service, accessed on March 24, 2014.
