What is Zontivity - vorapaxar used for and what is it used for?
Zontivity is a medicine used to reduce the occurrence of atherothrombotic events (problems caused by blood clots and thickening of the arteries) including new myocardial infarcts or strokes in adult patients with a history of myocardial infarction. It is given concomitantly with aspirin and, where appropriate, with a third medicine, clopidogrel; these two medicines also help prevent atherothrombotic events. Zontivity contains the active ingredient vorapaxar .
How is Zontivity used - vorapaxar?
Zontivity is available as tablets (2 mg) and can only be obtained with a prescription. The recommended dose is one tablet once a day. Treatment with Zontivity should be started at least 2 weeks after a myocardial infarction, preferably within the first 12 months following the event. Data on the use of Zontivity for periods longer than 2 years are limited; therefore, after 2 years of therapy, the benefits and risks of Zontivity must be re-evaluated in individual patients by the attending physician.
How does Zontivity - vorapaxar work?
The active substance in Zontivity, vorapaxar, is an inhibitor of platelet aggregation. This means that it helps prevent blood clots from forming. Blood coagulates when certain blood cells, called platelets, join one another. Vorapaxar blocks PAR-1 receptors (known as "thrombin receptors") on the platelet surface. Thrombin is one of the substances that contribute to the coagulation process: by binding to the PAR-1 receptor, it makes the platelets "viscous" and, in this way, favors the formation of clots. By blocking the PAR-1 receptor, the medicine prevents the platelets from becoming viscous, reducing the risk of clot formation and helping to prevent a stroke or new myocardial infarction.
What benefit has Zontivity - vorapaxar shown during the studies?
Zontivity was compared with placebo (a dummy treatment) in a main study involving over 26, 000 adults with a history of myocardial infarction or other atherothrombotic events. Almost all patients also took aspirin and / or another medicine for the prevention of atherothrombotic events, and were treated for at least a year. The main measure of effectiveness was the number of patients reporting an "event" including a new myocardial infarction or stroke, or who died of cardiovascular disease (problems affecting the heart and blood vessels). Zontivity was more effective than placebo in reducing the occurrence of atherothrombotic events. Overall, an atherothrombotic event was observed in 9.5% of patients (1 259 of 13 225 subjects) who took Zontivity compared to 10.7% (1, 417 of 13 224 subjects) of patients treated with placebo. The benefit of Zontivity was more evident in a subgroup of 16 897 patients with a history of myocardial infarction but who had never had a stroke or a transient ischemic attack (the so-called "mini-infarct"). In this group an atherothrombotic event was observed in 8.5% of patients (719 of 8 458 patients) who took Zontivity compared to 10.3% (867 of 8 439 patients) of patients treated with placebo.
What is the risk associated with Zontivity - vorapaxar?
The most common side effect of Zontivity (which may affect up to 1 in 10 people) is bleeding, especially nosebleeds (nose bleed). For the full list of all side effects reported with Zontivity, see the package leaflet. Zontivity should not be used in patients who have had a stroke or mini heart attack. It must also not be used in patients who have had intracranial hemorrhage (cerebral haemorrhage) or active bleeding or in patients with severe impairment of liver function. Zontivity should not be used in combination with prasugrel or ticagrelor, two other medicines that help prevent platelet aggregation. For the full list of limitations, see the package leaflet.
Why has Zontivity - vorapaxar been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zontivity's benefits are greater than its risks and recommended that it be approved for use in the EU. The medicine has been shown to be beneficial in reducing the number of atherothrombotic events in patients who have had a myocardial infarction. Regarding the safety profile of Zontivity, the CHMP expressed concern about the risk of bleeding in patients taking Zontivity in addition to standard therapy, in particular the risk of severe bleeding that is more frequent in patients with a history of stroke.
He therefore considered it appropriate to limit its use to patients who had never had a stroke before.
What measures are being taken to ensure the safe and effective use of Zontivity - vorapaxar?
A risk management plan has been developed to ensure that Zontivity 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 Zontivity, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Zontivity - vorapaxar
On 19 January 2015, the European Commission issued a marketing authorization for Zontivity, valid throughout the European Union. For the full version of the EPAR and the summary of the Zontivity risk management plan, consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Zontivity therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
