LONDON - Tuesday, August 28th 2012 [ME NewsWire]
(BUSINESS WIRE)-- AstraZeneca today announced that ticagrelor, an oral antiplatelet medicine, received a Class I recommendation from the European Society of Cardiology (ESC) in the revised “Guidelines on the Management of Acute Myocardial Infarction in Patients Presenting with Persistent ST-Segment Elevation (STEMI)” guidelines. Ticagrelor is known as BRILIQUE in the European Union and BRILINTA elsewhere.
For primary percutaneous coronary intervention (PCI), the guidelines now recommend ticagrelor with no restrictions for STEMI patients (Class I; LOE B). Prasugrel, (Class I; LOE B), is recommended only for clopidogrel-naïve patients with no prior history of stroke/TIA and aged <75 years. Clopidogrel is recommended when prasugrel or ticagrelor are either not available or contraindicated. All of these recommendations are in combination with aspirin.
Ticagrelor plus aspirin, or prasugrel plus aspirin, are recommended (over clopidogrel plus aspirin) in patients treated with PCI (Class I: LOE A). Treatment with ticagrelor is recommended for up to 12 months. In addition, the guidelines recommend antiplatelet therapy with low dose aspirin after STEMI indefinitely.
With this addition, ticagrelor is now recognised as a standard therapy for acute coronary syndromes (ACS) patients within a total of ten sets of US and global guidelines, including the ESC’s 2011 Guidelines for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation and 2010 Guidelines for Myocardial Revascularisation.
“The inclusion of ticagrelor in the ESC STEMI guidelines is recognition by the medical community of the established role of BRILINTA in contemporary standard-of-care ACS management. These guideline updates underscore a growing acceptance amongst the medical community of the benefits of ticagrelor (plus low dose aspirin) for a broad range of ACS patients,” said Dr. James Ferguson, VP Global Medical Affairs, CV, AstraZeneca. “The recommendation from the ESC is another important step toward improving access for ACS patients to ticagrelor in Europe, where ACS affects an estimated 1.4 million people every year – more than all cancers combined.”
The inclusion of ticagrelor in the new ESC guidelines were based on data from PLATO (A Study of PLATelet Inhibition and Patient Outcomes), which demonstrated that treatment with ticagrelor plus aspirin led to a greater reduction in the primary end point – a composite of CV death, myocardial infarction (MI), or stroke – compared to clopidogrel plus aspirin [9.8% vs. 11.7% at 12 months; 16% relative risk reduction (RRR); 95% CI, 0.77 to 0.92]. The difference in treatments was driven by CV death and MI with no difference in stroke. The PLATO study also demonstrated that treatment with ticagrelor for 12 months was associated with a 21% RRR in CV death [4% vs. 5.1%; 1.1% absolute risk reduction (ARR)] and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs. 6.9%; 1.1% ARR). With ticagrelor, there was no increase in overall major/fatal bleeding over the course of one year of treatment (11.6% for ticagrelor versus 11.2% for clopidogrel); however, non-CABG major bleeding was more common with ticagrelor versus clopidogrel (4.5% vs. 3.8).
These updates to the “Guidelines on the Management of Acute Myocardial Infarction in Patients Presenting with Persistent ST-Segment Elevation” were presented at ESC on 27 August in Munich, Germany, and also published in the European Heart Journal.
NOTES TO EDITORS:
About ESC Guidelines
Class I indicates "evidence and/or general agreement that a given treatment or procedure is beneficial, useful, effective," while level of evidence B signifies that this recommendation was based upon a single randomised clinical trial.
G-BA decision pursuant to § 35a SGB V:
In accordance to local requirements in Germany where the ESC meeting is being held, AstraZeneca is providing the following information.
Pursuant to § 35a SGB V the Federal Joint Committee (G-BA) has issued its final decision regarding the early benefit assessment of ticagrelor on 15.12.2011. In its final assessment of ticagrelor the G-BA acknowledged an additional benefit for: Non—ST-Elevation Myocardial Infarction/Unstable Angina (NSTEMI/UA), compared with clopidogrel (important additional benefit), ST-Elevation Myocardial Infarction/Percutaneous Coronary Intervention (STEMI/PCI) patients over 75 years, who according to a benefit-risk assessment are not qualified for therapy with prasugrel and aspirin, or those patients with prior stroke or TIA (additional benefit but not quantifiable compared with prasugrel). The G-BA has found no additional benefit for STEMI/PCI younger than 75 years, compared with prasugrel, STEMI Medically Managed, compared with clopidogrel and STEMI/CABG (ST-Elevation Myocardial Infarction Coronary Artery Bypass Graft), compared with aspirin monotherapy.
ABOUT PLATO
PLATO (PLATelet Inhibition and Patient Outcomes) was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of ticagrelor versus clopidogrel, both given in combination with aspirin. The study was designed to establish whether ticagrelor could achieve a clinically meaningful reduction in cardiovascular (CV) events in acute coronary syndrome (ACS) patients, above and beyond that afforded by clopidogrel.
PLATO demonstrated that treatment with ticagrelor led to a greater reduction in the primary end point – a composite of CV death, myocardial infarction (MI), or stroke – compared to patients who received clopidogrel [9.8% vs. 11.7% at 12 months; 16% relative risk reduction (RRR); 95% CI, 0.77 to 0.92; p<0.001]. The difference in treatments was driven by CV death and MI with no difference in stroke. The absolute difference in treatment benefit versus clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continued to diverge throughout the 12-month treatment period [1.9% absolute risk reduction (ARR)].
The PLATO study also demonstrated that treatment with ticagrelor for 12 months was associated with a 21% RRR in CV death (4% vs. 5.1%; 1.1% ARR; p=0.001) and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs. 6.9%; 1.1% ARR; p<0.005).
An analysis of PLATO formed the basis of the recommendation in all of the approved ticagrelor labels that patients taking ticagrelor should also take a low-maintenance dose of aspirin daily, unless specifically contraindicated.
With ticagrelor, there was no increase in total major bleeding, the primary safety endpoint, over the course of one year of treatment (11.6% for ticagrelor vs. 11.2% for clopidogrel; p=0.43), nor in fatal bleeding (0.3% in both groups; p=0.66). Non-coronary artery bypass graft (CABG)-related major bleeding was more common with ticagrelor compared to clopidogrel (4.5% vs. 3.8%; p=0.03), along with non-CABG-related major + minor bleeding (8.7% vs 7.0%). Dyspnoea was reported in 14% of patients treated with ticagrelor and in 8% of patients treated with clopidogrel (p<0.001), but most events were mild and transient. Due to observations of mostly asymptomatic ventricular pauses in an earlier clinical study, patients with an increased risk of bradycardic events (e.g. patients without a pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope) were excluded from the main PLATO study evaluating the safety and efficacy of ticagrelor. Therefore, due to the limited clinical experience, ticagrelor should be used with caution in these patients.
About ticagrelor
Ticagrelor is an oral antiplatelet treatment for acute coronary syndromes (ACS). Ticagrelor is a direct-acting P2Y12 receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). Regarding possible interactions, please see full prescribing information.
On 6 December 2010, the European Commission granted marketing authorisation to ticagrelor, co-administered with acetylsalicylic acid (maintenance dose 75-150mg daily), for the prevention of atherothrombotic events in adult patients with ACS [unstable angina (UA), non—ST-segment elevation myocardial infarction (NSTEMI) or STEMI], including patients managed medically and those who are managed with percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).
Ticagrelor is approved in 82 countries, including in the European Union under the trade name BRILIQUE and in the United States, Canada, Brazil, Australia and Russia under the trade name BRILINTA.
BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies. For detailed information regarding ticagrelor in your area, please refer to the local prescribing information.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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