(BPT) – A heart attack is a defining moment in a person’s life. Heart attack survivors may mistakenly assume the heart attack they suffered was a singular event. But in fact, a heart attack, or myocardial infarction (MI), may be an indication of underlying cardiovascular (CV) disease that can put patients at risk for recurrent CV events. In 2015, an estimated 735,000 heart attacks will occur, and 210,000 of these are recurrent or repeat heart attacks.
Every day health care professionals work to help people who have had a heart attack lower their chance of having another one. The standard of care for patients with a history of heart attack include aspirin, angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), beta blockers, and statins, among other therapies. Published data has shown that there is up to a 20 percent risk of a recurrent CV event or death in the first year post-MI and a 20 percent risk of a recurrent CV event in the subsequent three years in patients event-free one year post-MI.
The US Food and Drug Administration (FDA) has now approved BRILINTA? (ticagrelor) 60-mg tablets for the expanded indication to reduce the rate of CV death, MI, and stroke in patients with a history of MI beyond the first year. BRILINTA was approved in 2011 for patients with acute coronary syndrome (ACS). In the management of ACS, BRILINTA 90 mg should be taken twice daily during the first year after an ACS event. After one year, patients with a history of MI should take BRILINTA 60 mg twice daily. BRILINTA must be used with a daily maintenance dose of aspirin of 75-100 mg.
“Research indicates that heart attack patients remain at high and persistent risk over the long-term for recurrent CV events beyond 12 months after their initial event,” said Naeem Khan, MD, Executive Director, Medical Affairs, CV, and Medical Lead, BRILINTA. “We sought to determine whether taking BRILINTA beyond 12 months would help patients with a history of heart attack. The approval of BRILINTA 60-mg tablets, which is now available in US pharmacies, is a testament to AstraZeneca’s commitment to following the science.”
PEGASUS-TIMI 54 was a 21,000 patient study that investigated the use of BRILINTA plus aspirin for the long-term prevention of CV death, heart attack and stroke. Patients included in the study had to be 50 years of age or older and have had a history of heart attack one to three years prior to study start. Patients also had to have at least one additional risk factor for thrombotic CV events. Patients in PEGASUS were treated for at least 12 months and up to 48 months.
“The PEGASUS-TIMI 54 study data showed that long-term dual antiplatelet therapy with BRILINTA and low dose aspirin provided a reduction in the risk of long-term CV events in patients with a history of heart attack,” said Marc Cohen, MD, Professor of Medicine at Rutgers-New Jersey Medical School. “For these patients and their doctors, the expanded use of BRILINTA means we have more options for the long-term management of CV events.”
BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require blood transfusions or surgery. While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop.
If patients have a history of a heart attack, they should ask their doctor about BRILINTA today. For patients who have been prescribed BRILINTA, AstraZeneca offers the BRILINTA Patient Support Service (BPSS) tool that provides resources and support to help patients and caregivers from hospital discharge throughout the ACS treatment journey. To help loved ones, the program offers important patient education and coaching in addition to savings offers, refill reminders, personal pharmacy locator, co-pay calculator, and coverage verification and information. To enroll in BPSS, call 1-888-512-7454 or enroll online at www.BRILINTA.com. Health care professionals can visit www.BRILINTAtouchpoints.com.
IMPORTANT SAFETY INFORMATION ABOUT BRILINTA
BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke, but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require blood transfusions or surgery. While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop.
Call your doctor right away if you have any signs or symptoms of bleeding while taking BRILINTA, including: severe, uncontrollable bleeding; pink, red, or brown urine; vomit that is bloody or looks like coffee grounds; red or black stool; or if you cough up blood or blood clots.
Do not stop taking BRILINTA without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking BRILINTA too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop BRILINTA because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase. Tell all your doctors and dentists that you are taking BRILINTA. To decrease your risk of bleeding, your doctor may instruct you to stop taking BRILINTA 5 days before you have surgery. Your doctor should tell you when to start taking BRILINTA again, as soon as possible after surgery.
Take BRILINTA and aspirin exactly as instructed by your doctor. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well BRILINTA works. Tell your doctor if you take other medicines that contain aspirin. Do not take new medicines that contain aspirin.
Do not take BRILINTA if you have a history of bleeding in the brain, are bleeding now, or are allergic to ticagrelor or any of the ingredients in BRILINTA.
BRILINTA can cause serious side effects, including bleeding and shortness of breath. Call your doctor if you have new or unexpected shortness of breath or any side effect that bothers you or that does not go away. Your doctor can decide what treatment is needed.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BRILINTA may affect the way other medicines work, and other medicines may affect how BRILINTA works.
BRILINTA is a prescription medicine for people who have had a heart attack or severe chest pain that happened because their heart wasn’t getting enough oxygen.
BRILINTA is used with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clots in your stent if you received one. These can be fatal.
Please read Medication Guide and Prescribing Information, including Boxed WARNINGS for BRILINTA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
3175442 Last Updated 9/15