Cardiovascular disease (CVD) affects more than half of U.S. adults, and each year 805,000 people in the United States experience a myocardial infarction (MI), more commonly known as a heart attack, with 200,0000 of these being a recurrent attack. While men typically experience heart attack symptoms like extreme chest pressure, women often do not exhibit the same. Like Cathy, many women experience more subtle symptoms they attribute to other ailments like the flu, acid reflux or normal aging.
“My children called, texted and checked on me all the time,” said Cathy, a 72-year-old retired principal and mother of two from Northern California. “They were so concerned about my health and what would come next.”
Cathy, a proud grandmother of six and devoted member of “The Beach Sisters,” a close-knit group of friends from high school, always had chronically high "bad" cholesterol (also known as low-density lipoprotien cholesterol, or LDL-C). When she was 40, her doctor first started prescribing her statins, a common cholesterol-lowering therapy used to reduce levels of “bad” cholesterol. While physicians have relied on statins to help lower bad cholesterol for years, many patients fail to reach their targets even while on the highest dose possible, leaving them at an increased risk for cardiovascular events like a heart attack. Because Cathy was on statins, she assumed her risk for heart attack was low. This changed in January 2018 when Cathy suffered a life-altering heart attack that changed how she lived and the way she thought about treating her cholesterol.
After her heart attack, Cathy’s doctor increased her statin prescription to the maximally tolerated dose, but despite improving her diet and exercise regimen, her bad cholesterol still wouldn’t budge. “Finally, that’s when my doctor suggested I try a different treatment option, a PCSK9 inhibitor called Repatha® (evolocumab)," she said.
Repatha® (evolocumab) is a groundbreaking treatment that dramatically lowers LDL-C by helping the liver remove bad cholesterol from the body. It does this by blocking an enzyme—called PCSK9—whose function is to prevent the liver from clearing bad cholesterol. Repatha® is proven to dramatically lower LDL-C levels, significantly drops the risk of a heart attack or stroke, and reduces the need for a stent or open-heart bypass surgery in patients with established cardiovascular disease. Repatha® is the first medication of its kind to offer an every-two-week or single monthly at-home injection option.
Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®. The most common side effects of Repatha® include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes), and redness, pain, or bruising at the injection site. Please see Important Safety Information below.
After three months of adding Repatha® to her treatment regimen, Cathy’s LDL-C levels dropped from 100 mg/dL to 45 mg/dL (individual results may vary).
She continues to try to stay active by attending her grandchildren's baseball and football games and planning trips with The Beach Sisters.
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4. American Heart Association. Heart Attack Symptoms in Women. Available at: https://www.heart.org/en/health-topics/heart-attack/warning-signs-of-a-heart-attack/heart-attack-symptoms-in-women. Last accessed: January 2020.
5. Repatha® (evolocumab) prescribing information, Amgen.
6. Sabatine MS, et al. N Engl J Med. 2017;376:1713-22.
Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha.
Allergic reactions: Hypersensitivity reactions (e.g. angioedema, rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.
Adverse reactions: The most common adverse reactions (>5% of patients treated with Repatha and occurring more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising.
Allergic reactions occurred in 5.1% and 4.7% of Repatha-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
The most common adverse reactions in the Cardiovascular Outcomes Trial (>5% of patients treated with Repatha and occurring more frequently than placebo) were: diabetes mellitus (8.8% Repatha, 8.2% placebo), nasopharyngitis (7.8% Repatha, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha compared with 7.7% in those assigned to placebo.
Homozygous Familial Hypercholesterolemia (HoFH): The adverse reactions that occurred in at least two patients treated with Repatha and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis.
Immunogenicity: Repatha is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha.
Please see full Prescribing Information: pi.amgen.com
If you’ve had a heart attack, and you’re struggling to control your LDL-C levels, talk to your doctor about treatment options like Repatha®. You can find more information online by visiting www.Repatha®.com.
Why treat high LDL?
How to take Repatha®
What is Repatha®?
High cholesterol, which causes fatty deposits to build in the walls
of the arteries, is one of the single most important risk factors for experiencing a heart attack. If you’ve had a previous heart attack,
have a family history of heart disease, have been diagnosed with high cholesterol or heart disease or have other chronic conditions like diabetes, it is critically important to work with your doctor to regularly monitor your cholesterol,” said Dr. Blai Coll, M.D., U.S. Medical Lead, Repatha® at Amgen. “If your numbers remain high despite treatment and lifestyle modifications, it may also be important to talk to your doctor about additional cholesterol-lowering treatments that may help reduce your risk of having a heart attack.
One day, my granddaughter came to me and said,
‘Yaya, I'm happy you're here with me now,’ remembered Cathy.
At that point, you realize you are here for other people. It isn’t just your issue. It’s your family’s issue. I tell my friends, ‘If you have high cholesterol and it still doesn’t come down, then you need to ask your doctor about other treatment options.’
High LDL bad cholesterol can leave you at risk of having another heart attack or stroke. If your LDL numbers are still too high, talk to your doctor about Repatha®. To download some suggested conversation starters for your next doctor visit, click here.
Important Safety Information
Do not use Repatha® if you are allergic to evolocumab or to any of the ingredients in Repatha®.
Before you start using Repatha®, tell your healthcare provider about all your medical conditions, including if you are allergic to rubber or latex, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. The needle covers on the single-use prefilled syringes and the inside of the needle caps on the single-use prefilled SureClick® autoinjectors contain dry natural rubber.
The single-use Pushtronex® system (on-body infusor with prefilled cartridge) is not made with natural rubber latex.
Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines, vitamins, or herbal supplements you take.
What are the possible side effects of Repatha®?
Repatha® can cause serious side effects including, serious allergic reactions. Stop taking Repatha® and call your healthcare provider or seek emergency help right away if you have any of these symptoms: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.
The most common side effects of Repatha® include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes) and redness, pain, or bruising at the injection site.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Repatha®. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects.
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.
[INDICATIONS] OR [APPROVED USE]
[What is Repatha®?]
Repatha® is an injectable prescription medicine used:
- in adults with cardiovascular disease to reduce the risk of heart attack, stroke, and certain types of heart surgery.
- along with diet alone or together with other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia) to reduce low density lipoprotein (LDL) or bad cholesterol.
Please see full Prescribing Information.