Women and Cardiovascular Disease
Cardiovascular disease is responsible for 35% of deaths in women each year – more than all cancers combined1
Esperion is committed to improving cardiovascular outcomes in women
Due to challenges in diagnosis and the persistent misconception that it predominantly impacts men, heart disease is frequently undetected and untreated in women. Despite our understanding of risk factors specific to women, their utilization in clinical settings is lacking and physicians are not well prepared to manage CVD risk in females. Improving outcomes for women with heart disease requires prioritizing distinct symptoms and risk factors to provide more appropriate care. 2
Only 40% of women’s routine care includes a heart risk check 3
Only 22% of primary care providers feel well prepared to assess CVD risk in women 3
Only 42% of cardiologists feel well prepared to assess CVD risk in women 3
References
- https://world-heart-federation.org/what-we-do/women-cvd/ Accessed on May 22, 2024.
- Carratala Munuera C, et al. Gender Inequalities in Diagnostic Inertia around the Three Most Prevalent Cardiovascular Risk Studies: Protocol for a Population-Based Cohort Study. Int. J. Environ. Res. Public Health. 2021;18(8):4054.
- Bairey Merz, CN et al. Knowledge, Attitudes and Beliefs Regarding Cardiovascular Disease in Women: The Women’s Heart Alliance. JACC. 2017; 70 (2):123–132.
- Tobb K, et al. Underrepresentation of women in cardiovascular trials-it is time to shatter this glass ceiling. Am Heart J Plus. 2002; 5(13):100109.
The underrepresentation of women in cardiovascular clinical trials has limited the availability of sex-specific data, creating challenges as heart disease often presents differently in men than women 4
Women in Cardiovascular Research
Hear from the clinical experts on the importance of bridging the gap between the sexes in both research and clinical care.
“Women have contributed so much to the preservation and advancement of civilization.
Yet their well-being has been an afterthought, their health deprioritized. It’s time we change how we take care of women’s health. It’s time we find better ways to look after their hearts.”
Excerpt taken from The Pulse of Change: Women in Cardiology
Explore the full book, The Pulse of Change: Women in Cardiology here:
This book was developed collaboratively by Women as One and Esperion, with content provided in part from the Lancet Women and Cardiovascular Disease Commission report and artwork contributed by Dr. Charles Michael Gibson.
CLEAR Outcomes: Subgroup Analysis By Sex
A Prespecified, Exploratory Analysis of Bempedoic Acid Based On Sex
INDICATION 1
Bempedoic acid (NEXLETOL®) is indicated:
- To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- a high risk for a CVD event but without established CVD.
- As an adjunct to diet, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
Please see full prescribing information for NEXLETOL.
CLEAR Outcomes: Overall Population Primary Composite Endpoint 3
In the total CLEAR Outcomes population, which included both primary (30%) and secondary (70%) prevention patients, the composite primary endpoint, composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization (MACE-4). MACE-4 occurred in 819 patients (11.7%) in the bempedoic acid group vs. 927 patients (13.3%) in the placebo group; HR 0.87 (95% CI 0.79, 0.96), P=0.004
Primary Composite Endpoint 3,4
Click here to download the subgroup analysis by sex study summary.
Summary of Safety 1
NEXLETOL is contraindicated in patients with a prior serious hypersensitivity reaction to bempedoic acid or any of the excipients. Serious hypersensitivity reactions, such as angioedema, have occurred.
Hyperuricemia: NEXLETOL may increase
blood uric acid levels, which may lead to gout. Hyperuricemia may occur early
in treatment and persist throughout treatment, returning to baseline following
discontinuation of treatment. Assess uric acid levels periodically as clinically
indicated. Monitor for signs and symptoms of hyperuricemia, and initiate
treatment with urate-lowering drugs as appropriate.
Tendon Rupture: NEXLETOL is associated
with an increased risk of tendon rupture or injury. Tendon rupture may occur
more frequently in patients with previous tendon rupture, fluoroquinolone use,
corticosteroid use, and over 60 years of age. Discontinue NEXLETOL at the first
sign of tendon rupture. Consider alternative therapy in patients who have a
history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of NEXLETOL in ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.
The most common adverse reactions in the cardiovascular outcomes trial for NEXLETOL at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
References:
- NEXLETOL® (bempedoic acid) US Full Prescribing Information. Esperion Therapeutics, Inc.
- Nicholls SJ, et al. Am Heart J. 2021;235:104-112.
- Nissen SE, et al. N Engl J Med. 2023;388(15):1353-1364.
- Cho L, et al.. Impact of Bempedoic Acid on Cardiovascular Outcomes by Sex. Circulation. 2024 May 28;149(22):1775-1777.