The committee recommended granting marketing authorisations for three medicines to treat adults with primary hypercholesterolaemia or mixed dyslipidaemia, conditions that cause high cholesterol levels in the blood: Lyrokaul (lerodalcibep) is an injection that patients can self-administer monthly; Evlarco (obicetrapib / ezetimibe) and Ubeslo (obicetrapib) are both oral formulations to be taken daily.

The other nine products to get the green light were:

• Susvimo (rabinizumab) to treat adults with neovascular (wet) age-related macular degeneration.
• Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and adolescents from 12 years of age.
• Lynavoy (linerixibat) for the treatment of adults with cholestatic pruritus.
• Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy, a rare genetic disorder which affects the brain, typically during childhood.
• Zokovea (ensitrelvir), an antiviral medicine, for the post-exposure prophylaxis of COVID-19.
• Cavoley (pegfilgrastim) for the treatment of neutropenia (low levels of neutrophils, a type of white blood cell).
• Riociguat Accord (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension in adults and treatment of pulmonary arterial hypertension in adults and children from 6 years of age.
• Ruxolitinib Viatris (ruxolitinib hemifumarate) for the treatment of myelofibrosis, polycythaemia vera and graft-versus-host disease.
• Tafamidis Accord (tafamidis) for the treatment of hereditary transthyretin amyloidosis in adult patients with cardiomyopathy.

The CHMP recommended extensions of indication for eight medicines that are already authorised in the EU: Enhertu, Jivi, Piqray, Repatha, Riltrava Aerosphere, Rinvoq, Trixeo Aerosphere, and Trodelvy.

The committee also approved an update of the composition of the vaccines Bimervax, Comirnaty, Nuvaxovid and Spikevax to target the new XFG variant of the virus that causes COVID-19.

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“Cholesterol-lowering drugs save lives and prevent heart attacks, and should be prescribed to all patients with coronary artery disease,” said study author Dr. Nina Johnston of Uppsala University, Sweden. “Unfortunately, our study shows that women are missing out on these essential medications.”

Patients with coronary artery disease, also called chronic coronary syndrome, require medication to alleviate symptoms and prevent heart attacks and death. ESC guidelines recommend statins for all patients to lower cholesterol levels in the blood.² If levels are not sufficiently lowered with the maximum tolerated dose of statin, then patients should receive a statin plus another cholesterol-lowering drug called ezetimibe.² The recommendations are the same for women and men.

Despite having the same recommendations for treatment and for target levels of low-density lipoprotein (LDL; “bad”) cholesterol, previous studies have shown that women are less likely to meet target levels than men.³ This study examined whether women and men receive the same treatments.

This was a retrospective observational study that included 1,037 men and 415 women with a chronic coronary syndrome diagnosed between 2012 and 2020, and who had never had a heart attack. The median age was 68 years in men and 70 years in women. Electronic health records were used to obtain data on cholesterol levels. Information on dispensed medications was obtained from the Swedish National Prescribed Drug Registry.

Participants were followed up for three years following their diagnosis. The researchers found that at the end of the third year of follow-up, just 54% of women were treated with cholesterol-lowering drugs compared with 74% of men. Additionally, 5% of women were treated with statin plus ezetimibe compared with 8% of men. Factors which may explain the observed sex differences are under further investigation by the research group.

The researchers also examined treatments and cholesterol levels of women and men diagnosed with a chronic coronary syndrome at different ages (less than 60, 60 to 69.9, 70-79.9, 80 years or older). In all age groups, prescription of cholesterol-lowering treatment was highest at diagnosis and declined over the following three years. This decline in treatment over time was steeper in women compared with men. For example, in patients under 60 years of age, 65% of women and 79% of men were treated with cholesterol-lowering treatment the week after diagnosis, compared with 52% of women and 78% of men three years later. Achievement of LDL cholesterol targets was also lower in women than men.

Dr. Johnston said: “Our findings should be a wake-up call about the undertreatment of women with heart disease. Equal prescribing practices are needed so that women receive all recommended therapies and are protected from adverse outcomes.”

Contrary to common belief, cardiovascular disease kills more women than men, accounting for 45% of all deaths in women which is more than all cancers combined in the 57 ESC member countries.⁴

¹The abstract ‘Lipid-lowering treatment pattern in chronic coronary syndrome – lower proportion of treatment observed among women during 3 years of follow-up’ will be presented during the session ‘Lipid management in different populations’ which takes place on 25 April 2024 at 12:45 EEST on the Open stage.

²Knuuti J, Wijns W, Saraste A, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020;41:407–477.

³Hambraeus K, Tydén P, Lindahl B. Time trends and gender differences in prevention guideline adherence and outcome after myocardial infarction: Data from the SWEDEHEART registry. Eur J Prev Cardiol. 2016;23:340–348.

⁴Timmis A, Vardas P, Townsend N, et al. European Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022;43:716–799.

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The TACTiC trial is the first experiment with a prescription statin to show that consumers could self-select correctly and take statins appropriately without requiring clinician qualification and a prescription.

Statins are a mainstay of heart disease prevention, yet experts estimate that less than half of patients who are eligible to receive the drugs are currently taking them. The new findings offer evidence that a web-based process allowing nonprescription access to statins could facilitate safe and effective use of the drugs, according to researchers.

“We think this approach can make statins available to more people who are not currently taking these important drugs,” said Steven E. Nissen, MD, chief academic officer in the Heart, Vascular, and Thoracic Institute at Cleveland Clinic and the study’s lead author. “This therapeutic approach is designed to allow access to consumers who should be treated, while preventing access to those for whom statins are not indicated or unsafe.”

LDL or “bad” cholesterol contributes to the development of fatty deposits in the arteries, which raises the risk of heart attacks, strokes and other forms of heart disease. Statins help to remove cholesterol from the blood and reduce the amount of cholesterol the body produces, thereby lowering the risk of heart disease in people with high LDL cholesterol.

For the trial, researchers designed a system to make non-prescription statins available to the general population based on established eligibility criteria without requiring a doctor visit or prescription. First, people were invited to take a medical assessment using a web-based application designed as medical device software. The assessment required users to enter information about demographics, medication use, medical history, and cholesterol and blood pressure levels. If users did not know their cholesterol and blood pressure levels, they were given instructions on how to get this information, but no other assistance was provided.

Based on questionnaire responses, users were informed that they could use statins, could not use statins or should ask a doctor for further advice. Only those informed that they could use statins or should ask a doctor (and confirmed that they had done so) were eligible to set up an account and purchase medication. Participants could order up to a 90-day supply of 5 mg daily rosuvastatin, which they paid for and was shipped directly to their home. In total, 1,196 participants were enrolled; participants had a median age of 63 years and 39.6% were women.

After taking the self-assessment, participants were then interviewed by a clinician who determined whether they met the criteria for statin therapy. Clinicians were not aware of the responses or recommendations from the web-based assessment.

Next, participants entered the six-month treatment phase of the trial, which required them to reorder medicine and take an abbreviated web-app assessment prior to each reorder to ensure they continued to meet requirements for safe use. During this phase, participants were also instructed to have their LDL cholesterol re-tested at any point after starting treatment. At the end of the treatment phase, they were scheduled for a final virtual visit and again interviewed by a clinician.

The concordance between the self-assessment and the clinician assessment was high, showing agreement in 90.7% and 98.1% of cases at baseline and at the final treatment phase assessment, respectively. Participants also experienced a significant reduction in LDL cholesterol, which was reduced by 35.5%, on average, at six months from a baseline average of 140 mg/dL.

“Not only did participants self-select correctly, they also demonstrated they could appropriately self-administer the drug and they obtained a reduction in LDL cholesterol that was about what you’d expect with high adherence,” Nissen said.

Researchers said previous efforts to make statins available without a prescription have encountered challenges ensuring that statins were truly appropriate for the people who were allowed to access them. In this study participants’ median 10-year risk of cardiovascular disease was estimated to be 10%, clearly placing them in a risk category for which statins are recommended.

No participants experienced serious adverse reactions to rosuvastatin during the study.

One limitation of the web-based self-assessment approach is that it requires access to the internet, which could pose a barrier in some communities, Nissen said.

The study was funded by AstraZeneca, maker of rosuvastatin.

This study was simultaneously published online in the Journal of the American College of Cardiology at the time of presentation.

Nissen will be available to the media in a press conference on Monday, April 8, 2024, at 10:00 a.m. ET / 14:00 UTC in Room B203.

Nissen will present the study, “Outcomes after Technology Assisted Nonprescription Rosuvastatin Administration: The TACTiC Trial,” on Monday, April 8, 2024, at 8:30 a.m. ET / 12:30 UTC in the Hall B-1 Main Tent.

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These visits include video calls with registered dietitian nutritionists, who have a critical role in helping patients take on lifestyle changes through medical nutrition therapy.

With a focus on the changing digital landscape, researchers at Michigan Medicine found that telemedicine patients with hyperlipidemia — an excess of cholesterol or fats in the blood — experienced similar positive health benefits compared to those who had in-person visits.

The results are published in the Journal of Clinical Lipidology.

“This study reinforces the idea that comparable clinical outcomes can be achieved using the virtual format,” said Shannon Zoulek, M.D., first author and resident physician at University of Michigan Health.

“Improving cholesterol levels may reduce cardiovascular events, and having additional options to access treatment will benefit patients who seek treatment.”

Examining nutritional visits

Researchers assessed short term outcomes for over 250 patients seen by a registered dietitian at the U-M Health Frankel Cardiovascular Center’s Preventative Cardiology Clinic between early 2019 and late 2022.

Whether virtual or in-person, patients receiving medical nutrition therapy experienced significant decreases in LDL, or “bad”, cholesterol and non-HDL cholesterol, both of which are known to increase the risk of cardiovascular disease.

The research team found no significant difference between the two appointment types. However, Zoulek says, more research is needed to determine the scenarios in which a virtual or in-person visit may be more beneficial.

“Access to nutrition care is crucial, and our study shows just how effective virtual care can be for helping improve cholesterol levels,” said co-author Beverly Kuznicki, R.D.N., M.A., cardiovascular dietitian and allied health intermediate supervisor at U-M Health.

“Virtual care welcomes the dietitian into the patient’s kitchen where the two can work together to come up with a nutrition plan which focuses on foods that are already in their pantry and refrigerator.”

Despite challenges to remote health care, including access to devices and technological literacy, a national survey published in 2023 found that telehealth visits may improve access for minorities and patients with lower socioeconomic statuses.

“The expansion of virtual care can be considered as a silver lining to the COVID-19 pandemic,” said senior author  Eric J. Brandt, M.D., M.H.S., FACC, director of preventative cardiology at the U-M Health Frankel Cardiovascular Center.

“Virtual care has many benefits that can help overcome some barriers to traditional care. It can help increase access to individuals that have transportation limitations or live far away from in-person care centers.”

Additional authors include Navkiranjot Kaur, M.D., and Jackson Shriver, M.D., of University of Michigan.

Paper cited: “Comparison of virtual vs Face-to-face medical nutrition therapy in patients with hyperlipidemia,” Journal of Clinical Lipidology. DOI: 0.1016/j.jacl.2023.11.005

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Alexander C. Fanaroff, MD, MHS, an assistant professor of Cardiovascular Medicine, shared details of the clinical trial in a late-breaking science presentation today at the American Heart Association’s Scientific Sessions conference in Philadelphia, Pennsylvania (Abstract #23096).

The work of Fanaroff and his colleagues aimed to address the underutilization of statin therapy in U.S. adults who are candidates for such treatment. A large proportion of adults with or at high risk for cardiovascular disease do not receive statins at the recommended dose.

To bridge this gap, the research team conducted a cluster randomized clinical trial as part of the Penn Medicine Atherosclerotic Cardiovascular Disease Risk Reduction Initiative. The trial enrolled patients from ten primary care practices affiliated with the Penn Medicine Lancaster General Health System and explored the effects of automated referrals of eligible patients—those not already prescribed statins by a clinician— to a centralized pharmacy service. Pharmacists subsequently contacted appropriate patients, discussed their personalized risks and the benefits of statin initiation, and initiated therapy when appropriate. The primary goal was to assess the proportion of patients prescribed statins, and secondary outcomes included the proportion of prescribed statins at guideline recommended doses.

A total of 1,950 eligible patients were enrolled in the trial, with 975 assigned to the intervention arm—the automated referral group. The study revealed that 86.4 percent of eligible patients were not prescribed statins at all at baseline, and the rest were given inappropriately low doses. Patients in the intervention arm practices saw a significant increase in statin prescription rates, with 31.6 percent prescribed a statin, compared with 15.2 percent in usual care practices. Additionally, 24.8 percent of patients at intervention arm practices were prescribed a statin at the guideline-recommended dose during the study period, compared with 7.7 percent of patients at usual care practices.

“The findings suggest that automated referrals to centralized pharmacy services for lipid management are a game-changing strategy, drastically improving the odds of prescribing appropriate dose statins,” said Fanaroff.

The research was funded by a National Institutes of Health Clinical and Translational Science Award Grant (UL1TR001878).

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“Despite the promising effects of fenofibrate on SARS-CoV2, the virus that causes COVID-19, our findings convincingly showed that it is not a useful strategy for decreasing disease severity or preventing bad outcomes in patients with COVID-19,” said first author and principal investigator of the trial, Julio Chirinos, MD, PhD, a professor of Cardiovascular Medicine and co-director of clinical research for the T32 Training Program in Cardiovascular Biology and Medicine in the Perelman School of Medicine at the University of Pennsylvania. “Despite the time, complexity, and cost associated with executing rigorous clinical trials, they are essential to evaluating the efficacy of medications in patients with COVID-19, since the effectiveness of a medication can be substantially different from what in vitro studies may suggest. Clinical trials are necessary before clinical implementation of drug therapies, even for the case of medications that are already widely available for other indications.”

Fenofibrate is a widely available, low-cost generic drug previously approved by the United States Food and Drug Administration and many other regulatory agencies to reduce the amount of fatty substances, such as cholesterol and triglycerides, in the blood, while increasing “good” cholesterol (high-density lipoprotein cholesterol known as HDL).

The drug was initially targeted for COVID-19 research as part of an effort to test older, previously approved drugs for potential benefit against the virus. In laboratory studies, it was found that excessive production of certain fat molecules by cells is involved in the cellular damage caused by SARS-CoV2.  Fenofibrate affected the way cells handle fat in a way that reduced viral replication. In additional laboratory studies, fenofibrate also affected the cellular receptor for the virus, reducing viral replication.

Penn Medicine served as the sponsor of the FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial, which conducted the study and included 26 collaborating institutions from North America, South America, Europe, and Western Asia.

To test the drug’s effectiveness in people, the study team enrolled 701 participants, with each participant having first experienced COVID-19 symptoms within the past two weeks. The study team randomized assigned 351 patients to be treated with 145 milligrams of fenofibrate (or equivalent preparations in other countries) and 350 with a placebo. Patients were then ranked based on a novel severity score system that measured disease severity along with factors including death, the use of invasive and non-invasive ventilators, length of hospital stay, as well as time to hospitalization and symptom severity among outpatients.

Compared with placebo, fenofibrate had no significant effect either on severity scores or death from any cause, among other metrics. There was similarly no difference in outcomes up to 30 days after the initial randomization. Importantly, the findings were consistent across countries and were not affected by sex, age, race, body mass index, diabetes status, or the time when patients initiated treatment.

The authors noted there could be a number of potential explanations for the drug’s failure to achieve the same results in humans that it did in laboratory cells.

“COVID-19 is complex and involves not only its toxic effect on cells but also on a complex set of systemic host responses,” said co-author Jordana B. Cohen, MD, MSCE, an assistant professor of Renal-Electrolyte and Hypertension at Penn. “Therefore, cellular effects of drugs observed in a petri dish system may fail to translate to beneficial effects in people with COVID-19 as a result of a wide range of potential phenomena in whole organisms. Our trial reinforces the importance of not equating laboratory efficacy with clinical efficacy in the setting of COVID-19.”

The study team called for further studies to assess whether other interventions designed to affect cellular metabolic pathways can impact outcomes in people with COVID-19.

Support for this research was provided by the National Center for Advancing Translational Sciences (1-U01-TR-003734-01) and Abbott Laboratories.

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“The current American Heart Association guidelines for diagnosing high blood pressure and cholesterol recognize that otherwise healthy individuals with mildly or moderately elevated levels of these cardiovascular risk factors should actively attempt to reduce these risks. The first treatment strategy for many of these patients should be healthy lifestyle changes beginning with increasing physical activity,” said Bethany Barone Gibbs, Ph.D., FAHA, chair of the statement writing group and associate professor in the department of health and human development and clinical and translational sciences at the University of Pittsburgh in Pittsburgh, Pennsylvania.

An estimated 21% of U.S. adults, about 53 million, have systolic (top number) blood pressure between 120-139 mm Hg or diastolic (bottom number) blood pressure between 80-89 mm Hg; both values are abnormally high. Individuals in this range who have an otherwise low risk of heart disease or stroke meet the American College of Cardiology (ACC)/American Heart Association (AHA) High Blood Pressure Guideline criteria for lifestyle-only treatment for elevated blood pressure.

Likewise, the scientific statement authors estimate that 28% of U.S. adults, or about 71 million, have an LDL cholesterol score above 70 mg/dL and otherwise meet criteria for low risk of heart disease or stroke. These people would meet the 2018 AHA/ACC Cholesterol Treatment Guidelines criteria for lifestyle-only treatment. Lifestyle changes highlighted in the blood pressure and cholesterol guidelines include increased physical activity, weight loss, improving diet, stopping smoking and moderating alcohol intake.

“Increasing physical activity can help lower blood pressure and cholesterol, along with many other health benefits.” Gibbs said. Physical activity also has benefits beyond cardiovascular health, including a decreased risk of some cancers, improved bone, brain and mental health, and better sleep.

Increasing physical activity results in clinically meaningful reductions in systolic and diastolic blood pressure, typically an average reduction of 3 or 4 mm Hg. Similar improvements are seen with blood cholesterol. For example, increased physical activity typically decreases LDL cholesterol by 3 to 6 mg/dL.

The statement highlights research concluding that physically active people have a 21% lower risk of developing cardiovascular disease and a 36% lower risk of death from cardiovascular diseases compared to those who are not physically active.

To improve health, the U.S. Department of Health and Human Services 2018 Physical Activity Guidelines for Americans suggest individuals participate in either a cumulative 150 minutes of moderate intensity aerobic exercise, or 75 minutes of vigorous aerobic activity weekly plus two or more strength training sessions each week.

However, there is no minimum amount of time to receive benefits from physical activity. “Every little bit of activity is better than none,” said Gibbs. “Even small initial increases of 5 to 10 minutes a day can yield health benefits.”

The statement provides suggestions for clinicians to provide exercise “prescriptions” such as patient counselling, incorporating health behavior professionals (e.g., health coaches) and connecting patients to local resources like community centers to help meet their physical activity needs.

According to the statement, prescribing exercise includes:

• Screening patients about physical activity at every interaction, as recommended by the American College of Sports Medicine’s ‘Exercise is Medicine’ campaign. Clinicians can ask patients to report their physical activity with a few questions or by using a wearable device.
• Providing ideas and resources for supporting patients to improve and sustain regular physical activity;
• Meeting patients where they are by exploring activities that the patient enjoys and provide ideas for early success; and
• Encouraging and celebrating small increases in physical activity, such as walking more or taking the stairs.

“In our world where physical activity is increasingly engineered out of our lives and the overwhelming default is to sit — and even more so now as the nation and the world is practicing quarantine and isolation to reduce the spread of coronavirus — the message that we must be relentless in our pursuit to ‘sit less and move more’ throughout the day is more important than ever,” said Gibbs.

Journal Reference:

1. Bethany Barone Gibbs, Marie-France Hivert, Gerald J. Jerome, William E. Kraus, Sara K. Rosenkranz, Erica N. Schorr, Nicole L. Spartano, Felipe Lobelo. Physical Activity as a Critical Component of First-Line Treatment for Elevated Blood Pressure or Cholesterol: Who, What, and How?: A Scientific Statement From the American Heart Association. Hypertension, 2021; DOI: 1161/HYP.0000000000000196

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The blood-brain barrier is impermeable to cholesterol, yet high blood cholesterol is associated with increased risk of Alzheimer’s disease and vascular dementia. However, the underlying mechanisms mediating this relationship are poorly understood. A study published in the open-access journal PLOS Medicine by Vijay Varma and colleagues at the National Institute on Aging, part of the National Institutes of Health, in Baltimore, Maryland, suggests that disturbances in the conversion of cholesterol to bile acids (called cholesterol catabolism) may play a role in the development of dementia.

Little is known about how high blood cholesterol may lead to an increased risk of Alzheimer’s and dementia, yet understanding the underlying processes may lay the foundation for discovering effective therapeutics. To investigate whether abnormalities in cholesterol catabolism through its conversion to bile acids is associated with development of dementia, researchers drew on more than 1800 participants from two prospective studies: the Baltimore Longitudinal Study of Aging (BLSA) and the Alzheimer’s Disease Neuroimaging Initiative (ADNI).

First, the research team investigated whether cholesterol catabolism was associated with brain abnormalities typical of Alzheimer’s and vascular dementia. They next tested whether exposure to cholesterol medications that block bile acid absorption into the bloodstream was associated with an increased risk of dementia among more than 26,000 patients from general practice clinics in the United Kingdom. Finally, they examined 29 autopsy samples from the BLSA to determine whether people with Alzheimer’s disease tend to have altered levels of bile acids in their brains.

The authors found that the risk of vascular dementia increased for males, but not females, with greater number of prescriptions of bile acid blocking drugs. Their findings suggest that cholesterol catabolism and bile acid synthesis may impact dementia progression through sex-specific effects on brain signaling pathways. However, additional studies are needed as the research was limited by the relatively small numbers of autopsy samples. In addition, experimental studies are required to better understand the role of cholesterol breakdown in dementia.

“To further extend these findings, we are now testing whether approved drugs for other diseases that may correct bile acid signaling abnormalities in the brain could be novel treatments for Alzheimer’s disease and related dementias,” said senior author Madhav Thambisetty, M.D., Ph.D., investigator and chief of the Unit of Clinical and Translational Neuroscience in the NIA’s Laboratory of Behavioral Neuroscience. “These analyses are being pursued in the Drug Repurposing for Effective Alzheimer’s Medicines (DREAM) study.”

Journal Reference:

1. Vijay R. Varma, Youjin Wang, Yang An, Sudhir Varma, Murat Bilgel, Jimit Doshi, Cristina Legido-Quigley, João C. Delgado, Anup M. Oommen, Jackson A. Roberts, Dean F. Wong, Christos Davatzikos, Susan M. Resnick, Juan C. Troncoso, Olga Pletnikova, Richard O’Brien, Eelko Hak, Brenda N. Baak, Ruth Pfeiffer, Priyanka Baloni, Siamak Mohmoudiandehkordi, Kwangsik Nho, Rima Kaddurah-Daouk, David A. Bennett, Shahinaz M. Gadalla, Madhav Thambisetty. Bile acid synthesis, modulation, and dementia: A metabolomic, transcriptomic, and pharmacoepidemiologic study. PLOS Medicine, 2021; 18 (5): e1003615 DOI: 10.1371/journal.pmed.1003615

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The analysis included 20,046,11,719 and 6,430 women in Australia who were diagnosed with breast cancer, colorectal cancer, and melanoma, respectively, from 2003 to 2013. The women had been prescribed cholesterol-lowering medications such as statins before their diagnosis.

The more consistently women took these medications in the year after being diagnosed with cancer, the lower their likelihood of dying from the disease, suggesting that the drugs may have anti-tumour effects.

“If this inverse adherence-response relationship is confirmed, cholesterol-lowering medications–primarily statins–could be repurposed as adjuvant therapy to improve cancer prognosis,” said co-author Jia-Li Feng, BMed, MMed, PhD, of QIMR Berghofer Medical Research Institute.

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