Heart Health Breakthroughs: Top Advancements and Innovations of 2022
Heart Health Breakthroughs: Top Advancements and Innovations of 2022
ISLAMABAD, (Online) - Heart disease remains the top cause of deathTrusted Source in the U.S. for both men and women.
One major risk factor for heart disease is having high cholesterol.
High cholesterol and the impact it can have on one’s overall heart health is something that is all too familiar for millions of American nationwide.
The Centers for Disease Control and Prevention (CDC) reportTrusted Source that nearly 94 million adults over the age of 20 in the United States have total cholesterol levels above 200 mg/dL, while 28 million adults have cholesterol levels that climb above 240 mg/dL.
Almost 7% of children and teens 6 to 19 years old have high cholesterol.
Given that it has no clear symptoms, many might not even be aware their cholesterol levels are too high, with high cholesterol increasing your risk for heart disease and for stroke.
Very recently, a new study showed how high cholesterol combined with high blood pressure increases heart disease risk. Cholesterol is something that is incredibly important, affecting many aspects of one’s heart and overall health.
Experts say, as a result, it’s a key issue for your overall health.
When looking back at the state of treating this common condition over the past year, there were advancements in new medications and drug development, which have proven to be significant strides in the field. That being said, a lot more work needs to be done.
“We are not doing well at all,” said Dr. Donald M. Lloyd-JonesTrusted Source, Sc.M., FAHA, immediate past president of the American Heart Association, when asked about the state of treating high cholesterol in relation to heart health today.
“People at risk, including those who have already had a heart attack or stroke, with the most to benefit, are vastly under-treated with effective and safe evidence-based medicines. And of course we are failing with lifestyle approaches given our toxic food supply and obesity epidemic,” added LLoyd-Jones, who is also chair of the department of preventive medicine, the Eileen M. Foell Professor of Heart Research and professor of preventive medicine, medicine and pediatrics at Northwestern University’s Feinberg School of Medicine in Chicago.
Healthline spoke with Lloyd-Jones and Dr. Marwah Shahid, an internist at UCLA Health about what some of the top innovations and headlines were over the course of 2022, and what to look for in the year to come.
The FDA approval of injectable cholesterol-managing drugs
Both Shahid and Lloyd-Jones pointed to the Food and Drug Administration’s approval of the drug inclisiran—brand name Leqvio—as a potential step forward in the fight against cholesterol since it is an injectable people every six months.
“This drug has the potential to transform treatment of cholesterol, since it only requires a simple injection every 6 months, rather than taking a pill daily,” Lloyd-Jones explained. “Current research suggests it is quite safe and effective at reducing LDL-cholesterol. If it is shown to reduce cardiovascular events and is safe in large long-term studies (which are expected to complete in about 2 years), it could change the paradigm for reducing risk through cholesterol treatment — more like vaccination than daily medication.”
He said it is the “design and biology” of this drug that can serve as a model for other cholesterol-lowering, blood pressure-lowering, and cardiovascular disease risk-reducing drugs that are being tested right now.
The drug uses “a small interfering RNA that inhibits production of the PCSK9 protein specifically in the liver,” to help treat patients.
Shahid pointed out that the recent FDA approval of inclisiran came on the heels of the approval of another drug, evolcumab.
This drug, which is an add-on treatment to diet alone or that can work with other drugs to treat people with genetic disorders that predispose them to high cholesterol. These conditions include heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH).
The drug had previously been approved to reduce risk of complications of cardiovascular disease in adults. She explained that the approval for this drug’s use for treating people with these life-threatening, cholesterol-related conditions, puts things in perspective that we are in an era of positive developments in the cholesterol space.
“These are injectables and help with patient compliance,” Shahid added. “They [people using the medications] don’t have to remember to take the medications because they aren’t taken daily.”
This era of cholesterol-regulating injections that you might only need a few times a year, takes away the pressure to remember to take your daily statin, for example.
Promising clinical trials for new drugs
Lloyd-Jones pointed to recent clinical trials in drugs that target lipoprotein(a) that have been progressing through clinical trials this year.
“These trials have been showing good efficacy in lowering Lp(a) and safety in phase 2 trials,” he said. “Outcome trials are ongoing. If these prove to be positive, it will confirm the longstanding belief that Lp(a) is a causal risk factor, and provide the first therapy to treat it directly.”
For example, the double-blind, randomized, placebo-controlled Phase 2 DOSE Finding Study completed in November. There is also an ongoing clinical trial phase 3 study that is set to complete in May 2025 that is assessing a drug that aims to lower Lp(a) on major cardiovascular events in people with established heart disease.
Some trials weren’t all-around success stories
He also pointed out that according to some new studies, a type of drug known as fibrates wasn’t shown to be very successful at treating heart disease.
“The PROMINENT trial showed, once and for all that the class of drugs called fibrates, which target triglyceride lowering, really do nothing to reduce cardiovascular risk in the era of statins and other effective drugs,” he said. “They may still be useful to prevent hypertriglyceride-associated pancreatitis in the small proportion of patients with severe triglyceride elevations who are at risk for that, but should be de-emphasized in cardiovascular prevention.”
Lloyd-Jones emphasized that statins should still be utlized.
“We should double down on LDL-cholesterol reducing therapies and de-emphasize other approaches,” Lloyd-Jones added.
He added that another trial that generated more questions than answers was one that looked at a type of enriched fish oil called icosapent ethyl.
In that case, the placebo appeared to do harm, so the findings of the study remain unclear.
“In a related story, the controversy around icosapent ethyl related to the REDUCE-IT trial persisted this year, with a follow up study showing that the placebo used in that trial increased not only LDL-cholesterol but also inflammatory and other adverse biomarkers in people assigned to placebo,” Lloyd-Jones said. “It is therefore difficult to judge just how helpful icosapent ethy—an enriched form of EPA fish oil—may be given that it may be that the placebo harmed people and not that icospaent ethyl was as beneficial as first thought.”
A ‘polypill’ combination looks successful in treating people following a heart attack
This year saw a big success story in the form of a “polypill” that contains a statin, aspirin, and an ACE inhibitor for people after experiencing a heart attack.
“A polypill strategy successfully reduced second CVD [cardiovascular disease] events in people with a recent heart attack, largely by improving adherence rates to medication compared with usual care, in which people were asked to take multiple pills,” Lloyd-Jones explained. “We know that by one year after a heart attack, typically 50% or fewer of people are still on a statin. This prevention strategy may be an increasingly important one going forward.”
Other major findings
Shahid said that the big news surrounding high cholesterol didn’t just revolve around medications.
She said new research was made this year in uncovering how cholesterol-impacted diseases affect people from different groups differently on “the genetic and molecular basis.”
“Based on the guidelines from 2019, we started to emphasize certain high-risk populations—patients of South Asian descent and females, for instance—and the medical community is now for the first time saying ‘hey, there are risk factors beyond just LDL that affect your cholesterol,’ ” Shahid explained. “Being able to understand this and do research in this field is very important because it can help us create novel therapies for these specific treatment populations.”
Shahid pointed to how women who go through pregnancies and menopause are affected in a unique way at the molecular level where their hormones contribute to “how cholesterol affects their bodies.”
“We don’t completely understand this, but as we do research, developments are starting to understand how men and women differ in how cholesterol affects them,” she stressed.
In just one example, a study published late this year in the January 2023 issue of the journal HGG Advances points to the discovery of a genetic variant found in many people of Polynesian descent, but that is otherwise rare in other groups. It is shedding light on what contributes to high cholesterol in people at the genetic level.
Research like this is crucial in moving past research blind spots by examining underrepresented groups in medical research, something that can benefit our understanding of how high cholesterol manifests itself in humankind as a whole.
“If we had only been looking in populations with European ancestry, we might have missed this finding entirely,” said lead author Dr. Jenna Carlson, assistant professor of human genetics and biostatistics at Pitt Public Health, in a press release. “It was through the generosity of thousands of Polynesian people that we were able to find this variant, which is a smoking gun that will spark new research into the biology underlying cholesterol.”
The increasing role of technology
Beyond research and drug developments, Shahid said the increasing role of technology will continue to be a major factor in high cholesterol management.
“The integration in how patients automate their health is something I’ve noticed a lot, this year, and will persist,” she said. “We can invent 20 new medications, but if patients don’t actually take them, then it doesn’t matter.”
Shahid said she encourages her patients to track their medication use via their smartphones. This means uploading the information seamlessly via their own app or the one available by way of the health system they are a patient of so that she and they can be on top of when they’re taking the drugs they need.
She explained that the ever-present role smartphone technology and tracking all aspects of one’s health—especially managing their high cholesterol—is a part of daily life that is giving people “more ownership” and agency over taking care of themselves.
“More and more, we have this integration of patient ownership and AI in how we are managing patients’ data and care,” she added.
“I think it’s also important as much as we hate to admit it, us millennials, we are now having the chronic health issues that our parents had,” Shahid said. “While our parents may not be on TikTok and be able to investigate, from a technological standpoint, their health, our generation really is. I see a lot more of our generation wanting to integrate biosensors and data in our healthcare and how they manage disease beyond just medications.”