ISLAMABAD: Heart disease remains the top cause of death trusted 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) report Trusted 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.”
