It took the combination of a hypertensive crisis and a scan of my clogged arteries a few years ago to persuade my doctor (and eventually me) that I needed to start taking a statin. If practitioners are paying attention to recently updated clinical guidelines for cholesterol control, a lot of younger, healthier patients could soon be joining me in line at the pharmacy.
A recent report out of the University of Pittsburgh suggests that revised recommendations from the American Heart Association (AHA) will qualify more than half of Americans above the age of 30 for a statin regimen. The shift, notes lead study author Timothy Anderson, MD, a primary care physician and researcher, is based on a longer view of cardiovascular risks. Rather than assessing the risk 10 years out, the AHA now encourages physicians to look as far as 30 years into the future.
“Before the new guidelines, people who were flagged with high cholesterol in their 30s and 40s tended to be recommended to focus on diet and exercise and were not recommended medication — unless the patient already had heart disease or other factors that made them particularly high-risk, like diabetes,” Anderson says. “The shift to a longer view of cardiovascular risk is a sea change for doctors in counseling patients. We wanted to better understand the potential population-health effect of this shift.”
Anderson and his team analyzed data from 4,366 participants in the National Health and Nutrition Examination Survey, a cross section that represents more than 150 million U.S. adults without cardiovascular disease. Their results suggest that the new eligibility guidelines could increase the number of statin-eligible patients between the ages of 30 and 79 by 21.5 million — a rise of 56.6 percent.
Eligibility is one thing, of course, but accepting a prescription is quite another. When my elevated cholesterol numbers were revealed to me during (very) occasional visits to a doctor in my 30s and 40s, they were not persuasive enough for me to accept a pharmaceutical antidote. Anderson says he gets that response from many of his younger patients. With a low risk of a heart attack or stroke in the next 10 years, most prefer to focus on lifestyle fixes or, as in my case, simply ignore the warning. But, Anderson argues, the longer you wait, the higher the risks.
“Observational evidence suggests the longer people are exposed to high levels of inflammatory cholesterol molecules, the greater their downstream risks of heart attacks and strokes are,” he says. “Unfortunately, we do not have randomized clinical trials for low-risk people 30 years out that would directly support this new understanding of how risk builds more gradually over the years.”
What we do have is a general concern about statins’ side effects: muscle pain, liver damage, blood-sugar spikes, and neurological annoyances. I’ve been coping with nagging episodes of peripheral neuropathy — tingling and numbing throughout the left side of my body — since beginning my statin regimen. I’ve changed the type of drug, which seemed to help until my cholesterol levels rose to unacceptable levels, forcing me to increase my dosage and endure the neuropathic consequences. As I told my doctor, it’s a small price to pay if it prevents a stroke.
I’m not alone in my struggles to cope with statins’ often vexing tradeoffs. A 2019 AHA report analyzed the drug’s usage among 5,693 study participants whose cholesterol levels qualified them for statin therapy. The survey found that, among the 1,511 who were not using statins, 30.7 percent had stopped taking them due to their side effects and 10 percent refused to take one at all. I can only imagine how the millions of newly eligible patients will affect those numbers in the years ahead.
So I found it highly ironic that a few months after the AHA announced its new statin guidelines, Big Pharma giant Merck announced FDA approval of a new drug that has been shown in clinical studies to lower “bad” LDL cholesterol more effectively than statins.
The new drug, enlicitide (sold under the brand name Lipfendra), helps the body dispose of cholesterol by blocking a protein known as PCSK9. There are other PCSK9 inhibitors currently available, but Lipfendra is the first to be offered as a pill rather than an injection. It will also be cheaper ($315 for a month’s supply) than some of its injectable cousins, though whether it will be covered by Medicare or other carriers remains unknown at this point.
Adverse reactions to the drug, according to Merck, may be less exotic than the neuropathy I’ve been experiencing with my statins, but I do not consider diarrhea (reported by 9 percent of trial participants) nor dizziness (7 percent) to be an upgrade.
Brown University preventive cardiologist Vishal Khetpal, MD, isn’t concerned about Lipfendra’s side effects, but he doubts that the new drug will be embraced by physicians, even in light of the AHA’s expansion of eligible patients. “For the millions of Americans who fit into these groups, it has already been hailed as a game changer,” he writes in STAT News. “But the story here — of whom it would actually help, and what it implies about prevention today — is more complicated.”
PCSK9 inhibitors have been available since 2015, he notes, but they are not commonly prescribed due to out-of-pocket costs, prior authorizations, and patients’ general aversion to injectables. There have also been accessibility issues, as the injectable drugs require storage in temperature-controlled settings often available only in specialty pharmacies. “But even if these barriers around cost, access, and convenience were removed, in truth, I don’t anticipate prescribing patterns changing immediately,” Khetpal notes.
That’s because many cardiologists prefer to take a more holistic approach to chronic disease. “Inherently, PCSK9 inhibitors are not lower value; their value is conditional to the patient and situation,” he explains. “But if enlicitide’s entry into the market isn’t paired with efforts to better recognize and treat high cholesterol levels with generic therapies, [combat] misinformation around statins, and [promote] heart-healthy diets, it may inadvertently enable providing lower value care.”
In my immortal youth, I might have made the same case against statins, but I’ve learned to accept their tangible liabilities these days along with their potential benefits. If I can finally figure out the proper dosage.
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