The guidelines unveiled at the American Heart Association annual meeting discuss when patients at the highest risk could be treated with a PCSK9 inhibitor.
Nearly 1 in 3 Americans have high levels of low-density lipoprotein (LDL) or “bad” cholesterol, but deciding how to treat it requires a look at each person’s age, health status, family history, and other factors, according to new guidelines presented last weekend at the American Heart Association (AHA)'s Scientific Sessions 2018 and published in the journal Circulation.
LDL cholesterol contributes to plaque buildup and narrowing of the arteries. About 94.6 million (39.7%) of American adults have total cholesterol of 200 mg/dL or higher, while evidence shows that those with LDL cholesterol levels below 100 mg/dL are less likely to develop heart disease or have a stroke.
Two dozen experts from AHA and representatives from 11 other organizations weighed in on the guidelines, which call for paying closer attention to LDL cholesterol early in life and encouraging heart-healthy diet and lifestyle behavior across the life span. In some cases, children with a family history of heart disease or high cholesterol could be screened by age 2, while children without known risk factors could be screened for the first time between age 9 and 11 and again between age 17 and 21.
“We think doctors ought to pay more attention to young adults,” Scott M. Grundy, MD, PhD, chairman of the writing committee, said in a statement. If their cholesterol is elevated, “They might not need a statin, but they certainly need attention.”
The new guidelines call for patients to start with statins and add other therapies if statins do not lower LDL cholesterol to safe levels. High points from the recommendations call for treating patients with very high-risk atherosclerotic cardiovascular disease (ASCVD) to an LDL cholesterol threshold of 70 mg/dL (1.8 mmol/L); if the patient cannot achieve this target with maximally tolerated statins, physicians should consider the use of ezetimibe or other nonstatins.
“The truth about clinical medicine is there is no black and white. It’s all gray,” said Donald Lloyd Jones, MD, cardiologist and another member of the writing committee. “That’s why the emphasis in this document is making sure the patient and doctor are having well-informed discussions about the benefits and potential risks of drug therapy.”
Lloyd-Jones said decisions are more challenge when the patient has risk factors but has not had a heart attack or stroke, and prevention is the priority. “That’s when the decision is more difficult and detailed and personalized discussion is very important,” he said.
Other recommendations are included, some of which incorporate the use of the risk calculator first published in 2013 by AHA and the American College of Cardiology. They include:
The guidelines call for physicians to gauge adherence and response to therapy after 4 to 12 weeks, or after adjusting the statin dose. This step should be repeated every 3 to 12 months, as often as necessary.
The guideline includes a quality and value discussion of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, which were approved with great fanfare in 2015 after clinical trials showed they could reduce LDL cholesterol up to 60%. But list prices of more than $14,000 a year caused formulary managers to restrict access to only the most at-risk patients gain access. In recent months, manufacturers have cut prices after Sanofi worked out an agreement with Express Scripts.
Under the deal, Express Scripts would reduce prices and speed access for those who meet FDA-approved criteria of clinical ASCVD or heterozygous familial hypercholesterolemia if they cannot achieve safe levels of LDL cholesterol even while taking maximally tolerated statins. In return Sanofi’s alirocumab would receive exclusive formulary access over Amgen’s evolocumab. In recent weeks, Amgen reduced prices for evolocumab, as well.
“There have been concerns over the cost of PCSK9 inhibitors and some insurance companies have been slow to cover them, so it’s important to note that the economic value of these new medications may be substantial only for a very specific group of people for whom other treatments haven’t worked,” Ivor Benjamin, MD, FAHA, president of the AHA, said in a statement. “The association is bringing together stakeholders to discuss financial barriers to the care of heart disease and stroke. We have been heartened that drug makers have recently agreed to reduce the prices of PSCK9 inhibitors and are making arrangements with payors to ease the financial burden for patients who could benefit from the additional medication options.”
Gundy SM, Stone NJ, Bailey Al, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on the clinical practice guidelines published online November 10, 2018]. Circulation. doi: 10.1161/CIR.0000000000000625.