A patient’s family history of cardiovascular disease and in some cases a heart scan are among the factors that physicians should consider before prescribing drugs to lower cholesterol, according to new clinical guidelines released Saturday. The guidelines for cholesterol treatment also recommend prescribing two new types of drugs for high-risk patients when statins, the traditional cholesterol-lowering medication, don’t work. However, due to their cost, one type, known as PCSK9 inhibitors, should be prescribed only when the other, a generic medication, doesn’t work, the guidelines said. The recommendations were released at the American Heart Association’s annual scientific conference and update a sweeping overhaul of the way doctors should determine a patient’s risk of cardiovascular disease. That document, released in 2013, abandoned an easy-to-use recommendation to keep LDL, or bad cholesterol, below 100 or below 70 for people at high risk. Instead, it urged physicians to use a broader calculation of risk—a step that some physicians say caused confusion.
The new guidelines urge physicians to do even more to personalise the decision as to whether a patient needs a cholesterol-lowering drug. That means taking into account heart disease in the family, whether a patient has diabetes, whether he or she is of an ethnicity considered to be at higher risk, such as South Asian, and other factors, on top of more traditional measures such as the results of a cholesterol test. “Risk is more of a process than a calculation,” said Donald Lloyd-Jones, chair of the department of preventive medicine at North-Western University and a member of the panel that wrote the guidelines. “We can help personalise the decision.” Nearly one in every three American adults has high levels of LDL, the AHA says, which contributes to a build-up of fatty plaque and narrowing of the arteries. Research shows that people with LDL of 100 or lower have lower rates of heart disease and stroke, according to the AHA. When a patient’s risk level isn’t clear, a coronary artery calcium scan can help determine whether treatment is needed, the guidelines recommend. The test, which is like a CT scan, measures calcified plaque in the coronary arteries. While the test exposes patients to radiation, it is about the same as a mammogram, Dr Lloyd-Jones said.
The guidelines restore some benchmarks for physicians. For example, they recommend prescribing a drug on top of statins when a patient’s LDL cholesterol is 70 or above despite the statin. “They filled in a lot of the blanks,” said Amit Khera, a reviewer of the guidelines who is director of the University of Texas Southwestern Medical Center’s preventive cardiology programme. Ezetimibe, a low-cost generic drug, may be given to patients at high risk of a heart attack or stroke if statins don’t work, the guidelines said. Only if Ezetimibe doesn’t work should patients be prescribed a PCSK9 inhibitor—a class of drugs shown to be highly effective in lowering the cholesterol of patients whose LDL is 100 or more. The panel said PCSK9 inhibitors’ high cost makes treatment with the drugs worthwhile only for a small number of high-risk patients. That guidance acknowledges a current market reality. Insurers have placed restrictions on paying for the drugs, due to their cost. Many require patients to try other treatments and have their doctors submit reams of paperwork proving their need for the drug. As a result, many patients who are prescribed one don’t get it, makers of the drugs say. On Saturday, they welcomed the inclusion of their drugs in the guidelines.
Amgen Inc. noted that it slashed the list price of its PCSK9 inhibitor, Repatha, by 60% last month to $5,850 a year. Since then, five large statewide and national plans have adopted the lowered price, an Amgen spokeswoman said. Regeneron Pharmaceuticals Inc. and Sanofi SA, maker of Praluent, said in March they would reduce the U.S. net price of the drug to a range of $4,500 to $8,000 annually per patient, down from a list price of $14,600. “We’re optimistic that the new guidelines will enable more patients to benefit from Praluent and are eager to continue collaborating with stakeholders,” Regeneron and Sanofi said Saturday. Separately, researchers presented results of a trial of 8,179 patients showing that Vascepa, a drug derived from an Omega-3 fatty acid in fish oil cut the risk of cardiovascular death, heart attack and other events in study subjects by 25%. That included a 20% lower risk of cardiovascular death. The drug reduces levels of triglycerides rather than LDL cholesterol. The patients in the trial were on statins and had a wide range of triglyceride levels. Amarin Corp., maker of the drug, will apply to the Food and Drug Administration in early 2019 for approval to market it for heart disease prevention, said John Thero, Amarin’s president and chief executive officer.
Credit: Betsy McKay for The Wall Street Journal, 10 November 2018.