The first U.S. overhaul of guidelines for controlling cholesterol released in a decade may double the number of people on drug therapy while limiting the types of medicine they’re prescribed.
The recommendations are based on studies showing treatment with statins, a class of drugs that includes AstraZeneca Plc (AZN)’s Crestor and Pfizer Inc.’s Lipitor, and a heart-healthy lifestyle help many patients regardless of their cholesterol count. Drugs that work differently than statins, including Merck & Co. (MRK:US)’s Vytorin and Zetia, aren’t recommended.
The guidelines from the American Heart Association and the American College of Cardiology announced yesterday are supposed to make it easier to control cholesterol, a risk factor for heart attack and stroke. The biggest change may be a move away from treating patients to a preset goal, optimally under 100 milligrams per deciliter for LDL cholesterol and less than 70 mg/dl for those with heart disease. Now it’s advised that patients stay on statins no matter what their levels.
“This is kind of fire and forget,” said Steven Nissen, chairman of cardiology at the Cleveland Clinic in Ohio. “You decide whether to treat or not, pick a dose and stick with it.”
Statins will be recommended for almost 33 million Americans, about twice the number under previous guidelines. Since treatment is no longer tied to hitting target cholesterol levels, they also eliminate the need for repeat blood tests.
AstraZeneca’s Crestor, the only statin with patent protection, was the third-biggest selling drug in the U.S. last year, generating $5.1 billion for the London-based drugmaker, according to the research firm IMS Health Inc. Sales of atorvastatin, the chemical name for Pfizer Inc. (PFE:US)’s Lipitor and its generic competitors, remain strong with $2.3 billion in U.S. sales in 2012, IMS Health reported.
Merck’s Zetia, which isn’t recommended under the new guidelines, generated (MRK:US) $2.6 billion worldwide in 2012, according to data compiled by Bloomberg. The drug works by limiting cholesterol absorption in the small intestine. Vytorin, a combination of a statin and Zetia, had global sales of $1.7 billion for the Whitehouse Station, New Jersey-based drugmaker.
The goal is to identify people most likely to benefit from treatment and stop trying to hit arbitrary targets that haven’t been proven to improve health, said Neil Stone, professor medicine at Northwestern University Feinberg School of Medicine and chairman of the panel that wrote the cholesterol guidelines. It may be difficult for some doctors and patients to adjust.
“Millions of people, including doctors, are going to be scratching their heads,” said Harlan Krumholz, a cardiologist at Yale University in New Haven, Connecticut. “They have been taught since medical school they are supposed to lower those patients as much as possible, by whatever method they can.”
Heart disease is the No. 1 killer worldwide, and high cholesterol levels add to the risk. LDL or bad cholesterol can form into fatty plaque that builds up in the arteries, blocking blood flow to the heart, brain and other parts of the body.
More than 600,000 Americans die from heart disease every year, accounting for 1 in 4 deaths, according to the U.S. Centers for Disease Control and Prevention. Strokes occur in 795,000 Americans, and kill 137,000 annually.
The guidelines identify four groups of patients who may benefit from moderate to intense treatment with statins: patients who already have heart disease; all Type 2 diabetics ages 40 to 75; people with LDL cholesterol of 190 or greater, which is often genetic; and anyone ages 40 to 75 who has a 7.5 percent or greater risk of developing heart disease in the next decade. Under the new framework, about 31 percent of Americans may get treatment, an increase from 16 percent previously.
“With the new equations and the new approach, we are actually a lot smarter about identifying people who will benefit from risk reduction therapies,” said Donald Lloyd-Jones, chairman of preventive medicine at Northwestern, who helped lead the working group for assessing cardiovascular risk.
Treating patients until they hit their goal led to a surge in demand for drugs like Zetia, and Niaspan and TriLipix from North Chicago, Illinois-based AbbVie Inc. (ABBV:US) These medicines aren’t being recommended because there’s no evidence they help the heart enough to overcome potential side effects, according to the guidelines.
The drugs work differently than statins to lower cholesterol and are often added to get levels to a preset goal. No studies proved they reduced the risk of death, heart attack or stroke, and a string of failures suggested some, like niacin, may cause harm. The writers of the guidelines said the treatments could be considered for some high-risk patients, though there was no evidence to suggest they should be used routinely.
“These drugs are really going to have to prove they improve outcomes,” Krumholz said in a telephone interview. “We’re not chasing targets anymore.”
Merck agrees that cholesterol treatment should begin with a healthy lifestyle and statin therapy, said Pamela Eisele, a company spokeswoman. Zetia, Vytorin and Liptruzet remain important options for appropriate patients because of the additional LDL lowering benefit they provide, she said in a statement.
The focus on getting patients to a target may have actually caused harm, Northwestern’s Stone said. Some patients, such as diabetics, may not have had high enough cholesterol levels to get statins under the old rules. Others took three or four different medicines without ever reaching their target levels, setting them up to feel like failures.
The new guidelines are simpler and safer, said John Rumsfeld, national director for cardiology at the U.S. Veterans Health Administration in Denver. The VA, which once paid doctors to get patients to target levels, has been implementing an approach that avoids the “unfortunate incentive” to overtreat, he said in a telephone interview.
“This is more patient-centered,” he said. “It’s about treating people who are most likely to benefit from taking a chronic medicine. It reduces patient burden. There is no need for repeat blood tests and other unproven medications just to reach an arbitrary numerical target.”
The reduction in blood tests and unnecessary medication has also cut costs, Rumsfeld said. It also avoids side effects that stem from taking ever-higher doses of multiple drugs, he said.
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