Major drug study opens up vast new opportunities in combating heart disease – Washington Post

 In Health

(Rafiq Maqbool/Associated Press)

A landmark drug study has opened up a potent way to lower the risk of heart attacks — beyond the now standard advice of reducing cholesterol — promising new avenues of treatment of Americans’ number one killer.

The findings, more than two decades after the discovery of powerful cholesterol-lowering drugs, called statins, taken by tens of millions, were announced Sunday at a medical conference in Barcelona and published in two leading medical journals.

Physicians not involved in the study described the results as a scientific triumph, calling the implications for drug treatment of heart disease “huge.”

The findings provide validation of an idea that has been tantalizing cardiologists for years: that reducing inflammation could be a way to treat artery-clogging heart disease.

“It’s a new paradigm: a new opportunity to further reduce death and disability,” said Mark Creager, a past president of the American Heart Association, who was not involved in the study. “We’ve made such tremendous inroads in treating heart disease over the last couple of decades, and it’s hard to imagine we could confer additional benefits, but here you go.”

But the implications and timing of any benefit for patients remain to be seen. The drug company that sponsored the trial, Novartis, plans to meet with regulators this fall and file for approval by the end of the year. The drug, an injection given once every three months, would then be reviewed by the Food and Drug Administration.

A key question is which patients will benefit; the study showed its effect — a 15 percent drop in a combined measure of heart attacks, stroke and cardiovascular death — in a select, high-risk population of people who had suffered a previous heart attack and had high levels of a marker of inflammation in their blood. But a subset of patients appeared to get greater benefit from the drug, called canakinumab.

About 15 million people in the United States suffer from the general type of heart disease studied in the trial, according to David Goff, director of the division of cardiovascular sciences at the National Heart, Lung and Blood Institute. There are about 635,000 first-time heart attacks a year in the United States. Of those who survive a heart attack, about 40 percent have high inflammation that puts them at risk for another, despite current therapies.

“I would say the public health impact potential is really substantial,” Goff said, estimating a ballpark figure of about 3 million Americans who might benefit from the drug based on the study’s evidence.

Inflammation is a natural part of the body’s response to infections or injury, but it has been implicated in a growing number of diseases, including cancer.

When cells are injured, they release signaling chemicals and attract immune cells to the site of injury. This process is typically protective, but in heart disease, an inflammation response can contribute to the growth and rupture of fatty deposits that block blood vessels — the ingredients for a heart attack.

But successful heart disease drugs that lower inflammation have other effects, such as lowering cholesterol. That made it hard to distinguish how much of the benefit stems from changes to cholesterol vs. a reduction in inflammation.

By testing a Novartis drug that only affected inflammation — without budging cholesterol — researchers were able to show for the first time that the approach could reduce cardiovascular risk.

“To me, this is like rolling back the clock on statins all the way back to 1994. The first statin came out and we said, ‘Wow, here’s a new class of drugs that can really impact on heart attack and stroke,’ ” said Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston who has doggedly pursued the “inflammatory hypothesis” of heart disease for more than two decades. Ridker has served as a paid consultant to Novartis. “This is the first step, but a big one that is very exciting.”

The trial results don’t mean targeting inflammation is a magic bullet or that people should give up trying to manage cholesterol. Canakinumab, which is already approved for rare diseases under the brand name Ilaris, came with a serious side effect — an increase in the risk of rare fatal infections. Despite the cardiovascular benefit — and a reduction in lung cancer mortality — there was no overall survival benefit, although cardiologists noted that the trends were in the right direction.

The results provide a clue to better treating what Ridker calls the “missing half of heart disease”: the many people whose risk of heart attack remains high, despite well-controlled cholesterol.

It could offer another potential tool for cardiologists, but it does not replace existing therapies — and finding the patients who are likely to get the most benefit will be essential, several outside cardiologists said.

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