SAN DIEGO (AP) – New research boosts hope that a highly anticipated, experimental class of cholesterol drugs can greatly lower the risk for heart attacks, death and other heart-related problems. The government will decide this summer whether to allow two of these drugs on the market.
People taking one of these drugs had half the risk of dying or suffering a heart problem compared to others who were given usual care – typically one of the statin drugs such as Lipitor or Zocor, doctors found. Many people cannot tolerate statins or get enough help from them, so new medicines are badly needed.
The results are “really impressive and very encouraging” for the new drugs, said one independent expert, Dr. Judith Hochman of NYU Langone Medical Center.
The studies were published online Sunday by the New England Journal of Medicine and discussed at an American College of Cardiology conference in San Diego.
They are fresh analyses from older studies designed to look at how much the drugs lower cholesterol, so they can only suggest that the drugs also lower heart problems, not prove that point. Definitive studies will take about two more years, so the federal Food and Drug Administration will be deciding the drugs’ fates with only results like this in hand.
The drugs are evolocumab, which Amgen Inc. wants to call Repatha, and alirocumab, which Regeneron Pharmaceuticals Inc. and Sanofi SA have named Praluent.
They lower LDL or bad cholesterol more powerfully and in a different way than existing drugs, by blocking PCSK9, a substance that interferes with the liver’s ability to remove cholesterol from the blood.
Side effects remain a question, though, especially on thinking, confusion and memory – problems the FDA has already voiced concern about and asked the companies to track.
The problems affected only 1 or 2 percent of patients and may be temporary, but they were twice as common among people taking one of the new drugs and need to be closely monitored as studies continue, said Dr. Anthony DeMaria, a University of California at San Diego heart specialist and past president of the American College of Cardiology. As a patient facing potential side effects, “the last one I want” is one that affects the brain, he said.
Dr. Eric Topol, a cardiologist at Scripps Clinic in La Jolla, California, said the new results show “an unquestionable signal” of a potential safety issue. More side effects typically turn up once a drug is approved and used in a wider population, he said.
Two other heart experts – Drs. Neil Stone and Daniel
Lloyd-Jones of Northwestern University in Chicago – wrote in the medical journal that “it would be premature to endorse these drugs for widespread use” until the definitive studies are done in a couple of years. Other drugs that initially seemed good failed when put to the most rigorous test, they wrote.
Still, the results so far suggest that the drugs “appear to be on track” to be important new medicines, they wrote.
Dr. Clyde Yancy, cardiology chief at Northwestern University in Chicago and a former American Heart Association president, agreed.
“Science has revealed a brand new approach to treating cholesterol,” and there is “reasonable enthusiasm” it will be a big boon to patients, he said.
___
Online:
Cholesterol info: http://tinyurl.com/2dtc5vy
Heart facts: http://circ.ahajournals.org/content/127/1/e6
This AP story was strong overall, and did a great job discussing the drugs’ side effects and putting these new trials into perspective with older studies. However, the story was also shorter than the competing New York Times article and, consequently, left a few important details out, like a discussion of the likely costs of these drugs. A statement about risk reduction that exaggerates the size of the benefit (an issue we discuss in a related blog post) did not help matters. While patients on the drugs did technically have “half the risk of dying or suffering a heart problem,” that risk went from about 2% to 1% — a benefit that’s smaller than the story’s language implies. It would have been better to lead with the cautionary quotes from Drs. Neil Stone and Daniel Lloyd-Jones, whose comments were placed near the end of the article.
Lipid-lowering drugs, such as statins, are used to help people lower their cholesterol levels, which doctors believe may reduce the risk for heart attacks and strokes. But some people may not get their cholesterol into the recommended range with statins alone, and others are unable to tolerate a lifelong regimen of statins. If an experimental class of cholesterol drugs is shown to reduce cardiovascular risks and improve patient outcomes, then these may prove to be alternatives or adjuncts to the slew of cholesterol-lowering medications already out on the market. On the other hand, the safety of these new drugs must first be ascertained before they become widely available to consumers.
Unlike the competing article in The New York Times, the AP story did not attempt to estimate costs for this class of drugs.
Like The New York Times story, the AP story mentioned benefits in relative terms: “People taking one of these drugs had half the risk of dying or suffering a heart problem compared to others who were given usual care.” By describing this in terms of relative risk reduction, the numbers seem more impressive — misleadingly so — than if they were explained in absolute terms.
Unlike The New York Times story, however, the AP story did not also report the absolute percentages of people who had cardiovascular problems in each study, which would have helped clarify the size of the benefit.
For that reason, we’re rating the story Not Satisfactory.
The AP story did a more thorough job addressing the harms associated with the experimental drugs than The New York Times article. The AP story went more in-depth into the side effects – especially on thinking, confusion and memory – and pointed out that the Food and Drug Administration had even voiced concerns.
An independent expert, Dr. Anthony DeMaria, explained that the neurological side effects were more common with people taking one of the new drugs and added that this would have to be closely monitored.
Another expert source, Dr. Eric Topol, also raised concerns about the drugs’ safety, saying more side effects typically turn up once a drug is approved and used in a wider population.
This story was not quite as extensive in its discussion of limitations as the competing New York Times story. However, it did enough to merit a satisfactory rating.
Examples from the text:
“They are fresh analyses from older studies designed to look at how much the drugs lower cholesterol, so they can only suggest that the drugs also lower heart problems, not prove that point. Definitive studies will take about two more years, so the federal Food and Drug Administration will be deciding the drugs’ fates with only results like this in hand.”
“Lloyd-Jones of Northwestern University in Chicago – wrote in the medical journal that ‘it would be premature to endorse these drugs for widespread use’ until the definitive studies are done in a couple of years. Other drugs that initially seemed good failed when put to the most rigorous test, they wrote.
An important fact that was not mentioned was that these trials were funded by the drug manufacturers themselves – alirocumab by Sanofi and Regeneron Pharmaceuticals and evolocumab by Amgen. Many readers will likely recognize that fact, but some probably will not.
But the article quoted four experts who were not associated with the study, as well as the two authors from The New England Journal of Medicine editorial. Two of the independent experts shed some light on the trials’ safety concerns and explained how many people were affected by the drugs’ side effects. The story clears the bar here.
This story did a good job in bringing up “usual care,” which is normally one of the stain drugs like Lipitor or Zocor. But many people cannot tolerate statins or get enough help from them, it said.
The article made it clear in the first paragraph that these drugs are not approved by the US Food and Drug Administration. “The government will decide this summer whether to allow two of these drugs on the market,” it stated.
The story accurately establishes novelty. It pointed out that these studies were “fresh analyses from older studies,” designed to measure the extent these drugs lower cholesterol. “So they can only suggest that the drugs also lower heart problems, not prove the point,” it said.
We think that’s an excellent way to put these trials into perspective.
The article did not seem to be based on this press release or this one. The independent experts quoted in this story are evidence of original reporting.
Systematic, Criteria-Driven
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