Flurry of new heart health research requires careful, skeptical reading

1024px-Heart_anterior_exterior_viewHeart health news grabbed a lot of headlines in recent days, especially as experts gathered for a major national conference in New Orleans. But skeptical readers would do well to scrutinize the reports on topics like: who should take statins, what’s the role of lifestyle and genetics in heart disease, and how heart-safe is a well-known pain and inflammation medication?

U.S. task force issues new statin guidelines

Let’s start with the new recommendations on statins from the well-respected U.S. Preventive Services Task Force. The independent, influential advisory group—which sorts through research and seeks to offer authoritative, unbiased guidance about medical services and practices—said Americans 40 to 75 with no history of cardiovascular disease but certain risk factors might consider taking statins. The risk factors include whether they have high cholesterol, high blood pressure, diabetes or smoking. The panel said that puts them at a 10 percent or greater risk of having a heart attack or stroke in the next 10 years.

The task force did not definitively recommend the drugs, and it said there was insufficient evidence to decide firmly whether patients older than 75 should take them.

Please note that, of course, patients should discuss their health individually with their caregivers. But coverage of the task force recommendations needs to be parsed carefully, because statins aren’t the slam dunk heart care med that some may make them out to be. Healthnewsreview.org, a watchdog site, points out that many medical viewpoints on statins may be clouded because critical clinical information on the drugs and their outcomes are rooted in industry studies, where data are deemed proprietary and not disclosed publicly. The site also has qualms about the Washington Post report, which was prominent and had a troubling headline.

I’ve written that patient-consumers should consider carefully whether statins are for them, especially weighing their risks and benefits, rather than gulping down just another pill with potentially harmful side-effects. I’ve urged consumers to look hard at statins and the “number needed to treat,” a research-based, single figure that can be a boon to those trying to understand the efficacy of a given therapy. In brief, the NNT provides the answer to: How many people need to take this drug/treatment in for one person to benefit? The lower the number, the better the treatment.

Among people who don’t have high cholesterol but do have high levels of an inflammatory blood marker called C-reactive protein, drug makers like to tout a 50 percent reduction in heart attacks in a research group that took the statins. The reduction in heart attacks was from 4 in 1,000 patients to 2 in 1,000. Yes, that’s a relative 50 percent drop, but only a real drop of 2 people in 1,000 total, or a NNT of 500.

If it takes 500 patients getting the drug every day for years to save one life, how does that look in comparison to, for example, 10 patients? Not impressive.

Nature or nurture in heart disease? Live healthy, improve risks.

Coronary heart disease kills 365,000 Americans annually, 17.3 million worldwide. Research has shown that it has a significant genetic component, afflicting some families much more than others. But nature doesn’t totally rule. And a new study, published in the respected New England Journal of Medicine, suggests that taking certain healthy lifestyle steps can significantly reduce heart disease risks, even among those with genetic predispositions.

The steps make such good health sense overall that it’s nice to see them affirmed as a way to cut risks for those disposed by heredity to heart disease. Put simply: Don’t smoke, exercise moderately, eat healthy with a diet laden with fruits, vegetables, and grains, and don’t become overweight or obese.

The nature-nurture heart disease study had its limits, although it impressed experts not involved with its thoroughness and size. It involved the analysis of data on more than 55,000 people, examining them in four different groups and including for the calcium in their arteries (a heart disease marker) and with heart imaging of some.

Still, researchers had to rely on subjects’ recollection and responses about lifestyle issues, which also were analyzed slightly differently in each of the study groups. The study lacked sufficient data on African Americans. The study results, of course, show associations and not direct causation.

But as Dr. David Maron, the director of preventive cardiology at Stanford, who was not involved in the new study, told the New York Times: “If you are dealt a bad hand, there are things you can do to attenuate the risk.”

Celebrex revisited

Although a new kind of pain-relieving drug showed much promise and gained a lot of attention starting in the 1960s, concerns arose by 2004 about possible heart harms of nonsteroidal anti-inflammatories (NSAIDs) and especially COX inhibitors, those that worked by repressing prostaglandins, injury-site hormones like cyclooxygenase.

To the surprise of many, Celebrex, one of the most common, still-used NSAIDs, has been found by researchers to be no worse or even safer than alternatives like ibuprofen or naproxen. An estimated 2 million Americans take Celebrex or its generic form celecoxib.

Researchers studied more than 24,000 arthritics at high risk for heart disease or who already had it. A third were randomly assigned to take Celebrex, a third to take naproxen and a third to take ibuprofen. The doses were equivalent and were not disclosed to participants and researchers. As the New York Times summarizes the results, as published in the New England Journal of Medicine:

The study found that during the trial 188 of the celecoxib patients (2.3 percent) died of heart disease or hemorrhage, or had a heart attack or a stroke, compared with 201 patients taking naproxen (2.5 percent) and 218 patients (2.7 percent) taking ibuprofen. The real surprise was in other outcomes the study investigated. Significantly more patients taking ibuprofen had worsening kidney function. Patients taking either ibuprofen or naproxen were significantly more likely to be hospitalized for high blood pressure. And despite the assumption that naproxen was the safest, there were 25 percent more total deaths with naproxen than celecoxib — 163 with naproxen compared with 132 with celecoxib.

This study comes with many caveats: Researchers did not take money from the company but Pfizer paid for the study, described as one of the largest of its kind. The study did not use a placebo, just the three drugs. Many of those participating did not have documented heart disease, and many dropped out of the research.

Experts also noted that the work dealt only with those taking NSAIDs at higher doses and for long periods, not the occasional, casual user. They said physicians should use care not to give NSAIDs still for long periods and at high doses, and this research should not be misinterpreted as describing any of the medications as totally safe.

Photo credit: Creative Commons: Patrick J. Lynch, medical illustrator; C. Carl Jaffe, MD, cardiologist

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