‘Duel’ over statins’ use in healthy people moves to new venue

They’re at it again — debating whether otherwise healthy middle-aged men with elevated cholesterol should begin taking statins (Crestor, Lipitor, Zocor) to lower their risk of heart attack and stroke.

“They” are cardiologists Dr. Roger S. Blumenthal, professor of medicine and director of the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, and Dr. Rita Redberg, professor of medicine and director of women’s cardiovascular services at the University of California, San Francisco. Last January, Blumenthal and Redberg debated the statins-for-healthy-people issue in the Wall Street Journal. This month they’re doing it in the pages of the Journal of the American Medical Association (JAMA) as that publication launches its new “dueling viewpoints” series.

(The argument is only about whether doctors should prescribe statins to  healthy people who have risk factors like high cholesterol but no personal history of heart disease. Doctors mostly agree that statins should be given to those with a personal history of coronary heart disease.)

I wrote about the earlier debate, but I think the issue deserves to be revisited. Statins are, after all, the most widely prescribed drug in the world, and are currently taken by more than 20 million Americans.

The pros and cons

Here are a couple of the “no” arguments from Redberg and Dr. Mitchell Katz, who heads the County of Los Angeles’ Department of Health Services. (Redberg and Katz are also editor and deputy editor, respectively, of the journal Archives of Internal Medicine).

What is the benefit of statin therapy in healthy men with high cholesterol levels? Data from a meta-analysis of 11 trials including 65 229 persons with 244 000 person-years of follow-up in healthy but high-risk men and women showed no reduction in mortality associated with treatment with statins. A 2011 Cochrane review of treatment with statins among persons without documented coronary disease came to similar conclusions. The Cochrane review also observed that all but one of the clinical trials providing evidence on this issue were sponsored by the pharmaceutical industry. It is well established that industry-sponsored trials are more likely than non-industry-sponsored trials to report favorable results for drug treatment because of biased reporting, biased interpretation, or both of trial results. …

Do the potential benefits outweigh the potential risks? Based on all current evidence, a healthy man with elevated cholesterol will not live any longer if he takes statins. For every 100 patients with elevated cholesterol levels who take statins for 5 years, a myocardial infarction will be prevented in 1 or 2 patients. Preventing a heart attack is a meaningful outcome. However, by taking statins, 1 or more patients will develop diabetes and 20% or more will experience disabling symptoms, including muscle weakness, fatigue, and memory loss.

And here are a couple of points made by the “yes” team, which included Blumenthal and two of his Johns Hopkins colleagues, Dr. Michael Blaha and Dr. Khurram Nasir.

Are statins safe? Adverse effects with statin therapy are rare. Approximately 5% of patients will develop muscle-related complaints that are generally reversible after drug discontinuation.

Many of these patients can tolerate a different statin. There is no good peer-reviewed evidence that statins lead to cognitive impairment or memory loss, as has been anecdotally reported; one report suggested that statins may improve memory. In appropriate middle-aged patients, the risk of type 2 diabetes associated with statins is mainly seen in those with preexisting glucose intolerance and is minimal in comparison with CHD event reduction.

Is there a durable benefit to statin therapy, or should statins be prescribed only after a myocardial infarction? There is no apparent logic in waiting for a myocardial infarction or a stroke to occur before starting a risk-reducing therapy. A recent meta-analysis of trials confirms that statins retain their benefit after discontinuation of randomized therapy.

Points of agreement

Both groups agree on one thing: A healthy diet (one rich in fruits and vegetables), regular exercise and not smoking are even more important than taking statins for lowering the risk of heart disease.

For anybody who is taking statins (or being advised to take them), these would be great articles to read and then discuss with your doctor. JAMA has made them free to all on their website. I also highly recommend listening to an audio of Redberg and Blumenthal discussing their viewpoints with a JAMA interviewer. The audio is also available through the JAMA website.