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People’s Pharmacy: Dissenters challenge pro-statin dogma

There are few modern medications that have stirred as much controversy as statins. They have been hailed as magic bullets against heart disease ever since lovastatin (Mevacor) was approved in 1987.

Since then, tens of billions of dollars have been spent on drugs like atorvastatin (Lipitor), pitavastatin (Livalo), rosuvastatin (Crestor) and simvastatin (Zocor). Doctors tell patients that these cholesterol-lowering medications will protect them from a heart attack or stroke. Some cardiologists are so enthusiastic about the benefits of such drugs that they have jokingly suggested statins be put in the water supply.

No one is serious about that, but guidelines from the American Heart Association and the American College of Cardiology would put 97 percent of Americans between 66 and 75 years of age on statins (JAMA Internal Medicine, January 2015).

If cardiologists followed the recommendations of their organizations, all men and most women in that age group would be prescribed a statin-type medication, regardless of how fit or healthy they might be. The guidelines ignore the lack of high-quality studies showing a benefit for people this age who haven’t been diagnosed with heart disease.

Most cardiologists think that statin side effects are extremely rare, even in older adults. Reports of muscle pain, weakness, nerve damage, reduced libido, diabetes, cataracts and memory problems often are discounted as coincidental and not caused by statins.

There is, however, another side to the statin story. Two articles in the journal Expert Review of Clinical Pharmacology (March 2015) challenge the prevailing wisdom. One is titled “How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease.”

For example, in one highly quoted study, 3 percent of those on placebo had a heart attack, compared with 2 percent of those taking Lipitor. In other words, out of 100 people taking atorvastatin, one would benefit. But because the difference between 3 percent and 2 percent is only 1 percent, the manufacturer instead promoted the drug as reducing the risk of heart attack by 36 percent.

Other studies of statins show similarly unremarkable results. Statin users had between 1.2 percent and 1.5 percent fewer cardiovascular complications than those taking placebo. The authors believe that for statins, “their modest benefits are more than offset by their adverse effects.”

The other article is even more worrisome. The Japanese scientists who wrote the perspective “Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms” explain the biochemical basis for their contention that statins may be contributing to clogged arteries and heart-muscle failure. They conclude, “Thus, the epidemic of heart failure and atherosclerosis that plagues the modern world may paradoxically be aggravated by the pervasive use of statin drugs.”

While statins may provide protection for those with serious heart conditions, people without heart disease may not get as much benefit as they expect. Doctors and patients should review the clinical trial data before making a decision on statin use.