We don’t have miracle drugs. But to many, statins come awful close. They lower cholesterol levels, slash mortality rates in people with heart disease, and we’re learning more about how they can even prevent cancer in healthy people. They’re cheap, too, and some of the most-prescribed pills out there. Like any other drug, they come with side effects, of which doctors and patients taking statins are well aware: muscle pain tops the list, but there’s also a risk of liver damage and potentially even developing diabetes. But research published last week shows that the problem is bigger than we think: we thought only 5-10% of patients came down with side effects , but this study says it’s actually more like 17%—almost double. About 60% of those patients suffering side effects stopped taking statins, at least temporarily, as a result.
This is important information for clinicians, patients, and policymakers. A lively discussion is still underway on whether we should be giving statins to healthy patients who don’t currently have heart disease, and these new data should enter that discussion. Patients, too, deserve an accurate picture of what they’re getting themselves into.
The study also found that, of patients who gave up statins because of side effects, more than 90% got back on statins within a year. That number seems to be interpreted as evidence that the side effects were ultimately tolerable. But I don’t know how they can tease that out from the data, and am left wondering if those patients got back on simply because of the exhortations of their doctors.
More importantly, I’m uncomfortable with the way we’re discussing this whole issue. In NPR’s coverage, for example, I got the impression that those side effects were being downplayed:
The worry, of course, is that the ranks of statin quitters include people at high risk of heart disease, for whom the daily dose of cholesterol-lowering drug can reduce the risk of deadly heart attacks.
“Statins are important drugs, especially for patients with known heart disease,” says Dr. Alexander Turchin, an assistant professor of medicine at Harvard Medical School, who led the study. “These are not drugs you just want to throw away without a second thought.”
And many of the people in this study who quit the drug were able to get back on statins, Turchin and his colleagues found. Reasons varied.
“The side effects might have been tolerable,” he told Shots.
The title of Time‘s coverage? “Side Effects of Statins May Be Tolerable.” The subtext here bothers me. I’m worried that our knee-jerk reaction in medicine is to question the patient’s behavior, rather than to listen and dig deeper. The side effects might well be tolerable, but at what cost to their quality of life? Would muscle pain be enough to make a patient stop exercising? If a patient not taking statins complains of muscle pain, we’d try to diagnose and treat it. But if our treatment causes the muscle pain, why is it different? Why now is it something they should man up and deal with?
I don’t want to downplay how important it is to reduce cardiovascular mortality, nor how important it is to make sure patients adhere to their prescriptions—I’m sold on both. And I know some people stop taking medications for the wrong reasons. But the sooner we acknowledge that “noncompliance” can be a rational decision, the sooner we can figure out what’s causing it and incorporate that into smarter, more patient-centered treatment. For example, if an avid exerciser on statins (yes, people with high cholesterol can exercise too) starts having muscle pain, we could talk to him or her about controlling cholesterol through diet instead. Researchers could be looking into the mechanisms of that muscle pain and figuring out how to prevent it.
This is a well-constructed, fascinating, and important study . We now have a wealth of information on why patients stop taking one of the most effective classes of drugs. But let’s use it for the right reasons. Let’s use it to better understand our patients’ decisions, rather than to perpetuate a medication-adherence blame game.
1. The researchers also point out how this casts a dubious shadow on the 5-10% side effect rate reported from clinical trials:
“The discrepancy between clinical trials and observations of routine care has been attributed to many factors, including patient selection in randomized trials, which may exclude older participants, enroll insufficient numbers of women, or have a selection bias based on persons willing to participate. Patients who have multiple comorbid conditions, take other medications that may affect the metabolism of statins, have adverse effects during the run-in phase, have a history of statin-related adverse events, or are considered to be at high risk for such events are also generally excluded. In clinical practice, however, such patients may be prescribed statins.”
2. Allow me to geek out for just one moment about the study’s methodology:
“We have previously shown that many statin-related events are documented only in narrative provider notes. In our study, only 30.0% of patients with a statin-related event had the event recorded in a structured format. To overcome this barrier, we used a specially designed tool capable of processing up to 40 notes per second, enabling analysis of millions of documents. In the future, similar technologies could be used for both retrospective and prospective monitoring for adverse drug reactions.”
HOW COOL IS THAT???
Karan is a first-year student at Robert Wood Johnson Medical School and Duke graduate who previously worked in strategic research for hospital executives.