Researchers suggest 2 paths to get patients back on statins

Discontinuing the treatment is common and has been linked to increased risk of cardiovascular events and death in patients with coronary artery disease.

By — Posted April 15, 2013

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When a patient stops taking a statin medication due to an adverse health reaction, physicians should consider prescribing a lower dose or a different type of statin, a recent study said.

“In many cases it's possible to find a statin regimen that's tolerable by the patient after a possible adverse reaction,” said Alexander Turchin, MD, senior author of the study published in April 2 in Annals of Internal Medicine.

That is important, because statin discontinuation is common and has been linked to a greater risk of heart-related events and death in patients who have coronary artery disease, the study said.

A physician's decision to restart a patient on the medication should be an individual one that takes into consideration the severity of the patient's symptoms and the likelihood the symptoms are caused by the statin, said Dr. Turchin, an endocrinologist and assistant professor of medicine at Harvard Medical School in Boston.

“We don't advocate that all patients should be” restarted on a statin, he said. “But in many cases, it is worth trying again.”

Statins are among the most widely prescribed medications in the United States and their use is on the rise, said the Centers for Disease Control and Prevention. One in four adults 45 and older used the cholesterol-lowering drugs in 2005-08, up from the 2% who took them from 1988 to 1994, the CDC said.

Researchers for the Annals study examined clinical data on 107,835 adults who received at least one statin prescription at Brigham and Women's Hospital or Massachusetts General Hospital, both in Boston, from January 2000 to December 2008. Patients taking the statins cerivastatin or clofibrate were excluded because there were too few people on those medications to allow for meaningful analytic conclusions.

The researchers developed software to analyze structured data and physician notes in electronic health records. The software identified patients who had potential side effects to a statin and indicated whether they stopped taking the medication after those events. The program also identified people who later restarted statins and indicated what happened in those cases.

Millions of patients could restart statins

The study found that 17.4% of the adults had a statin-related event documented during the study period. More than half of those had their statin discontinued at least temporarily.

Myalgia and myopathy were the most common statin-related events. Other common statin-related issues included additional musculoskeletal and connective tissue disorders, gastrointestinal problems and nervous system conditions.

Among patients whose medication was stopped, 59.1% were restarted on a statin within a year, the study said. More than 90% of those individuals were still taking the drug 12 months after the statin-related event was reported.

1 in 4 adults 45 and older take statins, one of the most widely prescribed medications in the U.S.

“We interpret these results as a glass half-full, meaning that there are potentially millions of patients who could take statins again and ultimately reduce their risk of heart disease,” Dr. Turchin said. He added that the data show many reactions patients experience while taking a statin either are specific to a certain kind of statin or are not related to the drug at all.

When statin intolerance is real, however, “re-establishing therapy can be very difficult, and when the drug can be tolerated, it is often at subtherapeutic doses,” said Scott M. Grundy, MD, PhD, director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center in Dallas. He wrote an editorial on the study that was published in the same journal issue. In those instances, he recommends physicians use other cholesterol-lowering drugs.

Beyond statin-related side effects, adherence to the medication can be challenging because the drug typically has to be taken every day for the rest of the patient's life, Dr. Grundy said. He said better strategies are needed to promote statin adherence because the medication can greatly reduce the prevalence of atherosclerotic cardiovascular disease.

He recommends physicians use regular visits for monitoring patients' chronic diseases, such as diabetes, as an opportunity to discuss their adherence to statin medication if they have been prescribed the drug.

A limitation of the study is that because participants were from two hospitals in eastern Massachusetts, researchers can't guarantee the results can be generalized to patients in other locations. But Dr. Turchin said the findings probably relate to what most physicians are seeing.

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Key reasons for discontinuing a statin

Despite their well-documented benefits, statins are regularly stopped for a variety of reasons.

Reason for discontinuation Patients with statin-related event Patients without statin-related event
No longer necessary* 13.1% 7.8%
Adverse reaction 11.9% 0%
Therapeutic duplication warning** 7.5% 10.6%
Rejected by patient 3.3% 1.3%
Change requested by insurance 1.7% 5.5%
Ineffective 1.1% 1.0%
Too expensive 0.7% 2.7%
Inadequately covered by insurance 0.4% 1.5%
Other 13.7% 14.4%

* “No longer necessary” is the default reason for medication discontinuation in the electronic health record.

** A therapeutic duplication warning occurs when a patient already is taking a drug in the same class as the one being added to the medication list.

Source: “Discontinuation of statins in routine care settings: a cohort study,” Annals of Internal Medicine, April 2 (link)

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External links

“Statin discontinuation and intolerance: the challenge of lifelong therapy,” Annals of Internal Medicine, April 2 (link)

“Discontinuation of statins in routine care settings: a cohort study,” Annals of Internal Medicine, April 2 (link)

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