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Continued statin therapy after an adverse reaction lowers risk for death

The benefits of statin therapy, including reduced incidence of cardiovascular events and death, were maintained in patients who continued therapy despite an adverse reaction to the statin, according to findings published in Annals of Internal Medicine.

“Uncertainty exists regarding whether continued statin therapy after an adverse reaction is as beneficial as statin treatment in patients who tolerate these medications well,” Huabing Zhang, MD, from Peking Union Medical College Hospital in China, and colleagues wrote. “Improving our understanding of the benefits and risks of continuing statin treatment after an initial adverse reaction is critical to helping patients and their clinicians make informed decisions regarding statin management.”

In this retrospective cohort study, researchers assessed the connection between continuing statin therapy, defined as any prescription within 12 months after an adverse reaction, and clinical outcomes. They enrolled adults who received a statin prescription and were treated at primary care practices affiliated with Brigham and Women’s Hospital or Massachusetts General Hospital between 2000 and 2011. Using structured electronic medical record data or natural-language processing of narrative provider notes, they analyzed information on adverse reactions to statins to determine primary composite outcome — time to a cardiovascular event, such as myocardial infarction or stroke, or death.

Out of 28,266 patients studied, 70.7% continued receiving statin prescriptions after experiencing the adverse reaction. Four years after the adverse reaction, analysis showed that cumulative incidence of the composite primary outcome was 12.2% for patients who continued statin therapy compared with 13.9% for those who did not (difference, 1.7%; 95% CI, 0.8-2.7). Similarly, after 4 years of follow-up, 5.4% of patients who continued taking statins died, compared with 6.6% of patients not receiving statin therapy (difference, 1.2%; CI, 0.6-1.9); 7.6% of those receiving statin therapy experienced a cardiovascular event compared with 8.5% who discontinued therapy (difference, 0.9%; CI, 0.1-1.7). These findings showed that patients who continued receiving statin prescriptions had a 10% to 20% lower rate of both cardiovascular events and death. Secondary analysis revealed that out of 7,604 patients who were prescribed a different statin after the adverse event, 26.5% experienced a documented adverse reaction to the second statin; however, 84.2% of these patients continued receiving statin prescriptions.

“Whether therapy should be continued after an adverse reaction is an important decision that must take into account the balance of potential benefits and risks to the patient,” Zhang and colleagues wrote. “This study's findings may help patients and their clinicians inform their choice of treatment to best fit each patient's circumstances.”

In a related editorial, Steven E. Nissen, MD, chairman of cardiovascular medicine at Cleveland Clinic, explained that statin adherence rates are so low, despite their benefits for morbidity and mortality outcomes, because internet propaganda promotes unscientific, unproven criticisms of statins. These people, “the statin denial cult,” suggest that statins cause harm, and advocate for alternative “natural” remedies for improving elevated cholesterol levels. The origins of this support began in 1994 with the Dietary Supplement Health and Education Act, which gave the responsibility for ensuring the truth of dietary supplement advertising to the Federal Trade Commission, not the FDA, resulting in implied benefits of their products that have not been confirmed in scientific, clinical research, Nissen suggested.

“What can thoughtful physicians do to counter these dangerous cults? We must work together to educate the public and enlist media support, and we must take the time to explain to our patients that discontinuing statin treatment may be a life-threatening mistake. Passive acceptance of harmful pseudoscience is not an option,” he wrote. – by Savannah Demko

Disclosures: Zhang reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures. Nissen reports grants from Amgen, Astra Zeneca, Esperion Therapeutics and Pfizer.