Continued Statin Prescriptions After Adverse Reactions and Patient Outcomes: A Cohort Study.

BACKGROUND

Many patients discontinue statin treatment, often after having a possible adverse reaction. The risks and benefits of continued statin therapy after an adverse reaction are not known.

OBJECTIVE

To examine the relationship between continuation of statin therapy (any prescription within 12 months after an adverse reaction) and clinical outcomes.

DESIGN

Retrospective cohort study.

SETTING

Primary care practices affiliated with 2 academic medical centers.

PARTICIPANTS

Patients with a presumed adverse reaction to a statin between 2000 and 2011.

MEASUREMENTS

Information on adverse reactions to statins was obtained from structured electronic medical record data or natural-language processing of narrative provider notes. The primary composite outcome was time to a cardiovascular event (myocardial infarction or stroke) or death.

RESULTS

Most (81%) of the adverse reactions to statins were identified from the text of electronic provider notes. Among 28 266 study patients, 19 989 (70.7%) continued receiving statin prescriptions after the adverse reaction. Four years after the presumed adverse event, the cumulative incidence of the composite primary outcome was 12.2% for patients with continued statin prescriptions, compared with 13.9% for those without them (difference, 1.7% [95% CI, 0.8% to 2.7%]; P < 0.001). In a secondary analysis of 7604 patients for whom a different statin was prescribed after the adverse reaction, 2014 (26.5%) had a documented adverse reaction to the second statin, but 1696 (84.2%) of those patients continued receiving statin prescriptions.

LIMITATIONS

The risk for recurrent adverse reactions to statins could not be established for the entire sample. It was also not possible to determine whether patients actually took the statins.

CONCLUSION

Continued statin prescriptions after an adverse reaction were associated with a lower incidence of death and cardiovascular events.

PRIMARY FUNDING SOURCE

Chinese National Key Program of Clinical Science, National Natural Science Foundation of China, and Young Scientific Research Fund of Peking Union Medical College Hospital.