1. Continuation of statins after an adverse event is associated with reduced risk of cardiovascular events (stroke or myocardial infarction) and death.
2. Study results may assist patients and their doctors in weighing the benefits and risks of statin therapy and help them to select a treatment plan that is the most appropriate for the patient’s situation.
Evidence Rating Level: 2 (Good)
Study Rundown: Although statins are strongly recommended for primary and secondary prevention of cardiovascular events in high-risk patients, statin therapy is often halted. Cessation of statins is associated with higher risk of cardiovascular events and death. Adverse reactions may be a reason that patients stop statin therapy. Studies suggest that statins are not the cause of some reported adverse reactions and that many patients who had an adverse reaction can tolerate statins after resuming therapy. This retrospective cohort study used electronic medical records (EMR) to examine risk of cardiovascular event or death in patients with a reported adverse reaction to statins. Study findings suggest that continuing statin therapy after an adverse event is associated with a decreased risk of cardiovascular events or death. Continuing therapy after an adverse event is a critical choice where benefits and risks should be weighed carefully. The findings of this study may assist patients and their doctors in selecting a treatment plan that is the most appropriate for the patient’s situation.
A strength of the study is that the use of EMR data from two large medical centers allowed the ability to analyze data from over 28 000 patients of varied backgrounds for an average of over 4 years of follow-up. Also, use of natural-language processing software helped to detect adverse reactions to statins mentioned only in provider notes. Study limitations include the inability to confirm neither if the adverse reactions were actually caused by the statins nor patient compliancy in taking the statins. In addition, the use of information from two Massachusetts medical centers limits generalizability.
Relevant Reading: Statin intolerance and outcomes after MI
In-Depth [retrospective cohort]: In this study, participants were aged ≥18 years, received care from primary care providers affiliated with Brigham and Women’s Hospital or Massachusetts General Hospital, received prescriptions for statins, and had an adverse reaction thought to be caused by a statin (with documentation in the EMR between 2000 and 2011). Patients were followed until 12 months had passed since the last primary care note, an event outcome occurred, or the study period ended (31 December 2013). Primary composite outcomes included time until stroke, myocardial infarction, or death. Patients who received another statin prescription during the 12-month follow-up period after the adverse event were compared to those who did not receive another prescription. After an adverse reaction, 70.7% (19 989) of the 28 266 study patients continued receiving prescriptions for statins. For patients who received or did not receive prescriptions for statins, respectively, the cumulative occurrence of the primary composite outcome was 12.2% and 13.9% (1.7% difference; 95%CI 0.8% to 2.7%, p < 0.001), the occurrence of a cardiovascular event was 7.6% and 8.5%, and the risk of death was 5.4% and 6.6%.
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