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

Reviewed by Dr. Christopher B. Scoma
Huabing Zhang, et al. Ann Internal Med. 2017 Aug 15; 167(4):221-227

SUMMARY
This retrospective cohort study evaluated the clinical outcomes of continuing statin medications despite an adverse reaction to the statin. The study evaluated patients (n=28,266) who experienced an adverse reaction to a statin (measured based on either objective EMR data or obtained from notes via a natural-language processing software). It then analyzed the group of patients who were continued on the statin medication against those whose statins were discontinued. Primary outcome was time to cardiovascular event (MI, stroke) or death. Exclusion criteria included previous adverse reaction to a statin medication, incomplete demographic data, or loss to follow-up prior to documentation of adverse reaction. Adverse effects of statins included myalgias, hepatobiliary disorders, drug intolerance, GI disorders and others (n=6934, 2965, 2223, 2517 respectively). The majority of patients (70.7%, n=19,989) continued to receive the statin medication despite an adverse reaction. In this group, the incidence of MI, stroke or death (primary outcome) was 12.2%, compared to 13.9% in the group of patients whose statin medications were discontinued after adverse reaction (difference: 1.7% [95% CI, 0.8% to 2.7%]; P < 0.001).

COMMENTARY
Statin medications have been long known to provide excellent cardiovascular morbidity and mortality benefits, however their side effects pose a common problem for internists and primary care physicians. The most common patient complaint, myalgia, has been reported to occur in 9-20% of statin-users and can be safely treated through.1 More significant side effects, including rhabdomyolysis and hepatotoxicity, can be more difficult to work around and are a routine cause of statin discontinuation. This study suggests that, in the absence of truly severe or life-threatening side effects, statin use may be encouraged and continued despite adverse reactions. Strengths of the study include multi-year follow-up and over 28,000 patients enrolled. However, the retrospective study design suggests associational data instead of causal relationships. Additionally, while timing of death was reported, the authors were unable to collect cause-of-death, which may confound results. Another important weakness of the study is the lack of weight given to discerning a mild side effect from an adverse reaction; this raises the question of whether the same health benefit is seen in patients with mild reactions compared to severe reactions. Regardless, given the prevalence of cardiovascular disease both in the United States and worldwide, ensuring adequate statin use in the correct patient population will ultimately help save lives. It is important for primary care physicians to be vigilant in ensuring that their patients are prescribed statins when medically appropriate.

REFERENCES
1. Buettner C., et al. “Prevalence of Musculoskeletal Pain and Statin Use.” J Gen Intern Med. 2008 May 1. 23(8): 1182-1186

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