Statin use when not indicated for certain strokes could cause adverse events
Click Here to Manage Email Alerts
Key takeaways:
- Approximately one-quarter of strokes in the U.S. do not require statins for secondary prevention.
- Statin initiation in this population could lead to thousands of adverse events every year.
Statin initiation in patients with stroke etiologies not indicated for secondary prevention with statin therapy could hypothetically cause thousands of adverse events every year, according to a new meta-analysis published in Stroke.
“While statins have a generally favorable safety profile, they do cause clinically important adverse events in several organ systems. Statins increase the incidence of diabetes, acute renal failure, cataracts, liver disease, frank myopathy, and myalgias or muscle weakness,” Eleanor Mina Sung, MS, research assistant at the University of Southern California Viterbi School of Engineering, and colleagues wrote. “These adverse effects are acceptable for patients expected to benefit from statin therapy. But they are unwarranted in patients who have no statin indications. As the surgical adage states, ‘the less the indication, the greater the complication.’
“The population-level burden of adverse events arising from statin therapy in patients with cerebral ischemia without a statin indication has not been well delineated,” they wrote. “We therefore undertook a series of meta-analyses to determine the proportion of patients with ischemic stroke and transient ischemic attack who have no statin indication and the magnitude of the absolute increase in six side effects induced by statins.”
Multipart analysis of statin use and stroke
Sung, alongside Jeffrey L. Saver, MD, professor of neurology at UCLA David Geffen School of Medicine, conducted a series of three reviews and meta-analyses to evaluate the effects of statin therapy, potentially without indication in patients with ischemic stroke. No. 1 included 63 randomized clinical trials to assess frequency of adverse events related to statin therapy. No. 2 included 55 reports, enrolling 53,501 patients to assess the frequency of ischemic stroke subtypes. No. 3 was an analysis of the proportion of remaining patients with CAD and an indication for statin therapy for primary prevention.
In the first meta-analysis, the researchers noted that statin therapy was associated with an increased incidence of:
- diabetes (RR = 1.08; 95% CI, 1.03-1.14; P = .003);
- myalgia and/or muscle weakness (RR = 1.04; 95% CI, 1-1.09; P = .05);
- mild to severe myopathy (RR = 1.07; 95% CI, 1.01-1.13; P = .02);
- liver dysfunction (RR = 1.28; 95% CI, 1.09-1.5; P = .002);
- renal insufficiency (RR = 1.14; 95% CI, 1.04-1.25); and
- eye disease (RR = 1.22; 95% CI, 1.03-1.44; P = .02).
Current guidelines recommend statin therapy for patients with acute ischemic stroke of large or small vessel atherosclerotic origin or for patients with CAD without these stroke etiologies, according to the study.
In their analysis evaluating stroke subtype, the researchers noted that many of strokes were large artery atherosclerotic (21.6%) and small vessel disease etiologies (23.4%) and the rate of CAD and/or primary prevention indications for statins was 31.8%.
The rate of ischemic stroke without an indication for statin initiation was 23.2%.
Hypothetical effects of inappropriate statin use
Accordingly, the researchers estimated that statin treatment without an indication in this proportion of patients in the U.S. with ischemic stroke could confer approximately 5,601 excess adverse events per year.
“In the United States each year, while more than 715,000 patients with ischemic stroke or TIA have an indication for statin treatment, more than 216,000 patients do not. Giving statin therapy to all these patients without a statin indication would cause more than 5,600 individuals each year to have one of the known six adverse effects of statin,” the researchers wrote. “Statin therapy in appropriate patients was an important contributor to the more than 50% reduction in the age-adjusted incidence of stroke between 1987 and 2011. ... While administering statins to patients with stroke without guideline indications may result in a small proportion of individuals experiencing harm, administering statins to patients with stroke with guideline indications confers substantial benefit and is a foundational component of prevention practice.”
Collapse
Click Here to Manage Email Alerts