Prevalence and Management of Symptoms Associated With Statin Therapy in Community Practice
Insights From the PALM (Patient and Provider Assessment of Lipid Management) Registry
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- cardiovascular disease
- drug-related side effects and adverse reactions
- Hydroxymethylglutaryl-CoA reductase inhibitors
- nocebo effect
When compared against placebo in randomized trials, statins are extremely well tolerated, causing muscle-related side effects in 1% or fewer of treated patients.1 Yet in routine practice, patients often report having symptoms which are misattributed to their statin.2–4 Using data from the PALM Registry, we examined patient-reported rates of statin intolerance, characteristics of patients with perceived side effects, and response to perceived statin intolerance in contemporary practice.
Methods and Results
The data, analytic methods, and study materials will not be made available to other researchers for purposes of reproducing the results. The PALM Registry enrolled 7938 patients from 140 primary care, cardiology, and endocrinology practices in the United States (May 27, 2015 to November 12, 2015) and has been described in detail.5 Trained study coordinators identified eligible patients (patients on a statin, at risk for cardiovascular disease [CVD], or with prevalent CVD, in the Data Supplement) at the time of their visit, who were then sequentially enrolled. Of 9788 eligible patients, n=7937 (81%) consented and enrolled in the study. Patients were then surveyed on statin use, perceived statin-related symptoms and response to symptoms, beliefs about statins and CVD, and sociodemographic characteristics (response rate 95.3%, in the Data Supplement).
Clinical characteristics and medications were abstracted from the medical record by study coordinators. All patients had core laboratory lipid levels (LabCorp, Burlington, NC). Categorical variables were compared with Mantel–Haenszel χ2 tests and continuous variables using Wilcoxon rank-sum tests. Multivariable logistic regression modeling was used to evaluate factors associated with symptoms using generalized estimating equations to account for clustering within site, with backward model selection at P<0.05 for variable retention. Candidate variables were chosen based on either associations with statin use (eg, demographics, atherosclerotic cardiovascular disease history, education, and insurance) or prior associations with statin intolerance (eg, thyroid …