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Experience of Patients Reporting Side Effects of Statin Therapy

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Experience of Patients Reporting Side Effects of Statin Therapy Journal of Clinical Lipidology (2019) -, -–- Original Research The STatin Adverse Treatment Experience Survey: Experience of patients reporting side effects of statin therapy Terry A. Jacobson, MD*,1, Mary Katherine Cheeley, PharmD1, Peter H. Jones, MD, Ralph La Forge, MSc, Kevin C. Maki, PhD, J. Antonio G. Lopez, MD, Pin Xiang, PharmD, Donald M. Bushnell, MA, Mona L. Martin, MPA, Jerome D. Cohen, MD National Lipid Association Health Quality and Research Committee, Jacksonville, FL, USA (Drs Jacobson, Cheeley, Jones, LaForge, Maki, and Cohen); Emory University, Atlanta, GA, USA (Dr Jacobson); Grady Memorial Hospital, Atlanta, GA, USA (Dr Cheeley); Amgen Inc, Thousand Oaks, CA, USA (Drs Lopez and Xiang); and Health Research Associates, Mountlake Terrace, WA, USA KEYWORDS: BACKGROUND: It is important to understand patients’ experiences of statin-associated adverse ef- Adherence; fects to potentially identify those at risk for stopping treatment. Adverse experience; OBJECTIVE: The goal of the STatin Adverse Treatment Experience survey was to describe patients’ Discontinuation of experiences after reporting $1 recent statin-associated adverse event and identify opportunities to therapy; improve adherence and outcomes. Hypercholesterolemia; METHODS: The survey was developed in 3 stages: qualitative item development, pilot evaluation of Patient’s perspective; initial item performance, and quantitative evaluation using a large commercial sample. Respondents Patient-reported with self-reported high cholesterol who had taken a statin in the past 2 years and experienced $1 outcomes; statin-associated symptom in the past 6 months were included (N 5 1500). Shared decision-making; RESULTS: Mean age was 58 years, 40.3% were men, and 43.2% had tried $2 statins. Many had Statin-associated clinical comorbidities associated with increased risk for cardiovascular disease (atherosclerotic cardio- symptoms; vascular disease, 22.5%; diabetes, 25.8%; hypertension, 56.0%). The most important patient-reported Statin therapy; reasons for continuing current statin therapy (n 5 1168; 77.9%) were avoiding a heart attack or stroke, Symptom impact lowering cholesterol, and doctor recommendation. Being bothered by and not being able to tolerate side effects were the main reasons respondents discontinued statins (n 5 332; 22.1%). Respondents who discontinued statins reported significantly higher mean Symptom Severity (10.6 vs 8.7, P , .001) and Impact Severity scores (11.8 vs 9.8, P , .001) compared with those who continued. CONCLUSION: The STatin Adverse Treatment Experience survey highlights the importance of pa- tients’ adverse experiences with statins and how symptom and impact scores affect decisions to continue or discontinue therapy. These data provide a foundation to increase providers’ awareness of statin tolerability from the patient’s perspective and encourage benefit-risk discussions. Ó 2019 National Lipid Association. All rights reserved. 1 T.A.J. and M.K.C. are joint first authors. E-mail address: [email protected] * Corresponding author. Department of Medicine, Emory University, 49 Submitted April 2, 2019. Accepted for publication April 19, 2019. Jesse Hill Jr Drive SE, Atlanta, GA 30303, USA. 1933-2874/Ó 2019 National Lipid Association. All rights reserved. https://doi.org/10.1016/j.jacl.2019.04.011 2 Journal of Clinical Lipidology, Vol -,No-, - 2019 Introduction a patient-centric perspective.18 To gain a better understand- ing of patients’ experiences with statin therapy, we devel- Hypercholesterolemia is one of the most prevalent oped the STatin Adverse Treatment Experience (STATE) modifiable risk factors for cardiovascular disease, and survey. The STATE survey engaged patients who had expe- statins are recommended as first-line pharmacologic ther- rienced $ 1 recent statin-associated adverse event to apy to reduce the risk of heart attack and stroke in most describe their experiences with treatment. The goal of the patients with elevated low-density lipoprotein cholesterol investigation was to develop a better understanding of pa- (LDL-C) levels and in most high-risk patients with tients’ experiences with statin therapy to identify opportu- atherosclerotic cardiovascular disease (ASCVD).1–5 The nities to improve adherence, medication management, 2013 American College of Cardiology (ACC)/American clinical practice, and ultimately, outcomes. In addition, Heart Association (AHA) guideline recommended expand- patient-reported symptom severity and impact on daily ing the use of statin therapy in primary prevention to life were explored to characterize patients potentially at include more older adults and at-risk patients with elevated risk of stopping treatment. LDL-C, thereby substantially increasing the number of U.S. adults for whom statin therapy is recommended to 56 million individuals.6 During 2012 to 2013, an estimated Materials and methods 28% of adults aged $ 40 years (39.2 million individuals) were taking statins.7 Cholesterol-lowering medication use STATE survey development increases with age, with 43% of adults aged 60 to 74 years and 48% of adults aged $ 75 years receiving therapy dur- Briefly, the STATE survey was developed by a team of ing 2011 to 2012.8 expert clinicians and patient-reported outcome (PRO) The 2013 ACC/AHA guidelines also recommended measurement scientists in 3 stages. First, concept elicitation moderate- to high-intensity statin doses for most patients. and qualitative item development was conducted in 2016 The updated 2018 ACC/AHA guideline now recommends (N 5 36). Second, a quantitative pilot validation of initial high-intensity statin doses for many high-risk individuals.1 item performance was conducted in 2017 (N 5 98). Third, Overwhelmingly, muscle-related symptoms are the most the revised survey was used in a quantitative population- commonly reported side effects among statin-treated pa- level evaluation using a large commercial sample in 2018 tients. In clinical practice and observational studies, (N 5 1500). The goal in selecting concepts for measure- approximately 10% to 29% of patients report statin- ment and generating items for the STATE survey was to associated muscle symptoms9–12; these adverse experiences develop a content-relevant, low-burden, user-friendly sur- are a major factor for a change in statin therapy (ie, dose vey that reflected the most important and relevant symptom reduction or switch to a different agent), nonadherence, and impact information obtained from patients with statin- or discontinuation.9,11,13–15 In the Understanding Statin related symptoms during the qualitative concept elicitation Use in America and Gaps in Education (USAGE) survey, process. Item performance was then validated in the pilot muscle-related side effects were more commonly reported study, and the final survey was fielded in a larger sample. in former statin users (60%) vs current statin users All respondents provided informed consent before partici- (25%).9 In a real-world clinical setting involving 2 large pating in any stage of the survey development; the privacy primary care practices, this retrospective study showed rights of all participants were always observed. that approximately 17% of patients experienced a statin- Supplemental Appendix 1 provides the detailed methodol- related event, and of those who discontinued statin therapy ogy for the STATE survey development. because of symptoms, most had a muscle-related event.10 Finally, in a large medicare population (N 5 105,329) Stage 1: Concept elicitation and qualitative item receiving statin therapy after hospitalization for acute development myocardial infarction, those who experienced statin intoler- In stage 1 of the STATE survey development, a ance had a 50% higher risk for recurrent myocardial infarc- qualitative study was conducted with the following 3 tion and a 51% higher risk of being hospitalized for specific objectives: recurrent cardiovascular events.16 1) To identify concepts relevant to patients’ adverse expe- In light of the prevalence of statin use and current riences with statins, guidelines recommending high-intensity statins to obtain 2) to develop a draft PRO survey instrument based on con- the lowest possible LDL-C levels for many patients, based tent and language relevant to patients, and on evidence that lower LDL-C is associated with lower 3) to assess participant comprehension and thought pro- rates of major cardiovascular events,1–3,17 it is important to cesses used in formulating responses to the draft PRO understand the real-world impact of statin therapy from the survey. perspective of the patients who are expected to take these medications, potentially for the rest of their lives. The Na- In stage 1, a preliminary survey was developed after a tional Lipid Association Statin Intolerance Panel has literature review, interviews with opinion leaders, and emphasized that statin intolerance is best understood from qualitative interviews with patients (N 5 36). Patients Jacobson et al STATE survey 3 with varying education and socioeconomic status were memory problems. Symptom items were answered using recruited from lipid clinics across the United States. The a 5-point response scale, with the score being the sum of concept elicitation process involved patients describing the item responses (higher scores indicating greater their experience with statin therapy in their own words. symptomatology). Three waves of cognitive interviews were also conducted to The Impact Severity Scale was designed to assess assure proper comprehension
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