Abstract 216: Expert Review on Development of a Patient Measure for Statin Intolerance

Background: Despite proven efficacy and safety of statins for use in dyslipidemia patients, a significant proportion of patients report intolerance to statins leading to treatment discontinuation. In 2014, the National Lipid Association (NLA) Statin Intolerance (SI) Panel recognized a pressing need to better understand patient-centric experience of SI. We believe combining a clinical perspective with patient experience of SI provides a comprehensive view on management of SI.

Objective: This abstract describes clinician’s perspective of SI and patients’ presentation of SI in clinical practice.

Methods: Experts were identified based on publications in the CV and SI research area. Interviews were conducted with health care professionals with known expertise and practice experience in evaluating and treating patients with SI. Interviewers were trained to follow the open-ended, semi-structured guide. The experts summarized their professional background, defined and described characteristics of SI, and their current management of SI in clinical practice. Additionally, targeted probes by the interviewers obtained information pertinent to research questions not spontaneously reported by experts. Following the completion of coding, data were pooled and qualitatively analyzed for common themes.

Results: Four physicians and one nurse practitioner participated in the interviews and reported that they had been treating patients for a range of 19-29 years. Each of the experts provided a unique definition of SI, and four (80.0%) reported that SI is different than experiencing side effects from statins. A total of 13 characteristics reflecting the patient experience with SI were identified from the expert perspective: muscle symptoms (muscle pain (n=5; 100%), muscle weakness (n=4; 80%), muscle cramps (n=1; 20%), fatigue (n=1; 20%)), CNS symptoms (forgetfulness (n=2; 40%), headache(n=1; 20%)), or GI symptoms (i.e.- (n=1; 20%), burping, constipation, diarrhea, gas, indigestion, reflux, or upset stomach ). Experts displayed common approaches to the management of SI patients, including changing the type of statin the patient was receiving, usually at a lower dose, and using alternative treatments either alone or in combination with a statin (n=5; 100%). Regardless of the strategies used for managing SI patients, four experts (80.0%) indicated that they encouraged their patients to continue using statins despite experiences of intolerance.

Conclusions: This study reports the opinions of 5 experts with varying backgrounds concluding that SI is multi-faceted and primarily characterized in the context of muscle pain and weakness which is best assessed from the perspective of the patient. These results, in concert with results from a literature review and patient interviews, will inform a comprehensive and patient-centric understanding of SI and a measure to assess this phenomenon.