INTRODUCTION: Statin intolerance (SI) occurs in patients with dyslipidemia treated with statins. Statin-associated symptoms have been reported, but the overall patient experience is poorly understood. No instruments are available to collect this patient experience. Our aim is to develop a patient survey to define SI from the patient's perspective, inform clinical practice, and identify potential patient characteristics and barriers associated with discontinuing treatment when statin-related difficulties are encountered. METHODS: We conducted qualitative concept elicitation interviews with 65 patients across 12 European study sites. A semi-structured qualitative interview guide was developed based on literature review and clinician interviews. Concept elicitation interviews with patients were used to describe the patient experience and develop the conceptual framework for the survey. RESULTS: Symptoms experienced by patients included muscle and non-muscle-related pain and discomfort; other muscle-related symptoms; gastrointestinal, cardiovascular, cold-like, fatigue-related, and sensory and systems symptoms; mood changes; and cognitive and memory problems. Impacts included limitations on general physical functioning; physical activities; social functioning; emotional impacts; sleep disturbances; decreased productivity; and increased healthcare use. Conceptual framework elements to support survey goals include demographic and clinical characteristics, health information and beliefs, statin side-effect history, symptom severity, and impact severity. CONCLUSIONS: Symptoms and impacts described by patients showed a wider range of symptoms and impacts than usually discussed clinically. The patient survey is designed to capture information from patients who experience difficulties with statin therapy and may be useful in identifying patients who are at higher risk for giving up or discontinuing their treatment. FUNDING: Amgen Inc.

• MeSH
• Anticholesteremic Agents adverse effects   therapeutic use   MeSH
• Pain chemically induced   MeSH
• Adult MeSH
• Dyslipidemias drug therapy   epidemiology   MeSH
• Qualitative Research MeSH
• Middle Aged MeSH
• Humans MeSH
• Surveys and Questionnaires MeSH
• Aged MeSH
• Patient Satisfaction statistics & numerical data   MeSH
• Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects   therapeutic use   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Europe MeSH

• MeSH
• Blood Vessels * physiology   physiopathology   MeSH
• Vascular Diseases physiopathology   MeSH
• Publication type
• Textbook MeSH

• Conspectus
• Patologie. Klinická medicína
• NML Fields
• angiologie
• kardiologie
• NML Publication type
• kolektivní monografie