QUALITATIVE STUDY TO IDENTIFY PATIENT PERCEIVED SYMPTOMS OF STATIN INTOLERANCE

Author(s)

Martin ML1, Jacobson T2, Cheeley MK2, Harrison DJ3, Jones P2, LaForge R4, Lopez JA5, Maki K2, McCarrier KP6, Miller T6, Patel J3, Thompson P4, Cohen J4
1Health Research Associates, Inc., Seattle, CA, USA, 2National Lipid Association, Jacksonville, FL, USA, 3Amgen Inc., Thousand Oaks, CA, USA, 4National Lipid Association, Jacksonville, CA, USA, 5Amgen, Inc, Thousand Oaks, CA, USA, 6Health Research Associates, Inc., Seattle, WA, USA

OBJECTIVES: Patient perceptions of symptoms related to statin intolerance are not well understood. This study describes patient perceived difficulties with statins and identifies key symptoms to assess when evaluating statin intolerance. METHODS: Adults with dyslipidemia and history of physician-reported statin intolerance to ≥2 statins within the past 6-months were recruited from three lipid clinics in the US. Qualitative interviews were conducted to understand patients’ experiences with statins and describe adverse events they attributed to statins. Interview sessions were audio recorded, transcribed and coded for qualitative content analysis. Coded concepts were grouped by similar content for analysis. RESULTS: Twenty patients were interviewed, mean age 65 (range 48-83), 65% male. Sixty percent had tried ≥4 statins and tried lower doses, non-daily doses, pain relievers, and other supplements to reduce symptoms. There were 486 distinct patient expressions of symptoms related to statin intolerance in the transcript database. Symptoms most frequently described were muscle related pain/discomfort (35%) including aching, cramps, pain, soreness and general discomfort. Other muscle symptoms (9%) included muscle fatigue, heaviness, stiffness, tightness and weakness. Non-muscle-related pain symptoms were also reported (16% of symptom expressions) including bone and joint pain and pain in the chest, neck and back. Fatigue, exhaustion, tiredness and low energy made up 15% of all symptom expressions. Cognitive issues (memory and concentration) comprised 8% of the difficulties reported. Other patient symptom expressions included mood changes (e.g., irritability), gastrointestinal problems, and generally feeling ill. Across all reported symptoms, severity ratings (11 point scale) ranged from 2.0-10.0 (mean 7.2, sd 2.2). CONCLUSIONS: We identified a broad range of symptoms experienced by patients with statin intolerance. Levels of symptom severity are also important and both should be considered when evaluating statin intolerance. More research is needed to identify symptoms and severity that relate to patient’s decision to withdraw from statins.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PCV80

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Cardiovascular Disorders

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