Quality of life and clusters of patient characteristics in individuals with statin intolerance

Abstract Background Statin intolerance (SI) is associated with increased risk for cardiovascular events and mortality. The characteristics and symptoms of patients with SI are incompletely known. Methods The statin intolerance registry (SIR) is an observational, prospective, multicenter study that included n = 1111 patients between 2021 and 2023 in Germany. SI was defined as the inability to tolerate at least two different statins due to symptoms that resolved after statin-discontinuation. SIR baseline data were compared with the population-based LIFE-Adult-Study (n = 9983). Results The mean age was 66.1 years. Patients with SI had impaired quality of life with a mean EQ VAS score of 64.9 (SD 18.1) (Figure 1). The problems related to pain/discomfort (55.0%), mobility (32.3%), usual activity (23.9%), and anxiety/depression (20.4%). Diagnosis of depression was frequent (10.3%). 95.9% of patients with SI reported muscle symptoms that were associated with high severity of pain in 43.2% of patients. A higher percentage of SI patients was female in comparison to patients on statin in LIFE-Adult (57.6 vs. 38.2%). Women reported more depressive symptoms and lower quality of life in all domains compared to men. The symptoms increased with age. A data-driven k-means analysis based on variables predicting severity of pain while on statin therapy identified 5 clusters of SI patients (Figure 1). The clusters differed in sex, premature ASCVD, depression, quality of life, comorbidities, and expectations to tolerate statin therapy. Conclusion Overall, patients with SI have a highly impaired quality of life. Women are more frequently and more severely affected. The identified clusters may help identify patients at risk for SI and to develop individualized strategies to improve patient trajectories.