Background

Statin intolerance (SI) is a frequent and important reason for statin non-adherence and discontinuation. SI may be associated with increased cardiovascular risk. However, the characteristics of patients with SI, their risk factors, medical history, and treatment are incompletely known. 

Methods 

The statin intolerance registry (SIR) is an observational, prospective, multicenter study (NCT04975594) in Germany. SI is defined as the inability to tolerate at least two different statins due to symptoms that had to resolve after discontinuation of statin. This interim analysis included all completed patient records between May 2021 and September 2022 (N = 378). Patients with SI were compared with the subgroup of individuals in the population-based LIFE Adult study (NCT02550236) (N = 9983) who were taking statins (LIFE.Statin, N = 1284) and those who were not taking statins (LIFE.NoStatin, N = 8699).

Results

Population characteristics are presented in the Table. Muscle symptoms were the most frequent complaint in 94.4% of SI patients. The median Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) was 9 out of 11 indicating that the muscle symptoms are likely related to statin use. Statin-intolerant patients and patients in LIFE.Statin are older than patients without statin medication (mean±SD; 66.1±10.4 vs. 66.7±8.7 vs. 56.1±12.4 years, p<0.0001). A significantly higher percentage of SI patients is female in comparison to LIFE.Statin (58.7% vs 38.2%, p<0.0001). 86% of SI patients and 76% of patients in LIFE.Statin are diagnosed with cardiovascular disease (carotid atherosclerosis, coronary heart disease, peripheral atherosclerotic disease). More SI patients take medication for hypothyroidism in comparison to LIFE.Statin (20.4% vs. 11.5%; P<0.0001) and LIFE.NoStatin (10.9%; P<0.0001). Significantly more SI patients are diagnosed with depression compared to the LIFE.Statin and LIFE.NoStatin populations (9.3% vs. 4.5% vs. 5.1%; P 0.001). The mean PHQ9 score in the SIR was 5 (~ mild depression). Overall, mean low density lipoprotein cholesterol (LDL-C) was 2.8±1.7 mmol/l in SIR, 2.9±0.8 mmol/l in LIFE.Statin and 3.6±0.9 mmol/l in LIFE.NoStatin. A high percentage of SI patients is treated with a PCSK9 Inhibitor (47.0% vs. 0.0% in LIFE). 16.0% of SI patients are not taking any lipid-lowering therapy with high LDL-C (5.0±1.3 mmol/l) in this subgroup. 

Conclusion

Patients with statin intolerance in the SIR are characterized by a higher percentage of women, a higher prevalence of medication for hypothyroidism and more depressive symptoms. The follow-up of the SI registry will show how baseline characteristics correlate with future treatments and clinical events.

Table. Population characteristics