Quality of life analysis in the prospective, multicenter statin intolerance registry

Paulina Stürzebecher (Leipzig)1, C. Mateev (Leipzig)1, O. Frenzel (Leipzig)1, U. Schatz (Dresden)2, O. Weingärtner (Jena)3, U. Kassler (Berlin)4, I. Gouni-Berthold (Köln)5, U. Laufs (Leipzig)1

1Universitätsklinikum Leipzig Klinik und Poliklinik für Kardiologie Leipzig, Deutschland; 2Universitätsklinikum Carl Gustav Carus an der TU Dresden Medizinische Klinik & Poliklinik III Dresden, Deutschland; 3Universitätsklinikum Jena Klinik für Innere Medizin I - Kardiologie Jena, Deutschland; 4Charité - Universitätsmedizin Berlin Berlin, Deutschland; 5Universitätsklinikum Köln Center for Endocrinology, Diabetes and Preventive Medicine Köln, Deutschland



Statin intolerance (SI) is a common and important reason for not taking and discontinuing statins. Characteristics of patients with SI are incompletely known. Data on the impact of SI on perception and daily activity is scarce.  


The statin intolerance registry (SIR) is an observational, prospective, multicenter study (NCT04975594) in Germany. 1116 patients were included in the registry between 2021 and 2023. SI was defined as the inability to tolerate at least two different statins due to symptoms that resolved after discontinuation of statin. Detailed patient characteristics including quality of life (EuroQol EQ-5D-5L) and depressive symptoms (PHQ9) were assessed at inclusion. 


The mean age was 66.1 years (SD 10). 57.7% were female. In 95.9% the SI was related to statin associated muscles symptoms (SAMS). The median SAMS-Clinical Index score was 9.0, indicating that the symptoms are likely related to statin use. Severe muscle pain (defined as >7/10 points on NRPS (numeric rating pain scale)) were present in 52.1% of SI patients while taking statins. Almost 50% reported relevant limitations of daily activities due to SAMS. A high percentage (58.2%) of SI patients required analgesic medications due to SAMS. Almost a quarter of SI patients (25.4%) showed signs of moderate depression (PHQ9 score ≥10) at baseline and 23.5% of mild depression (PHQ9 score 5-9). Mean EQ VAS score (assessment of quality of life via a visual analogue scale ranging from 0 to 100) was 64.9 (SD 18.1) indicating a reduced quality of life. Only 10.7% of patients reported to not have any complaints as assessed by EQ-5D-5L. Moderate or severe complaints were most frequently related to pain/discomfort (56.3%), mobility (34.3%), and daily activity (26.1%). 


Patients in this cohort are characterized by a significantly impaired quality of life. A high prevalence of signs and symptoms of depression was observed. In the majority of patients a high severity of pain requiring use of analgesic medication is reported. Additional research is needed to better understand patient trajectories and to improve care of this understudied population.

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