Stürzebecher Paulina E, Gouni-Berthold Ioanna, Mateev Christina, Frenzel Ole, Erbe Stephan, Boeckel Jes-Niels, Scholz Markus, Schatz Ulrike, Weingärtner Oliver, Kassner Ursula, Laufs Ulrich
Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Leipzig, Germany.
Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Lancet Reg Health Eur. 2024 Jul 1;43:100981. doi: 10.1016/j.lanepe.2024.100981. eCollection 2024 Aug.
Statin intolerance is associated with increased cardiovascular risk. Symptoms and patients' characteristics are incompletely known. We aimed to analyse the health-related quality of life (QOL) associated with statin intolerance.
The Statin Intolerance Registry (SIR) is an observational, prospective, multicentre study that included 1111 patients, with intolerance to at least two different statins, between 2021 and 2023 in Germany. SIR baseline data were compared to individuals with and without statin therapy of the population-based LIFE-Adult Study (n = 9983).
The mean age in SIR was 66.1 years (standard deviation (SD) 9.9). The cohort was characterized by a higher proportion of women compared to patients on statins in LIFE-Adult (57.7% vs. 38.2%). SIR patients had impaired QOL (mean EQ VAS score of 64.9 (SD 18.1)) as measured by EuroQol (EQ-5D-5L)), which further deteriorated with age. Muscle symptoms were frequent (95.8%) and were associated with severe pain in 43.2% and intake of pain medication in 32.3% of statin intolerant patients. 10.3% had a diagnosis of depression. Women reported more pronounced symptoms than men. A data-driven k-means analysis, based on variables predicting severity of pain while on statin therapy, identified five clusters of SIR patients. The clusters differed in sex, prevalence of depression, QOL, comorbidities, and expectations to tolerate statin therapy.
Statin intolerance is associated with impaired QOL. Women are more frequently and severely affected. The identified clusters may help to identify patients at risk and to develop individualized strategies to improve patient trajectories and outcomes.
Leipzig University, research grants from Daiichi Sankyo, Novartis, and Amgen to Leipzig University.
他汀不耐受与心血管风险增加相关。症状和患者特征尚不完全清楚。我们旨在分析与他汀不耐受相关的健康相关生活质量（QOL）。
他汀不耐受登记处（SIR）是一项观察性、前瞻性、多中心研究，在2021年至2023年期间纳入了德国1111名对至少两种不同他汀不耐受的患者。将SIR基线数据与基于人群的LIFE-成人研究（n = 9983）中接受和未接受他汀治疗的个体进行比较。
SIR患者的平均年龄为66.1岁（标准差（SD）9.9）。与LIFE-成人研究中接受他汀治疗的患者相比，该队列女性比例更高（57.7%对38.2%）。通过欧洲五维健康量表（EQ-5D-5L）测量，SIR患者的生活质量受损（平均EQ VAS评分为64.9（SD 18.1）），且随年龄进一步恶化。肌肉症状很常见（95.8%），43.2%的他汀不耐受患者伴有严重疼痛，32.3%的患者服用止痛药物。10.3%的患者被诊断为抑郁症。女性报告的症状比男性更明显。基于预测他汀治疗期间疼痛严重程度的变量进行的数据驱动k均值分析，确定了SIR患者的五个聚类。这些聚类在性别、抑郁症患病率、生活质量、合并症以及耐受他汀治疗的期望方面存在差异。
他汀不耐受与生活质量受损相关。女性受影响更频繁且更严重。识别出的聚类可能有助于识别有风险的患者，并制定个性化策略以改善患者病程和结局。
莱比锡大学，第一三共、诺华和安进公司给莱比锡大学的研究资助。
