Chaipichit Nataporn, Krska Janet, Pratipanawatr Thongchai, Jarernsiripornkul Narumol
Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002, Thailand.
Int J Clin Pharm. 2015 Apr;37(2):355-64. doi: 10.1007/s11096-015-0068-5. Epub 2015 Jan 29.
Although statins have great benefit on the prevention of cardiovascular diseases with limited adverse effects (AEs), little is known about patients' contribution of AE reports in clinical practice.
To explore patients' experiences of statin AEs and related laboratory monitoring in clinical practice.
Outpatient clinics of two University hospitals in northeast Thailand.
Generic symptom checklist questionnaires for self-reporting AEs were distributed to patients prescribed simvastatin, atorvastatin, or rosuvastatin at outpatient clinics. Clinical information was obtained from medical records. Reported symptoms were assessed for causality considering previously known statin AEs, concomitant diseases and drugs.
Potential statin AEs reported by patients and monitoring of laboratory parameters related to musculoskeletal and liver disorders.
Of the total 718 valid responses, 76.0 % of patients reported at least one symptom, most of which (69.0 %) were probable/possible statin AEs. Musculoskeletal and liver-related symptoms were reported by 283 (39.4 %) and 134 patients (18.7 %), respectively. Probable/possible AEs were categorized in 56.7 % of their musculoskeletal and gastrointestinal symptoms. Majority of patients had at least one laboratory test on initiation of (64.8 %) and during statin treatment (61.8 %). Patients taking atorvastatin or rosuvastatin, and patients with history of chronic renal diseases were more likely to have creatine kinase (CK) monitored on initiation of and during statin treatment. Additionally, taking drugs which could potentially increase muscle injury (OR 1.929, P < 0.01) and self-reporting of musculoskeletal symptoms (OR 1.805, P < 0.01) were associated with CK monitoring during statin treatment. Reporters of musculoskeletal symptoms also had significantly higher mean CK level than those not reporting any musculoskeletal symptoms (207.35 ± 155.40 vs. 143.95 ± 83.07 U/L, respectively; P = 0.037). Patient reporting of liver AEs was not related to alanine aminotransferase (ALT) level and monitoring, however, prior history of liver disorders was significantly associated with monitoring of ALT on initiation of and during statin treatment (OR 5.745 and OR 23.063, respectively; P < 0.01).
Many patients experienced at least one possible adverse effects on a statin. The findings suggest that laboratory monitoring is relatively selective in relation to risks and patient-reported adverse symptoms.
尽管他汀类药物在预防心血管疾病方面有很大益处且不良反应有限，但在临床实践中，患者对不良反应报告的贡献知之甚少。
探讨临床实践中患者使用他汀类药物的不良反应经历及相关实验室监测情况。
泰国东北部两所大学医院的门诊。
在门诊向服用辛伐他汀、阿托伐他汀或瑞舒伐他汀的患者发放用于自我报告不良反应的通用症状清单问卷。从病历中获取临床信息。考虑到先前已知的他汀类药物不良反应、伴随疾病和药物，对报告的症状进行因果关系评估。
患者报告的潜在他汀类药物不良反应以及与肌肉骨骼和肝脏疾病相关的实验室参数监测。
在718份有效回复中，76.0%的患者报告了至少一种症状，其中大部分（69.0%）可能是/可能是他汀类药物不良反应。分别有283名（39.4%）和134名患者（18.7%）报告了肌肉骨骼和肝脏相关症状。其肌肉骨骼和胃肠道症状中56.7%被归类为可能的/可能的不良反应。大多数患者在开始服用他汀类药物时（64.8%）和治疗期间（61.8%）至少进行了一次实验室检查。服用阿托伐他汀或瑞舒伐他汀的患者以及有慢性肾脏疾病史的患者在开始服用他汀类药物时和治疗期间更有可能接受肌酸激酶（CK）监测。此外，服用可能增加肌肉损伤的药物（比值比1.929，P<0.01）和自我报告肌肉骨骼症状（比值比1.805，P<0.01）与他汀类药物治疗期间的CK监测相关。报告肌肉骨骼症状的患者的平均CK水平也显著高于未报告任何肌肉骨骼症状的患者（分别为207.35±155.40 vs.143.95±83.07 U/L；P = 0.037）。患者报告肝脏不良反应与丙氨酸氨基转移酶（ALT）水平及监测无关，然而，肝脏疾病史与开始服用他汀类药物时和治疗期间的ALT监测显著相关（分别为比值比5.745和比值比23.063；P<0.01）。
许多患者经历了至少一种他汀类药物可能的不良反应。研究结果表明，实验室监测在风险和患者报告的不良症状方面相对具有选择性。
