Tennessee Valley Health Care System, Nashville, TN 37129, USA.
Ann Pharmacother. 2010 Jan;44(1):211-4. doi: 10.1345/aph.1M411. Epub 2009 Nov 24.
To describe a case of gemfibrozil monotherapy-induced myositis in a patient with normal renal function
A 68-year-old white man presented to his primary care clinic complaining of a 6-month history of total body pain. His past medical history was significant for hypertension, diabetes mellitus, hyperlipidemia, gastroesophageal reflux disease, benign prostatic hypertrophy, arthritis, impotence, and pancreatic cancer that required excision of part of his pancreas. His home drug regimen included bupropion 75 mg twice daily, gemfibrozil 600 mg twice daily for the past 8 months, glimiperide 1 mg daily, insulin glargine 5 units at bedtime, insulin aspart 5 units in the evening, lisinopril 10 mg daily, omeprazole 40 mg daily, pregabalin 100 mg daily, and sildenafil 100 mg as needed. Laboratory test results were significant for elevated aspartate aminotransferase (AST) 78 U/L (reference range 15-46 U/L), alanine aminotransferase (ALT) 83 U/L (13-69 U/L), and creatine kinase (CK) 3495 U/L (55-170 U/L). Serum creatinine was normal at 1.19 mg/dL. The physician determined that the elevated CK indicated myositis secondary to gemfibrozil use, and gemfibrozil was subsequently discontinued. The patient returned 1 week later to repeat the laboratory tests. Results were CK 220 U/L, AST 26 U/L, ALT 43 U/L, and serum creatinine 1.28 mg/dL. The patient was asked to return in 3 weeks to repeat the laboratory tests. At that time, CK had continued to decrease to 142 U/L, and the AST and ALT had returned to normal, at 22 and 29 U/L, respectively. The patient reported complete resolution of total body pain 3 weeks after discontinuation of gemfibrozil. Follow-up 5 weeks after discontinuation revealed no change compared to the 3-week follow-up.
Myositis most often produces weakness and elevated CK levels more than 10 times the upper limit of normal. The risk of developing myositis, myopathy, or rhabdomyolysis is low (1%) when fibrates such as gemfibrozil are used as monotherapy. Evaluation of the literature revealed one case of gemfibrozil-related myositis in a patient with chronic renal failure. There is also one report of myopathy associated with gemfibrozil monotherapy in a patient with normal renal function. The present case is the first documented case of gemfibrozil monotherapy-induced myositis in a patient with normal renal function. The Naranjo probability scale indicated a probable relationship between gemfibrozil treatment and the onset of myositis in our patient. Other potential causes of myositis were ruled out by patient interview and chart review.
Although the risk of myositis appears to be low with gemfibrozil monotherapy, clinicians should be aware of the potential for this adverse event. For patients taking gemfibrozil monotherapy who present with myalgia, discontinuation of the medication may be necessary for the alleviation of pain.
描述 1 例肾功能正常的患者使用吉非贝齐单药治疗引起的肌炎病例。
一名 68 岁白人男性因全身疼痛 6 个月到他的初级保健诊所就诊。他的既往病史包括高血压、糖尿病、高脂血症、胃食管反流病、良性前列腺增生、关节炎、阳萎和需要切除部分胰腺的胰腺癌。他的家庭用药方案包括每天两次口服 75 毫克安非他酮、过去 8 个月每天两次口服 600 毫克吉非贝齐、每天 1 毫克格列美脲、每晚睡前 5 单位甘精胰岛素、晚上 5 单位门冬胰岛素、每天 10 毫克赖诺普利、每天 40 毫克奥美拉唑、每天 100 毫克普瑞巴林和按需服用 100 毫克西地那非。实验室检查结果显示天门冬氨酸氨基转移酶（AST）78U/L（参考范围 15-46U/L）、丙氨酸氨基转移酶（ALT）83U/L（13-69U/L）和肌酸激酶（CK）3495U/L（55-170U/L）升高。血清肌酐正常，为 1.19mg/dL。医生确定升高的 CK 表明肌炎继发于吉非贝齐的使用，随后停用了吉非贝齐。一周后患者返回重复实验室检查。结果为 CK 220U/L、AST 26U/L、ALT 43U/L 和血清肌酐 1.28mg/dL。要求患者在 3 周后再次重复实验室检查。此时，CK 持续下降至 142U/L，AST 和 ALT 恢复正常，分别为 22U/L 和 29U/L。停药 3 周后，患者报告全身疼痛完全缓解。停药 5 周后的随访结果与 3 周随访时相比没有变化。
肌炎最常导致无力和 CK 水平升高超过正常值的 10 倍。当单独使用非诺贝特等贝特类药物时，发生肌炎、肌病或横纹肌溶解的风险较低（1%）。对文献的评估显示，在 1 例慢性肾功能衰竭患者中发现了 1 例与吉非贝齐相关的肌炎。还有 1 例关于在肾功能正常的患者中与吉非贝齐单药治疗相关的肌病的报告。本病例是首例在肾功能正常的患者中记录到的与吉非贝齐单药治疗相关的肌炎病例。Naranjo 概率量表表明，我们的患者中，吉非贝齐治疗与肌炎的发生之间存在可能的关系。通过对患者的访谈和图表审查排除了其他肌炎的潜在病因。
尽管吉非贝齐单药治疗的肌炎风险似乎较低，但临床医生应意识到这种不良事件的可能性。对于正在接受吉非贝齐单药治疗且出现肌痛的患者，可能需要停药以缓解疼痛。
