Fuhrmann Saskia, Koppen Aline, Seeling Andreas, Knoth Holger, Schröder Jane
Center for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; Hospital Pharmacy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Center for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany; Hospital Pharmacy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Z Evid Fortbild Qual Gesundhwes. 2019 Oct;146:21-27. doi: 10.1016/j.zefq.2019.06.003. Epub 2019 Jul 17.
Pharmacokinetic analyses revealed an increase in the bioavailability of simvastatin when co-administered with amlodipine [Nishio S et al. Hypertensin research 2005; Son H et al. Drug metabolism and pharmacokinetics 2014]. This may induce an increased risk of muscle toxicity for patients who receive this combination. So far, no in vivo data on the clinical relevance of this interaction exist. The objective of the present analysis was to determine the number of patients with concomitant treatment of amlodipine and simvastatin. Subsequently, the data was analyzed for the indication of muscular discomfort. Patients with combined prescription of amlodipine and another hydroxymethylglutaryl-CoA-reductase inhibitor except simvastatin or patients receiving simvastatin without amlodipine served as control groups.
The present analysis used secondary data from the health insurance company AOK PLUS including information regarding diagnosis and drug prescriptions.
In total, 67.081 patients corresponding to 4.93% of the analyzed collective received a combined prescription of amlodipine and simvastatin. The absolute frequency increased continuously over time. Muscular discomfort was detected in a) 6.20% of the patients receiving amlodipine and simvastatin, b) 6.60% of the patients receiving amlodipine and another hydroxymethylglutaryl-CoA- reductase inhibitor and c) 8.04% of the patients with simvastatin only.
The present analysis shows an increasing trend of combined prescriptions of amlodipine and simvastatin. Evidence for simvastatin dose adaptation or therapy switch to another hydroxymethylglutaryl-CoA-reductase inhibitor, however, was not found. Muscular discomfort does not occur more often in patients with amlodipine and simvastatin compared to the two control groups. The results of the present analysis reveal no evidence for a clinically relevant interaction between amlodipine and simvastatin.
药代动力学分析显示，辛伐他汀与氨氯地平合用时生物利用度增加[西尾S等人，《高血压研究》，2005年；孙H等人，《药物代谢与药代动力学》，2014年]。这可能会增加接受这种联合治疗的患者发生肌肉毒性的风险。到目前为止，尚无关于这种相互作用临床相关性的体内数据。本分析的目的是确定同时接受氨氯地平与辛伐他汀治疗的患者数量。随后，对数据进行分析以寻找肌肉不适的迹象。氨氯地平与除辛伐他汀之外的另一种羟甲基戊二酰辅酶A还原酶抑制剂联合处方的患者，或接受辛伐他汀但未使用氨氯地平的患者作为对照组。
本分析使用了来自健康保险公司AOK PLUS的二次数据，包括诊断和药物处方信息。
总计67081名患者（占分析总体的4.93%）接受了氨氯地平与辛伐他汀的联合处方。绝对频率随时间持续增加。在以下患者中检测到肌肉不适：a）6.20%接受氨氯地平与辛伐他汀治疗的患者；b）6.60%接受氨氯地平与另一种羟甲基戊二酰辅酶A还原酶抑制剂治疗的患者；c）8.04%仅接受辛伐他汀治疗的患者。
本分析显示氨氯地平与辛伐他汀联合处方呈增加趋势。然而，未发现辛伐他汀剂量调整或换用另一种羟甲基戊二酰辅酶A还原酶抑制剂治疗的证据。与两个对照组相比，氨氯地平与辛伐他汀联合治疗的患者肌肉不适的发生率并未更高。本分析结果未发现氨氯地平与辛伐他汀之间存在临床相关相互作用的证据。
