Davidson Michael H, Jones Peter H
University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA.
Clin Drug Investig. 2008;28(10):615-23. doi: 10.2165/00044011-200828100-00002.
To compare changes in lipid levels (total cholesterol [total-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG], and high-density lipoprotein cholesterol [HDL-C]) for patients who switched from standard fenofibrate 160 mg (requiring dosing with food) to fenofibrate 145 mg with no food effect (NFE).
The analyses were performed using an electronic medical records dataset from 1 January 2003 to 31 July 2005. Patients were eligible for the analysis if they had a diagnosis of hypertension, dyslipidaemia or diabetes mellitus, were written a prescription for standard fenofibrate 160 mg during the period 1 May 2004 to 30 April 2005, and were written a subsequent prescription for fenofibrate 145 mg NFE at least 60 days after first receiving the 160 mg dose. The outcomes measured were lipid levels: total-C, LDL-C, HDL-C and TG.
491 patients who switched from standard fenofibrate 160 mg to fenofibrate 145 mg NFE met all of the inclusion criteria. Patients who changed therapy to fenofibrate 145 mg NFE from standard fenofibrate 160 mg showed a beneficial response in lipid levels. Statistically significant patient-specific changes in lipid levels were observed for the change from baseline to standard fenofibrate 160 mg for three lipid levels (total-C, HDL-C and TG). Statistically significant changes were observed for the switch to fenofibrate 145 mg NFE for three lipid levels (total-C, LDL-C and TG).
More patients treated in an outpatient clinical practice had better lipid results when prescribed fenofibrate 145 mg NFE than those prescribed standard fenofibrate 160 mg, suggesting that a less restrictive dosing regimen improves lipid outcomes.
比较从标准非诺贝特160毫克(需与食物同服)换用无食物效应的非诺贝特145毫克的患者的血脂水平变化(总胆固醇[总胆固醇-C]、低密度脂蛋白胆固醇[LDL-C]、甘油三酯[TG]和高密度脂蛋白胆固醇[HDL-C])。
分析使用了2003年1月1日至2005年7月31日的电子病历数据集。如果患者被诊断为高血压、血脂异常或糖尿病,在2004年5月1日至2005年4月30日期间开具了标准非诺贝特160毫克的处方,并且在首次接受160毫克剂量后至少60天开具了后续非诺贝特145毫克无食物效应(NFE)的处方,则符合分析条件。测量的结果是血脂水平:总胆固醇-C、LDL-C、HDL-C和TG。
491名从标准非诺贝特160毫克换用非诺贝特145毫克NFE的患者符合所有纳入标准。从标准非诺贝特160毫克换用非诺贝特145毫克NFE的患者在血脂水平上显示出有益反应。从基线到标准非诺贝特160毫克,观察到三种血脂水平(总胆固醇-C、HDL-C和TG)的患者特异性血脂水平有统计学意义的变化。换用非诺贝特145毫克NFE后,观察到三种血脂水平(总胆固醇-C、LDL-C和TG)有统计学意义的变化。
在门诊临床实践中,与服用标准非诺贝特160毫克的患者相比,服用非诺贝特145毫克NFE的更多患者血脂结果更好,这表明限制较少的给药方案可改善血脂结果。