Eloso Jessica, Awad Asma, Zhao Xinhua, Cunningham Francesca E, Zhang Rongping, Dong Diane, Kelley Cathy, Glassman Peter A, Aspinall Sherrie L
VA Center for Medication Safety/Pharmacy Benefits Management Services, Hines, Ill.
Jesse Brown VA Medical Center, Chicago, Ill.
Am J Med Open. 2023 Feb 18;9:100035. doi: 10.1016/j.ajmo.2023.100035. eCollection 2023 Jun.
Real-world data on use of PCSK9 inhibitors (PCSK9-Is), with or without statins and/or ezetimibe, and associated outcomes, can inform more effective prescribing. The objective was to evaluate clinical effectiveness and safety of PCSK9-Is within the Veterans Health Administration (VHA).
In this retrospective cohort study, we included Veterans who had at least one outpatient prescription for alirocumab and/or evolocumab filled within VHA between August 21, 2015, and September 30, 2020. Analyses included 4 mutually exclusive subgroups: PCSK9-I alone, PCSK9-I+statin, PCSK9-I+ezetimibe, and PCSK9-I+statin+ezetimibe subgroups. Primary outcomes included medication possession ratio, persistence, and low-density lipoprotein (LDL).
Among Veterans in the analytical cohort ( = 2428), 36.2% were on PCSK9-I monotherapy; 24.0% received a PCSK9-I+statin; 27.4% were on a PCSK9-I+ezetimibe; and 12.4% received triple therapy, that is, PCSK9-I+statin+ezetimibe. The mean medication possession ratio (standard deviation [SD]) for PCSK9-I monotherapy was 83.8% (13.3) compared to 84.3% (11.2) with PCSK9-I+statin therapy, 87.1% (10.1) with PCSK9-I+ezetimibe therapy, and 85.8% (11.7) with triple therapy. The percentage of patients who discontinued PCSK9-I in the monotherapy subgroup was 12.3% vs 9.5%, 6.6%, and 7.4% in the concomitant statin, ezetimibe, and triple-therapy subgroups, respectively ( = .002 among the groups). Mean LDL level was greater in the PCSK9-I monotherapy subgroup (85.6 mg/dL) compared with the concomitant statin (66.5 mg/dL), ezetimibe (65.7 mg/dL), and triple-therapy subgroups (68.1 mg/dL).
Veterans showed good adherence and/or persistence with PCSK9-I regimens. On average, those receiving concomitant therapy with a statin and/or ezetimibe achieved significantly lower LDL levels.
关于使用前蛋白转化酶枯草溶菌素9抑制剂（PCSK9-Is）（无论是否联合他汀类药物和/或依折麦布）及其相关结果的真实世界数据，可为更有效的处方提供参考。目的是评估退伍军人健康管理局（VHA）内PCSK9-Is的临床有效性和安全性。
在这项回顾性队列研究中，我们纳入了在2015年8月21日至2020年9月30日期间在VHA内至少有一张阿利西尤单抗和/或依洛尤单抗门诊处方的退伍军人。分析包括4个相互排斥的亚组：单独使用PCSK9-I、PCSK9-I+他汀类药物、PCSK9-I+依折麦布以及PCSK9-I+他汀类药物+依折麦布亚组。主要结局包括药物持有率、持续性和低密度脂蛋白（LDL）。
在分析队列中的退伍军人（n = 2428）中，36.2%接受PCSK9-I单药治疗；24.0%接受PCSK9-I + 他汀类药物治疗；27.4%接受PCSK9-I + 依折麦布治疗；12.4%接受三联疗法，即PCSK9-I + 他汀类药物 + 依折麦布。PCSK9-I单药治疗的平均药物持有率（标准差[SD]）为83.8%（13.3），PCSK9-I + 他汀类药物治疗为84.3%（11.2），PCSK9-I + 依折麦布治疗为87.1%（10.1），三联疗法为85.8%（11.7）。单药治疗亚组中停用PCSK9-I的患者百分比为12.3%，而在联合他汀类药物、依折麦布和三联疗法亚组中分别为9.5%、6.6%和7.4%（组间P = 0.002）。PCSK9-I单药治疗亚组的平均LDL水平（85.6mg/dL）高于联合他汀类药物（66.5mg/dL）、依折麦布（65.7mg/dL）和三联疗法亚组（68.1mg/dL）。
退伍军人对PCSK9-I治疗方案表现出良好的依从性和/或持续性。平均而言，接受他汀类药物和/或依折麦布联合治疗的患者LDL水平显著更低。
