Davis Lindsay E, Pogge Elizabeth K
Midwestern University College of Pharmacy, 19555 North 59th Avenue, Glendale, AZ, 85308, USA.
High Blood Press Cardiovasc Prev. 2020 Aug;27(4):331-338. doi: 10.1007/s40292-020-00399-6. Epub 2020 Jul 10.
Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are proven to have profound lowering of low-density lipoprotein cholesterol (LDL-C) in patients with clinical atherosclerotic cardiovascular disease or familial hypercholesterolemia.
The primary purpose of this study was to evaluate PCSK9i utilization in older adults, with a focus on efficacy outcomes within 6 months of initiation. Secondary outcomes included tolerability, out-of-pocket expenses (OPE), and barriers to initiation of therapy.
We conducted a retrospective chart review of patients ≥ 65 years prescribed PCSK9i therapy by a pharmacist-run lipid clinic within a cardiology practice.
A total of 136 older adults were prescribed PCSK9i therapy for a Food and Drug Administration-approved indication between September 2015 and March 2019 with 98 patients included in the analyses. In terms of efficacy, 51 patients who took ≥ 3 doses of PCSK9i with baseline and follow-up lipid panels were assessed. On average, LDL-C reduced by 60% (169-67 mg/dL, p < 0.001). For tolerability, 15 patients reported treatment-emergent side effects, resulting in 10 therapy discontinuations. For the cost analysis, 72 patients reported anticipated OPE for 1 month of therapy. Ultimately 17 patients were approved for manufacturer patient assistance with $0 OPE and 31 patients utilized insurance coverage to obtain therapy reporting a median OPE of $9 United States Dollars ($0-$450). The main barrier to initiation was high OPE.
PCSK9i are effective at lowering LDL-C in older adults. Tolerability was high among patients without a history of statin intolerance. PCSK9i remain high-cost medications to both insurance companies and patients in terms of cost-sharing responsibilities.
前蛋白转化酶枯草溶菌素/kexin 9型抑制剂（PCSK9i）已被证明可显著降低临床动脉粥样硬化性心血管疾病或家族性高胆固醇血症患者的低密度脂蛋白胆固醇（LDL-C）水平。
本研究的主要目的是评估PCSK9i在老年人中的使用情况，重点关注开始治疗后6个月内的疗效结果。次要结果包括耐受性、自付费用（OPE）以及治疗开始的障碍。
我们对一家心脏病学诊所内由药剂师管理的血脂门诊为65岁及以上患者开具PCSK9i治疗的病历进行了回顾性分析。
2015年9月至2019年3月期间，共有136名老年人因美国食品药品监督管理局批准的适应症接受了PCSK9i治疗，其中98名患者纳入分析。在疗效方面，对51名服用≥3剂PCSK9i且有基线和随访血脂检测结果的患者进行了评估。平均而言，LDL-C降低了60%（从169降至67mg/dL，p<0.001）。在耐受性方面，15名患者报告了治疗期间出现的副作用，导致10人停药。在成本分析中，72名患者报告了1个月治疗的预期自付费用。最终，17名患者获得了制造商的患者援助，自付费用为0美元，31名患者使用保险覆盖获得治疗，报告的自付费用中位数为9美元（0至450美元）。开始治疗的主要障碍是自付费用高。
PCSK9i在降低老年人LDL-C方面有效。在无他汀类药物不耐受病史的患者中耐受性较高。就成本分担责任而言，PCSK9i对保险公司和患者来说仍然是高成本药物。
