Director of Cardiology, Surana Sethia Hospital, Mumbai, Maharashtra, India, Corresponding Author.
J Assoc Physicians India. 2024 Sep;72(9):64-72. doi: 10.59556/japi.72.0622.
India has the highest burden of cardiovascular disease (CVD) among developing nations. Data from international studies show significant underimplementation of recommended aggressive lipid-lowering strategies for achieving low-density lipoprotein cholesterol (LDL-C) goals, especially after percutaneous coronary intervention (PCI), a pattern also observed in India. Moreover, ethnic variation in response to statin therapy has prompted clinicians to adopt lower doses of statin therapy in Asians to achieve comparable LDL-C lowering.
To document the dose of statin ± ezetimibe required to achieve the European Society of Cardiology (ESC) goals of LDL-C <55 mg/dL in Indian patients with established atherosclerotic cardiovascular disease (ASCVD).
This retrospective single-center, cross-sectional, observational, all-comers study in Mumbai evaluated the dose of atorvastatin (A)/rosuvastatin (R) ± ezetimibe (E) treatment at which patients with established ASCVD ( 542), irrespective of their baseline level, achieved LDL-C goals (<55 mg/dL). Those with LDL-C levels >55 mg/dL on current therapy were switched to R 40 mg ± E 10 mg daily. The final data set ( 340) included those who achieved LDL-C goals at the initial visit and those at follow-up. The primary and secondary outcomes assessed the impact of R 40 mg ± E 10 mg (R40 ± E10) on LDL-C (<55 mg/dL) and non-high-density lipoprotein cholesterol [non-HDL-C (<85 mg/dL)] goal achievement, respectively.
At the end of follow-up, LDL-C <55 mg/dL was observed in 42.16% of patients ( 113) with R40 and in another 43.28% ( 116) with R40 + E10. A few patients ( 39; 14.6%) achieved this goal with other dosages. Similarly, non-HDL-C <85 mg/dL was observed in 39.3% of patients ( 107) with R40 and in another 47.4% of patients ( 129) with R40 + E10. Overall, around 20% of patients were unable to achieve their LDL-C and non-HDL-C goals despite being on high-intensity statin ± E therapy.
In the first report of its kind in India, this study showed that suboptimal LDL-C goal achievement occurred in around 20% of high-risk ASCVD patients on dual therapy. This indicates that clinicians should consider the addition of other therapies [e.g., bempedoic acid, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, and inclisiran] to mitigate the residual risk. Several more trials are needed to determine the most suitable treatment regimen for this population.
印度是发展中国家中心血管疾病（CVD）负担最重的国家。来自国际研究的数据表明，在推荐的降脂治疗策略方面，实现低密度脂蛋白胆固醇（LDL-C）目标的执行情况严重不足，尤其是在经皮冠状动脉介入治疗（PCI）之后，这种情况在印度也同样存在。此外，他汀类药物治疗反应的种族差异促使临床医生在亚洲人群中采用较低剂量的他汀类药物治疗来实现可比的 LDL-C 降低。
记录在印度患有已确立的动脉粥样硬化性心血管疾病（ASCVD）的患者中，实现欧洲心脏病学会（ESC） LDL-C<55mg/dL 目标所需的他汀类药物±依折麦布的剂量。
这项在孟买进行的回顾性单中心、横断面、观察性、所有患者研究评估了阿托伐他汀（A）/罗苏伐他汀（R）±依折麦布（E）治疗剂量，使已确立的 ASCVD 患者（542 例）达到 LDL-C 目标（<55mg/dL），无论其基线水平如何。那些当前治疗 LDL-C 水平>55mg/dL 的患者被转换为每天 R40mg±E10mg。最终数据集（340 例）包括在初次就诊时和随访时达到 LDL-C 目标的患者。主要和次要结局分别评估了 R40mg±E10mg（R40±E10）对 LDL-C（<55mg/dL）和非高密度脂蛋白胆固醇[非-HDL-C（<85mg/dL）]目标达成的影响。
随访结束时，42.16%（113 例）接受 R40 治疗的患者和 43.28%（116 例）接受 R40+E10 治疗的患者 LDL-C<55mg/dL。少数患者（39 例；14.6%）用其他剂量达到了这一目标。同样，39.3%（107 例）接受 R40 治疗的患者和 47.4%（129 例）接受 R40+E10 治疗的患者非-HDL-C<85mg/dL。总的来说，尽管接受高强度他汀类药物±E 治疗，但约 20%的患者仍无法达到 LDL-C 和非-HDL-C 目标。
在印度此类研究的首次报告中，该研究表明，在接受双重治疗的高危 ASCVD 患者中，约 20%的患者 LDL-C 目标未得到充分实现。这表明临床医生应考虑添加其他治疗方法[例如，贝匹达酸、前蛋白转化酶枯草溶菌素 9（PCSK9）抑制剂和inclisiran]来减轻残余风险。还需要更多的试验来确定最适合该人群的治疗方案。
