Department of Cardiology, Narayana Hrudayalaya Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India.
Mission Arogya Health and Information Technology Research Foundation, Kolkata, West Bengal, India.
PLoS One. 2020 May 19;15(5):e0233230. doi: 10.1371/journal.pone.0233230. eCollection 2020.
Atorvastatin-80mg/day and Rosuvastatin-40mg/day are the commonest high-dose statin (3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors) regimes for post-PCI (Percutaneous Coronary Interventions) patients to lower (by ≥50%) blood low-density-lipoprotein cholesterol (LDL-C). Dearth of conclusive evidence from developing world, regarding overall safety, tolerability and comparative effectiveness (outcome/safety/tolerability/endothelial inflammation control) of Rosuvastatin over Atorvastatin in high-dose, given its higher cost, called for an overall and comparative assessment among post-PCI patients in a tertiary cardiac-care hospital of Kolkata, India.
A record-based non-concurrent cohort study was conducted involving 942 post-PCI patients, aged 18-75 years, on high-dose statin for three months and followed up for ≥one year. Those on Atorvastatin-80mg (n = 321) and Rosuvastatin-40mg (n = 621) were compared regarding outcome (death/non-fatal myocardial infarction: MI/repeated hospitalization/target-vessel revascularisation/control of LDL and high-sensitivity C-reactive protein: hsCRP), safety (transaminitis/myopathy/myalgia/myositis/rhabdomyolysis), tolerability (gastroesophageal reflux disease: GERD/gastritis) and inflammation control adjusting for socio-demographics, tobacco-use, medications and comorbidities using SAS-9.4.
Groups varied minimally regarding distribution of age/gender/tobacco-use/medication/comorbidity/baseline (pre-PCI) LDL and hs-CRP level. During one-year post-PCI follow up, none died. One acute MI and two target vessel revascularizations occurred per group. Repeated hospitalization for angina/stroke was 2.18% in Atorvastatin group vs. 2.90% in Rosuvastatin group. At three-months follow up, GERD/Gastritis (2.18% vs 4.83%), uncontrolled hs-CRP (22.74% vs 31.08%) and overall non-tolerability (4.67% vs. 8.21%) were lower for Atorvastatin group. Multiple logistic regression did show that compared to Atorvastatin-80mg, Rosuvastatin-40mg regime had poorer control of hs-CRP (A3OR = 1.45,p = 0.0202), higher (A3OR = 2.07) adverse effects, poorer safety profile (A3OR = 1.23), higher GERD/Gastritis (A3OR = 1.50) and poorer overall tolerability (A3OR = 1.50).
Post-PCI high dose statins were effective, safe and well-tolerated. High dose Rosuvastatin as compared to high dose Atorvastatin were similar in their clinical efficacy. Patients treated with Atrovastatin had significantly lower number of patients with hs-CRP (high-sensitivity C-reactive protein)/C-reactive protein (CRP) level beyond comparable safe limit and relatively better tolerated as opposed to Rosuvastatin-40mg.Thus given the lower price, Atorvastatin 80mg/day appeared to be more cost-effective. A head-to-head cost-effectiveness as well as efficacy trial may be the need of the hour.
阿托伐他汀 80mg/天和瑞舒伐他汀 40mg/天是经皮冠状动脉介入治疗（PCI）后最常用的高剂量他汀类药物（3-羟基-3-甲基戊二酰基辅酶 A 还原酶抑制剂）方案，用于降低（降低≥50%）血液低密度脂蛋白胆固醇（LDL-C）。来自发展中国家的结论性证据不足，关于瑞舒伐他汀相对于阿托伐他汀在高剂量下的总体安全性、耐受性和比较效果（结局/安全性/耐受性/内皮炎症控制），由于其较高的成本，需要在印度加尔各答的一家三级心脏护理医院对 PCI 后患者进行总体和比较评估。
进行了一项基于记录的非同期队列研究，涉及 942 名年龄在 18-75 岁之间的 PCI 后患者，他们接受高剂量他汀类药物治疗三个月，并随访≥一年。比较阿托伐他汀 80mg（n=321）和瑞舒伐他汀 40mg（n=621）组的结局（死亡/非致命性心肌梗死：MI/再次住院/靶血管血运重建/ LDL 和高敏 C 反应蛋白的控制：hsCRP）、安全性（转氨基酶升高/肌病/肌痛/肌炎/横纹肌溶解症）、耐受性（胃食管反流病：GERD/胃炎）和炎症控制，调整社会人口统计学、烟草使用、药物和合并症使用 SAS-9.4。
两组在年龄/性别/烟草使用/药物/合并症/基线（PCI 前）LDL 和 hs-CRP 水平的分布上差异极小。在 PCI 后一年的随访期间，没有人死亡。每组均发生 1 例急性 MI 和 2 例靶血管血运重建。心绞痛/中风的再次住院率在阿托伐他汀组为 2.18%，在瑞舒伐他汀组为 2.90%。在三个月随访时，GERD/胃炎（2.18% vs 4.83%）、hs-CRP 控制不佳（22.74% vs 31.08%）和总体不耐受（4.67% vs 8.21%）在阿托伐他汀组较低。多变量逻辑回归显示，与阿托伐他汀 80mg 相比，瑞舒伐他汀 40mg 方案 hs-CRP 控制较差（A3OR=1.45，p=0.0202），不良反应较高（A3OR=2.07），安全性较差（A3OR=1.23），GERD/胃炎发生率较高（A3OR=1.50），总体耐受性较差（A3OR=1.50）。
PCI 后高剂量他汀类药物有效、安全且耐受性良好。与高剂量阿托伐他汀相比，高剂量瑞舒伐他汀在临床疗效上相似。与瑞舒伐他汀 40mg 相比，阿托伐他汀治疗的患者 hs-CRP（高敏 C 反应蛋白）/C 反应蛋白（CRP）水平超出可比安全范围的患者数量明显较少，且耐受性相对较好。因此，考虑到较低的价格，阿托伐他汀 80mg/天似乎更具成本效益。可能需要进行头对头的成本效益和疗效试验。
