Pravastatin and cardiovascular outcomes stratified by baseline eGFR in the lipid- lowering component of ALLHAT.
Pravastatin and cardiovascular outcomes stratified by baseline eGFR in the lipid- lowering component of ALLHAT.
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DOI：
10.5414/cn107922
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发表时间：
2013-10
影响因子：
1.1
通讯作者：
ALLHAT Collaborative Research Group
中科院分区：
文献类型：
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作者：
Rahman M;Baimbridge C;Davis BR;Barzilay JI;Basile JN;Henriquez MA;Huml A;Kopyt N;Louis GT;Pressel SL;Rosendorff C;Sastrasinh S;Stanford C;ALLHAT Collaborative Research Group
背景/目的：他汀类药物在预防慢性肾脏疾病(CKD)患者心血管结局中的作用尚不清楚。本文通过基线估计肾小球滤过率(EGFR)分层，比较了服用普伐他汀与常规护理的心血管结局。方法：前瞻性随机开放临床试验的后处理分析；10,151名参加抗高血压和降脂治疗以预防心脏病发作试验(降脂成分)的参与者随机接受普伐他汀40 mg/天或常规治疗。平均随访时间为4.8年。结果：在第6年，普伐他汀组(-20.7%)和常规护理组(-11.2%)的总胆固醇下降。普伐他汀组使用他汀类药物的比例为89.8%(2年)和87.0%(6年)。常规护理组他汀类药物的使用率从第2年的8.2%增加到第6年的23.5%。通过初步意向治疗分析，冠心病(CHD)、总死亡率或合并心血管疾病组之间没有显著差异；研究结果在EGFR层级之间是一致的。在探索性“治疗前”分析(实际使用普伐他汀与未使用普伐他汀的患者)中，普伐他汀治疗与较低的死亡率(HR=0.76(0.68~0.85)，p<；0.001)和较低的冠心病(HR=0.84(0.73~0.97)，p=0.01)有关，但与合并心血管疾病(HR=100.95(0.88~101.04)，p=0.30)无关。从基线到第二年，总胆固醇降低10 mg/dl与CHD风险降低5%相关。结论：在中度血脂异常的高血压患者中，普伐他汀在预防总死亡率或冠心病方面并不优于常规护理，而不依赖于基线EGFR水平。然而，探索性的“治疗前”分析表明，服用普伐他汀的参与者死亡率和冠心病风险有所改善，冠心病事件的发生与总胆固醇的降低有关。他汀类药物治疗的潜在益处可能取决于总胆固醇和低密度脂蛋白的降低程度以及坚持治疗。
Background/Aims: The role of statins in preventing cardiovascular outcomes in patients with chronic kidney disease (CKD) is unclear. This paper compares cardiovascular outcomes with pravastatin vs. usual care, stratified by baseline estimated glomerular filtration rate (eGFR). Methods: Post-hoc analyses of a prospective randomized open-label clinical trial; 10,151 participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (lipid-lowering component) were randomized to pravastatin 40 mg/day or usual care. Mean follow-up was 4.8 years. Results: Through Year 6, total cholesterol declined in pravastatin (–20.7%) and usual-care groups (–11.2%). Use of statin therapy in the pravastatin group was 89.8% (Year 2) and 87.0% (Year 6). Usual-care group statin use increased from 8.2% (Year 2) to 23.5% (Year 6). By primary intention-to-treat analyses, no significant differences were seen between groups for coronary heart disease (CHD), total mortality or combined cardiovascular disease; findings were consistent across eGFR strata. In exploratory “as-treated” analyses (patients actually using pravastatin vs. not using), pravastatin therapy was associated with lower mortality (HR = 0.76 (0.68 – 0.85), p < 0.001) and lower CHD (HR = 0.84 (0.73 – 0.97), p = 0.01), but not combined cardiovascular disease (HR = 0.95 (0.88 – 1.04), p = 0.30). Total cholesterol reduction of 10 mg/dl from baseline to Year 2 was associated with 5% lower CHD risk. Conclusions: In hypertensive patients with moderate dyslipidemia, pravastatin was not superior to usual care in preventing total mortality or CHD independent of baseline eGFR level. However, exploratory “as-treated” analyses suggest improved mortality and CHD risk in participants using pravastatin, and decreased CHD events associated with achieved reduction in total cholesterol. Potential benefit from statin therapy may depend on degree of reduction achieved in total and LDL-cholesterol and adherence to therapy.