Rahman Mahboob, Baimbridge Charles, Davis Barry R, Barzilay Joshua I, Basile Jan N, Henriquez Mario A, Huml Anne, Kopyt Nelson, Louis Gail T, Pressel Sara L, Rosendorff Clive, Sastrasinh Sithiporn, Stanford Carol
Clin Nephrol. 2013 Oct;80(4):235-48. doi: 10.5414/CN107922.
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).
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.
Through Year 6, total cholesterol declined in pravastatin (-20.7%) and usualcare 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 lover 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.
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.
背景/目的：他汀类药物在预防慢性肾脏病（CKD）患者心血管疾病转归方面的作用尚不清楚。本文比较了普伐他汀与常规治疗对心血管疾病转归的影响，并根据基线估计肾小球滤过率（eGFR）进行分层。
一项前瞻性随机开放标签临床试验的事后分析；高血压和降脂治疗预防心脏病发作试验（降脂部分）的10151名参与者被随机分为普伐他汀40mg/天组或常规治疗组。平均随访4.8年。
至第6年，普伐他汀组（-20.7%）和常规治疗组（-11.2%）的总胆固醇均下降。普伐他汀组他汀类药物治疗的使用率在第2年为89.8%，第6年为87.0%。常规治疗组他汀类药物的使用率从第2年的8.2%增至第6年的23.5%。根据主要意向性治疗分析，两组在冠心病（CHD）、总死亡率或合并心血管疾病方面无显著差异；在各eGFR分层中结果一致。在探索性“实际治疗”分析（实际使用普伐他汀的患者与未使用者）中，普伐他汀治疗与较低的死亡率（HR = 0.76（0.68 - 0.85），p<0.001）和较低的冠心病发生率（HR = 0.84（0.73 - 0.97），p = 0.01）相关，但与合并心血管疾病无关（HR = 0.95（0.88 - 1.04），p = 0.30）。从基线到第2年总胆固醇降低10mg/dl与冠心病风险降低5%相关。
在患有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治疗，且与基线eGFR水平无关。然而，探索性“实际治疗”分析表明，使用普伐他汀的参与者死亡率和冠心病风险有所改善，且冠心病事件减少与总胆固醇降低有关。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胆固醇的降低程度以及治疗依从性。
