Continuation of Statin Therapy in Patients with Presumed Infection A Randomized Controlled Trial
Continuation of Statin Therapy in Patients with Presumed Infection A Randomized Controlled Trial
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DOI：
10.1164/rccm.201006-0955oc
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发表时间：
2011-03-15
影响因子：
24.7
通讯作者：
Venkatesh, Bala
中科院分区：
文献类型：
--
作者：
Kruger, Peter S.;Harward, Meg L.;Venkatesh, Bala
基本原理 对于因急性感染而住院的既往接受过他汀类药物治疗的患者，目前的文献尚不清楚住院期间是否应继续使用他汀类药物。 目的： 检验继续使用他汀类药物治疗会影响对感染的炎症反应以及停止使用他汀类药物可能会导致炎症反弹的假设。 方法： 在 150 名既往患有阿托伐他汀类药物的患者中进行阿托伐他汀 (20 mg) 或匹配安慰剂的前瞻性随机双盲安慰剂对照试验他汀类药物治疗需要因感染而住院。测量和主要结果：主要终点是住院期间败血症的进展。基线时，两组的严重脓毒症发生率为 32%。与基线相比，两组严重脓毒症的比值比均有所下降：安慰剂组为 0.43，他汀类药物组为 0.5（第 3 天），而安慰剂组为 0.14，他汀类药物组为 0.12（第 14 天）。各组之间严重败血症的下降率相似（比值比 1.17 [0.56-2.47]，P = 0.7 第 3 天；0.85 [0.21-3.34]，P = 0.8 第 14 天）。两组的 IL-6 和 C 反应蛋白均下降，但无统计学差异（分别为 P = 0.7 和 P = 0.2）。安慰剂组胆固醇增加（P < 0.0001）。大多数患者病情并不危重。医院死亡率为 6.6%，各组间无差异（75 例他汀类药物组中有 6 例[8%]；75 例安慰剂组有 4 例[5.3%]；P = 0.75）。结论：本研究不支持继续先前存在的他汀类药物治疗对脓毒症和炎症参数的有益作用。停止既定的他汀类药物治疗与炎症反弹无关。临床试验在澳大利亚新西兰临床试验注册中心注册（ACTRN 12605000756628）。
Rationale In patients on prior statin therapy who are hospitalized for acute infections, current literature is unclear on whether statins should be continued during their hospitalization.Objectives: To test the hypothesis that continuation of therapy with statins influences the inflammatory response to infection and that cessation may cause an inflammatory rebound.Methods: Prospective randomized double-blind placebo-controlled trial of atorvastatin (20 mg) or matched placebo in 150 patients on preexisting statin therapy requiring hospitalization for infection.Measurements and Main Results: The primary end point was progression of sepsis during hospitalization. At baseline, the rate of severe sepsis was 32% in both groups. Compared with baseline, the odds ratio for severe sepsis declined in both groups: 0.43 placebo and 0.5 statins (Day 3) versus 0.14 placebo and 0.12 statins (Day 14). The rate of decline of severe sepsis was similar between the groups (odds ratio 1.17 [0.56-2.47], P = 0.7 Day 3; 0.85 [0.21-3.34], P = 0.8 Day 14). IL-6 and C-reactive protein declined in both groups with no statistically significant difference (P = 0.7 and P = 0.2, respectively). An increase in cholesterol occurred in the placebo group (P < 0.0001). Most patients were not critically ill. Hospital mortality was 6.6%, with no difference between the groups (6 [8%] of 75 statin group; 4 [5.3%] of 75 placebo group; P = 0.75).Conclusions: This study does not support a beneficial role of continuing preexisting statin therapy on sepsis and inflammatory parameters. Cessation of established statin therapy was not associated with an inflammatory rebound.Clinical trial registered at the Australian New Zealand Clinical Trials Registry (ACTRN 12605000756628).