Cheung Bernard M Y, Lauder Ian J, Lau Chu-Pak, Kumana Cyrus R
Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
Br J Clin Pharmacol. 2004 May;57(5):640-51. doi: 10.1111/j.1365-2125.2003.02060.x.
Since 2002, there have been five major outcome trials of statins reporting findings from more than 47,000 subjects. As individual trial results differed, we performed a meta-analysis to ascertain the effectiveness and safety of statins overall and in subgroups. The aim of the study was to estimate the effect of statins on major coronary events and strokes, all-cause mortality and noncardiovascular mortality, and in different subgroups.
PubMed was searched for trials published in English. Randomized placebo-controlled statin trials with an average follow up of at least 3 years and at least 100 major coronary events were included. For each trial, the statin used, number and type of subjects, proportion of women, mean age and follow up, baseline and change in lipid profile, cardiovascular and non-cardiovascular outcomes were recorded.
Ten trials involving 79,494 subjects were included in the meta-analysis. Due to heterogeneity, ALLHAT-LLT was excluded from some analyses. Statin therapy reduced major coronary events by 27% (95%CI 23, 30%), stroke by 18% (95%CI 10, 25%) and all-cause mortality by 15% (95%CI 8, 21%). There was a 4% (95%CI -10, 3%) nonsignificant reduction in noncardiovascular mortality. The reduction in major coronary events is independent of gender and presence of hypertension or diabetes. The risk reduction was greater in smokers (P < 0.05). Coronary events were reduced by 23% (95%CI 18, 29%) in pravastatin trials and 29% (95%CI 25, 33%) in five trials using other statins. Pravastatin reduced strokes by 12% (95%CI 1, 21%) whilst other statins reduced strokes by 24% (95%CI 16, 32%) (P = 0.04).
Statins reduce coronary events, strokes and all-cause mortality without increasing noncoronary mortality. The benefits accrue in men and women, hypertensives and normotensives, diabetics and nondiabetics, and particularly in smokers. Pravastatin appears to have less impact on strokes.
自2002年以来，已有五项关于他汀类药物的主要结局试验报告了超过47000名受试者的研究结果。由于各个试验结果不同，我们进行了一项荟萃分析，以确定他汀类药物总体及亚组中的有效性和安全性。本研究的目的是评估他汀类药物对主要冠状动脉事件和中风、全因死亡率和非心血管死亡率以及不同亚组的影响。
在PubMed上检索以英文发表的试验。纳入平均随访至少3年且至少有100例主要冠状动脉事件的随机安慰剂对照他汀类药物试验。对于每项试验，记录所使用的他汀类药物、受试者数量和类型、女性比例、平均年龄和随访情况、血脂谱的基线及变化、心血管和非心血管结局。
荟萃分析纳入了涉及79494名受试者的10项试验。由于存在异质性，ALLHAT - LLT在一些分析中被排除。他汀类药物治疗使主要冠状动脉事件减少27%（95%置信区间23，30%），中风减少18%（95%置信区间10，25%），全因死亡率减少15%（95%置信区间8，21%）。非心血管死亡率有4%（95%置信区间 - 10，3%）的非显著降低。主要冠状动脉事件的减少与性别以及高血压或糖尿病的存在无关。吸烟者的风险降低幅度更大（P < 0.05）。普伐他汀试验中冠状动脉事件减少23%（95%置信区间18，29%），使用其他他汀类药物的五项试验中减少29%（95%置信区间25，33%）。普伐他汀使中风减少12%（95%置信区间1，21%），而其他他汀类药物使中风减少24%（95%置信区间16，32%）（P = 0.04）。
他汀类药物可降低冠状动脉事件、中风和全因死亡率，且不增加非冠状动脉死亡率。益处见于男性和女性、高血压患者和血压正常者、糖尿病患者和非糖尿病患者，尤其是吸烟者。普伐他汀似乎对中风的影响较小。
