Gemfibrozil in the treatment of dyslipidemia: an 18-year mortality follow-up of the Helsinki Heart Study.
Gemfibrozil in the treatment of dyslipidemia: an 18-year mortality follow-up of the Helsinki Heart Study.
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DOI：
10.1001/archinte.166.7.743
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发表时间：
2006-04
影响因子：
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通讯作者：
L. Tenkanen;M. Mänttäri;P. Kovanen;H. Virkkunen;V. Manninen
中科院分区：
文献类型：
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作者：
L. Tenkanen;M. Mänttäri;P. Kovanen;H. Virkkunen;V. Manninen
赫尔辛基心脏研究是一项双盲、安慰剂对照的一级预防试验，共有4081名血脂异常的中年男性参加，目的是检验吉非齐齐预防冠心病（CHD）的疗效。在5年的试验之后，参与者被告知他们的治疗组，并被邀请继续或开始免费的吉非罗齐治疗直到1995年。两组中大约三分之二的参与者选择了吉非罗齐治疗。在到2000年的18年随访中，我们比较了原吉非罗齐（OG）组（n = 2046）和原安慰剂（OP）组（n = 2035）受试者的冠心病、癌症和全因死亡率。方法通过对数秩检验计算粗死亡率，并绘制Kaplan-Meier生存图，概述两个治疗组的绝对风险以及它们之间的风险差异。我们还使用有和没有协变量的Cox比例风险模型估计了相对风险（rr）。结果随访至1995年，OG组冠心病死亡率RR比OP组低32% (P = 0.03)，随访至2000年RR比OP组低23% （P = 0.05）。总的来说，全因死亡率和癌症死亡率没有差异。然而，与OP组相比，OG组体重指数和甘油三酯水平均处于最高水平的患者冠心病死亡率的RR降低了71% (P< 0.001)，全因死亡率的RR降低了33% (P = 0.03)，癌症死亡率的RR降低了36% （P = 0.22）。结论：长期死亡率随访显示，早期开始使用吉非罗齐治疗可使血脂异常患者受益，特别是当他们的血脂异常伴有代谢综合征相关因素时。
BACKGROUND The Helsinki Heart Study was a double-blind, placebo-controlled primary prevention trial among 4081 dyslipidemic middle-aged men to test the efficacy of gemfibrozil in the prevention of coronary heart disease (CHD). After the 5-year trial, the participants were notified of their treatment group and invited to continue or start gemfibrozil therapy free of charge through 1995. Approximately two thirds of participants in both groups chose gemfibrozil therapy. In this 18-year follow-up through 2000, we compared the CHD, cancer, and all-cause mortality among subjects in the original gemfibrozil (OG) group (n = 2046) with those in the original placebo (OP) group (n = 2035). METHODS To provide an overview of the absolute risks in the 2 treatment groups as well as risk differences between them, we calculated crude mortality rates and presented Kaplan-Meier plots of survival with log-rank tests. We also estimated the relative risks (RRs) using Cox proportional hazards models with and without covariates. RESULTS During the follow-up until 1995, subjects in the OG group had a 32% lower RR of CHD mortality (P = .03) compared with those in the OP group, and when followed up until 2000, the RR was 23% lower (P = .05). Overall, there were no differences in all-cause or cancer mortality. However, those in the OG group with both body mass index and triglyceride level in the highest tertiles had a 71% lower RR of CHD mortality (P<.001), a 33% lower RR of all-cause mortality (P = .03), and a 36% lower RR of cancer mortality (P = .22) compared with those in the OP group. CONCLUSION Long-term mortality follow-up showed that patients with dyslipidemia benefited from beginning treatment with gemfibrozil early, especially if their dyslipidemia entailed factors related to the metabolic syndrome.