Department of Cardiology, Thoraxcenter, Universitair Medical Center Groningen, University of Groningen, The Netherlands.
Am Heart J. 2011 Jun;161(6):1171-8. doi: 10.1016/j.ahj.2011.03.028. Epub 2011 May 11.
The PREVEND IT investigated whether treatment targeted at lowering urinary albumin excretion (UAE) would reduce adverse cardiovascular events. We obtained extended follow-up data to approximately 10 years to investigate the long-term effects of fosinopril 20 mg and pravastatin 40 mg on cardiovascular outcomes in subjects with UAE >15 mg per 24 hours.
The original PREVEND IT consisted of 864 participants and 839 survivors after 4 years. For every survivor, the primary end point determined by the combined incidence of cardiovascular mortality and hospitalization for cardiovascular morbidity was registered in several national databases and electronic hospital systems.
Mean total follow-up of the extended PREVEND IT was 9.5 years (range 9.4-10.7 years). Four years of treatment with fosinopril was not associated with a reduction in the primary end point compared with placebo (hazard ratio 0.87, 95% CI 0.61-1.24 [P = .42]) during long-term follow-up. After 9.5 years, subjects with a baseline UAE in the upper quintile (>50 mg/24 hours) had a total event rate of 29.5% and were at a higher risk for developing cardiovascular disease compared with less UAE (hazard ratio 2.03, 95% CI 1.38-2.97 [P ≤ .01]). In addition, 4 years of fosinopril treatment resulted in a risk reduction of 45% (95% CI 6%-75% [P = .04]) in this group compared with placebo. Subjects originally assigned to pravastatin had no overall risk reduction in the primary end point (P = .99).
Elevated UAE is associated with increased cardiovascular mortality and morbidity after 9.5 years of follow-up, with a doubling of the risk if the UAE is >50 mg per 24 hours. In this group, the benefits of 4-year treatment with fosinopril were sustained during posttrial follow-up for cardiovascular mortality and morbidity. We propose that UAE be used to estimate risk in the general population and that large clinical trials be designed to confirm the hypothesis that angiotensin-converting enzyme-inhibitor treatment may be beneficial in patients with mildly elevated UAE despite the absence of other comorbidities.
PREVEND IT 研究旨在探讨针对降低尿白蛋白排泄率（UAE）的治疗是否会减少不良心血管事件。我们获得了大约 10 年的扩展随访数据，以研究福辛普利 20mg 和普伐他汀 40mg 对 UAE>15mg/24 小时的受试者心血管结局的长期影响。
原始 PREVEND IT 研究纳入 864 名参与者和 4 年后的 839 名幸存者。对于每一位幸存者，通过心血管死亡率和心血管发病率住院的联合发生率确定的主要终点都在多个国家数据库和电子医院系统中进行了登记。
扩展 PREVEND IT 的平均总随访时间为 9.5 年（范围 9.4-10.7 年）。与安慰剂相比，4 年的福辛普利治疗并未降低主要终点（风险比 0.87，95%置信区间 0.61-1.24[P=0.42]）在长期随访期间。9.5 年后，UAE 处于上限五分位数（>50mg/24 小时）的患者总事件发生率为 29.5%，发生心血管疾病的风险高于 UAE 较低的患者（风险比 2.03，95%置信区间 1.38-2.97[P≤0.01]）。此外，与安慰剂相比，福辛普利治疗 4 年可使该组的风险降低 45%（95%置信区间 6%-75%[P=0.04]）。最初分配给普伐他汀的患者主要终点无总体风险降低（P=0.99）。
UAE 升高与 9.5 年随访后心血管死亡率和发病率增加相关，如果 UAE 超过 50mg/24 小时，则风险增加一倍。在该组中，福辛普利治疗 4 年对心血管死亡率和发病率的获益在试验后随访期间得以维持。我们建议使用 UAE 来估计普通人群的风险，并设计大型临床试验来证实这样一种假设，即尽管没有其他合并症，血管紧张素转换酶抑制剂治疗可能对 UAE 轻度升高的患者有益。
