Leicester Real World Evidence Unit, Diabetes Research Centre, University of Leicester, Leicester, UK.
Leicester Real World Evidence Unit, Diabetes Research Centre, University of Leicester, Leicester, UK; Diabetes Research Centre, University of Leicester, Leicester, UK.
Nutr Metab Cardiovasc Dis. 2019 Oct;29(10):1023-1029. doi: 10.1016/j.numecd.2019.06.022. Epub 2019 Jul 6.
Meta-analyses of randomised controlled trials (RCTs) and observational studies indicate a lower risk of venous thromboembolism (VTE) associated with statin treatment. We aimed to compare the effect of statin therapy in these two settings and to identify and quantify potential factors to explain statin efficacy and effectiveness.
We electronically searched on December 11th, 2018, articles reporting on first VTE events in RCTs (statin vs placebo) and in observational studies (participants exposed vs non-exposed to statin). We performed Knapp-Hartung random-effect meta-analyses to calculate pooled relative risks (RRs) of VTE events associated with statin treatment, separately for RCTs and observational studies; and estimated the ratio of the relative risk (RRR) comparing RCTs and observational studies using meta-regressions, progressively adjusted for study-level characteristics. Twenty-one RCTs (115,107 participants; 959 events) and 8 observational studies (2,898,096 participants; 19,671 events) were included. Pooled RRs for RCTs and observational studies were 0.82 (95% confidence interval (CI): 0.67-1.00; I 19.2%) and 0.60 (95% CI: 0.42-0.86; I 86.3%), respectively. In meta-regressions, the unadjusted RRR indicated a nonsignificant 23% smaller benefit in RCTs (RRR 0.77; 95% CI: 0.52-1.13); accounting for age, sex, geographical region, and duration of follow-up, there was a sensible change of the RRR which resulted 0.30 (95% CI: 0.13-0.68).
Differences in the characteristics between patients included in RCTs and those in observational studies may account for the differential effect of statins in preventing VTE in the two settings.
随机对照试验（RCT）和观察性研究的荟萃分析表明，他汀类药物治疗与静脉血栓栓塞（VTE）风险降低相关。我们旨在比较这两种情况下他汀类药物治疗的效果，并确定和量化潜在因素，以解释他汀类药物的疗效和有效性。
我们于 2018 年 12 月 11 日电子检索了报告 RCT 中（他汀类药物与安慰剂）和观察性研究中（暴露于他汀类药物与未暴露于他汀类药物的参与者）首次 VTE 事件的文章。我们分别对 RCT 和观察性研究中他汀类药物治疗与 VTE 事件相关的汇总相对风险（RR）进行了 Knapp-Hartung 随机效应荟萃分析；并使用逐步调整研究水平特征的荟萃回归估计了比较 RCT 和观察性研究的相对风险比（RRR）。共纳入 21 项 RCT（115107 名参与者；959 例事件）和 8 项观察性研究（2898096 名参与者；19671 例事件）。RCT 和观察性研究的汇总 RR 分别为 0.82（95%置信区间[CI]：0.67-1.00；I 19.2%）和 0.60（95%CI：0.42-0.86；I 86.3%）。在荟萃回归中，未调整的 RRR 表明 RCT 中获益较小，幅度为 23%（RRR 0.77；95%CI：0.52-1.13）；考虑到年龄、性别、地理位置和随访时间，RRR 发生了合理变化，结果为 0.30（95%CI：0.13-0.68）。
纳入 RCT 和观察性研究的患者特征的差异可能解释了他汀类药物在两种情况下预防 VTE 的不同效果。
