Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Denmark.
J Cardiovasc Pharmacol. 2010 Feb;55(2):123-8. doi: 10.1097/FJC.0b013e3181c87e37.
In the CLARICOR trial, significantly increased cardiovascular (CV) and all-cause mortality in stable patients with coronary heart disease were observed after a short course of clarithromycin. We report on the impact of statin treatment at entry on the CV and all-cause mortality. The multicenter CLARICOR trial randomized patients to oral clarithromycin (500 mg daily; n = 2172) versus matching placebo (daily; n = 2201) for 2 weeks. Patients were followed through public databases. In the 41% patients on statin treatment at entry, no significant effect of clarithromycin was observed on CV (hazard ratio [HR], 0.68, 95% confidence interval [CI], 0.38-1.22; P = 0.20) or all-cause mortality (HR, 1.08; 95% CI, 0.71-1.65; P = 0.72) at 2.6-year follow up. In the patients not on statin treatment at entry, clarithromycin was associated with a significant increase in CV (HR, 1.90; 95% CI, 1.34-2.67; P = 0.0003; statin-clarithromycin interaction P = 0.0029) and all-cause mortality (HR, 1.33; 95% CI, 1.05-1.67; P = 0.016; statin-clarithromycin interaction P = 0.41). Multivariate analysis and 6-year follow up confirmed these results. Concomitant statin treatment in stable patients with coronary heart disease abrogated the observed increased CV mortality associated with 2 weeks of clarithromycin.
在 CLARICOR 试验中,稳定型冠心病患者短期使用克拉霉素后,心血管(CV)和全因死亡率显著增加。我们报告了他汀类药物治疗对 CV 和全因死亡率的影响。这项多中心 CLARICOR 试验将患者随机分为口服克拉霉素(每日 500mg;n=2172)与匹配安慰剂(每日;n=2201)治疗 2 周。患者通过公共数据库进行随访。在入组时接受他汀类药物治疗的 41%患者中,克拉霉素对 CV(风险比[HR],0.68,95%置信区间[CI],0.38-1.22;P=0.20)或全因死亡率(HR,1.08;95%CI,0.71-1.65;P=0.72)无显著影响,随访 2.6 年。在入组时未接受他汀类药物治疗的患者中,克拉霉素与 CV(HR,1.90;95%CI,1.34-2.67;P=0.0003;他汀类药物-克拉霉素交互作用 P=0.0029)和全因死亡率(HR,1.33;95%CI,1.05-1.67;P=0.016;他汀类药物-克拉霉素交互作用 P=0.41)显著增加相关。多变量分析和 6 年随访证实了这些结果。稳定型冠心病患者同时接受他汀类药物治疗,可消除克拉霉素治疗 2 周后观察到的 CV 死亡率增加。