Itenov Theis Skovsgaard, Bai Anthony D, Biering-Sørensen Tor, Verma Amol, Razak Fahad, Bhasin Ajay, Bundgaard Henning, Sivapalan Pradeesh, Iversen Kasper, Rasmussen Christian, Rasmussen Jens, Klitfod Lotte, Dircks Kathrine, Jensen Jens-Ulrik S, Fralick Mike
Department of Anesthesiology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Pharmacoepidemiol Drug Saf. 2025 Jun;34(6):e70163. doi: 10.1002/pds.70163.
Studies suggest that clarithromycin is associated with an increased risk of major adverse cardiovascular events (MACE) among adults with coronary artery disease. However, data comparing clarithromycin to other macrolides, such as azithromycin, in a broader population are lacking.
A multicenter study was conducted in 33 hospitals in Ontario, Canada, and Copenhagen, Denmark, using the Target Trial framework. Adults hospitalized with community-acquired pneumonia (CAP) who received either clarithromycin or azithromycin were included. The primary outcome was MACE, defined as the one-year risk of nonfatal myocardial infarction, nonfatal stroke, or all-cause mortality. Propensity score matching and Cox proportional hazards models were used for analysis.
In Ontario, we identified 23 081 patients with CAP, and 11 164 received oral macrolides. After propensity score matching, the primary outcome occurred in 7.8% of clarithromycin patients and 9.1% of azithromycin patients (HR 0.85, 95% CI 0.60-1.21). In Copenhagen, there were 11 280 patients with CAP and 3924 received oral macrolides. After propensity score matching, 19% of clarithromycin patients and 12% of azithromycin patients experienced the primary outcome for oral macrolides (HR 1.7, 95% CI 1.2-2.4, p = 0.002). Meta-analysis of the point estimate from each country provided an overall HR of 1.21 (95% CI 0.61-2.39). For intravenous macrolides in Copenhagen, the HR was 1.15 (95% CI 1.0-1.3, p = 0.007) for clarithromycin compared to azithromycin.
This study did not consistently observe an increased risk of cardiovascular events with clarithromycin among adults hospitalized with CAP. However, the observational nature of the study may introduce selection bias and unmeasured confounding.
研究表明,在患有冠状动脉疾病的成年人中,克拉霉素与主要不良心血管事件(MACE)风险增加有关。然而,在更广泛人群中比较克拉霉素与其他大环内酯类药物(如阿奇霉素)的数据尚缺乏。
采用目标试验框架,在加拿大安大略省和丹麦哥本哈根的33家医院进行了一项多中心研究。纳入因社区获得性肺炎(CAP)住院且接受克拉霉素或阿奇霉素治疗的成年人。主要结局为MACE,定义为非致命性心肌梗死、非致命性中风或全因死亡率的一年风险。采用倾向评分匹配和Cox比例风险模型进行分析。
在安大略省,我们确定了23081例CAP患者,其中11164例接受口服大环内酯类药物治疗。倾向评分匹配后,克拉霉素组主要结局发生率为7.8%,阿奇霉素组为9.1%(风险比[HR]0.85,95%置信区间[CI]0.60 - 1.21)。在哥本哈根,有11280例CAP患者,3924例接受口服大环内酯类药物治疗。倾向评分匹配后,克拉霉素组口服大环内酯类药物主要结局发生率为19%,阿奇霉素组为12%(HR 1.7,95% CI 1.2 - 2.4,p = 0.002)。对每个国家的点估计值进行荟萃分析,得出总体HR为1.21(95% CI 0.61 - 2.39)。在哥本哈根,对于静脉用大环内酯类药物,与阿奇霉素相比,克拉霉素的HR为1.15(95% CI 1.0 - 1.3,p = 0.007)。
本研究并未始终观察到因CAP住院的成年人使用克拉霉素会增加心血管事件风险。然而,该研究的观察性质可能会引入选择偏倚和未测量的混杂因素。