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Cardiovascular events and safety outcomes associated with azithromycin therapy: a meta-analysis of randomized
Ziyad S Almalki1, Jeff Jianfei Guo2
1Graduate Student, The James L. Winkle College of Pharmacy, University of Cincinnati Academic Health Center, OH.
Background:
Azithromycin has been used for many years for the treatment of patients with various types of bacterial infections, as well as for the secondary prevention of coronary events. There is a growing concern, however, that azithromycin may be associated with an increased cardiovascular (CV) risk and may lead to CV-related death in high-risk patients.
Objective:
This systematic review of randomized controlled trials was conducted to analyze and describe the CV risk and safety outcomes associated with azithromycin therapy.
Methods:
A meta-analysis was conducted based on the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from 1990 through September 2013. Specific medical search terms in the English language included "azithromycin," "macrolide," "antibiotic," "cardiovascular diseases," and "cardiovascular events" and were used to identify relevant randomized clinical trials that assessed the risk for CV events in patients receiving azithromycin therapy or placebo. The randomized clinical trials that were selected included patients who received azithromycin or placebo for the treatment of infection or for the secondary prevention of coronary events. Major health outcome measures included mortality, hospitalization, and coronary intervention. Meta-analyses were performed using a random effects model.
Results:
A total of 12 randomized clinical trials included 15,588 patients. Patients were divided into 2 groups, either to azithromycin therapy or to placebo. Compared with patients who had not received azithromycin, patients who had received azithromycin had an overall risk ratio (RR) of death of 0.877 (95% confidence interval [CI], 0.752-1.024; P = .097). No heterogeneity was observed (I(2) = 0%). Similarly, no differences were found in the pooled RRs for hospitalization or for clinical intervention for CV events (RR, 1.005; 95% CI, 0.922-1.094; P = .915; I(2) = 0% and RR, 0.999; 95% CI, 0.896-1.125; P = .984; I(2) = 0%, respectively).
Conclusion:
No increased risks for mortality or for CV events associated with azithromycin therapy compared with placebo were found among patients included in the 12 randomized clinical trials reviewed in this analysis.
Insights
This review found no increased cardiovascular risk or death associated with azithromycin use. The antibiotic azithromycin is safe for patients, showing no elevated risks in randomized trials.
Area of Science:
- Pharmacology
- Cardiology
- Infectious Diseases
Background:
- Azithromycin is widely used for bacterial infections and secondary prevention of coronary events.
- Concerns exist regarding azithromycin's potential to increase cardiovascular (CV) risk and CV-related death in high-risk patients.
Purpose of the Study:
- To systematically review randomized controlled trials (RCTs) to analyze CV risk and safety outcomes of azithromycin therapy.
- To evaluate the association between azithromycin and cardiovascular events, mortality, and interventions.
Main Methods:
- A meta-analysis of RCTs from MEDLINE, EMBASE, and Cochrane databases (1990-2013) was performed.
- Search terms included "azithromycin," "macrolide," "antibiotic," "cardiovascular diseases," and "cardiovascular events."
- Outcome measures included mortality, hospitalization, and coronary intervention, analyzed using a random effects model.
Main Results:
- 12 RCTs with 15,588 patients were analyzed, comparing azithromycin to placebo.
- No significant difference in the risk ratio (RR) for death was observed (RR, 0.877; P = .097).
- Pooled RRs for hospitalization (RR, 1.005; P = .915) and CV interventions (RR, 0.999; P = .984) also showed no differences.
Conclusions:
- This systematic review found no increased risk of mortality or cardiovascular events associated with azithromycin therapy compared to placebo.
- The findings suggest azithromycin is safe concerning cardiovascular outcomes in the analyzed patient populations.
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