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Safety Of Azithromycin Therapy In Patients With High Cardiovascular Risk: A Meta-Analysis Of Randomized Controlled Trials

      Objectives

      Azithromycin has an attractive safety profile in treating or preventing certain bacterial infections. However, there is growing concern that Azithromycin may be associated with increased cardiovascular risk and lead to cardiovascular death in high risk patients. We therefore conducted a meta-analysis of randomized Controlled trials to describe the cardiovascular risk profile of those patients receiving Azithromycin.

      Methods

      The MEDLINE and Cochrane Central Register of Controlled Trials databases were searched from 1991 to September 2013 using specific search terms for English-language trials of comparing high baseline risk of cardiovascular disease patients receiving Azithromycin or placebo and have reported cardiovascular outcomes. Abstracts from major scientific meetings were also reviewed.In the analysis, Methods based on odds ratios (ORs) was used. OR was calculated using a random-effects model (because we assume that the treatment effect in all the included studies are not identical) from the ORs and 95% confidence intervals (CIs) were used for each end point in each study. Statistical heterogeneity scores were assessed with an I42test. Sensitivity analyses were performed by removing some trials and recalculating the combined ORs for the remaining studies.

      Results

      12 trials randomized a total of 15,588 patients into two groups, treatment and placebo. Treatment effect on any cardiovascular outcome was not significantly different in any of the nine trials. For all trials combined, the pooled odds ratio for mortality was not significantly different [(OR, 0.873; 95% CI, 0.743–1.027), p = 0.102]. No heterogeneity was observed (I2=0). Similarly, there was no difference in the pooled odds ratio for hospitalization and coronary intervention [(OR, 1.021; 95% CI, 0.882–1.182), p = 0.774, I2=0%] and [(OR, 0.998; 95% CI, 0.885–1.125), p = 0.982, I2=0%], respectively.

      Conclusions

      The findings of this systematic review suggest that no significant relationships exist between Azithromycin and risk of cardiovascular events in high risk patients.