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Azithromycin prevents bronchiectasis exacerbations in adults without cystic fibrosis (EMBRACE)

Clinical Question:
Does azithromycin prevent exacerbations in adults without cystic fibrosis?

Bottom Line:
In adults with bronchiectasis not due to cystic fibrosis, azithromycin prevents exacerbations. (LOE = 1b)

Reference:
Wong C, Jayaram L, Karalus N, et al. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet 2012;380(9842):660-667.  [PMID:22901887]

Study Design:
Randomized controlled trial (double-blinded)

Funding:
Government

Allocation:
Concealed

Setting:
Outpatient (specialty)

Synopsis:
These researchers assigned adults with at least one exacerbation of computed tomography-confirmed bronchiectasis to receive azithromycin (500 mg on every Monday, Wednesday, and Friday for 6 months; n = 71) or a matching placebo on the same schedule (n = 70). The research team evaluated the patients 4, 13, 26, 39, and 52 weeks after enrollment and scheduled monthly phone calls between each assessment visit. The authors used intention-to-treat analysis to evaluate the rate of exacerbations, spirometric changes, and a symptom-based score. Fourteen (10%) of the patients did not complete the study. During the 6 months of active treatment, patients receiving azithromycin had 0.6 exacerbations per year compared with 1.6 in placebo-treated patients. Over the full 12 months of the study, the rates were 1.6 and 2.7, respectively. Additionally, after 6 months, one third of the azithromycin-treated patients had at least one exacerbation compared with approximately two thirds of patients receiving placebo (number needed to treat = 3; 95% CI, 2 - 6). Spirometric performance and symptom scores did not differ, however. The authors report that 83% of azithromycin-treated patients and 93% of placebo-treated patients reported adverse events, with severe events occurring in 6% and 13%, respectively. Two patients in each group stopped their treatment because of gastrointestinal symptoms.

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