(HealthDay)—For patients after allogeneic hematopoietic stem cell transplant (HSCT), early administration of azithromycin is associated with worse airflow decline-free survival, according to a study published in the Aug. 8 issue of the Journal of the American Medical Association.
Anne Bergeron, M.D., Ph.D., from the Hôpital Saint-Louis in Paris, and colleagues randomized patients to receive azithromycin or placebo three times per week for two years (243 and 237 patients, respectively), starting at the time of the conditioning regimen.
The independent data and safety monitoring board detected an unanticipated imbalance across blinded groups in terms of the number of hematological relapses at 13 months after enrollment, and treatment was stopped. The researchers found that the two-year airflow decline-free survival was 32.8 and 41.3 percent with azithromycin and placebo, respectively (unadjusted hazard ratio, 1.3). Overall, 15 patients (6 percent) in the azithromycin group and seven (3 percent) in the placebo group experienced bronchiolitis obliterans (P = 0.08). Increased mortality was seen in the azithromycin group, with two-year survival of 56.6 and 70.1 percent in the azithromycin and placebo groups, respectively (unadjusted hazard ratio, 1.5). The two-year cumulative incidence of hematological relapse was 33.5 and 22.3 percent with azithromycin and placebo, respectively (unadjusted cause-specific hazard ratio, 1.7).
“Early administration of azithromycin resulted in worse airflow decline-free survival than did placebo; these findings are limited by early trial termination,” the authors write.
Several authors disclosed financial ties to pharmaceutical and respiratory assistance companies, including SOS Oxygène, which partially funded the study.