Randomized double-blind controlled trial of roxithromycin for prevention of abdominal aortic aneurysm expansion.

Abstract

Macrolide treatment has been reported to lower the risk of recurrent ischaemic heart disease. The influence of macrolides on the expansion rate of abdominal aortic aneurysms (AAAs) remains unknown. The aim was to investigate the effect of roxithromycin on the expansion rate of small AAAs. A total of 92 subjects with a small AAA were recruited from two populations. One population consisted of 6339 men aged 65-73 years who were offered a hospital-based mass screening programme for AAA. From this population 66 subjects were recruited. The remaining 26 men were recruited from among 49 subjects diagnosed at interval screening for an initial aortic diameter between 25 and 29 mm. Subjects were randomized to receive either oral roxithromycin 300 mg once daily for 28 days or matching placebo, and followed for a mean of 1.5 years. During the first year the mean annual expansion rate of AAAs was reduced by 44 [corrected] per cent in the intervention group (1.56 mm per year), compared with 2.80 mm per year following placebo (P = 0.02). During the second year the difference was only 5 per cent [corrected]. Multiple linear regression analysis showed that roxithromycin treatment and initial AAA size were significantly related to AAA expansion when adjusted for smoking, diastolic blood pressure and immunoglobulin A level of 20 or more [corrected]. Logistic regression analysis confirmed a significant difference in expansion rates above 2 mm annually between the intervention and placebo groups: odds ratio = 0.09 (95 per cent confidence interval 0.01-0.83) [corrected]. In comparison to placebo, roxithromycin 300 mg daily for 4 weeks reduced the expansion rate of AAAs.