Treatment with the antibiotic roxithromycin in patients with acute non-Q-wave coronary syndromes. The final report of the ROXIS study

• Published in: European heart journal 1999-01, Vol.20 (2), p.121-127
• Main Authors: Gurfinkel, E., Bozovich, G., Beck, E., Testa, E., Livellara, B., Mautner, B., ROXIS Study Group
• Format: Article
• Language: English
• Subjects: Aged; Angina, Unstable - diagnosis; Angina, Unstable - drug therapy; Angina, Unstable - mortality; Angina, Unstable - physiopathology; Anti-Bacterial Agents - administration & dosage; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Atherosclerosis; Biological and medical sciences; Chi-Square Distribution; Chlamydia pneumoniae; coronary artery disease; Coronary Disease - diagnosis; Coronary Disease - drug therapy; Coronary Disease - mortality; Coronary Disease - physiopathology; Electrocardiography - drug effects; Female; Follow-Up Studies; Humans; macrolide; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Pilot Projects; roxithromycin; Roxithromycin - administration & dosage; Survival Rate; Syndrome; Treatment Outcome; unstable angina
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1053/euhj.1998.1283

Aims Mounting evidence suggests infection, specificallyChlamydia pneumoniae,plays a role in atherosclerosis. We tested whether antibiotic treatment with the macrolide roxithromycin improves clinical outcome in patients with acute non-Q-wave coronary syndromes. Preliminary reports revealed a reduction in events in the roxithromycin group at 30 days. We now report the long-term follow-up results. Methods and Results Sixty-four per cent of the initial 202 patients with unstable angina who were randomly assigned to receive either roxithromycin or placebo for 30 days completed the active treatment period. At day 30, the primary triple and double end-point rates were 9% and 4% in the placebo group compared to 2% and 0% in the roxithromycin group (unadjustedP=0·032 and 0·058, respectively). The secondary triple and double end-point rates were again higher in the placebo group at day 90 (12·5% and 6·25% vs 4·37% and 0%, unadjustedP=0·065 and 0·029, respectively), and at day 180 (14·6% and 7·29% vs 8·69% and 2·17%, unadjustedP=0·259 and 0·17, respectively). Anti-C. pneumoniaeIgG titres were unchanged in both groups while C-reactive protein levels decreased in both strategies, with a more significant decrease in the roxithromycin arm (P=0·03). Elevated C-reactive protein levels predicted the need for revascularization. Conclusions In this pilot trial, roxithromycin appears to extend the clinical benefit of preventing death and re-infarction for at least 6 months after initial treatment.