Early ReportRandomised trial of roxithromycin in non-Q-wave coronary syndromes: ROXIS pilot study
Introduction
There has been renewed interest in the possibility of an association between coronary heart disease and infection, specifically with Chlamydia pneumoniae. This organism is now recognised as a common cause of respiratory-tract infection. Several investigators have documented an association between coronary heart disease and the presence of high titres of antibodies to C pneumoniae.1, 2, 3 The organism has also been detected in atherosclerotic plaques.4 Furthermore, it has been found that C pneumoniae might be involved both in atherogenesis and in plaque instability.5 We decided to test the hypothesis that treatment of patients with unstable angina with an antibiotic with antichlamydial activity, roxithromycin, in addition to conventional therapy, would reduce subsequent plaque instability and associated clinical events.
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Patients and methods
This study was a double-blind, randomised, prospective, multicentre, parallel-group, placebo-controlled pilot study of patients with unstable angina or non-Q-wave myocardial infarction. Recruitment began in May, 1996, and was completed in March, 1997. A total of 205 patients, from eight coronary-care units in Argentina, were recruited into the study. At admission, all patients meeting the criteria for type
IIIb of Braunwald's classification for unstable angina6 and non-Q-wave myocardial
Results
Of the 205 patients recruited into the study, three failed to meet the inclusion criteria (figure). The remaining 202 eligible patients were randomly assigned roxithromycin (n=102) or placebo (n=100). A secondary analysis of patients who took the study treatment for at least 72 h (six doses) was done. Of the 202 patients nine patients of the roxithromycin-treated and seven patients of the placebo-treated group did not complete the minimum 72 h, because of the need for coronary artery bypass
Discussion
A substantial number of patients with unstable angina have an adverse clinical outcome despite the use of aspirin and heparin during the acute and chronic phases of angina.8 This loss of an initial benefit could be explained in part by the rebound activation of the coagulation system that follows the discontinuation of a heparin infusion and the continuing inflammatory process that persists for up to 6 months from the onset of a coronary event.
Data have shown that immunological and
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Other members of the ROXIS Study Group are listed at the end of the paper