WIZARD and the design of trials for secondary prevention of atherosclerosis with antibiotics

Authors
Citation
M. Dunne, WIZARD and the design of trials for secondary prevention of atherosclerosis with antibiotics, AM HEART J, 138(5), 1999, pp. S542-S544
Citations number
5
Categorie Soggetti
Cardiovascular & Respiratory Systems","Cardiovascular & Hematology Research
Journal title
AMERICAN HEART JOURNAL
ISSN journal
00028703 → ACNP
Volume
138
Issue
5
Year of publication
1999
Part
2
Supplement
S
Pages
S542 - S544
Database
ISI
SICI code
0002-8703(199911)138:5<S542:WATDOT>2.0.ZU;2-8
Abstract
Clinical trials to assess the merit of antibiotic intervention in the treat ment of ischemic cardiovascular disease are now underway, spurred on by an association between Chlamydia pneumoniae and atherogenesis noted in epidemi ologic investigations, histopathologic studies, and results from various an imal models. The design of such clinical trials must take into account a nu mber of issues: the primary event as strictly defined by objective criteria , the event rate in the chosen population, the potential treatment effect, the availability of patients, the underlying cause of their atherosclerotic disease, the determination of the C pneumoniae-infected population to stud y, the dose and duration of the antibiotic, and the length of follow-up. In the design of the WIZARD study (Weekly Intervention with Zithromax for Ath erosclerosis and its Related Disorders), an attempt was made to take these issues under consideration. Patients were randomly assigned either to 600 m g/d zithromax for 3 days then 600 mg/wk for 11 additional weeks or to place bo. Patients in the study had a myocardial infarction at least 6 weeks prev iously, had no recent coronary artery bypass graft or percutaneous translum inal coronary angioplasty, and did not required long-term administration of antibiotics. Patients were required to have an immunoglobulin G titer to C pneumoniae of greater than or equal to 1:16. The primary end point was the time to a composite of all-cause death, myocardial infarction, a revascula rization procedure, or hospitalization for angina, the study enrolled 3500 patients, sufficient to detect a 25% reduction in the presumed 8% placebo e vent rate with 90% power. Follow-up will continue through the prespecified number of end points.