ROXIthromycin in non-Q wave coronary Syndromes - ROXIS

Description:

The goal of this study was to assess the safety and efficacy of roxithromycin among patients with unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI).

Hypothesis:

Since evidence exists that there may be an association between Chlamydia pneumoniae and coronary artery disease, it was hypothesized that roxithromycin, a macrolide antibiotic, would reduce or prevent major adverse ischemic events among patients with unstable angina or NSTEMI.

Study Design

Study Design:

Patients Screened: 205
Patients Enrolled: 202
Mean Follow Up: Six months
Mean Patient Age: 61 ± 12 years
Female: 26

Patient Populations:

1) Severe recurrent ischemia (chest pain lasting at least five minutes, with ST-T changes in at least two contiguous leads [ST elevation or depression >0.1 mV and/or T-wave inversion] and/or prompting decision to revascularize within 24 hours following the event).
2) Acute MI (CK-MB elevated above normal and at least 3% of total CK and CK value twice the upper limit of normal; Q-wave MI was defined as chest pain lasting five minutes or more followed by the appearance of new significant Q waves in at least two leads on the ECG).
3) Death due to cardiac ischemia.

Exclusions:

1) Serological response (Chlamydia pneumoniae-specific IgG titers at day 31, day 90, and at six months).
2) Inflammatory response (C-reactive protein concentrations at baseline and day 31 of the study).

Primary Endpoints:

1) Severe recurrent ischemia (chest pain lasting at least five minutes, with ST-T changes in at least two contiguous leads [ST elevation or depression >0.1 mV and/or T-wave inversion] and/or prompting decision to revascularize within 24 hours following the event).
2) Acute MI (creatinine kinase-MB [CK-MB] elevated above normal and at least 3% of total CK and CK value twice the upper limit of normal; Q-wave MI was defined as chest pain lasting five minutes or more followed by the appearance of new significant Q waves in at least two leads on the ECG).
3) Death due to cardiac ischemia.

Secondary Endpoints:

1) Serological response (Chlamydia pneumoniae-specific IgG titers at day 31, day 90, and at six months).
2) Inflammatory response (C-reactive protein concentrations at baseline and day 31 of the study).

Drug/Procedures Used:

Eligible patients were randomized to receive either roxithromycin (150 mg orally twice a day) or placebo for a minimum of 72 hours with a goal of 30 days.

Concomitant Medications:

100–325 mg aspirin a day, intravenous nitroglycerine, and unfractionated heparin; beta-blockers or calcium-channel blockers were administered when appropriate.

Principal Findings:

There was a statistically significant reduction in the composite triple endpoint of recurrent ischemia, MI, and ischemic death observed in the roxithromycin group compared with the placebo group (9% vs. 2%, p=0.032). However, there was no significant difference between the groups in the individual endpoints.

Interpretation:

Among patients with unstable angina and NSTEMI, treatment with roxithromycin (150 mg orally twice a day) significantly reduced the composite endpoint of recurrent ischemia, MI, and ischemic death compared to placebo.

These results suggest that roxithromycin therapy may be safe and effective in the setting of acute coronary syndromes. Further prospective studies utilizing a longer duration of therapy with a later endpoint are needed to validate these findings.

References:

Gurfinkel E, Bozovich G, Daroca A, Beck E, Mautner B. Randomised trial of roxithromycin in non-Q wave coronary syndromes: ROXIS pilot study. ROXIS Study Group. Lancet 1997;350:404-7.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Atherosclerotic Disease (CAD/PAD), Anticoagulation Management and ACS

Keywords: Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease, Heparin, Calcium Channel Blockers, Macrolides, Roxithromycin, Chlamydophila pneumoniae, Nitroglycerin


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