TY - JOUR
T1 - Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial
AU - Jespersen, Christian M
AU - Als-Nielsen, Bodil
AU - Damgaard, Morten
AU - Hansen, Jørgen Fischer
AU - Hansen, Stig
AU - Helø, Olav H
AU - Hildebrandt, Per
AU - Hilden, Jørgen
AU - Jensen, Gorm B
AU - Kastrup, Jens
AU - Kolmos, Hans Jørn
AU - Kjøller, Erik
AU - Lind, Inga
AU - Nielsen, Henrik
AU - Petersen, Lars
AU - Gluud, Christian
AU - CLARICOR Trial Group
N1 - Keywords: Adolescent; Adult; Aged; Aged, 80 and over; Angina Pectoris; Anti-Bacterial Agents; Chlamydophila Infections; Chlamydophila pneumoniae; Clarithromycin; Humans; Middle Aged; Myocardial Infarction; Treatment Outcome
PY - 2005
Y1 - 2005
N2 - OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks' treatment with clarithromycin 500 mg/day or matching placebo. MAIN OUTCOME MEASURES: Primary outcome: composite of all cause mortality, myocardial infarction, or unstable angina pectoris during three years' follow-up. Secondary outcome: composite of cardiovascular mortality, myocardial infarction, or unstable angina pectoris. The outcomes were obtained from Danish registers and were blindly assessed by the event committee. RESULTS: 2172 participants were randomised to clarithromycin and 2201 to placebo. We found no significant effects of clarithromycin on the primary outcome (hazard ratio 1.15, 95% confidence interval 0.99 to 1.34) or secondary outcome (1.17, 0.98 to 1.40). Mortality was significantly higher in the clarithromycin arm (1.27, 1.03 to 1.54; P = 0.03) as a result of significantly higher cardiovascular mortality (1.45, 1.09 to 1.92; P = 0.01). CONCLUSIONS: Short term clarithromycin in patients with stable coronary heart disease may cause significantly higher cardiovascular mortality. The long term safety of clarithromycin in patients with stable ischaemic heart disease should be examined. Trial registration ClinicalTrials.gov NCT00121550.
AB - OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five Copenhagen University cardiology departments and a coordinating centre. PARTICIPANTS: 13,702 patients aged 18 to 85 years who had a discharge diagnosis of myocardial infarction or angina pectoris in 1993-9 and alive in August 1999 were invited by letter; 4373 were randomised. INTERVENTIONS: Two weeks' treatment with clarithromycin 500 mg/day or matching placebo. MAIN OUTCOME MEASURES: Primary outcome: composite of all cause mortality, myocardial infarction, or unstable angina pectoris during three years' follow-up. Secondary outcome: composite of cardiovascular mortality, myocardial infarction, or unstable angina pectoris. The outcomes were obtained from Danish registers and were blindly assessed by the event committee. RESULTS: 2172 participants were randomised to clarithromycin and 2201 to placebo. We found no significant effects of clarithromycin on the primary outcome (hazard ratio 1.15, 95% confidence interval 0.99 to 1.34) or secondary outcome (1.17, 0.98 to 1.40). Mortality was significantly higher in the clarithromycin arm (1.27, 1.03 to 1.54; P = 0.03) as a result of significantly higher cardiovascular mortality (1.45, 1.09 to 1.92; P = 0.01). CONCLUSIONS: Short term clarithromycin in patients with stable coronary heart disease may cause significantly higher cardiovascular mortality. The long term safety of clarithromycin in patients with stable ischaemic heart disease should be examined. Trial registration ClinicalTrials.gov NCT00121550.
U2 - 10.1136/bmj.38666.653600.55
DO - 10.1136/bmj.38666.653600.55
M3 - Journal article
C2 - 16339220
SN - 0959-8138
VL - 332
SP - 22
EP - 27
JO - B M J (Clinical Research Edition)
JF - B M J (Clinical Research Edition)
IS - 7532
ER -