Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease.

Christian Gluud; Bodil Als-Nielsen; Morten Damgaard; Jørgen Fischer Hansen; Stig Hansen; Olav H Helø; Per Hildebrandt; Jørgen Hilden; Gorm Boje Jensen; Jens Kastrup; Hans Jørn Kolmos; Erik Kjøller; Inga Lind; Henrik Nielsen; Lars Petersen; Christian M Jespersen; CLARICOR Trial Group; Christian Gluud; Bodil Als-Nielsen; Morten Damgaard; Jørgen Fischer Hansen; Stig Henrik Strange Hansen; Olav H Helø; Per Hildebrandt; Jørgen Hilden; Gorm Boje Jensen; Jens Kastrup; Hans Jørn Kolmos; Erik Kjøller; Inga Lind; Henrik Nielsen; Lars Petersen; Christian M Jespersen

doi:10.1159/000128994

Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease.

Christian Gluud, Bodil Als-Nielsen, Morten Damgaard, Jørgen Fischer Hansen, Stig Hansen, Olav H Helø, Per Hildebrandt, Jørgen Hilden, Gorm Boje Jensen, Jens Kastrup, Hans Jørn Kolmos, Erik Kjøller, Inga Lind, Henrik Nielsen, Lars Petersen, Christian M Jespersen, CLARICOR Trial Group, Christian Gluud, Bodil Als-Nielsen, Morten DamgaardJørgen Fischer Hansen, Stig Henrik Strange Hansen, Olav H Helø, Per Hildebrandt, Jørgen Hilden, Gorm Boje Jensen, Jens Kastrup, Hans Jørn Kolmos, Erik Kjøller, Inga Lind, Henrik Nielsen, Lars Petersen, Christian M Jespersen

48 Citations (Scopus)

Abstract

Objectives: We have reported increased 2.6-year mortality in clarithromycin- versus placebo-exposed stable coronary heart disease patients, but meta-analysis of randomized trials in coronary heart disease patients showed no significant effect of antibiotics on mortality. Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses. Methods: Centrally randomized, placebo controlled multicenter trial. All parties were blinded. Analyses were by intention to treat. Meta-analyses followed the Cochrane Collaboration methodology. Results: We randomized 4,372 patients with stable coronary heart disease to clarithromycin 500 mg (n = 2,172) or placebo (n = 2,200) once daily for 2 weeks. Mortality was followed through public register. Nine hundred and twenty-three patients (21.1%) died. Six-year mortality was significantly higher in the clarithromycin group (hazard ratio 1.21, 95% confidence interval 1.06-1.38). Adjustment for entry characteristics (sex, age, prior myocardial infarction, center, and smoking) did not change the results (1.18, 1.04-1.35). Addition of our data to that of other randomized trials on antibiotics for patients with coronary heart disease versus placebo/no intervention (17 trials, 25,271 patients, 1,877 deaths) showed a significantly increased relative risk of death from antibiotics of 1.10 (1.01-1.20) without heterogeneity. Conclusions: Our results stress the necessity to consider carefully the strength of the indication before administering antibiotics to patients with coronary heart disease.

Original language	English
Journal	Cardiology
Volume	111
Issue number	4
Pages (from-to)	280-287
Number of pages	7
ISSN	0008-6312
DOIs	https://doi.org/10.1159/000128994 https://doi.org/10.1159/000128994
Publication status	Published - 2008

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Gluud, C., Als-Nielsen, B., Damgaard, M., Fischer Hansen, J., Hansen, S., Helø, O. H., Hildebrandt, P., Hilden, J., Jensen, G. B., Kastrup, J., Kolmos, H. J., Kjøller, E., Lind, I., Nielsen, H., Petersen, L., Jespersen, C. M., CLARICOR Trial Group, Gluud, C., Als-Nielsen, B., ... Jespersen, C. M. (2008). Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease. Cardiology, 111(4), 280-287. https://doi.org/10.1159/000128994, https://doi.org/10.1159/000128994

Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease. / Gluud, Christian; Als-Nielsen, Bodil; Damgaard, Morten et al.

In: Cardiology, Vol. 111, No. 4, 2008, p. 280-287.

Research output: Contribution to journal › Journal article › Research › peer-review

Gluud, C, Als-Nielsen, B, Damgaard, M, Fischer Hansen, J, Hansen, S, Helø, OH, Hildebrandt, P, Hilden, J, Jensen, GB, Kastrup, J, Kolmos, HJ, Kjøller, E, Lind, I, Nielsen, H, Petersen, L, Jespersen, CM, CLARICOR Trial Group, Gluud, C, Als-Nielsen, B, Damgaard, M, Fischer Hansen, J, Hansen, SHS, Helø, OH, Hildebrandt, P, Hilden, J, Jensen, GB, Kastrup, J, Kolmos, HJ, Kjøller, E, Lind, I, Nielsen, H, Petersen, L & Jespersen, CM 2008, 'Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease.', Cardiology, vol. 111, no. 4, pp. 280-287. https://doi.org/10.1159/000128994, https://doi.org/10.1159/000128994

@article{a022f5c09d4a11debc73000ea68e967b,

title = "Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease.",

abstract = "Objectives: We have reported increased 2.6-year mortality in clarithromycin- versus placebo-exposed stable coronary heart disease patients, but meta-analysis of randomized trials in coronary heart disease patients showed no significant effect of antibiotics on mortality. Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses. Methods: Centrally randomized, placebo controlled multicenter trial. All parties were blinded. Analyses were by intention to treat. Meta-analyses followed the Cochrane Collaboration methodology. Results: We randomized 4,372 patients with stable coronary heart disease to clarithromycin 500 mg (n = 2,172) or placebo (n = 2,200) once daily for 2 weeks. Mortality was followed through public register. Nine hundred and twenty-three patients (21.1%) died. Six-year mortality was significantly higher in the clarithromycin group (hazard ratio 1.21, 95% confidence interval 1.06-1.38). Adjustment for entry characteristics (sex, age, prior myocardial infarction, center, and smoking) did not change the results (1.18, 1.04-1.35). Addition of our data to that of other randomized trials on antibiotics for patients with coronary heart disease versus placebo/no intervention (17 trials, 25,271 patients, 1,877 deaths) showed a significantly increased relative risk of death from antibiotics of 1.10 (1.01-1.20) without heterogeneity. Conclusions: Our results stress the necessity to consider carefully the strength of the indication before administering antibiotics to patients with coronary heart disease.",

author = "Christian Gluud and Bodil Als-Nielsen and Morten Damgaard and {Fischer Hansen}, J{\o}rgen and Stig Hansen and Hel{\o}, {Olav H} and Per Hildebrandt and J{\o}rgen Hilden and Jensen, {Gorm Boje} and Jens Kastrup and Kolmos, {Hans J{\o}rn} and Erik Kj{\o}ller and Inga Lind and Henrik Nielsen and Lars Petersen and Jespersen, {Christian M} and {CLARICOR Trial Group} and Christian Gluud and Bodil Als-Nielsen and Morten Damgaard and {Fischer Hansen}, J{\o}rgen and Hansen, {Stig Henrik Strange} and Hel{\o}, {Olav H} and Per Hildebrandt and J{\o}rgen Hilden and Jensen, {Gorm Boje} and Jens Kastrup and Kolmos, {Hans J{\o}rn} and Erik Kj{\o}ller and Inga Lind and Henrik Nielsen and Lars Petersen and Jespersen, {Christian M}",

note = "Keywords: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Clarithromycin; Confidence Intervals; Coronary Disease; Denmark; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Meta-Analysis as Topic; Middle Aged; Odds Ratio; Risk; Survival Analysis",

year = "2008",

doi = "10.1159/000128994",

language = "English",

volume = "111",

pages = "280--287",

journal = "Cardiologia",

issn = "0008-6312",

publisher = "S Karger AG",

number = "4",

}

TY - JOUR

T1 - Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease.

AU - Gluud, Christian

AU - Als-Nielsen, Bodil

AU - Damgaard, Morten

AU - Fischer Hansen, Jørgen

AU - Hansen, Stig

AU - Helø, Olav H

AU - Hildebrandt, Per

AU - Hilden, Jørgen

AU - Jensen, Gorm Boje

AU - Kastrup, Jens

AU - Kolmos, Hans Jørn

AU - Kjøller, Erik

AU - Lind, Inga

AU - Nielsen, Henrik

AU - Petersen, Lars

AU - Jespersen, Christian M

AU - CLARICOR Trial Group

AU - Gluud, Christian

AU - Als-Nielsen, Bodil

AU - Damgaard, Morten

AU - Fischer Hansen, Jørgen

AU - Hansen, Stig Henrik Strange

AU - Helø, Olav H

AU - Hildebrandt, Per

AU - Hilden, Jørgen

AU - Jensen, Gorm Boje

AU - Kastrup, Jens

AU - Kolmos, Hans Jørn

AU - Kjøller, Erik

AU - Lind, Inga

AU - Nielsen, Henrik

AU - Petersen, Lars

AU - Jespersen, Christian M

N1 - Keywords: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Clarithromycin; Confidence Intervals; Coronary Disease; Denmark; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Meta-Analysis as Topic; Middle Aged; Odds Ratio; Risk; Survival Analysis

PY - 2008

Y1 - 2008

N2 - Objectives: We have reported increased 2.6-year mortality in clarithromycin- versus placebo-exposed stable coronary heart disease patients, but meta-analysis of randomized trials in coronary heart disease patients showed no significant effect of antibiotics on mortality. Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses. Methods: Centrally randomized, placebo controlled multicenter trial. All parties were blinded. Analyses were by intention to treat. Meta-analyses followed the Cochrane Collaboration methodology. Results: We randomized 4,372 patients with stable coronary heart disease to clarithromycin 500 mg (n = 2,172) or placebo (n = 2,200) once daily for 2 weeks. Mortality was followed through public register. Nine hundred and twenty-three patients (21.1%) died. Six-year mortality was significantly higher in the clarithromycin group (hazard ratio 1.21, 95% confidence interval 1.06-1.38). Adjustment for entry characteristics (sex, age, prior myocardial infarction, center, and smoking) did not change the results (1.18, 1.04-1.35). Addition of our data to that of other randomized trials on antibiotics for patients with coronary heart disease versus placebo/no intervention (17 trials, 25,271 patients, 1,877 deaths) showed a significantly increased relative risk of death from antibiotics of 1.10 (1.01-1.20) without heterogeneity. Conclusions: Our results stress the necessity to consider carefully the strength of the indication before administering antibiotics to patients with coronary heart disease.

AB - Objectives: We have reported increased 2.6-year mortality in clarithromycin- versus placebo-exposed stable coronary heart disease patients, but meta-analysis of randomized trials in coronary heart disease patients showed no significant effect of antibiotics on mortality. Here we report the 6-year mortality of clarithromycin- versus placebo-exposed patients and updated meta-analyses. Methods: Centrally randomized, placebo controlled multicenter trial. All parties were blinded. Analyses were by intention to treat. Meta-analyses followed the Cochrane Collaboration methodology. Results: We randomized 4,372 patients with stable coronary heart disease to clarithromycin 500 mg (n = 2,172) or placebo (n = 2,200) once daily for 2 weeks. Mortality was followed through public register. Nine hundred and twenty-three patients (21.1%) died. Six-year mortality was significantly higher in the clarithromycin group (hazard ratio 1.21, 95% confidence interval 1.06-1.38). Adjustment for entry characteristics (sex, age, prior myocardial infarction, center, and smoking) did not change the results (1.18, 1.04-1.35). Addition of our data to that of other randomized trials on antibiotics for patients with coronary heart disease versus placebo/no intervention (17 trials, 25,271 patients, 1,877 deaths) showed a significantly increased relative risk of death from antibiotics of 1.10 (1.01-1.20) without heterogeneity. Conclusions: Our results stress the necessity to consider carefully the strength of the indication before administering antibiotics to patients with coronary heart disease.

U2 - 10.1159/000128994

DO - 10.1159/000128994

M3 - Journal article

C2 - 18451646

SN - 0008-6312

VL - 111

SP - 280

EP - 287

JO - Cardiologia

JF - Cardiologia

IS - 4

ER -

Clarithromycin for 2 Weeks for Stable Coronary Heart Disease: 6-Year Follow-Up of the CLARICOR Randomized Trial and Updated Meta-Analysis of Antibiotics for Coronary Heart Disease.

Abstract

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