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document
Cardiovascular effects of tamoxifen in women with and without heart disease : breast cancer prevention trial . National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial Investigators . BACKGROUND The overall effect of prophylactic tamoxifen in women depends on the balance between the effects of the drug , which include preventing breast cancer and altering cardiovascular risk . In a recent clinical trial , postmenopausal estrogen-progestin therapy was shown to increase the risk of early cardiovascular events among women with a history of coronary heart disease ( CHD ) . The cardiovascular effects of tamoxifen in women with and without CHD are not known . The National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial ( BCPT ) is the only clinical trial that provides data to assess the cardiovascular effects of tamoxifen in women with and without CHD . METHODS A total of 13 388 women at increased risk for breast cancer were randomly assigned in the BCPT to receive either tamoxifen ( 20 mg/day ) or placebo . Cardiovascular follow-up was available for 13 194 women , 1048 of whom had prior clinical CHD . Fatal and nonfatal myocardial infarction , unstable angina , and severe angina were tabulated ( mean follow-up : 49 months ) . All statistical tests were two-sided . RESULTS Cardiovascular event rates were not statistically significantly different between women assigned to receive tamoxifen and those assigned to receive placebo , independent of pre-existing CHD . Among women without CHD ( 6074 on tamoxifen versus 6072 on placebo ) , risk ratios ( 95 % confidence intervals [ CIs ] ) for tamoxifen users were 1.75 ( 0.44 to 8.13 ) for fatal myocardial infarction , 1.11 ( 0.55 to 2.28 ) for nonfatal myocardial infarction , 0.69 ( 0.29 to 1.57 ) for unstable angina , and 0.83 ( 0.32 to 2.10 ) for severe angina . In women with CHD ( 516 on tamoxifen versus 532 on placebo ) , risk ratios ( 95 % CIs ) for tamoxifen users were 0.00 ( 0 to 1.58 ) for fatal myocardial infarction , 1.25 ( 0.32 to 5.18 ) for nonfatal myocardial infarction , 2.26 ( 0.87 to 6.55 ) for unstable angina , and 1.39 ( 0.23 to 9.47 ) for severe angina . There was no evidence that the lack of association between tamoxifen and cardiovascular events was related to an early increase in risk that may have been offset by a late decrease in risk . CONCLUSION When used for breast cancer prevention in women with or without heart disease , tamoxifen is not associated with beneficial or adverse cardiovascular effects .
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Intervention_Pharmacological
tamoxifen
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Intervention_Pharmacological
tamoxifen ( 20 mg/day )
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Intervention_Control
placebo
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Outcome_Physical
preventing breast cancer
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Outcome_Physical
cardiovascular risk
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Outcome_Physical
early cardiovascular events
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Outcome_Adverse-effects
cardiovascular effects
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Outcome_Adverse-effects
cardiovascular effects
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Outcome_Mortality
Fatal and nonfatal myocardial infarction
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Outcome_Physical
unstable angina , and severe angina
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Outcome_Other
Cardiovascular event rates
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Outcome_Mortality
fatal myocardial infarction
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Outcome_Physical
nonfatal myocardial infarction
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Outcome_Physical
unstable angina
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Outcome_Physical
severe angina
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Outcome_Other
risk ratios
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Outcome_Mortality
fatal myocardial infarction
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Outcome_Physical
nonfatal myocardial infarction
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Outcome_Physical
unstable angina
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Outcome_Physical
severe angina
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Outcome_Physical
cardiovascular events
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Outcome_Physical
increase in risk
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Outcome_Adverse-effects
cardiovascular effects