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document
Effects of long-term vitamin E supplementation on cardiovascular events and cancer : a randomized controlled trial . CONTEXT Experimental and epidemiological data suggest that vitamin E supplementation may prevent cancer and cardiovascular events . Clinical trials have generally failed to confirm benefits , possibly due to their relatively short duration . OBJECTIVE To evaluate whether long-term supplementation with vitamin E decreases the risk of cancer , cancer death , and major cardiovascular events . DESIGN , SETTING , AND PATIENTS A randomized , double-blind , placebo-controlled international trial ( the initial Heart Outcomes Prevention Evaluation [ HOPE ] trial conducted between December 21 , 1993 , and April 15 , 1999 ) of patients at least 55 years old with vascular disease or diabetes mellitus was extended ( HOPE-The Ongoing Outcomes [ HOPE-TOO ] ) between April 16 , 1999 , and May 26 , 2003 . Of the initial 267 HOPE centers that had enrolled 9541 patients , 174 centers participated in the HOPE-TOO trial . Of 7030 patients enrolled at these centers , 916 were deceased at the beginning of the extension , 1382 refused participation , 3994 continued to take the study intervention , and 738 agreed to passive follow-up . Median duration of follow-up was 7.0 years . INTERVENTION Daily dose of natural source vitamin E ( 400 IU ) or matching placebo . MAIN OUTCOME MEASURES Primary outcomes included cancer incidence , cancer deaths , and major cardiovascular events ( myocardial infarction , stroke , and cardiovascular death ) . Secondary outcomes included heart failure , unstable angina , and revascularizations . RESULTS Among all HOPE patients , there were no significant differences in the primary analysis : for cancer incidence , there were 552 patients ( 11.6 % ) in the vitamin E group vs 586 ( 12.3 % ) in the placebo group ( relative risk [ RR ] , 0.94 ; 95 % confidence interval [ CI ] , 0.84-1.06 ; P = .30 ) ; for cancer deaths , 156 ( 3.3 % ) vs 178 ( 3.7 % ) , respectively ( RR , 0.88 ; 95 % CI , 0.71-1.09 ; P = .24 ) ; and for major cardiovascular events , 1022 ( 21.5 % ) vs 985 ( 20.6 % ) , respectively ( RR , 1.04 ; 95 % CI , 0.96-1.14 ; P = .34 ) . Patients in the vitamin E group had a higher risk of heart failure ( RR , 1.13 ; 95 % CI , 1.01-1.26 ; P = .03 ) and hospitalization for heart failure ( RR , 1.21 ; 95 % CI , 1.00-1.47 ; P = .045 ) . Similarly , among patients enrolled at the centers participating in the HOPE-TOO trial , there were no differences in cancer incidence , cancer deaths , and major cardiovascular events , but higher rates of heart failure and hospitalizations for heart failure . CONCLUSION In patients with vascular disease or diabetes mellitus , long-term vitamin E supplementation does not prevent cancer or major cardiovascular events and may increase the risk for heart failure .
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Intervention_Pharmacological
long-term vitamin E supplementation
20961
Intervention_Pharmacological
vitamin E supplementation
20962
Intervention_Pharmacological
long-term supplementation with vitamin E
20963
Intervention_Pharmacological
Daily dose of natural source vitamin E ( 400 IU )
20964
Intervention_Control
placebo
20965
Intervention_Pharmacological
vitamin E
20966
Intervention_Control
placebo
20967
Intervention_Pharmacological
vitamin E
20968
Intervention_Pharmacological
long-term vitamin E supplementation
20969
Outcome_Physical
cardiovascular events and cancer
20970
Outcome_Physical
risk of cancer ,
20971
Outcome_Mortality
cancer death
20972
Outcome_Physical
, and major cardiovascular events
20973
Outcome_Physical
cancer incidence ,
20974
Outcome_Mortality
cancer deaths
20975
Outcome_Physical
, and major cardiovascular events ( myocardial infarction , stroke , and cardiovascular death )
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Outcome_Physical
heart failure , unstable angina , and revascularizations
20977
Outcome_Physical
cancer incidence
20978
Outcome_Mortality
cancer deaths
20979
Outcome_Physical
major cardiovascular events
20980
Outcome_Physical
risk of heart failure
20981
Outcome_Other
hospitalization for heart failure
20982
Outcome_Physical
cancer incidence
20983
Outcome_Mortality
cancer deaths
20984
Outcome_Physical
major cardiovascular events
20985
Outcome_Physical
rates of heart failure
20986
Outcome_Other
hospitalizations for heart failure
20987
Outcome_Physical
cancer
20988
Outcome_Physical
major cardiovascular events
20989
Outcome_Physical
risk for heart failure
20990
Participant_Condition
cardiovascular events
20991
Participant_Condition
cancer
20992
Participant_Condition
cancer
20993
Participant_Condition
cardiovascular events
20994
Participant_Condition
cancer
20995
Participant_Condition
cardiovascular events
20996
Participant_Age
at least 55 years old
20997
Participant_Condition
vascular disease or diabetes mellitus
20998
Participant_Sample-size
9541
20999
Participant_Sample-size
7030
21000
Participant_Sample-size
916
21001
Participant_Sample-size
1382
21002
Participant_Sample-size
3994
21003
Participant_Sample-size
738
21004
Participant_Condition
vascular disease or diabetes mellitus