A study has shown that in patients with vascular disease or diabetes mellitus, long-term vitamin E supplementation does not prevent cancer or major cardiovascular events, and can increase the risk for heart failure.
The HOPE and HOPE-TOO investigators evaluated whether long-term supplementation with vitamin E decreases the risk of cancer, cancer death, and major cardiovascular events.
The HOPE ( Heart Outcomes Prevention Evaluation ) trial conducted between December 1993, and April 1999, enrolled 9541 patients, age 55 and older, with vascular disease or diabetes mellitus.
Of the initial 267 HOPE centers,174 centers participated in the HOPE-TOO trial, an extension of the HOPE trial, between April 1999, and May 2003..
A total of 3994 patients from the original study consented to continuing in the extended study, and 738 agreed to passive follow-up.
Median duration of follow-up was 7.0 years.
The patients were randomized to receive either natural source vitamin E, 400 IU daily, or placebo.
Primary end points included cancer incidence, cancer deaths, and major cardiovascular events ( myocardial infarction, stroke, and cardiovascular death ), and the secondary end points, heart failure, unstable angina, and revascularizations.
Among all HOPE patients, there were no significant differences in the primary end points between the vitamin E group and the placebo group.
Patients in the vitamin E group had a higher risk of heart failure ( RR, 1.13; P = .03 ) and hospitalization for heart failure ( RR, 1.21; 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.
Source: JAMA, 2005