Original Communication
European Journal of Clinical Nutrition (2005) 59, 1173–1180. doi:10.1038/sj.ejcn.1602229; published online 13 July 2005
Changes in cholesterol and triglyceride concentrations in the Vanguard population of the Carotene and Retinol Efficacy Trial (CARET)
Guarantor: B Cartmel.
Contributors: JD and SV conducted the statistical analysis. All authors participated in the design, interpretation and writing up of the research work.
B Cartmel1, J Dziura2, M R Cullen3,1, S Vegso3, G S Omenn4, G E Goodman5 and C A Redlich3,1
- 1Department of Epidemiology and Public Health and the Yale Cancer Center, Yale University School of Medicine, New Haven, CT, USA
- 2GCRC, Yale University School of Medicine, New Haven, CT, USA
- 3Yale Occupational and Environmental Medicine Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA
- 4University of Michigan, Ann Arbor, MI, USA
- 5Fred Hutchinson Cancer Research Center and Swedish Cancer Institute, Seattle, WA, USA
Correspondence: B Cartmel, Department of Epidemiology and Public Health, Yale University School of Medicine, 200 College St, New Haven, CT 06510, USA. E-mail: brenda.cartmel@yale.edu
Received 9 August 2004; Revised 8 March 2005; Accepted 2 June 2005; Published online 13 July 2005.
Abstract
Background:
The Beta-Carotene and Retinol Efficacy Trial (CARET) was terminated 21 months ahead of schedule due to an excess of lung cancers. Deaths from cardiovascular disease also increased (relative risk=1.26 (95% confidence interval (CI) 0.99–1.61)) in the group assigned to a combination of 30 mg beta-carotene and 25 000 IU retinyl palmitate (vitamin A) daily. The basis for increased cardiovascular mortality is unexplained.
Design:
We analyzed data on serum lipids, available for 1474 CARET Vanguard participants who were enrolled in the two CARET pilot studies and transitioned to the Vanguard study. Total cholesterol and triglycerides were measured 2 months prior to, 4 and 12 months following randomization, and annually thereafter for up to 7 y.
Intervention:
In the asbestos-exposed pilot (N=816), participants were assigned to beta-carotene and retinol or to placebo; in the smokers pilot (N=1029), participants were assigned to beta-carotene, retinol, a combination, or placebo.
Results:
Serum cholesterol showed a decline over time in both arms; serum triglycerides had a continuous decline over time in the placebo arm, but an initial increase that persisted in the active arm. Both serum cholesterol concentrations (P<0.0003) and serum triglycerides (P<0.0001) were significantly higher in the participants receiving vitamin A and/or a combination of vitamin A and beta-carotene (n=863) as compared to the placebo group (n=611). Those in this active intervention group had an average cholesterol concentration 5.3 mg/dl (0.137 mmol/l) higher than those in the placebo arm.
Conclusion:
The differences in cholesterol and triglyceride concentrations between the groups following randomization may account in part for the unexpected excess in cardiovascular deaths seen in the active intervention arm of CARET.
Sponsorship:
Supported by grants U01 CA63673, U01 CA63674, U01 CA47989, U01 CA48200, U01 CA48203, U01 CA48196, and U01 CA52596 from the National Cancer Institute, USA.
Keywords:
randomized trial, cholesterol, triglycerides, vitamin A, beta-carotene
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