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Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk: A Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial.
JAMA Cardiol. 2017 06 01; 2(6):617-625.JC

Abstract

Importance

Long-term multivitamin use had no effect on risk of cardiovascular disease (CVD) in the Physicians' Health Study II. Baseline nutritional status may have modified the lack of effect.

Objective

To investigate effect modification by various baseline dietary factors on CVD risk in the Physicians' Health Study II.

Design, Setting, and Participants

The Physicians' Health Study II was a randomized, double-blind, placebo-controlled trial testing multivitamin use (multivitamin [Centrum Silver] or placebo daily) among US male physicians. The Physicians' Health Study II included 14 641 male physicians 50 years or older, 13 316 of whom (91.0%) completed a baseline 116-item semiquantitative food frequency questionnaire and were included in the analyses. This study examined effect modification by baseline intake of key foods, individual nutrients, dietary patterns (Alternate Healthy Eating Index and Alternate Mediterranean Diet Score), and dietary supplement use. The study began in 1997, with continued treatment and follow-up through June 1, 2011.

Interventions

Multivitamin or placebo daily.

Main Outcomes and Measures

Major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and CVD mortality. Secondary outcomes included myocardial infarction, total stroke, CVD mortality, and total mortality individually.

Results

In total, 13 316 male physicians (mean [SD] age at randomization, 64.0 [9.0] years in those receiving the active multivitamin and 64.0 [9.1] years in those receiving the placebo) were observed for a mean (SD) follow-up of 11.4 (2.3) years. There was no consistent evidence of effect modification by various foods, nutrients, dietary patterns, or baseline supplement use on the effect of multivitamin use on CVD end points. Statistically significant interaction effects were observed between multivitamin use and vitamin B6 intake on myocardial infarction, between multivitamin use and vitamin D intake on CVD mortality, and between multivitamin use and vitamin B12 intake on CVD mortality and total mortality. However, there were inconsistent patterns in hazard ratios across tertiles of each dietary factor that are likely explained by multiple testing.

Conclusions and Relevance

The results suggest that baseline nutritional status does not influence the effect of randomized long-term multivitamin use on major CVD events. Future studies are needed to investigate the role of baseline nutritional biomarkers on the effect of multivitamin use on CVD and other outcomes.

Trial Registration

clinicaltrials.gov Identifier: NCT00270647.

Authors+Show Affiliations

Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts2Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts3Division of Aging, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts4Veterans Affairs Boston Healthcare System, Boston, Massachusetts.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts5Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts3Division of Aging, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts5Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts3Division of Aging, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts5Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28384735

Citation

Rautiainen, Susanne, et al. "Effect of Baseline Nutritional Status On Long-term Multivitamin Use and Cardiovascular Disease Risk: a Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial." JAMA Cardiology, vol. 2, no. 6, 2017, pp. 617-625.
Rautiainen S, Gaziano JM, Christen WG, et al. Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk: A Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial. JAMA Cardiol. 2017;2(6):617-625.
Rautiainen, S., Gaziano, J. M., Christen, W. G., Bubes, V., Kotler, G., Glynn, R. J., Manson, J. E., Buring, J. E., & Sesso, H. D. (2017). Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk: A Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial. JAMA Cardiology, 2(6), 617-625. https://doi.org/10.1001/jamacardio.2017.0176
Rautiainen S, et al. Effect of Baseline Nutritional Status On Long-term Multivitamin Use and Cardiovascular Disease Risk: a Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial. JAMA Cardiol. 2017 06 1;2(6):617-625. PubMed PMID: 28384735.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Baseline Nutritional Status on Long-term Multivitamin Use and Cardiovascular Disease Risk: A Secondary Analysis of the Physicians' Health Study II Randomized Clinical Trial. AU - Rautiainen,Susanne, AU - Gaziano,J Michael, AU - Christen,William G, AU - Bubes,Vadim, AU - Kotler,Gregory, AU - Glynn,Robert J, AU - Manson,JoAnn E, AU - Buring,Julie E, AU - Sesso,Howard D, PY - 2017/4/7/pubmed PY - 2019/6/4/medline PY - 2017/4/7/entrez SP - 617 EP - 625 JF - JAMA cardiology JO - JAMA Cardiol VL - 2 IS - 6 N2 - Importance: Long-term multivitamin use had no effect on risk of cardiovascular disease (CVD) in the Physicians' Health Study II. Baseline nutritional status may have modified the lack of effect. Objective: To investigate effect modification by various baseline dietary factors on CVD risk in the Physicians' Health Study II. Design, Setting, and Participants: The Physicians' Health Study II was a randomized, double-blind, placebo-controlled trial testing multivitamin use (multivitamin [Centrum Silver] or placebo daily) among US male physicians. The Physicians' Health Study II included 14 641 male physicians 50 years or older, 13 316 of whom (91.0%) completed a baseline 116-item semiquantitative food frequency questionnaire and were included in the analyses. This study examined effect modification by baseline intake of key foods, individual nutrients, dietary patterns (Alternate Healthy Eating Index and Alternate Mediterranean Diet Score), and dietary supplement use. The study began in 1997, with continued treatment and follow-up through June 1, 2011. Interventions: Multivitamin or placebo daily. Main Outcomes and Measures: Major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and CVD mortality. Secondary outcomes included myocardial infarction, total stroke, CVD mortality, and total mortality individually. Results: In total, 13 316 male physicians (mean [SD] age at randomization, 64.0 [9.0] years in those receiving the active multivitamin and 64.0 [9.1] years in those receiving the placebo) were observed for a mean (SD) follow-up of 11.4 (2.3) years. There was no consistent evidence of effect modification by various foods, nutrients, dietary patterns, or baseline supplement use on the effect of multivitamin use on CVD end points. Statistically significant interaction effects were observed between multivitamin use and vitamin B6 intake on myocardial infarction, between multivitamin use and vitamin D intake on CVD mortality, and between multivitamin use and vitamin B12 intake on CVD mortality and total mortality. However, there were inconsistent patterns in hazard ratios across tertiles of each dietary factor that are likely explained by multiple testing. Conclusions and Relevance: The results suggest that baseline nutritional status does not influence the effect of randomized long-term multivitamin use on major CVD events. Future studies are needed to investigate the role of baseline nutritional biomarkers on the effect of multivitamin use on CVD and other outcomes. Trial Registration: clinicaltrials.gov Identifier: NCT00270647. SN - 2380-6591 UR - https://www.unboundmedicine.com/medline/citation/28384735/Effect_of_Baseline_Nutritional_Status_on_Long_term_Multivitamin_Use_and_Cardiovascular_Disease_Risk:_A_Secondary_Analysis_of_the_Physicians'_Health_Study_II_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jamacardiology/fullarticle/10.1001/jamacardio.2017.0176 DB - PRIME DP - Unbound Medicine ER -