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HD Sesso, WC Christen, V Bubes, JP Smith, J MacFadyen, M Schvartz, JE Manson, RJ Glynn,

A Randomized Trial of a Multivitamin in the Prevention of Cardiovascular Disease in Men: The Physicians’ Health Study II. HD Sesso, WC Christen, V Bubes, JP Smith, J MacFadyen, M Schvartz, JE Manson, RJ Glynn, JE Buring, JM Gaziano Division of Preventive Medicine

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HD Sesso, WC Christen, V Bubes, JP Smith, J MacFadyen, M Schvartz, JE Manson, RJ Glynn,

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  1. A Randomized Trial of a Multivitamin in the Prevention of Cardiovascular Disease in Men: The Physicians’ Health Study II HD Sesso, WC Christen, V Bubes, JP Smith, J MacFadyen, M Schvartz, JE Manson, RJ Glynn, JE Buring, JM Gaziano Division of Preventive Medicine Brigham and Women’s Hospital Boston, MA Funding: NIH (NCI, NHLBI, NIA, and NEI) and an investigator-initiated grant from BASF Corporation. Pills and/or packaging were provided by BASF, Pfizer and DSM Nutritional Products.

  2. Background • More than half of US adults take vitamin supplements, with common multivitamins (MVM) the most widely used. • Basic research suggests that some components of MVMs might reduce the risk of cardiovascular disease (CVD). • Observational studies have not clearly demonstrated an association between MVMs and a lower risk of CVD. • There are no large-scale, long-term randomized trials of a MVM in the prevention of CVD and other chronic diseases.

  3. Physicians’ Health Study (PHS) 1982 – 1996: PHS I enrolled 22,071 male physicians in a trial by mail of aspirin and beta-carotene in the prevention of CVD and cancer. 1997 –present: PHS II enrolled 7,641 PHS I participants and 7,000 new physicians in a new trial by mail.

  4. Physicians’ Health Study II: Design • Randomized, double-blind, placebo-controlled, factorial trial conducted by mail among 14,641 male physicians aged 50 years and older. • Evaluated the long-term risks and benefits of vitamin E, vitamin C, and a multivitamin (Centrum Silver daily) • Primary outcomes: CVD and cancer • Secondary outcomes: Eye disease and cognitive function

  5. ActiveMulti-Vitamin Multi-VitaminPlacebo ActiveMulti-Vitamin Multi-VitaminPlacebo ActiveMulti-Vitamin ActiveMulti-Vitamin Multi-VitaminPlacebo Multi- VitaminPlacebo PHYSICIANS’ HEALTH STUDY II RANDOMIZATION SCHEME Phase II:Mailed invitations to 254,597 new physicians Phase I:Mailed Invitations to 18,763 PHS I participants 11,128 Enrolled in a Placebo Run-in 7,641 7,000 14,641 Randomized Participants Active Vitamin E Vitamin E Placebo Active Vitamin C Vitamin C Placebo Vitamin C Placebo Active Vitamin C

  6. Monthly Calendar Pack

  7. Physicians’ Health Study II: Follow-up Mean follow-up was 11.2 years, with a total of more than 164,000person-years of follow-up. MVM compliance: 77% at 4 years, 72% at 8 years, and 67% at study end Primary CVD Outcome: Major cardiovascular events (nonfatal myocardial infarction (MI), nonfatal stroke, and CVD death) Other CVD Outcomes: Total and fatal MI, total and fatal stroke, ischemic and hemorrhagic stroke, CVD mortality, and total mortality

  8. Baseline Characteristics by Multivitamin Treatment Assignment Active (n = 7317) Placebo (n = 7324) P>.05 for all comparisons between multivitamin and placebo groups JAMA 2012 In press

  9. Crude log-rank P = .69 JAMA 2012 In press

  10. Crude log-rank P = .44 Crude log-rank P = .44 JAMA 2012 In press

  11. Cardiovascular Events by Multivitamin Treatment Assignment Active (n = 7317) Placebo (n = 7324) P HR (95% CI) Outcome JAMA 2012 In press

  12. Crude log-rank P = .71 Crude log-rank P = .94 JAMA 2012 In press

  13. Effect Modification by Selected Baseline Characteristics on Major Cardiovascular Events Active (n = 7317) Placebo (n = 7324) P int Baseline Characteristic HR (95% CI) JAMA 2012 In press

  14. Effect Modification by Selected Baseline Characteristics on Major Cardiovascular Events Active (n = 7317) Placebo (n = 7324) P int Baseline Characteristic HR (95% CI) JAMA 2012 In press

  15. Cancer Events by Multivitamin Treatment Assignment Active (n = 7317) Placebo (n = 7324) P HR (95% CI) Outcome JAMA 2012; Online October 17, 2012

  16. PHS II is the only large-scale randomized trial testing long-term MVM use, finding no effect on major cardiovascular events in men. The main reason to take a daily MVM remains to prevent vitamin and mineral deficiency. The decision to take a MVM should also consider its modest beneficial effects on cancer. We will be providing additional trial results for the effects of a MVM on other important outcomes along with extending follow-up of the PHS II cohort. Conclusions

  17. HD Sesso and coauthors Multivitamins in the Prevention of Cardiovascular Disease in Men: The Physicians’ Health Study II Randomized Controlled Trial Available at www.jama.com jamanetwork.com

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