Multivitamins don't prevent cardiovascular events

LOS ANGELES – Taking multivitamins daily did not provide any cardiovascular benefits to a large group of American men who were followed for more than a decade in a randomized trial.

While the results showed that multivitamins posed no health risks, experts said at the annual scientific sessions of the American Heart Association that the findings will help them frame the conversation when advising patients.

©Graça Victoria/iStockphoto.com

"The message needs to remain simple and focused," Dr. Eva M. Lonn, professor of medicine at McMaster University, Ontario, wrote in an editorial (JAMA 2012 Nov. 7;308:1802-3). "CVD is largely preventable, and this can be achieved by eating healthy foods, exercising regularly, avoiding tobacco products, and, for those with high risk factor levels or previous CVD events, taking proven, safe, and effective medications."

This is the second arm of the Physicians’ Health Study II, a randomized, double-blind, placebo-controlled trial, which followed nearly 15,000 male U.S. physicians for 11 years, aiming to evaluate the risk and benefits of a multivitamin, vitamin E, vitamin C, and beta carotene in prevention of cancer, cardiovascular disease, eye disease, and cognitive decline.

The results from the first arm of the large trial, published recently, showed that daily multivitamin supplementation had a modest but significant effect on reducing the risk of cancer. Researchers will present the two remaining studies in the near future.

It’s not clear whether the findings can be applied to the population as a whole, according to the study’s authors and other experts, especially since the study’s participants were relatively homogenous, healthy, and had a good nutritional intake.

Still, "this is a very well-run study," said Dr. John G. Harold, a cardiologist at Cedar Sinai Heart Institute, Los Angeles, who was not involved in the study. "This is one more example of a clinical trial that is changing what was up until now driven by opinion rather than fact."

Multivitamins are the most common supplement consumed by U.S. adults, yet most of the studies about their effect on cardiovascular health have been observational, and their results inconsistent. And while randomized trials like this are needed, conducting them is difficult, said Howard D. Sesso, Sc.D., the study’s lead author and an associate epidemiologist at Brigham and Women’s Hospital, Boston. "Many people who take multivitamins are unwilling to be randomized and receive placebos," he said.

Meanwhile, the physicians who participated in the study were incredibly dedicated to the trial, said Dr. Sesso, showing photos of some who had posed with their multivitamin packets at home, while traveling, or exploring nature.

Researchers followed 14,641 male U.S. physicians, initially 50 years or older, from 1997 to June 2011. There were 7,317 participants in the multivitamin group and 7,324 in the placebo group. They received monthly packs of multivitamins or placebo every 6 months during the first year, and annually thereafter. Morbidity and mortality follow-up were 98.2% and 99.9%, respectively.

Adherence was 67.5% in the multivitamin group and 67.1% in the placebo group at the end of the follow-up period.

The mean age of the study population was 64.3 years, and the population was predominantly white, and relatively healthy. Only 4% said that they were current smokers and close to 60% said that they exercised once or more per week.

In addition, 42% of the participants said that they had a history of hypertension, and 35% had a history of high cholesterol. Almost 6% had a history of diabetes.

At baseline, 5% of the men at a history of cardiovascular disease and 9% had a history of cancer.

The primary end point was major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular mortality. Secondary end points included stroke and MI individually.

Results showed that men who took a daily multivitamin didn’t experience any benefit for the primary end point and secondary end points.

There were 867 major cardiovascular events in the multivitamin group and 856 in the placebo group, or 11.0 and 10.8 events/1,000 person-years, a nonsignificant difference. Likewise, there were no significant differences between groups in total strokes (317 in the multivitamin group and 311 in the placebo group) or cardiovascular deaths (408 and 421, respectively). The results were published simultaneously with the presentation at the meeting (JAMA 2012 Nov. 7;308:1751-60).

The results showed no significant effects on gastrointestinal tract symptoms, fatigue, drowsiness, skin discoloration, and migraine.

The population was relatively well nourished, researchers pointed out, "for which supplementation may offer no additional benefit," they wrote.

Also, behavioral interventions such as exercise and medications such as lipid-lowering therapies can effectively lower the CVD risk and make it difficult for a multivitamin to "meaningfully contribute toward risk reduction," researchers wrote.

They added that there is a need to further understand how essential vitamins and minerals, even at standard levels, may differently interact and influence cardiovascular and cancer mechanisms.

"We’re seeing more and more negative studies," about supplements, said Dr. Harold, highlighting the research’s limited understanding of the agents’ biological impact and pathophysiology.

Coinvestigator J. Michael Gaziano, a cardiologist at Brigham and Women’s Hospital, said that he had no problems with his patients taking multivitamins as long as it was to mainly prevent vitamin deficiencies, and for its modest effect in reducing cancer. "But when it comes to preventing heart disease, we don’t have to invest our energy on multivitamins," he said.

Dr. Sesso, who is younger than the study’s cohort, said he did not take multivitamins but kept a good diet and exercised. Dr. Harold said he took multivitamins. Dr. Gaziano said he was trim, had a healthy diet, didn’t smoke, and exercised, but he wouldn’t say whether he took multivitamins. He said he wouldn’t reveal that information until all the data from the Physicians’ Health Study II were published. "I think it’s not unreasonable to take a multivitamin," he said.

Dr. Gaziano reported having received investigator-initiated research funding from the National Institutes of Health, the Veterans Administration, and BASF Corp. He received assistance with the study agents and packaging from BASF and Pfizer. Study packaging was provided by DSM Nutritional Products. Dr. Harold said he had no relevant disclosures. Dr. Sesso received research support from NIH and investigator-initiated grant from BASF. Dr. Lonn reported serving as a consultant to Merck and Servier; providing expert testimony for Merck; receiving grants or grants pending from AstraZeneca, GlaxoSmithKline, and Hoffman-LaRoche; and receiving payment for lectures from Novartis and Merck.

LOS ANGELES – Taking multivitamins daily did not provide any cardiovascular benefits to a large group of American men who were followed for more than a decade in a randomized trial.

While the results showed that multivitamins posed no health risks, experts said at the annual scientific sessions of the American Heart Association that the findings will help them frame the conversation when advising patients.

©Graça Victoria/iStockphoto.com

"The message needs to remain simple and focused," Dr. Eva M. Lonn, professor of medicine at McMaster University, Ontario, wrote in an editorial (JAMA 2012 Nov. 7;308:1802-3). "CVD is largely preventable, and this can be achieved by eating healthy foods, exercising regularly, avoiding tobacco products, and, for those with high risk factor levels or previous CVD events, taking proven, safe, and effective medications."

This is the second arm of the Physicians’ Health Study II, a randomized, double-blind, placebo-controlled trial, which followed nearly 15,000 male U.S. physicians for 11 years, aiming to evaluate the risk and benefits of a multivitamin, vitamin E, vitamin C, and beta carotene in prevention of cancer, cardiovascular disease, eye disease, and cognitive decline.

The results from the first arm of the large trial, published recently, showed that daily multivitamin supplementation had a modest but significant effect on reducing the risk of cancer. Researchers will present the two remaining studies in the near future.

It’s not clear whether the findings can be applied to the population as a whole, according to the study’s authors and other experts, especially since the study’s participants were relatively homogenous, healthy, and had a good nutritional intake.

Still, "this is a very well-run study," said Dr. John G. Harold, a cardiologist at Cedar Sinai Heart Institute, Los Angeles, who was not involved in the study. "This is one more example of a clinical trial that is changing what was up until now driven by opinion rather than fact."

Multivitamins are the most common supplement consumed by U.S. adults, yet most of the studies about their effect on cardiovascular health have been observational, and their results inconsistent. And while randomized trials like this are needed, conducting them is difficult, said Howard D. Sesso, Sc.D., the study’s lead author and an associate epidemiologist at Brigham and Women’s Hospital, Boston. "Many people who take multivitamins are unwilling to be randomized and receive placebos," he said.

Meanwhile, the physicians who participated in the study were incredibly dedicated to the trial, said Dr. Sesso, showing photos of some who had posed with their multivitamin packets at home, while traveling, or exploring nature.

Researchers followed 14,641 male U.S. physicians, initially 50 years or older, from 1997 to June 2011. There were 7,317 participants in the multivitamin group and 7,324 in the placebo group. They received monthly packs of multivitamins or placebo every 6 months during the first year, and annually thereafter. Morbidity and mortality follow-up were 98.2% and 99.9%, respectively.

Adherence was 67.5% in the multivitamin group and 67.1% in the placebo group at the end of the follow-up period.

The mean age of the study population was 64.3 years, and the population was predominantly white, and relatively healthy. Only 4% said that they were current smokers and close to 60% said that they exercised once or more per week.

In addition, 42% of the participants said that they had a history of hypertension, and 35% had a history of high cholesterol. Almost 6% had a history of diabetes.

At baseline, 5% of the men at a history of cardiovascular disease and 9% had a history of cancer.

The primary end point was major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular mortality. Secondary end points included stroke and MI individually.

Results showed that men who took a daily multivitamin didn’t experience any benefit for the primary end point and secondary end points.

There were 867 major cardiovascular events in the multivitamin group and 856 in the placebo group, or 11.0 and 10.8 events/1,000 person-years, a nonsignificant difference. Likewise, there were no significant differences between groups in total strokes (317 in the multivitamin group and 311 in the placebo group) or cardiovascular deaths (408 and 421, respectively). The results were published simultaneously with the presentation at the meeting (JAMA 2012 Nov. 7;308:1751-60).

The results showed no significant effects on gastrointestinal tract symptoms, fatigue, drowsiness, skin discoloration, and migraine.

The population was relatively well nourished, researchers pointed out, "for which supplementation may offer no additional benefit," they wrote.

Also, behavioral interventions such as exercise and medications such as lipid-lowering therapies can effectively lower the CVD risk and make it difficult for a multivitamin to "meaningfully contribute toward risk reduction," researchers wrote.

They added that there is a need to further understand how essential vitamins and minerals, even at standard levels, may differently interact and influence cardiovascular and cancer mechanisms.

"We’re seeing more and more negative studies," about supplements, said Dr. Harold, highlighting the research’s limited understanding of the agents’ biological impact and pathophysiology.

Coinvestigator J. Michael Gaziano, a cardiologist at Brigham and Women’s Hospital, said that he had no problems with his patients taking multivitamins as long as it was to mainly prevent vitamin deficiencies, and for its modest effect in reducing cancer. "But when it comes to preventing heart disease, we don’t have to invest our energy on multivitamins," he said.

Dr. Sesso, who is younger than the study’s cohort, said he did not take multivitamins but kept a good diet and exercised. Dr. Harold said he took multivitamins. Dr. Gaziano said he was trim, had a healthy diet, didn’t smoke, and exercised, but he wouldn’t say whether he took multivitamins. He said he wouldn’t reveal that information until all the data from the Physicians’ Health Study II were published. "I think it’s not unreasonable to take a multivitamin," he said.

Dr. Gaziano reported having received investigator-initiated research funding from the National Institutes of Health, the Veterans Administration, and BASF Corp. He received assistance with the study agents and packaging from BASF and Pfizer. Study packaging was provided by DSM Nutritional Products. Dr. Harold said he had no relevant disclosures. Dr. Sesso received research support from NIH and investigator-initiated grant from BASF. Dr. Lonn reported serving as a consultant to Merck and Servier; providing expert testimony for Merck; receiving grants or grants pending from AstraZeneca, GlaxoSmithKline, and Hoffman-LaRoche; and receiving payment for lectures from Novartis and Merck.

LOS ANGELES – Taking multivitamins daily did not provide any cardiovascular benefits to a large group of American men who were followed for more than a decade in a randomized trial.

While the results showed that multivitamins posed no health risks, experts said at the annual scientific sessions of the American Heart Association that the findings will help them frame the conversation when advising patients.

©Graça Victoria/iStockphoto.com

"The message needs to remain simple and focused," Dr. Eva M. Lonn, professor of medicine at McMaster University, Ontario, wrote in an editorial (JAMA 2012 Nov. 7;308:1802-3). "CVD is largely preventable, and this can be achieved by eating healthy foods, exercising regularly, avoiding tobacco products, and, for those with high risk factor levels or previous CVD events, taking proven, safe, and effective medications."

This is the second arm of the Physicians’ Health Study II, a randomized, double-blind, placebo-controlled trial, which followed nearly 15,000 male U.S. physicians for 11 years, aiming to evaluate the risk and benefits of a multivitamin, vitamin E, vitamin C, and beta carotene in prevention of cancer, cardiovascular disease, eye disease, and cognitive decline.

The results from the first arm of the large trial, published recently, showed that daily multivitamin supplementation had a modest but significant effect on reducing the risk of cancer. Researchers will present the two remaining studies in the near future.

It’s not clear whether the findings can be applied to the population as a whole, according to the study’s authors and other experts, especially since the study’s participants were relatively homogenous, healthy, and had a good nutritional intake.

Still, "this is a very well-run study," said Dr. John G. Harold, a cardiologist at Cedar Sinai Heart Institute, Los Angeles, who was not involved in the study. "This is one more example of a clinical trial that is changing what was up until now driven by opinion rather than fact."

Multivitamins are the most common supplement consumed by U.S. adults, yet most of the studies about their effect on cardiovascular health have been observational, and their results inconsistent. And while randomized trials like this are needed, conducting them is difficult, said Howard D. Sesso, Sc.D., the study’s lead author and an associate epidemiologist at Brigham and Women’s Hospital, Boston. "Many people who take multivitamins are unwilling to be randomized and receive placebos," he said.

Meanwhile, the physicians who participated in the study were incredibly dedicated to the trial, said Dr. Sesso, showing photos of some who had posed with their multivitamin packets at home, while traveling, or exploring nature.

Researchers followed 14,641 male U.S. physicians, initially 50 years or older, from 1997 to June 2011. There were 7,317 participants in the multivitamin group and 7,324 in the placebo group. They received monthly packs of multivitamins or placebo every 6 months during the first year, and annually thereafter. Morbidity and mortality follow-up were 98.2% and 99.9%, respectively.

Adherence was 67.5% in the multivitamin group and 67.1% in the placebo group at the end of the follow-up period.

The mean age of the study population was 64.3 years, and the population was predominantly white, and relatively healthy. Only 4% said that they were current smokers and close to 60% said that they exercised once or more per week.

In addition, 42% of the participants said that they had a history of hypertension, and 35% had a history of high cholesterol. Almost 6% had a history of diabetes.

At baseline, 5% of the men at a history of cardiovascular disease and 9% had a history of cancer.

The primary end point was major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, and cardiovascular mortality. Secondary end points included stroke and MI individually.

Results showed that men who took a daily multivitamin didn’t experience any benefit for the primary end point and secondary end points.

There were 867 major cardiovascular events in the multivitamin group and 856 in the placebo group, or 11.0 and 10.8 events/1,000 person-years, a nonsignificant difference. Likewise, there were no significant differences between groups in total strokes (317 in the multivitamin group and 311 in the placebo group) or cardiovascular deaths (408 and 421, respectively). The results were published simultaneously with the presentation at the meeting (JAMA 2012 Nov. 7;308:1751-60).

The results showed no significant effects on gastrointestinal tract symptoms, fatigue, drowsiness, skin discoloration, and migraine.

The population was relatively well nourished, researchers pointed out, "for which supplementation may offer no additional benefit," they wrote.

Also, behavioral interventions such as exercise and medications such as lipid-lowering therapies can effectively lower the CVD risk and make it difficult for a multivitamin to "meaningfully contribute toward risk reduction," researchers wrote.

They added that there is a need to further understand how essential vitamins and minerals, even at standard levels, may differently interact and influence cardiovascular and cancer mechanisms.

"We’re seeing more and more negative studies," about supplements, said Dr. Harold, highlighting the research’s limited understanding of the agents’ biological impact and pathophysiology.

Coinvestigator J. Michael Gaziano, a cardiologist at Brigham and Women’s Hospital, said that he had no problems with his patients taking multivitamins as long as it was to mainly prevent vitamin deficiencies, and for its modest effect in reducing cancer. "But when it comes to preventing heart disease, we don’t have to invest our energy on multivitamins," he said.

Dr. Sesso, who is younger than the study’s cohort, said he did not take multivitamins but kept a good diet and exercised. Dr. Harold said he took multivitamins. Dr. Gaziano said he was trim, had a healthy diet, didn’t smoke, and exercised, but he wouldn’t say whether he took multivitamins. He said he wouldn’t reveal that information until all the data from the Physicians’ Health Study II were published. "I think it’s not unreasonable to take a multivitamin," he said.

Dr. Gaziano reported having received investigator-initiated research funding from the National Institutes of Health, the Veterans Administration, and BASF Corp. He received assistance with the study agents and packaging from BASF and Pfizer. Study packaging was provided by DSM Nutritional Products. Dr. Harold said he had no relevant disclosures. Dr. Sesso received research support from NIH and investigator-initiated grant from BASF. Dr. Lonn reported serving as a consultant to Merck and Servier; providing expert testimony for Merck; receiving grants or grants pending from AstraZeneca, GlaxoSmithKline, and Hoffman-LaRoche; and receiving payment for lectures from Novartis and Merck.