JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENT
JAMA EARLY NEWS RELEASES
(Embargoed for Early Release: 12 p.m. CT Sunday, November 9, 2008)
JAMA EARLY NEWS RELEASES
VITAMINS E AND C SUPPLEMENTS NOT EFFECTIVE FOR PREVENTION OF CARDIOVASCULAR DISEASE IN MEN
LOW-DOSE ASPIRIN DOES NOT APPEAR TO SIGNIFICANTLY REDUCE RISK OF CARDIOVASCULAR EVENTS IN PATIENTS WITH TYPE 2 DIABETES
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
STUDY FINDS HIGH-DOSE INTAKE OF VITAMINS C & E DOES NOT REDUCE RISK OF CARDIOVASCULAR DISEASE IN MEN
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
Please Note: This week's JAMA Report video has an early embargo (1 p.m. ET Sunday, November 9) and two feed dates. The report, on the effectiveness of vitamin E and C supplements for preventing cardiovascular diseases, will be fed: Sunday, November 9, 9:00 - 9:30 a.m. (ET) and 2:00 - 2:30 p.m. (ET), Galaxy 28 (C band), Transponder 15, downlink frequency: 4000 Vertical ~ Audio: 6.2/6.8; and Tuesday, November 11, 9:00 - 9:30 a.m. (ET) and 2:00 - 2:30 p.m. (ET), Galaxy 28 (C band), Transponder 19, downlink frequency: 4080 Vertical ~ Audio: 6.2/6.8. For more information, call 312/464-JAMA.
JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ONLINE
Go to www.jamamedia.org for more information and to apply for access.
Embargoed for Early Release: 12 p.m. (CT) Sunday, November 9, 2008
To contact Howard D. Sesso, Sc.D., M.P.H., or co-author J. Michael Gaziano, M.D., M.P.H., call Lori Shanks at 617-534-1604.
VITAMINS E AND C SUPPLEMENTS NOT EFFECTIVE FOR PREVENTION OF CARDIOVASCULAR DISEASE IN MEN
CHICAGO—Neither vitamin E nor vitamin C supplements reduced the risk of major cardiovascular events in a large, long-term study of male physicians, according to a study in the November 12 issue of JAMA. The article is being released early online November 9 to coincide with the scientific presentation of the study findings at the American Heart Association meeting.
Most adults in the United States have taken vitamin supplements in the past year, according to background information provided by the authors. "Basic research studies suggest that vitamin E, vitamin C, and other antioxidants reduce cardiovascular disease by trapping organic free radicals, by deactivating excited oxygen molecules, or both, to prevent tissue damage." Some previous observational studies have supported a role for vitamin E in cardiovascular disease prevention. Some previous observational studies have also shown a role for vitamin C in reducing coronary heart disease risk.
In this study, known as the Physicians' Health Study II, Howard D. Sesso, Sc.D, M.P.H., and colleagues from Brigham and Women's Hospital, Harvard Medical School and School of Public Health and VA Boston Healthcare System, Boston, assessed the effects of vitamin E and vitamin C supplements on the risk of major cardiovascular disease events among 14,641 male physicians. These physicians were 50 years or older and at low risk of cardiovascular disease at the beginning of the study in 1997, and 754 (5.1 percent) had prevalent cardiovascular disease. The study participants were randomized to receive 400 IU of vitamin E every other day or a placebo and 500 mg of vitamin C daily or a placebo.
"During a mean (average) follow-up of 8 years, there were 1,245 confirmed major cardiovascular events," the researchers report. There were 511 total myocardial infarctions (heart attacks), 464 total strokes, and 509 cardiovascular deaths, with some men experiencing multiple events. A total of 1,661 men died during follow-up. Compared with placebo, neither vitamin E nor vitamin C had an effect on the prevention of major cardiovascular events. "Neither vitamin E nor vitamin C had a significant effect on total mortality, but vitamin E was associated with an increased risk of hemorrhagic stroke."
In conclusion the authors write: "In this large, long-term trial of male physicians, neither vitamin E nor vitamin C supplementation reduced the risk of major cardiovascular events. These data provide no support for the use of these supplements for the prevention of cardiovascular disease in middle-aged and older men."
(JAMA. 2008;300[18]:2123-2133. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This work was supported by grants from the National Institutes of Health and an investigator-initiated grant from BASF Corporation. Study agents and packaging were provided by BASF Corporation, Wyeth Pharmaceuticals, and DSM Nutritional Products Inc. (formerly Roche Vitamins). Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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Embargoed for Early Release: 12 p.m. (CT) Sunday, November 9, 2008
Media Advisory: To contact Hisao Ogawa, M.D., Ph.D., email: ogawah{at}kumamoto-u.ac.jp. To contact editorial author Antonio Nicolucci, M.D., email: nicolucci{at}negrisud.it.
LOW-DOSE ASPIRIN DOES NOT APPEAR TO REDUCE RISK OF CARDIOVASCULAR EVENTS IN PATIENTS WITH TYPE 2 DIABETES
CHICAGO—Low-dose aspirin as primary prevention did not appear to significantly reduce the risk of a combined end point of coronary, cerebrovascular and peripheral vascular events in patients with type 2 diabetes, according to a new study in JAMA. However, aspirin did significantly reduce the combination of fatal coronary and fatal cerebrovascular events. The article is being released early online Sunday, November 9 to coincide with its scientific presentation at the American Heart Association meeting. The study will appear in the JAMA.
"Diabetes mellitus is a powerful risk factor for cardiovascular events," the authors write. "Individuals with diabetes have a two- to four-fold increased risk of developing cardiovascular events than those without diabetes." The authors note that the "American Diabetes Association recommends use of aspirin as a primary prevention strategy in patients with diabetes who are at increased cardiovascular risk," including those who are older than 40 years or who have additional risk factors, such as family history, hypertension or smoking.
In this study conducted by Hisao Ogawa, M.D., Ph.D., from the Graduate School of Medical Sciences, Kumamoto University, Japan and colleagues from the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) Trial Investigators, the researchers examined whether low-dose aspirin would be beneficial for primary prevention of atherosclerotic (atherosclerosis, which involves narrowing or hardening of the arteries because of plaque build-up) events in patients with type 2 diabetes. From Dec. 2002 through April 2008, 2,539 patients with type 2 diabetes and no history of atherosclerotic disease from 163 institutions from throughout Japan were enrolled in the study. Patients were randomly assigned to the low-dose aspirin group receiving 81 or 100 mg per day (n = 1,262) or the nonaspirin (n = 1,277) group. The average age was 65 and 55 percent of the patients were men. The median (midpoint) follow-up period was 4.37 years. The main outcome measures were atherosclerotic events, including fatal or nonfatal ischemic heart disease, fatal or nonfatal stroke, and peripheral arterial disease.
"A total of 154 atherosclerotic events occurred: 68 in the aspirin group and 86 in the nonaspirin group," the researchers write. "In the 1,363 patients aged 65 years or older (719 in the aspirin group and 644 in the nonaspirin group), the incidence of atherosclerotic events was significantly lower in the aspirin group (45 events, 6.3 percent) than in the nonaspirin group (59 events, 9.2 percent)." In the 1,176 patients younger than 65 the difference among events in the two groups was not significant.
Aspirin was well tolerated: in comparing bleeding events, the researchers reported 13 hemorrhagic strokes, with no statistically significant difference between aspirin takers and non-takers (six such strokes in the aspirin group; seven in the non-aspirin group). There was a comparable number of the combined endpoint of serious hemorrhagic events (hemorrhagic strokes and major gastrointestinal bleeds).
"Myocardial infarction [heart attack] and ischemic stroke are leading causes of mortality and morbidity in patients with type 2 diabetes. Given the rapid increase in the number of patients with type 2 diabetes worldwide and especially in Asia, establishing effective means of primary prevention of coronary and cerebrovascular events is an important public health priority," the authors comment.
While this study did not find that low-dose aspirin significantly reduced the risk of atherosclerotic events in primary prevention therapy in patients with type 2 diabetes, the authors suggest more research is needed. "These findings should be interpreted in context with the low incidence of atherosclerotic disease in Japan and the current management practice for cardiovascular risk factors and suggest the need to conduct additional studies of aspirin for primary prevention of cardiovascular disease in diabetic patients."
(JAMA. 2008;300[18]:2134-2141. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was supported by the Ministry of Health, Labour and Welfare of Japan. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: ASPIRIN FOR PRIMARY PREVENTION—STILL AN OPEN QUESTION FOR PATIENTS WITH DIABETES
"The use of aspirin for primary prevention of cardiovascular events in individuals with diabetes is widely recommended by existing guidelines, but the evidence supporting its efficacy is surprisingly scarce," writes Antonio Nicolucci, M.D., from Consorzio Mario Negri Sud, Italy, in an accompanying editorial.
"The lack of precision and the low statistical power in the JPAD trial are the consequence of the substantially lower than expected event rate in the trial population." Dr. Nicolucci writes that the study population had a very low baseline risk of cardiovascular events and questions whether the results can be generalized to other populations with substantially higher cardiovascular risks.
"The issue of aspirin therapy for patients with diabetes is an example of how, in the presence of a long-lasting uncertainty, scientific organizations or governmental bodies should provide the foundation for answering this question by promoting pragmatic, large-scale clinical trials. Considering all diabetic patients with no history of cardiovascular disease (except those with documented contraindications or perceived indications) as candidates for randomized clinical trials would represent a major contribution to the credibility of scientific methods in guiding practice."
(JAMA. 2008;300[18]:2180-2181. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Dr. Nicolucci reported being the principal investigator of the Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes (ACCEPT-D) trial, a nonprofit trial supported by the Italian Drug Agency (AIFA). He reported receiving research grants from Bayer in the past.
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JAMA REPORTS
VIDEO:
Windows Media |
Quicktime
STUDY FINDS HIGH-DOSE INTAKE OF VITAMINS C & E DOES NOT REDUCE RISK OF CARDIOVASCULAR DISEASE IN MEN
INTRO:
INTRO: More than twelve percent of U.S. adults take Vitamin C and E supplements. But do large, daily doses of those vitamins help reduce the risk of cardiovascular disease in men? Results of a new study on this topic are now available. Alissa Krinsky explains in this week's JAMA Report.
VIDEO:
B-ROLL
Computer Screen, Pans Over To Man on Treadmill
Arm Blood Pressure Monitor
AUDIO:
CARDIOVASCULAR DISEASE IS A CONCERN FOR MILLIONS OF PEOPLE: IT'S A LEADING CAUSE OF DEATH, AND A FOCUS FOR MEDICAL RESEARCHERS.
VIDEO:
SOT/FULL
Super @ :10
Howard D. Sesso, Sc.D., M.P.H.
Brigham and Women's Hospital
Runs :06
AUDIO:
"I think it's our challenge as researchers to continually ask questions and see if we can do even better than we've done thus far."
VIDEO:
B-ROLL
Doctors walk down hall
Vitamin E & C bottles and tablets
AUDIO:
DOCTORS HOWARD SESSO AND MICHAEL GAZIANO - OF BOSTON'S BRIGHAM AND WOMEN'S HOSPITAL—AND THEIR COLLEAGUES—DECIDED TO FIND OUT IF INTAKE OF TWO ANTIOXIDANTS - VITAMINS C AND E - COULD HELP PREVENT CARDIOVASCULAR DISEASE.
VIDEO:
SOT/FULL
Super @ :30
J. Michael Gaziano, M.D., M.P.H
Brigham and Women's Hospital/VA-Boston
Runs :06
AUDIO:
"A lot of the population take vitamin supplements. And these are two of the more popular vitamin supplements."
VIDEO:
B-ROLL
GXF/JAMA COVER
GFX:
Vitamin C & E Study
- Up To 10 Years
- More Than 14,000 Men
- All Physicians
- Age 50 and Over
- Low Risk for Cardiovascular Disease
AUDIO:
THEIR STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCATION. IT ANALYZED HIGH-DOSE VITAMIN C AND E INTAKE FOR UP TO TEN YEARS BY MORE THAN FOURTEEN THOUSAND MEN—ALL PHYSICIANS OVER AGE FIFTY AND MOSTLY AT LOW RISK FOR CARDIOVASCULAR DISEASE.
VIDEO:
SOT/FULL
J. Michael Gaziano, M.D., M.P.H
Brigham and Women's Hospital/VA-Boston
Runs :13
AUDIO:
"So this is the only study done for this duration with a significant dose of Vitamin C, looking at the long-term preventive effects, particularly in men."
VIDEO:
SOT/FULL
Howard D. Sesso, Sc.D., M.P.H.
Brigham and Women's Hospital
Runs :13
AUDIO:
"And in selecting physicians, it also enables us, with their excellent ability to provide medical information, risk factors, compliance and other relevant information for the trial, to track their health status over a long period of time."
VIDEO:
B-ROLL
Vitamin C bottle
Vitamin E bottle
Man on treadmill
AUDIO:
BUT THE STUDY FOUND NO EVIDENCE THAT VITAMINS C AND E HELP PREVENT CARDIOVASCULAR DISEASE IN MEN. NO BREAKTHROUGH, BUT STILL, IMPORTANT RESEARCH.
VIDEO:
SOT/FULL
J. Michael Gaziano, M.D., M.P.H
Brigham and Women's Hospital/VA-Boston
Runs :08
AUDIO:
"So a 'no finding'—or a finding of 'no effect' is just as important as a finding of 'benefit' or a finding of 'harm'."
VIDEO:
SOT/FULL
Howard D. Sesso, Sc.D., M.P.H.
Brigham and Women's Hospital
Runs :13
AUDIO:
"It's still incredibly important for individuals to remember what the basics are in terms of cardiovascular disease prevention: it's stopping smoking, it's keeping your weight in balance, it's maintaining a healthy diet..."
VIDEO:
B-ROLL
Man on treadmill
AUDIO:
AND SO THERE'S STILL A LOT AMERICANS CAN DO TO FIGHT CARDIOVASCULAR DISEASE. ALISSA KRINSKY, THE JAMA REPORT.
TAG:
In this study, participants were sent monthly packs of vitamins—they took Vitamin E or the placebo every other day, and took Vitamin C or the placebo daily. For more information about this study you can log on to www.jama.com.
