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 NEWS RELEASES
(Embargoed for Release: 3 p.m. CT, Tuesday, July 6, 2004)
JAMA NEWS RELEASES
TWO MAJOR STUDIES SHOW ENOXAPARIN AN EFFECTIVE ALTERNATIVE TO HEPARIN FOR TREATMENT FOR ACUTE CORONARY SYNDROMES
SOY PROTEIN SUPPLEMENTS WITH ISOFLAVONES DO NOT IMPROVE COGNITIVE FUNCTION, BONE MINERAL DENSITY OR CHOLESTEROL LEVELS IN POSTMENOPAUSAL WOMEN
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week's JAMA video news release is on the effect of soy protein supplements containing isoflavones. The release will be fed Tuesday, July 6, from 9:00 - 9:30 a.m. ET on Telstar 6, Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Telstar 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).
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SAVE THE DATE: New research from JAMA's theme issue on HIV/AIDS will be presented at the 15th International AIDS Conference in Bangkok, Thailand, on Sunday, July 11, from 9 a.m. to 11 a.m., at the Oriental Hotel in Bangkok. A program and registration form will be included in a future email.
Embargoed for Release: 3 p.m. CT, TUESDAY, July 6, 2004
Media Advisory: To contact SYNERGY trial corresponding author Kenneth W. Mahaffey, M.D., or the A to Z trial corresponding author Michael A. Blazing, M.D., call Richard Merritt at 919-684-4148. To contact editorialist David J. Moliterno, M.D., call Amanda White at 859-323-6363.
TWO MAJOR STUDIES SHOW ENOXAPARIN AN EFFECTIVE ALTERNATIVE TO HEPARIN FOR TREATMENT FOR ACUTE CORONARY SYNDROMES
CHICAGO—Two new major studies suggest that anticoagulant therapy with enoxaparin is an effective alternative to heparin therapy for patients with acute coronary syndromes (ACS), according to articles in the July 7 issue of the Journal of the American Medical Association (JAMA).
In the first study, investigators with the Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa inhibitors (SYNERGY) trial compared the outcomes of patients treated with enoxaparin vs. unfractionated heparin. Although previous trials have demonstrated the superiority of enoxaparin compared with unfractionated heparin for patients with non-ST-elevation (a certain pattern on the electrocardiogram) ACS receiving medical therapy as their primary treatment strategy, the value of enoxaparin as the principal anticoagulant regimen for ACS has been debated.
The SYNERGY trial was a randomized, multicenter, international trial conducted between August 2001 and December 2003. A total of 10,027 high-risk patients with non-ST-elevation ACS to be treated with an intended early invasive strategy were recruited. Participants received either subcutaneous enoxaparin (n=4,993) or intravenous unfractionated heparin (n=4,985), administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician.
The primary efficacy outcome was the composite clinical end point of death or nonfatal myocardial infarction (MI, heart attack) during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke.
The researchers found that the primary end point of death or nonfatal MI by 30 days occurred in 14.0 percent of patients assigned to enoxaparin and 14.5 percent of patients assigned to unfractionated heparin. Enoxaparin was not superior to unfractionated heparin but fulfilled the noninferiority criteria. "No differences in ischemic events reported by the physician during percutaneous coronary intervention [PCI, i.e., a stent] were observed between enoxaparin and unfractionated heparin, including similar rates of abrupt closure, threatened abrupt closure, unsuccessful PCI, or emergency coronary artery bypass graft [CABG] surgery. Bleeding was modestly increased in patients assigned to enoxaparin...," the researchers write.
"In high-risk patients with an intended early invasive treatment strategy, enoxaparin and unfractionated heparin are safe and effective alternatives as the antithrombin regimen. Enoxaparin has the advantages of convenience (fixed dosing without need for monitoring or intravenous infusion) and a trend toward a lower rate of nonfatal MI with a modest excess of bleeding. As a first-line agent in the absence of changing antithrombin therapy during treatment, enoxaparin appears to be superior without an increased bleeding risk," the authors write.
(JAMA. 2004;292:45-54. Available post-embargo at jama.com)
Editor's Note: This study was supported by Aventis Inc. For the financial disclosures of the authors, please see the JAMA article.
FOR ACS PATIENTS RECEIVING COMBINATION THERAPY, ENOXAPARIN AN EFFECTIVE ALTERNATIVE TO HEPARIN
In a related study, investigators with the A to Z trial assessed whether combining enoxaparin with the glycoprotein IIb/IIIa inhibitor tirofiban and aspirin is a suitable alternative to the current standard combination of unfractionated heparin with tirofiban and aspirin, in patients with non-ST-elevation ACS.
Participants in the international, randomized trial received either 1 mg/kg of enoxaparin every 12 hours (n = 2,026) and tirofiban and aspirin or intravenous unfractionated heparin (n = 1,961) and tirofiban and aspirin. Phase A of the A to Z trial was conducted between December 1999 and May 2002. The primary outcome measures were death, recurrent heart attack, or ischemia at 7 days, with the study designed to assess both superiority and noninferiority. Safety was based on measures of major and minor bleeding.
The authors write, "Analysis of the 3,987 patients randomized into phase A of the A to Z trial revealed a 1 percent absolute and 12 percent relative difference in favor of enoxaparin compared with unfractionated heparin for the prevention of the composite end point of death, MI, or refractory ischemia. This benefit did not meet criteria to declare superiority but fell well within specified bounds for noninferiority. We found a consistent but nonsignificant risk reduction of 10 percent to 15 percent with enoxaparin across various subpopulations and most subgroups. These risk reductions were of a larger magnitude for patients at higher risk, those who were being managed conservatively, and those who received no antithrombotic agent within 24 hours before randomization. These trends should be interpreted with caution in the absence of a finding of superiority; however, they are consistent with prior studies of glycoprotein IIb/IIIa inhibition with tirofiban and previous studies comparing enoxaparin with unfractionated heparin, which found greater relative efficacy among higher risk patients," the authors write.
"Because it is easier to use and modestly reduces recurrent ischemic events without an increase in the need for blood products, enoxaparin compares favorably with unfractionated heparin in patients with non-ST-segment elevation ACS who are receiving tirofiban and aspirin," the authors conclude.
(JAMA. 2004;292:55-64. Available post-embargo at jama.com)
Editor's Note: This study was funded by Merck & Company, Whitehouse Station, N.J. Enoxaparin was provided by Aventis Inc, Bridgewater, N.J. For the financial disclosures of the authors, please see the JAMA article.
EDITORIAL: FRACTIONATING HEPARINS AND THEIR CLINICAL TRIAL DATA - SOMETHING FOR EVERYONE
In an accompanying editorial, Pranab Das, M.D., and David J. Moliterno, M.D., of the University of Kentucky, Lexington, write that these 2 new trials "advance the current understanding and potential future role of enoxaparin in the management of non-ST-segment elevation ACS."
The authors note, "Indeed, there is something for everyone. Had the 'A' portion of A to Z or SYNERGY shown enoxaparin to be superior to unfractionated heparin, as some had expected and many had hoped, commentators would be giving accolades instead of point-counterpoint perspectives."
"Both the A to Z and SYNERGY trials provide evidence that enoxaparin remains a reasonable alternative to unfractionated heparin in contemporary ACS treatment. Enoxaparin has several unique benefits and apparently few limitations. From SYNERGY, the numbers needed to treat with enoxaparin to prevent an occurrence of death or MI at 30 days and to produce a ... major bleeding event are 184 and 68, respectively. It will be interesting to see if these latest mega-trials affect the use of enoxaparin and the associated guidelines related to non-ST-segment elevation ACS," the authors conclude.
(JAMA. 2004;292:101-103. Available post-embargo at jama.com)
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org (please note new email address).
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Embargoed for Release: 3 p.m. CT, TUESDAY, July 6, 2004
Media Advisory: To contact corresponding author Yvonne T. Van der Schouw, Ph.D., call Annette Aarts at +31 30 250 7483. To contact co-author Johanna Lampe, Ph.D., R.D., call Kristen Woodward at 206-667-5095.
SOY PROTEIN SUPPLEMENTS WITH ISOFLAVONES DO NOT IMPROVE COGNITIVE FUNCTION, BONE MINERAL DENSITY OR CHOLESTEROL LEVELS IN POSTMENOPAUSAL WOMEN
CHICAGO—No beneficial effects were found on cognitive function, bone mineral density or plasma lipids when postmenopausal women age 60 years or older took soy protein supplements with isoflavones for one year, according to a study in the July 7 issue of the Journal of the American Medical Association (JAMA).
"The sudden decline in estrogen levels after menopause coincides with acceleration of several aging processes," according to background information in the article. "On average, bone mineral density (BMD) decreases and cognitive function declines, whereas total cholesterol and low-density lipoprotein cholesterol (LDL-C) [the bad type of cholesterol] increase." The authors write that some women have taken hormone therapy to counteract some of these changes; however, hormone therapy has short- and long-term risks. Isoflavones, estrogenlike compounds naturally occurring in plant foods, have been suggested as an alternative for traditional estrogen therapy with fewer adverse effects.
Sanne Kreijkamp-Kaspers, M.D., Ph.D., from the University Medical Center, Utrecht, the Netherlands, and colleagues conducted a study with 202 healthy postmenopausal women aged 60 to 75 years between April 2000 and September 2001 in the Netherlands. The women were randomly assigned to receive 25.6 grams of soy protein containing 99 milligrams (mg) of isoflavones or the placebo, a total milk protein as a powder, each of which could be mixed with food or beverages on a daily basis for 12 months. Cognitive testing was performed at baseline and at the final visit, one year later, using several standardized tests. Bone mineral density was measured at baseline and 12 months using dual-energy x-ray absorptiometry (DXA) scans, and plasma lipid levels also were assessed at baseline and 12 months.
"In this longer-term, relatively large double-blind, placebo-controlled , randomized trial, we did not find any effect of soy protein supplementation, which naturally contains large amounts of isoflavones, on cognitive function, BMD, or plasma lipids in the relevant population of aging women," the authors report. Timing of the supplementation may provide an explanation for the difference in findings from this study compared to previous ones that were more promising, the authors write. "...the most pronounced effects of estrogen on cognitive function have been reported in perimenopausal women, and not in late postmenopausal women. With respect to bone, it has been suggested that it is easier to prevent changes or losses after menopause than reverse them when they have already taken place. ...The influence of the timing of supplementation needs to be elucidated in further research," the authors suggest.
(JAMA. 2004;292:65-74. Available post-embargo at jama.com)
Editor's Note: The study was financially supported by grants from the Netherlands Organization for Scientific Research and from the Netherlands Organization for Health Research and Development. The Solae Co., St. Louis, Mo., provided the supplements.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org
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JAMA VIDEO NEWS REPORT
SOY PROTEIN NOT EFFECTIVE IN IMPROVING MEMORY, BONE DENSITY OR BLOOD CHOLESTEROL LEVELS IN POST-MENOPAUSAL WOMEN
VIDEO:
B-ROLL
Older woman mixing and drinking soy drink 2:8:50
AUDIO:
THIS WOMAN IS DRINKING A POWDERED FORM OF SOY BEANS, WHICH CONTAIN NATURAL, ESTROGEN-LIKE ELEMENTS. RESEARCHERS HAD REASON TO BELIEVE THAT SOY COULD HELP POST-MENOPAUSAL WOMEN COMBAT SOME TYPICAL EFFECTS OF AGING: COGNITIVE DECLINE, SUCH AS MEMORY LOSS, BONE DENSITY LOSS, AND INCREASED CHOLESTEROL.
VIDEO:
SOT/FULL @ :18
Super: Johanna Lampe, Ph.D., R.D., Fred Hutchinson Cancer Research Center
Runs :08
AUDIO:
"Previous smaller studies had shown effects of soy on both cognitive function and bone density in younger women and also blood cholesterol in men."
VIDEO:
B-ROLL
Dr. Lampe walking down hall
With colleague at computer
Female lab technician performing tests
GFX/JAMA COVER
AUDIO:
SO DR. JOHANNA LAMPE (jo-HA-na LAMP-ee) AT FRED HUTCHINSON CANCER RESEARCH CENTER IN SEATTLE, AND COLLEAGUES AT THREE INSTITUTIONS IN THE NETHERLANDS, STUDIED THE EFFECTS OF SOY IN POST-MENOPAUSAL WOMEN AGES SIXTY TO SEVENTY-FIVE. THEY TRACKED ONE-HUNDRED-SEVENTY-FIVE DUTCH WOMEN FOR A YEAR, MEASURING THEIR COGNITIVE ABILITIES, BONE DENSITY AND CHOLESTEROL LEVELS. HALF THE WOMEN DRANK THE SOY PROTEIN POWDER DAILY, AND IN ORDER TO MAKE A COMPARISON, THE OTHER HALF DRANK A MILK POWDER INSTEAD. THE STUDY FINDINGS APPEAR IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
Johanna Lampe, Ph.D., R.D., Fred Hutchinson Cancer Research Center Runs :09
AUDIO:
"Soy protein treatment had no effect on memory, or bone density or blood cholesterol levels in the post-menopausal women."
VIDEO:
B-ROLL
Older women walking on the street
AUDIO:
DR. LAMPE SAYS TIMING MAY BE THE ISSUE HERE. FOR INSTANCE, SHE SAYS THAT BONE DENSITY DECLINES RAPIDLY AT THE BEGINNING OF MENOPAUSE, AND THEN SLOWS AS WOMEN GET OLDER.
VIDEO:
SOT/FULL
Johanna Lampe, Ph.D., R.D., Fred Hutchinson Cancer Research Center
Runs :04
AUDIO:
"Maybe by age 60 it's too late for soy to have an effect."
VIDEO:
B-ROLL
Tight shot of powdered soy
AUDIO:
BUT DR. LAMPE SAYS SOY WON'T HURT OLDER WOMEN.
VIDEO:
SOT/FULL
Johanna Lampe, Ph.D., R.D., Fred Hutchinson Cancer Research Center
Runs :07
AUDIO:
"There is no indication that consuming soy would be detrimental, and actually soy protein is a very complete source of protein."
VIDEO:
B-ROLL
Woman drinking soy drink
AUDIO:
SOY MAY NOT PREVENT SPECIFIC EFFECTS OF AGING IN POST-MENOPAUSAL WOMEN, BUT IT CAN STILL BE A HEALTHY PART OF THEIR DIETS.
THIS IS MAVIS PRALL REPORTING.
