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March 02, 2004

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, March 02, 2004)


JAMA NEW RELEASES

>   INTENSIVE STATIN THERAPY REDUCES AMOUNT OF PLAQUE BUILDUP IN ARTERIES COMPARED TO MODERATE STATIN TREATMENT

>   PRIMARY-CARE BASED PROGRAM REDUCES THOUGHTS OF SUICIDE AMONG OLDER DEPRESSED PATIENTS

>   STUDY REPORTS IMPROVED METHOD TO IDENTIFY FETAL DNA IN MATERNAL BLOOD SAMPLES


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 comparing statin treatments for slowing the progression of coronary atherosclerosis. The release will be fed Tuesday, March 2, 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).

Please Note: Our e-mail has changed to mediarelations{at}jama-archives.org

JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ONLINE

Go to www.jamamedia.org for more information and to apply for access.

Please Note: The FOR THE MEDIA Web site now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org

EMBARGOED FOR RELEASE: 3 P.M. CT, TUESDAY, March 02, 2004
Media Advisory: To contact Steven E. Nissen, M.D., call Alicia Sokol at 216-445-9661.
To contact editorial author Frank M. Sacks, M.D., call Kevin Myron at 617-432-3952.

INTENSIVE STATIN THERAPY REDUCES AMOUNT OF PLAQUE BUILDUP IN ARTERIES COMPARED TO MODERATE STATIN TREATMENT

CHICAGO—Patients with coronary heart disease who received intensive lipid-lowering treatment had less progression of coronary atherosclerosis (plaque buildup in the arteries) than patients treated with a moderate lipid-lowering regimen, according to a study in the March 3 issue of the Journal of the American Medical Association (JAMA).

According to background information in the article, statin drugs (lipid-lowering medications) have been shown to reduce both atherogenic (development of plaque in arterial walls) lipoproteins and cardiovascular illness and death. However, the optimal approach and target level for lipid reduction with statins in patients with established coronary artery disease (CAD) remains uncertain.

Steven E. Nissen, M.D., of the Cleveland Clinic Lerner School of Medicine, Cleveland, and colleagues compared the effects of two statin regimens. The Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL) study was a double-blind, randomized trial at 34 centers in the United States. Intravascular ultrasound, which provides detailed images within a blood vessel, was used to measure plaque buildup in the wall of the coronary arteries.

Between June 1999 and September 2001, 654 patients were randomized and received a study drug; 502 had intravascular ultrasound examinations at baseline and after 18 months of treatment. Patients were randomly assigned to receive a regimen designed to moderately reduce low-density lipoprotein cholesterol (LDL-C) using 40 mg of pravastatin, or an intensive LDL-C lowering regimen, using 80 mg of atorvastatin.

The researchers found that patients with moderate cholesterol levels who received 18 months of intensive lipid-lowering therapy had greater reductions in LDL-cholesterol than patients who received the moderate lipid lowering regimen, and also had greater reductions in C-reactive protein (a measure of inflammation). Patients in the intensive therapy group also showed significantly less progression of coronary atherosclerosis in comparison with patients who received a more moderate regimen. The change in volume of plaque buildup was positive in the pravastatin group (2.7 percent), indicating net progression compared with the baseline measurement, whereas in the atorvastatin group, the change was negative (?-0.4 percent), showing no disease progression since baseline.

"These findings have potential implications for treatment guidelines for patients with dyslipidemia and established CAD," the authors write. "A more intensive lipid-lowering therapy is required than is currently recommended by national and international guidelines to obtain maximal reduction in the progression of coronary atherosclerosis," the researchers conclude.
(
JAMA. 2004;291:1071-1080. Available post-embargo at jama.com)

Editor's Note: The study was funded by Pfizer. For the financial disclosures of the authors, please see the JAMA article.

EDITORIAL: HIGH-INTENSITY STATIN TREATMENT FOR CORONARY HEART DISEASE

In an accompanying editorial, Frank M. Sacks, M.D., of the Harvard School of Public Health, Brigham and Women's Hospital, and Harvard Medical School, Boston, writes that a policy to use the highest statin doses as standard therapy has implications for cost and potential adverse effects.

"The vast majority of clinical and research experience is with conventional statin doses, which have provided a deservedly positive view of statin therapy. To put maximal statin therapy, such as with 80 mg of atorvastatin or 40 mg of rosuvastatin, on the same footing of clinical confidence requires results from large long-term clinical trials. Fortunately, several large trials comparing intensive with conventional statin therapy are near completion and results are expected soon," he writes.

"Until the results of these studies are available, it is prudent to treat any high-risk patient, as defined by national guidelines, with a statin at an intensity appropriate to achieve the recommended goals for LDL-C. In addition, with this focus on LDL-C reduction, clinicians must not lose sight of the need to manage other established cardiovascular disease risk factors including hypertension and atherogenic dyslipidemia, manifested by low levels of high-density lipoprotein cholesterol and high levels of triglycerides. At least as important, this concentration on drug treatment should not deflect attention from diet and lifestyle interventions that have the potential even with moderate improvements to reduce cardiovascular disease incidence by between 75 percent and 80 percent," he concludes.
(JAMA. 2004;291:1132-1134. Available post-embargo at jama.com)

Editor's Note: Dr. Sacks is a consultant for the following companies: Abbott, AstraZeneca, Bristol-Myers Squibb, Fournier, Kos, Kowa, Lilly, Pfizer, Reliant and Sankyo.

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, March 02, 2004
Media Advisory: To contact the corresponding author Charles F. Reynolds III, M.D., call Craig Dunhoff at 412-624-2607.

PRIMARY-CARE BASED PROGRAM REDUCES THOUGHTS OF SUICIDE AMONG OLDER DEPRESSED PATIENTS

CHICAGO—An intervention that includes interaction with a depression care manager reduces levels of depression and thoughts of suicide among older patients with depression, according to a study in the March 3 issue of the Journal of the American Medical Association (JAMA).

Older Americans comprise about 13 percent of the U.S. population, yet account for 18 percent of all suicide deaths, according to background information in the article. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation (thoughts of suicide). The majority of older adults who die by suicide have seen a primary care physician in preceding months. Recent national reports emphasize the public health need for intervention trials to reduce the risk for suicide in late life.

Martha L. Bruce, Ph.D., M.P.H., of Weill Medical College of Cornell University, White Plains, N.Y., and colleagues conducted a study to test the impact of a primary care-based intervention on reducing depression and major risk factors for suicide in older patients. The randomized trial, known as PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial), was conducted at 20 primary care practices in New York City, Philadelphia, and Pittsburgh regions, May 1999 through August 2001. The trial included a two-stage, age-stratified (60-74; 75 years and older) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of screened negative patients. This analysis included patients with a depression diagnosis (N=598).

The intervention focused on two major components of care. First was physician knowledge, addressed by a clinical algorithm for treating geriatric depression in a primary care setting. The second was treatment management, put into practice by depression care managers. The intervention was compared with usual care after the physicians were educated about treatment guidelines and notified when a patient had a depression diagnosis.

The researchers found that in the intervention group, over two-thirds of patients expressing suicidal ideation were no longer suicidal at 4 months, an improvement rate resembling that observed among specialty mental health patients in an academic-based clinic.

"... the multisite PROSPECT demonstrated that an intervention consisting of guideline treatment managed by a master's-level clinician is both feasible and effective in significantly reducing [and resolving more quickly] suicidal ideation in geriatric patients suffering depression in primary care. The intervention was also effective in reducing depressive symptoms in patients with major depression and, when suicidal ideation was present, minor depression. Together, these findings indicate that efforts to improve the quality of depression treatment for geriatric primary care patients can focus on patients with suicidal ideation or major depression with the expectation that appropriate management will reduce depressive symptoms, suicidal ideation, and the risk of suicide in late life," the authors write.
(
JAMA. 2004;291:1081-1091. Available post-embargo at jama.com)

Editor's Note: For information on the funding of the study and the financial disclosures of the author's, please see the JAMA article.

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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EMBARGOED FOR RELEASE: 3 P.M. CT, TUESDAY, March 02, 2004
Media Advisory: To contact Ravinder Dhallan, M.D., Ph.D., call Susan Higgins at 410-715-2111, ext. 100.
To contact editorial author Joe Leigh Simpson, M.D., call Anissa Orr at 713-798-4712.

STUDY REPORTS IMPROVED METHOD TO IDENTIFY FETAL DNA IN MATERNAL BLOOD SAMPLES

CHICAGO—A new method to increase the recovery of DNA from unborn babies in a blood sample from their mothers may be helpful for future development of non-invasive prenatal genetic tests to identify fetal abnormalities, according to an article in the March 3 issue of the Journal of the American Medical Association (JAMA).

"Prenatal diagnosis is useful in managing a pregnancy with an identified fetal abnormality and may allow for planning and coordinating care during delivery and the neonatal period," the authors provide as background information. "... invasive diagnostic tests (e.g., amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling) for fetal chromosomal abnormalities are highly reliable, but the procedure used for each test carries a risk for loss of pregnancy. Many patients who are candidates for these tests decline them because of the risk of pregnancy loss." The authors continue, "... the use of free fetal DNA for detecting chromosomal abnormalities has been limited by the seemingly low percentage of free fetal DNA in the maternal circulation."

Ravinder Dhallan, M.D., Ph.D., from Ravgen, Inc., Columbia, Md., and colleagues, analyzed blood samples from pregnant women to determine if the percentage of free fetal DNA could be increased by using formaldehyde to stabilize blood cell membranes and reduce the number of the mother's blood cells that are destroyed during sample collection, handling, and processing, which reduces the amount of maternal DNA released, thereby increasing the percentage of fetal DNA. The study was conducted in two phases from January through February 2002 at one clinical site and March 2002 through May 2003 at a network of 27 clinical sites in 16 U.S. states. The first phase collected two samples of blood from ten pregnant women - one blood sample was treated with formaldehyde and the other blood sample was untreated. In the second phase, all 69 blood samples were treated with formaldehyde.

"In the first phase of the study, the mean (average) percentage of free fetal DNA in the untreated samples was 7.7 percent, while the mean percentage of free fetal DNA in the formaldehyde-treated samples was 20.2. percent. In the second phase, a median (half-way point) of 25 percent free fetal DNA was obtained for the 69 formaldehyde-treated maternal blood samples. Approximately 59 percent of the samples in this study had 25 percent or greater fetal DNA, and only 16 percent of the samples had less than 10 percent fetal DNA. In addition, 27.5 percent of the samples in this study had 50 percent or greater fetal DNA."

The authors conclude, "When samples have a high percentage of free fetal DNA, the difference between the expected ratio of the chromosomes for a healthy fetus and that for an abnormal fetus is greater, which makes it easier to diagnose chromosomal abnormalities," and suggest that their methods "for increasing the percentage of free fetal DNA provide a solid foundation for the development of a noninvasive prenatal diagnostic test."
(
JAMA. 2004;291:1114-1119. Available post-embargo at jama.com)

Editor's Note: The study was financed in its entirety by Ravgen, Inc. Please see the JAMA article for authors' financial disclosures regarding their association with Ravgen, Inc.

EDITORIAL: CELL-FREE FETAL DNA IN MATERNAL BLOOD

In an accompanying editorial, Joe Leigh Simpson, M.D., and Farideh Bischoff, Ph.D., from Baylor College of Medicine, Houston, write that "the findings reported in the study by Dhallan and colleagues on enhancing recovery of cell-free DNA in maternal blood have major clinical implications. Developing a reliable, transportable technology for cell-free DNA analysis impacts 2 crucial areas - prenatal genetic diagnosis and cancer detection and surveillance. In prenatal genetic diagnosis, detecting a fetal abnormality without an invasive procedure (or with fewer invasive procedures) is a major advantage."

"The report by Dhallan et al is an important step in improving detection of cell-free DNA. Further refinements in techniques should maximize recovery of cell-free DNA and facilitate practical application. With prospective studies focusing on clinical applications of these findings, profound clinical implications could emerge for prenatal diagnosis and cancer surveillance."
(JAMA. 2004;291:1135-1137. Available post-embargo at jama.com)

Editor's Note: Drs. Simpson and Bischoff have received research support from the National Institute of Child Health and Human Development and maintain contractual relationships with Biosciences Inc., San Diego, Calif., and Ikonysis Inc., New Haven, Conn.

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 REPORTS

STATIN REDUCED HEART DISEASE

VIDEO:
B-roll: Patients Hejcl and Jarer in their hospital beds


AUDIO:
MILLIONS OF AMERICANS LIKE ALLEN HEJCL AND DAVID JARER TAKE STATINS TO LOWER THEIR CHOLESTEROL.

VIDEO:
B-roll: Dr. Nissen talking with colleague in hallway
GFX: cover of JAMA


AUDIO:
CARDIOLOGIST STEVEN NISSEN AT THE CLEVELAND CLINIC AND SEVERAL COLLEAGUES HAVE UNCOVERED A SECOND BENEFIT OF TAKING STATINS THAT COULD CHANGE THE WAY DOCTORS TREAT HEART DISEASE. THE FINDINGS ARE PUBLISHED IN THIS WEEK'S JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL Super @:20
Steven Nissen, M.D., Cleveland Clinic Cardiologist


AUDIO:
"We found that those that were treated more intensively with the drug atorvastatin, also known as Lipitor, actually had no progression at all in their coronary disease, where as those who were treated to a more moderate cholesterol level with the drug pravastatin, also known as Provachol had significant progression of the coronary disease."

VIDEO:
B-roll: Dr. Nissen working on computer with data
Shots of ultrasound images on computer screen


AUDIO:
STATIN DRUGS HAVE BEEN TESTED BEFORE BUT ALWAYS AGAINST A PLACEBO. THIS TIME DR. NISSEN PUT TWO STATINS UP AGAINST ONE ANOTHER IN A HEAD TO HEAD STUDY-ATORVASTATIN (BRAND NAME, LIPITOR) AND PRAVASTATIN (BRAND NAME PROVACHOL). YOU CAN SEE THE BIGGEST RESULTS ON THESE ULTRASOUND IMAGES. THE PROGRESSION IN THE PATIENTS WHO WERE GIVEN ATORVASTATIN ACTUALLY STOPPED AND IN SOME CASES PLAQUE IN THE ARTERIES WAS REDUCED.

VIDEO:
SOT/FULL
Steven Nissen, M.D., Cleveland Clinic Cardiologist

AUDIO:
"We think this is the most compelling evidence yet that statin drugs can actually help to remove some of the plaque from the coronary arteries."

VIDEO:
B-roll: Dr. Nissen
Plaque build up images
Dr. Nissen


AUDIO:
THE STUDY ALSO REVEALED JUST HOW LOW TO GO WITH CHOLESTEROL. BEFORE DOCTORS TRIED TO GET PATIENTS' LDL, THE BAD CHOLESTEROL, UNDER 100. BUT IT WAS WHEN THE LDL WAS REDUCED TO 79 THAT THE PROGRESSION OF PLAQUE IN THE ARTERIES STOPPED.

VIDEO:
SOT/FULL
Super @:1:35
David Jarer, Heart disease patient


AUDIO:
"That'd be great. If they could stall it or reverse it that would be great!"

AUDIO:
DR. NISSEN FORESEES MANY DOCTORS WILL NOW PUT THEIR PATIENTS ON A HIGHER DOSAGE OF STATIN. THIS IS LAURA MEEHAN REPORTING.

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