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April 27, 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, April 27, 2004)


JAMA NEW RELEASES

>   MEDICATION FOR HEART FAILURE MAY BE HELPFUL ADDITION TO STANDARD THERAPIES

>   DENTAL X-RAYS DURING PREGNANCY ASSOCIATED WITH LOW BIRTH WEIGHT BABIES

>   ANTHRAX SURVIVORS CONTINUED TO HAVE HEALTH PROBLEMS ONE YEAR AFTER EXPOSURE


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 association of low birth weight babies and dental x-rays during pregnancy. The release will be fed Tuesday, April 27, 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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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, April 27, 2004
Media Advisory: To contact Mihai Gheorghiade, M.D., call Elizabeth Crown at 312-503-8928. To contact editorialist Gary S. Francis, M.D., call Alicia Sokol at 216-445-9661.

MEDICATION FOR HEART FAILURE MAY BE HELPFUL ADDITION TO STANDARD THERAPIES

CHICAGO—Results from a clinical trial indicate that the medication tolvaptan may be a promising addition to standard therapy for treating patients hospitalized for heart failure, according to a study in the April 28 issue of the Journal of the American Medical Association (JAMA).

Hospitalizations for heart failure are common in the United States, with 995,000 hospital discharges for heart failure in 2001, according to background information in the article. Pharmacological management of systemic congestion in heart failure (buildup of excess fluid in the lungs and some other body tissues) is often inadequate; the 6-month postdischarge readmission rates are as high as 50 percent. Although diuretics are the mainstay therapy for congestion, their use has been associated with hypotension (abnormally low blood pressure), electrolyte abnormalities and worsening kidney function. The medication tolvaptan is thought to help treat heart failure without adversely affecting electrolytes and kidney function.

Mihai Gheorghiade, M.D., of Northwestern University Feinberg School of Medicine, Chicago, and investigators with the Acute and Chronic Therapeutic Impact of a Vasopressin Antagonist in Congestive Heart Failure (ACTIV in CHF) trial evaluated the clinical effects of tolvaptan in patients hospitalized for heart failure. This randomized, double blind, placebo-controlled trial was conducted at 45 centers in the United States and Argentina, and enrolled 319 patients who were hospitalized for heart failure and who had persistent signs and symptoms of systemic congestion despite standard therapy.

After admission, patients were randomized to receive 30, 60, or 90 mg of oral tolvaptan or placebo in addition to standard therapy, including diuretics. The study drug was continued for up to 60 days.

The researchers found that "tolvaptan in addition to standard therapy including diuretics increased net fluid loss resulting in decreased body weight more effectively than standard therapy alone in patients hospitalized for heart failure. This desirable effect was achieved without adversely affecting blood pressure, heart rate, electrolyte levels, or renal [kidney] function," they write. "Tolvaptan also improved serum sodium levels in patients with hyponatremia [abnormally low level of sodium in the blood; associated with dehydration]. Although tolvaptan did not reduce the rate of worsening heart failure after discharge, post hoc analysis suggested that mortality might be reduced in high-risk patients treated with tolvaptan."
(
JAMA. 2004;291:1963-1971. Available post-embargo at jama.com)

Editor's Note: The study was sponsored by the Otsuka Maryland Research Institute, Rockville, Md. All authors served as consultants for Otsuka Maryland Research Institute, received grants or honoraria from the company, or both.

EDITORIAL: VASOPRESSIN RECEPTOR ANTAGONISTS

In an accompanying editorial, Gary S. Francis, M.D., and W. H. Wilson Tang, M.D., of the Cleveland Clinic Foundation, write that tolvaptan is one of a new class of drugs that may be helpful for addressing important problems in acute heart failure, e.g., hyponatremia, water retention, and renal dysfunction.

"The study by Gheorghiade et al also raises important regulatory issues. The question arises as to what should be measured to demonstrate efficacy in clinical trials of such new therapy for the treatment of acute or decompensated heart failure. Payers such as the Center for Medicare and Medicaid Services (CMS) and insurance carriers have a stake in this question, as new agents are likely to be expensive. Some demonstration of physiologic improvement, such as weight loss and correction of hyponatremia, is necessary but should be coupled to some index of improvement in clinical outcome. Heart failure researchers are still struggling to identify a measure of improved clinical outcome in the setting of acute heart failure that is objective, quantitative, reproducible, relevant, and reliable."
(JAMA. 2004;291:2017-2018. Available post-embargo at jama.com)

Editor's Note: Dr. Francis has served as a consultant to Yamanouchi Pharmaceuticals, which is developing conivaptan, a dual vasopressin V1A and V2 receptor antagonist.

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, April 27, 2004
Media Advisory:To contact Philippe P. Hujoel, Ph.D., call Pam Sowers at 206-685-4232.

DENTAL X-RAYS DURING PREGNANCY ASSOCIATED WITH LOW BIRTH WEIGHT BABIES

CHICAGO—Pregnant women who are exposed to dental radiography may be more likely to give birth to an infant who weighs less than normal, according to a study in the April 28 issue of the Journal of the American Medical Association (JAMA).

According to background information in the article, the link between radiation and low birth weight (LBW) babies has been established with medical x-rays, but not dental x-ray radiation. "Because dental diagnostic radiography results in measurable radiation doses to the hypothalamus-pituitary-thyroid axis and not the reproductive organs or the fetus, it provides an opportunity to test the role of the hypothalamus-pituitary-thyroid axis in the radiation-LBW association," the authors write.

Philippe P. Hujoel, Ph.D., and colleagues from the University of Washington, Seattle, analyzed data from Washington Dental Services, a non-profit dental insurance company in Washington State, for women who received dental treatment between January 1993 and December 2000. Those records were then linked to birth certificates. There were 1,117 low birth weight infants (defined as weighing less than 2,500 grams or 5.5 pounds) born to women with Washington Dental Service insurance during that time period. A total of 4,468 normal birth weight (NBW) infants were selected as the control group for this study.

The investigators estimated the amount of radiation exposure based on the dental x-ray studies performed and published radiation dosages. (For example, a full mouth 21 x-ray series has a typical dose of 1.6 mGy [milligray] of radiation, whereas a series of 4 "bitewing" x-rays has a dose of 0.22 mGy). For their analysis, the authors categorized the cumulative radiation exposure into three dose groups: 0 mGy (no dental x-rays), 0.1-0.4 mGy, and higher than 0.4 mGy (which corresponded to the 90th percentile of the cumulative radiation doses among women who had at least one dental x-ray.)

Among the women who delivered a LBW infant, 1.9 percent (n = 21, including 10 LBW infants born at term) had higher than 0.4 mGy radiation dose, compared with 1.0 percent of women with NBW infants. When compared to women with no known dental diagnostic x-rays during pregnancy, a radiation dose of more than 0.4 mGy was associated with an increased adjusted odds for LBW of 2.27, and an increased adjusted odds for term LBW of 3.61.

"In this study, antepartum (before birth) dental radiography in pregnant women was associated with an increased risk for a LBW infant, especially a TLBW (term low birth weight) infant. The prevalence of dental radiography during pregnancy in this dentally insured population was approximately 10 percent. Since women may not always be aware of their pregnancy status, it may not be possible to eliminate all dental radiography during pregnancy, but if this goal could be achieved and if the identified association is causal, the prevalence of TLBW infants could be reduced by up to five percent," the authors suggest. In conclusion the authors write: "The notion that very low-dose radiation exposures to nonreproductive organs in expectant mothers are safe needs to be investigated further."
(
JAMA. 2004;291:1987-1993. Available post-embargo at jama.com)

Editor's Note: This project was supported in part by the Washington Dental Service Foundation.

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, April 27, 2004
Media Advisory: To contact Dori B. Reissman, M.D., M.P.H., call Gail Hayes at 770-488-4902.

ANTHRAX SURVIVORS CONTINUED TO HAVE HEALTH PROBLEMS ONE YEAR AFTER EXPOSURE

CHICAGO—People infected with anthrax continued to report health problems, poor life adjustment, and psychological distress one year after their exposure, according to a study in the April 28 issue of the Journal of the American Medical Association (JAMA).

In 2001, bioterrorist activities involving the U.S. Postal Service infected 22 individuals with Bacillus anthracis (anthrax), according to background information in the article. Six survivors had inhalational anthrax and 11 cutaneous anthrax disease. Little is known about potential long-term health effects of bioterrorism-related anthrax infection.

Dori B. Reissman, M.D., M.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues conducted a cross-sectional health assessment approximately 1 year after the 2001 onset of anthrax infection to better characterize the somatic (affecting the body) symptoms, health status, and functional capacity of the bioterrorism-related anthrax survivors.

The study included assessment of 15 of 16 adult survivors from September through December 2002 using a clinical interview, a medical review-of-system questionnaire, 2 standardized self-administered questionnaires, and a review of available medical records.

The researchers found that the anthrax survivors reported symptoms affecting multiple body systems, significantly greater psychological distress, and significantly reduced health-related quality-of-life indices compared with U.S. referent populations. "Eight survivors (53 percent) had not returned to work since their infection. Comparing disease manifestations, inhalational survivors reported significantly lower overall physical health than cutaneous survivors. Available medical records could not explain the persisting health complaints," the authors write.

The most common health complaints included respiratory tract problems (e.g., chronic cough), fatigue, joint complaints (e.g., swelling, pain), and cognitive impairment (e.g., memory problems). The most frequently reported psychological distress symptoms included depression, anxiety, obsessive-compulsive, and hostility.

The researchers write that these finding are "similar to findings reported after exposure to other types of traumatic events and highlights the importance of measuring these dimensions as standard practice. Many factors may contribute to the distress variance reported by the anthrax survivors, including differences in exposure characteristics, sociocultural and occupational considerations, and perceived inequities of case management."

"Our findings support those of other studies in the United States in which terrorism has led to significant chronic physical and mental health problems. Standard assessment of terrorism survivors should include medically unexplained health complaints and psychiatric comorbidity, such as symptoms of posttraumatic stress disorder, depression, and anxiety disorders. Psychiatric and medical systems of care and rehabilitation should be coordinated to minimize functional impairment and improve health-related quality of life," the authors conclude.
(
JAMA. 2004;291:1994-1998. Available post-embargo at jama.com)

Editor's Note: The Centers for Disease Control and Prevention funded this work.

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

DENTAL X-RAYS & LOW-BIRTH WEIGHT BABIES

VIDEO:
NAT SOT
Technician with dental patient who is getting x-rays


AUDIO:
"Go ahead and close down."

VIDEO:
B-roll: X-rays being done on female patient
GFX: JAMA cover


AUDIO:
DENTAL X-RAYS ARE ALMOST AS ROUTINE AS GETTING YOUR TEETH CLEANED, BUT MAY BE HARMFUL TO A PREGNANT WOMAN'S UNBORN CHILD. A NEW STUDY JUST PUBLISHED IN THIS WEEK'S JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION REVEALS A LINK BETWEEN LOW DOSAGE DENTAL RADIATION AND INFANT LOW BIRTH WEIGHT.

VIDEO:
SOT/FULL
Super @:17
Philippe Hujoel, Ph.D.
University of Washington


AUDIO:
"The type of radiation we were studying can be compared to roughly four to sixteen roundtrips from London to JFK. So it's a very low dose radiation we were studying."

VIDEO:
B-roll: X-ray footage
Dr. Hujoel with colleagues chatting


AUDIO:
MEDICAL RADIATION HAS ALREADY BEEN ASSOCIATED WITH LOW BIRTH WEIGHT, BUT IT REMAINS UNCLEAR WHY. SOME THEORIES POINT TO THE REPRODUCTIVE ORGANS, OTHERS TO THE THYROID. DENTAL RADIATION WAS A GOOD TEST OF BOTH THEORIES BECAUSE DENTAL X-RAYS ARE AIMED NEAR THE THYROID AND NOT THE REPRODUCTIVE ORGANS. .

VIDEO:
SOT/FULL
Philippe Hujoel, Ph.D.
University of Washington


AUDIO:
"Currently the guidelines say that women who are pregnant are eligible for receiving very low dose diagnostic radiation to the head and neck, because up until now people assumed that head and neck radiation will not have any adverse affects on pregnant women. They assumed that only direct radiation to the uterus or the fetus would be associated with adverse pregnancy outcomes."

VIDEO:
B-roll of young women who fit the profile getting a dental exam
Dr. Hujoel looking over computer data


AUDIO:
THE STUDY WAS CONDUCTED BY DR. PHILIPPE HUJOEL (PHIL-EPE WHO-JHOLE) WITH THE UNIVERSITY OF WASHINGTON, ALONG WITH SEVERAL COLLEAGUES. THEY STUDIED THE HEALTH RECORDS OF MORE THAN 11-HUNDRED WOMEN BETWEEN 1993 AND 2000 AND FOUND THAT RECEIVING DENTAL X-RAYS DURING PREGNANCY WAS ASSOCIATED WITH HAVING A LOW BIRTH-WEIGHT INFANT. THE STUDY DOES NOT CLEARLY POINT TO THE THYROID AS THE CULPRIT, BUT MAY HELP RESEARCHERS IN THE FUTURE SOLVE THE PROBLEM.
THIS IS LAURA MEEHAN REPORTING.

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