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.

JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT, Tuesday, June 14, 2005)

JAMA NEWS RELEASES

   INVASIVE TREATMENT MAY BE MORE EFFECTIVE THAN CONSERVATIVE APPROACH FOR HEART ATTACK PATIENTS PRESENTING TO HOSPITAL MORE THAN 12 HOURS AFTER SYMPTOM ONSET

   MEDICATION ORLISTAT, COUPLED WITH WEIGHT-LOSS TECHNIQUES, APPEARS HELPFUL IN IMPROVING WEIGHT MANAGEMENT FOR OBESE ADOLESCENTS

   STUDY INDICATES FISH OIL SUPPLEMENTS DO NOT LOWER RISK OF SERIOUS HEART RHYTHM PROBLEMS FOR PATIENTS WITH IMPLANTABLE DEFIBRILLATORS

   QUALITY OF CARE FOR MEDICARE PATIENTS NOT NECESSARILY BETTER IN HOSPITALS THAT PARTICIPATE IN QUALITY IMPROVEMENT ORGANIZATION PROGRAM

JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)

   VIDEO: Windows Media | Quicktime

   FISH OIL LINKED TO INCREASED HEART PROBLEMS FOR PATIENTS WITH IMPLANTABLE DEFIBRILLATORS

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TV Note: This week's JAMA video news release is on the effect of fish oil supplements and heart rhythm problems for patients with implantable defibrillators. The release will be fed Tuesday, June 14, from 9:00 - 9:30 a.m. ET on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Intelsat America 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).

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Embargoed for Release: 3 p.m. CT, Tuesday, June 14, 2005
Media Advisory: To contact Albert Schömig, M.D., email: aschoemig{at}dhm.mhn.de. To contact editorialist Raymond J. Gibbons, M.D., call Lee Aase at 507-284-5005.

CHICAGO—Invasive treatment including stenting may have better outcomes than conventional treatments for heart attack patients who arrive at the hospital more than 12 hours after symptoms began, according to a study in the June 15 issue of JAMA.

In patients with acute ST-segment elevation myocardial infarction (STEMI - a certain finding on an electrocardiogram, suggesting a heart attack), numerous studies have demonstrated that early reperfusion (restoration of blood flow) within 12 hours of symptom onset is associated with increased myocardial (heart muscle) salvage, preservation of left ventricular function, and improved survival, according to background information in the article. Due to time-dependent reduction in the efficacy of thrombolysis (administration of medications to help dissolve blood clots), the application of this reperfusion method after 12 hours from symptom onset of acute myocardial infarction (MI, heart attack) offers little or no benefit and may be even harmful. Between 8.5 percent to 40 percent of patients with acute MI present late after symptom onset, thus being no longer eligible for thrombolysis.

Despite efforts to reduce time to presentation, recent studies have demonstrated that time-to-arrival at the hospital after the onset of symptoms has not changed or has even increased. Several findings suggest that reperfusion therapy may be beneficial even among patients with acute MI who present late after symptom onset. Current guidelines do not recommend reperfusion treatment in these patients. No specifically designed studies have addressed the role of primary percutaneous coronary intervention (PCI) in patients with STEMI presenting more than 12 hours after symptom onset.

Albert Schömig, M.D., of Technische Universität, Munich, Germany, and colleagues conducted a study to assess whether an invasive strategy based on PCI with stenting is associated with reduction of infarct (dead tissue from lack of blood) size in patients with acute STEMI presenting more than 12 hours after the symptom onset, compared with a conventional conservative treatment strategy.

The study, conducted from May 23, 2001, to December 15, 2004, included 365 patients aged 18 to 80 years, without persistent heart attack symptoms admitted with the diagnosis of acute STEMI between 12 and 48 hours from symptom onset. Patients were randomized to receive either an invasive strategy (n=182) based predominantly on coronary stenting plus the intravenous medication abciximab or a conventional conservative treatment strategy (n=183), which included an intravenous infusion of heparin.

The researchers found that the final left ventricular infarct size was significantly smaller in patients assigned to the invasive group (median, 8.0 percent) vs. those assigned to the conservative group (median, 13.0 percent). The average difference in final left ventricular infarct size between the invasive and conservative groups was ?-6.8 percent. The outcomes of death, recurrent MI, or stroke at 30 days occurred in 8 patients in the invasive group (4.4 percent) and 12 patients in the conservative group (6.6 percent) (a 33 percent lower risk of these outcomes for patients in the invasive group).

"This finding increases the level of evidence in support of the invasive strategy and deserves consideration when current treatment guidelines for this category of patients will be reassessed," the researchers conclude.
(JAMA. 2005;293:2865-2872. Available post-embargo at jama.com)

Editor's Note: This work was supported by grants from Deutsches Herzzentrum, Munich, Germany, as well as by unrestricted research grants from Lilly Deutschland GmbH, Bad Homburg, Germany, and Guidant Advanced Cardiovascular Systems Inc., Santa Clara, Calif.

EDITORIAL: ACUTE PCI FOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION - IS LATER BETTER THAN NEVER?

In an accompanying editorial, Raymond J. Gibbons, M.D., and Cindy L. Grines, M.D., of Mayo Clinic and Foundation, Rochester, Minn.; and William Beaumont Hospital, Detroit, comment on the findings of Schömig et al, the BRAVE-2 trial.

"Should the next update of STEMI Clinical Practice Guidelines consider PCI to be generally indicated (a class I indication) for all patients presenting with STEMI after 12 hours? Probably not yet. Existing guidelines consider the presence of ongoing symptoms after 12 hours to be a class IIa indication for PCI. On the basis of BRAVE-2, it would seem appropriate to expand this class IIa indication. Although it seems reasonable to consider acute PCI in all patients with STEMI who present 12 hours or longer after the onset of chest pain, regardless of whether they have ongoing pain, this single small trial does not provide sufficient evidence to warrant a class I indication. Such an indication would require confirmation at least in a second small trial using infarct size as an end point or preferably in a larger trial using clinical end points."

"Should patients with STEMI presenting after 12 hours be considered 'medical emergencies' requiring acute mobilization of the catheterization laboratory in the middle of the night? Probably not. Although the BRAVE-2 investigators proceeded with urgent PCI in the patients who were included in this trial, the trial results do not reveal whether this urgency was justified."

"The BRAVE-2 trial results are a noteworthy challenge to existing dogma and an important contribution to current knowledge. However, the results do not yet justify a revolution in clinical practice," the authors conclude.
(JAMA. 2005;293:2930-2932. Available post-embargo at jama.com)

Editor's Note: For the financial disclosures of the authors, please see the JAMA editorial.

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, June 14, 2005
Media Advisory: To contact Jean Pierre Chanoine, M.D., Ph.D., call 604-875-2301. To contact editorialist Alain Joffe, M.D., M.P.H., call Staci Vernick Goldberg at 410-516-4958.

MEDICATION ORLISTAT, COUPLED WITH WEIGHT-LOSS TECHNIQUES, APPEARS HELPFUL IN IMPROVING WEIGHT MANAGEMENT FOR OBESE ADOLESCENTS

CHICAGO—When combined with diet, exercise and behavioral therapy, orlistat, a drug that decreases fat absorption, appears helpful for improving weight management in obese adolescents, compared with placebo, according to an article in the June 15 issue of JAMA.

Excess weight in adolescents is associated with increased risk of hyperlipidemia and type 2 diabetes, and its prevalence is increasing worldwide, according to background information in the article. In the United States, the proportion of adolescents with a body mass index (BMI) at or above the 95th percentile for age, a widely accepted definition of obesity in adolescents, has increased 15.5 percent to 23.4 percent in certain ethnic minorities. Overweight children are at a 15-fold greater risk of becoming overweight adults compared to children and adolescents not overweight. Pediatric obesity can be particularly difficult to treat, with long-term success depending on the type of therapy used. Orlistat is a gastrointestinal tract lipase (an enzyme) inhibitor which decreases intestinal fat absorption by up to 30 percent; in adults, the drug has a good safety profile and is generally well tolerated.

Jean-Pierre Chanoine, M.D., Ph.D., from the British Columbia Children's Hospital, Vancouver, and colleagues examined the effectiveness and safety of orlistat for weight management in adolescents, in this 54-week, randomized, double-blind study. Participants were aged 12 to 16 years and had a BMI (calculated as weight in kilograms divided by the square of height in meters) two units or more above the 95th percentile at baseline. Three hundred fifty-seven patients received 120 mg of orlistat three times daily and 182 participants received placebo three times daily for one year. Both groups were given instructions on how to maintain a reduced calorie diet, and received counseling for exercise and behavior modification (i.e., recording food intake, recognizing cues for overeating). The researchers also assessed the impact of orlistat treatment on waist circumference, lipid levels, blood pressure, and glucose and insulin.

The researchers found that both groups experienced a decrease in BMI up to week 12, thereafter stabilizing with orlistat but increasing beyond baseline with placebo. At the end of the study, BMI had decreased by 0.55 with orlistat, and had increased by 0.31 with placebo; weight had increased 0.53 kg. with orlistat and 3.14 kg. with placebo. At the study's end, 15.7 percent of the placebo group compared to 26.5 percent of orlistat patients had a five percent or higher decrease in BMI, and 4.5 percent of the placebo group and 13.3 percent of the orlistat group had a ten percent or higher decrease in BMI.

Waist circumference also decreased in the orlistat group by 1.33 cm (.52 inches) and increased by .12 cm (.047 inches) in the placebo group. Mild to moderate gastrointestinal tract adverse effects (such as nausea, fatty/oily stools, and abdominal pain) occurred in 9 percent to 50 percent of the orlistat group, and one percent to 13 percent of the placebo group.

"We conclude that treatment with 120 mg of orlistat three times daily for 52 weeks, in conjunction with a reduced-calorie diet, exercise, and behavioral modification, statistically significantly improves weight management in obese adolescent participants," the authors write. "This effect is probably due to the decrease in the absorption of fat and its associated calories."
(JAMA. 2005;293:2873-2883. Available post-embargo at jama.com)

Editor's Note: This study was funded by F. Hoffmann-La Roche Ltd. Dr. Chanoine has received honoraria from Hoffmann-La Roche for speakers presentations. No other authors reported financial disclosures.

EDITORIAL: PHARMACOTHERAPY FOR ADOLESCENT OBESITY - A WEIGHTY ISSUE

In an accompanying editorial, Alain Joffe, M.D., M.P.H., from Johns Hopkins University, Baltimore, writes "Until public health efforts to prevent child and adolescent obesity are developed and successfully implemented on a broad scale, physicians are likely to encounter significant numbers of obese adolescents for the foreseeable future. ...appropriate management of this chronic health condition is a pressing but daunting task for physicians."

"Obesity is by nature a chronic disease. Many obese individuals who lose weight regain it over time, often exceeding their original weight," Dr. Joffe writes. "What will be critical to determine is whether the weight loss (or slowing of weight gain) achieved by those treated with orlistat is sustainable over time. Once adolescents stop using orlistat, will they maintain their weight loss, or will maintenance required ongoing use of the medication?"

He concludes by saying "It would not be surprising that no single weight-loss medication will find favor with all adolescents; pharmacotherapy will need to be individualized following a comprehensive assessment of the adolescent including the presence or absence of various comorbidities [related disease]. ...Until [more] data are available, use of orlistat should be limited to settings that offer comprehensive assessment and management of obese adolescents. There is no justification for using it as a stand-alone treatment.
(JAMA. 2005;293:2932-2934. 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.

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Embargoed for Release: 3 p.m. CT, Tuesday, June 14, 2005
Media Advisory: To contact Merritt H. Raitt, M.D., call Christine Pashley at 503-494-1360.

STUDY INDICATES FISH OIL SUPPLEMENTS DO NOT LOWER RISK OF SERIOUS HEART RHYTHM PROBLEMS FOR PATIENTS WITH IMPLANTABLE DEFIBRILLATORS

CHICAGO—Even though previous research has shown that fatty acids from fish oil reduce the risk of sudden cardiac death, patients with implantable defibrillators who took fish oil supplements did not see a reduction in serious heart rhythm abnormalities, according to a study in the June 15 issue of JAMA.

Since the original observations that Greenland Eskimos eating a diet high in omega-3 polyunsaturated fats (PUFAs) from sea mammals and fish had an unexpectedly low risk of cardiac death, multiple lines of evidence have suggested that omega-3 PUFAs have antiarrhythmic properties, according to background information in the article. Several clinical trials have shown that dietary changes or supplements to increase omega-3 PUFA intake result in a reduced risk of sudden death without a consistent change in risk of heart attack.

Merritt H. Raitt, M.D., of Oregon Health and Science University and the Portland VA Medical Center, Portland, Ore., and colleagues conducted a study to determine if fish oil supplements would have antiarrhythmic properties in patients with a recent episode of sustained ventricular arrhythmia. The double-blind, placebo-controlled trial was performed at 6 U.S. medical centers with enrollment from February 1999 until January 2003. The study included 200 patients with an implantable cardioverter defibrillator (ICD) and a recent episode of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). Patients were randomly assigned to receive fish oil, 1.8 g/d, 72 percent omega-3 PUFAs, or placebo and were followed up for a median of 718 days.

The researchers found that at 6, 12, and 24 months, 46 percent, 51 percent, and 65 percent of patients randomized to receive fish oil had ICD therapy for VT/VF compared with 36 percent, 41 percent, and 59 percent for patients randomized to receive placebo. In the subset of 133 patients whose qualifying arrhythmia was VT, 61 percent, 66 percent, and 79 percent of patients in the fish oil group had VT/VF at 6, 12, and 24 months compared with 37 percent, 43 percent, and 65 percent of patients in the control group. Recurrent VT/VF events were more common in patients randomized to receive fish oil.

"This study was undertaken to better understand the previously observed reduction in sudden death mortality after myocardial infarction associated with fish oil supplementation. The fact that we were not able to demonstrate an antiarrhythmic effect of fish oil does not call into question the potential benefits of fish oil or dietary fish intake in patients who have had a myocardial infarction. Instead, our results suggest that the mechanism of benefit, if due to antiarrhythmic properties, may not be due to the suppression of reentrant VT or VF. The lack of benefit and the suggestion that fish oil supplementation may increase the risk of VT or VF in some patients with ICDs can reasonably be interpreted as evidence that the routine use of fish oil supplementation in patients with ICDs and recurrent ventricular arrhythmias should be avoided," the authors conclude.
(JAMA.2005;293:2884-2891. Available post-embargo at jama.com)

Editor's Note: This study was supported by a National Institutes of Health grant, Public Health Service grant, and Hoffman-LaRoche Inc.

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, June 14, 2005
Media Advisory: To contact Claire Snyder, Ph.D., call Tim Parsons at 410-955-6878.

QUALITY OF CARE FOR MEDICARE PATIENTS NOT NECESSARILY BETTER IN HOSPITALS THAT PARTICIPATE IN QUALITY IMPROVEMENT ORGANIZATION PROGRAM

CHICAGO—Hospitals that participate with the quality improvement organization (QIO) program are not more likely to show improvement on quality indicators than hospitals that do not participate, according to a study in the June 15 issue of JAMA.

According to background information in the article, "Since its inception in 1965, the Medicare program has been concerned that Medicare beneficiaries receive appropriate and efficiently provided medical care." The authors explain: "Medicare currently contracts with quality improvement organizations (QIOs) and allocates approximately $200 million annually for quality improvement. Quality improvement organizations work with hospitals on quality improvement in a variety of ways, including providing educational materials, using data collection and feedback to track performance on quality indicators, and assisting hospitals in implementing systems changes (e.g., standing orders, clinical pathways.) In dollar terms, the QIOs are the federal government's largest initiative for improving the quality of care."

Claire Snyder, Ph.D., and Gerard Anderson, Ph.D., from The Johns Hopkins Bloomberg School of Public Health, Baltimore, reviewed data from four QIOs charged with improving the quality of care in five states (Maryland, Nevada, New York, Utah, and Washington) and the District of Columbia. A retrospective study was conducted comparing improvement in the quality of care of patients in hospitals that actively participated with the QIOs versus the hospitals that did not participate. The researchers analyzed data from the medical records of approximately 750 Medicare beneficiaries per state in each of five clinical areas: atrial fibrillation, acute myocardial infarction, heart failure, pneumonia, and stroke. The researchers looked at 15 quality indicators associated with improvement outcomes in the prevention or treatment of those five clinical areas at the study's baseline (1998) and again in 2000 - 2001 as a follow-up.

"At baseline, there were statistically significant differences between participating and nonparticipating hospitals on 5 of 15 quality indicators, with participating hospitals performing better on 3 of 5," the authors found. "There was no statistically significant difference in change from baseline to follow-up between participating and nonparticipating hospitals on 14 of 15 quality indicators. The one exception was that participating hospitals improved more on the pneumonia immunization indicator than nonparticipating hospitals," the authors note.

"The IOM (Institute of Medicine) is currently evaluating the QIO program, including operations, program evaluations, and whether other entities could perform the QIOs' functions. The findings from this study do not support the hypothesis that the QIO program improves the quality of care for Medicare beneficiaries in the inpatient setting," the authors write. "Additional efforts to assess and improve the QIOs effectiveness may be needed. The current IOM assessment of the QIO program provides an opportunity to evaluate the program further and recommend program modifications as needed," the authors conclude.
(JAMA. 2005;293:2900-2907. Available post-embargo at jama.com)

Editor's Note: This project was supported by grants from the Agency for Healthcare Research and Quality.

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

VIDEO: Windows Media | Quicktime

FISH OIL LINKED TO INCREASED HEART PROBLEMS FOR PATIENTS WITH IMPLANTABLE DEFIBRILLATORS

VIDEO:
B-ROLL
Frank putting soap, etc, in care packages

AUDIO:
58-YEAR OLD FRANK BROWER DOES VOLUNTEER WORK, COMPILING CARE PACKAGES AT THE VETERANS MEDICAL CENTER IN PORTLAND, OREGON.

VIDEO:
NAT SOT UP FULL FOR :03
Dr. Raitt with Frank in exam room

AUDIO:
"Let’s check your defibrillator"

VIDEO:
B-ROLL
Dr. Raitt checking Frank’s defibrillator
Implantable defibrillators (not implanted)
Frank holding monitor over his heart/defibrillator

AUDIO:
FRANK ALSO VOLUNTEERED TO BE PART OF A MEDICAL STUDY OF HEART PATIENTS. HE HAS AN IMPLANTABLE DEFIBRILLATOR, LIKE ONE OF THESE, UNDER THE SKIN IN HIS CHEST. WHEN HIS HEART STARTS BEATING TOO FAST OR ERRATICALLY, THE DEFIBRILLATOR SENDS A JOLT TO HIS HEART.

VIDEO:
SOT/FULL
@ :23
Super: Frank Brower
Has implantable defibrillator
Runs :15

AUDIO:
"It’s a big kick, I mean, you flop, just like, you know, on TV when they put the paddles on someone. It’s the same reaction. But it was just a relief. It’s a relief after that, you know, that your heart beats normal after that."

VIDEO:
B-ROLL
Fish oil capsules
Frank in exam room with Dr. Raitt
Capsules being poured into hand
GFX/FULL SCREEN

AUDIO:
RESEARCHERS HERE WANTED TO KNOW IF TAKING FISH OIL, WHICH HAS SHOWN TO INCREASE HEART HEALTH, COULD REDUCE THOSE ABNORMAL HEART RYTHYMS IN PATIENTS LIKE FRANK. SO THEY STUDIED TWO-HUNDRED PATIENTS WHO HAD IMPLANTABLE DEFIBRILLATORS, GIVING HALF FISH OIL AND HALF PLACEBO. THEIR FINDINGS APPEAR IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL
@ :58
Super: Merritt Raitt, M.D.
Portland VA Medical Center
Runs :11

AUDIO:
"The patients that were given fish oil had an increased risk of dangerous heart rhythms compared to patients that were given placebo."

VIDEO:
FULL SCREEN GRAPHIC
Title: Fish oil in patients with dangerous heart rhythms
Placebo = 36% had dangerous heart rhythm
Fish oil = up to 61% had dangerous heart rhythm
B-ROLL
Dr. Raitt going over data with colleague
Implantable defibrillators (not implanted)

AUDIO:
OVER A SIX-MONTH PERIOD, 36 PERCENT OF THE PATIENTS ON PLACEBO EXPERIENCED DANGEROUS HEART RHYTHMS. UP TO 61 PERCENT OF THE PATIENTS ON FISH OIL EXPERIENCED DANGEROUS RHYTHMS. DR. MERRITT RAITT LED THE STUDY. HE SAYS HIS STUDY FINDINGS ONLY APPLY TO PATIENTS WHO ALREADY HAD HEART RHYTHMS TREATED WITH IMPLANTABLE DEFIBRILLATORS.

VIDEO:
SOT/FULL
Merritt Raitt, M.D.
Portland VA Medical Center
Runs :13

AUDIO:
"I think there’s very good evidence that patients who’ve had a recent heart attack are very likely to benefit from taking fish oil and I wouldn’t want to alarm the general public who might be taking fish oil."

VIDEO:
B-ROLL
Frank compiling care packages

AUDIO:
BUT FOR PATIENTS LIKE FRANK, FISH OIL MAY NOT BE WHAT THE DOCTOR ORDERED. THIS IS MAVIS PRALL WITH THE JAMA REPORT.