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: 3:00 p.m. CT, Tuesday, April 8, 2008)
JAMA NEWS RELEASES
COMBINATION THERAPY IMPROVES SURVIVAL TIME FOR PATIENTS WITH MORE ADVANCED LIVER CANCER
ACHIEVING LOWER TARGET LEVELS FOR BLOOD PRESSURE, LDL-CHOLESTEROL MAY PROVIDE CARDIOVASCULAR BENEFITS
USE OF OMEGA-3 FREE FATTY ACIDS DOES NOT APPEAR EFFECTIVE FOR PREVENTING RELAPSE OF CROHN DISEASE
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
LOWER BLOOD PRESSURE AND CHOLESTEROL TARGETS FOR DIABETICS MAY REDUCE THEIR RISK OF HEART ATTACKS AND STROKES
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Embargoed for Release: 3:00 p.m. CT, Tuesday, April 8, 2008
Media Advisory: To contact Bao-Quan Cheng, M.D., Ph.D., email: dcbq{at}sohu.com. To contact editorial co-author Andrew X. Zhu, M.D., Ph.D., call Sue McGreevey at 617-724-2764.
COMBINATION THERAPY IMPROVES SURVIVAL TIME FOR PATIENTS WITH MORE ADVANCED LIVER CANCER
CHICAGO—Combining a type of chemotherapy with radiothermal therapy resulted in longer survival time for patients with advanced liver cancer, compared to receiving the therapies alone, according to a study in the April 9 issue of JAMA.
The incidence of liver cancer is increasing worldwide. Most liver cancers are diagnosed at intermediate or advanced stages, and until now, no standard therapy has been established for treatment of liver cancer, according to background information in the article.
The therapy called transcatheter arterial chemoembolization (TACE) slows tumor progression and improves survival by combining the effect of targeted chemotherapy with that of blocking the blood supply to the tumor. Radiofrequency thermal ablation (RFA) is an emerging technology that typically is performed by advancing a specially designed probe into the tumor and applying radiofrequency energy. However, both TACE and RFA have limitations, with neither resulting in adequate control of liver cancer tumors larger than 3 cm (1.2 inches). TACE combined with RFA therapy has been used for patients with large liver cancer tumors, but the survival benefits are not known.
Bao-Quan Cheng, M.D., Ph.D., and colleagues from Shandong University, Jinan, China, conducted a randomized controlled trial to assess the long-term benefits of combining TACE and RFA therapies for liver cancer tumors larger than 3 cm. The trial was conducted from January 2001 to May 2004 and included 291 patients at a single center in China. Patients were randomly assigned to treatment with combined TACE-RFA (n = 96), TACE alone (n = 95), or RFA alone (n = 100).
At the end of follow-up, 80 patients in the TACE group (84 percent), 84 in the RFA group (84 percent), and 66 in the TACE-RFA group (69 percent) had died. The lower rate of death in the TACE-RFA group was the result of fewer deaths due to tumor progression in this group than in the TACE group or the RFA group. Median (midpoint) survival times were 24 months in the TACE group, 22 months in the RFA group, and 37 months in TACE-RFA group. Survival rates were significantly better in the TACE-RFA group than in the TACE or RFA group.
For patients with a type of liver cancer known as uninodular or multinodular, overall survival was statistically significantly better in the TACE-RFA group than in the RFA group, and TACE group, respectively.
Thirty-three patients (35 percent) achieved an objective response to treatment that was sustained for at least six months in the TACE group, 36 (36 percent) in the RFA group, and 52 (54 percent) in the TACE-RFA group.
“The current study demonstrates that combination therapy with TACE and RFA was an effective and safe treatment that may improve long-term survival for patients with hepatocellular carcinoma [liver cancer] larger than 3 cm,” the authors conclude.
(JAMA. 2008;299[14]:1669-1677. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: EXPANDING THE TREATMENT OPTIONS FOR HEPATOCELLULAR CARCINOMA
In an accompanying editorial, Andrew X. Zhu, M.D., Ph.D., of the Massachusetts General Hospital Cancer Center, and Harvard Medical School, Boston, and Ghassan K. Abou-Alfa, M.D., of Memorial Sloan-Kettering Cancer Center, New York, write that these findings are promising.
“The study by Cheng et al provides initial evidence to support the use of TACE-RFA as a new treatment option in highly selected patients with unresectable [unable to be removed by surgery] hepatocellular carcinoma [HCC]. ...However, despite the positive findings in this study, the exact role for TACE-RFA in the treatment of patients with unresectable HCC remains a controversial and unresolved issue, similar to the situation for many of the interventional-based therapies.”
(JAMA. 2008;299[14]:1716-1717. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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: 3:00 p.m. CT, Tuesday, April 8, 2008
Media Advisory: To contact Barbara V. Howard, Ph.D., call 301-602-0125. To contact editorial co-author Eric D. Peterson, M.D., M.P.H., call Michelle Gailiun at 919-660-1306.
ACHIEVING LOWER TARGET LEVELS FOR BLOOD PRESSURE, LDL-CHOLESTEROL MAY PROVIDE CARDIOVASCULAR BENEFITS
CHICAGO—Patients with diabetes who reduced their blood pressure and LDL-cholesterol to below standard target levels had a greater decrease in carotid artery wall thickness, but did not have a significant difference in cardiovascular disease events than patients who had recommended blood pressure and LDL-cholesterol levels, according to a study in the April 9 issue of JAMA.
Individuals with diabetes are at increased risk for developing cardiovascular disease (CVD), and coronary heart disease (CHD) is the leading cause of death in adults with diabetes, according to background information in the article. The increased diabetes-associated CVD risk is due in large part to higher prevalences of other major CVD risk factors, such as dyslipidemia (disorders of lipoprotein metabolism, which includes high cholesterol levels) and hypertension. Some studies have suggested that lowering systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDL-C) below recommended levels in patients with diabetes may be beneficial regarding CVD.
Barbara V. Howard, Ph.D., of MedStar Research Institute, Hyattsville, Md., and colleagues conducted SANDS (Stop Atherosclerosis in Native Diabetics Study), a clinical trial that compared the progression of subclinical atherosclerotic disease (process in which plaque builds up in the inner lining of the arteries) in 499 American Indian men and women with type 2 diabetes, randomly assigned either to reach aggressive targets of LDL-C of 70 mg/dL or lower plus SBP of 115 mm Hg or lower or to reach standard targets of LDL-C of 100 mg/dL or lower and SBP of 130 mm Hg or lower. American Indians have a high prevalence of diabetes and diabetes-related CVD. The 3-year trial was conducted at four clinical centers in Oklahoma, Arizona and South Dakota.
Average target LDL-C and SBP levels for both groups were reached and maintained. Compared with baseline, intimal medial thickness (IMT; measurement of thickness of the wall in an artery and a marker for atherosclerosis) regressed in the aggressive treatment group and progressed in the standard treatment group; carotid arterial (one of two major arteries) cross-sectional area also regressed. Rates of adverse events (38.5 percent and 26.7 percent) and serious adverse events (n = 4 vs. 1) related to blood pressure medications were higher in the aggressive group. Clinical CVD events did not differ significantly between groups.
“Although there were no differences in clinical CVD outcomes, event rates were low in both groups, and progression of subclinical disease in the standard treatment group was lower than expected. The data suggest that targeted treatment of LDL-C and SBP improved surrogate measures of CVD, with greater benefits being attributable to the lower target levels. Conversely, the lack of difference in occurrence of events and the increase in adverse events and serious adverse events attributable to the BP lowering raise the possibility that there may not be favorable long-term outcomes. Whether the strategy of more aggressive targets for either LDL-C or BP will result in lower long-term CVD event rates or economic benefit remains to be determined.”
(JAMA. 2008;299[14]:1678-1689. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: THE GREAT DEBATE OF 2008 — HOW LOW TO GO IN PREVENTIVE CARDIOLOGY?
In an accompanying editorial, Eric D. Peterson, M.D., M.P.H., and Tracy Y. Wang, M.D., M.S., of Duke University Medical Center, Durham, N.C., (Dr. Peterson is also Contributing Editor, JAMA), comment on the findings of Howard and colleagues.
“What are the take-home messages from SANDS? For the true believers, the study confirms that aggressive lipid and hypertension treatment has a favorable effect on proven ‘early markers’ of disease. Thus, with longer duration of follow-up (which will hopefully be the case), the study would most assuredly demonstrate improved patient outcomes. For the therapeutic nihilists, however, SANDS took high-risk patients with type 2 diabetes, studied them under idealized circumstances, and still found no clinical benefit after 3 years of follow-up. In fact, an aggressive approach involved greater polypharmacy and costs and had a higher risk of adverse effects.”
“In conclusion, SANDS is an important step forward in discovering whether lower goals are truly better for primary prevention. While the study results can be interpreted to support both viewpoints on the ideal target of therapy, such debates are healthy and will ultimately drive physicians to search for more definitive evidence as well as to seek system-wide strategies to effectively reach therapeutic goals in community practice,” they write.
(JAMA. 2008;299[14]:1718-1720. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, April 8, 2008
Media Advisory: To contact Brian G. Feagan, M.D., call Anthea Rowe at 519-663-3524.
USE OF OMEGA-3 FREE FATTY ACIDS DOES NOT APPEAR EFFECTIVE FOR PREVENTING RELAPSE OF CROHN DISEASE
CHICAGO—Patients with Crohn disease who took omega-3 free fatty acids supplements did not have a significantly different rate of relapse compared to patients who took placebo, according to a study in the April 9 issue of JAMA.
Effective therapy to maintain remission in Crohn disease (a chronic inflammatory disease primarily involving the small and large intestine) is an unmet medical need, with the use of some immunosuppressive drugs associated with an increased risk of infection. Omega-3 free fatty acids are anti-inflammatory substances found in marine fish that have several health benefits and have been used to treat inflammatory disorders such as rheumatoid arthritis. Previous clinical trials that evaluated omega-3 free fatty acids for maintenance of remission in Crohn disease have yielded inconsistent results, according to background information in the article.
Brian G. Feagan, M.D., of Robarts Research Institute, University of Western Ontario, London, Ontario, and colleagues conducted two large-scale trials of high-dose omega-3 free fatty acids as maintenance therapy in patients with Crohn disease in remission. The studies (Epanova Program in Crohn’s Study 1 [EPIC-1] and EPIC-2) were conducted between January 2003 and February 2007 at 98 centers in Canada, Europe, Israel and the United States. Data from 363 and 375 patients with Crohn disease in remission were evaluated in EPIC-1 and EPIC-2, respectively. Patients were randomly assigned to receive either 4 grams/day of omega-3 free fatty acids or placebo for up to 58 weeks. For EPIC-1, 188 patients were assigned to receive omega-3 free fatty acids and 186 patients to receive placebo. Corresponding numbers for EPIC-2 were 189 and 190 patients, respectively.
The researchers found that there was no significant difference in relapse rates observed between the two treatment groups in either trial. In EPIC-1, 54 patients treated with omega-3 free fatty acids and 62 patients treated with placebo experienced a clinical relapse. The proportion of patients assigned to receive omega-3 free fatty acids who experienced a relapse within 360 days was estimated to be 31.6 percent, compared with 35.7 percent for those who received placebo.
In EPIC-2, 84 patients treated with omega-3 free fatty acids and 94 patients treated with placebo experienced a clinical relapse. The proportion of patients assigned to receive omega-3 free fatty acids who experienced a relapse within 360 days was estimated to be 47.8 percent, compared with 48.8 percent of those who received placebo.
Serious adverse events were uncommon and mostly related to Crohn disease.
“Our results are important because the use of alternative medicines in general, and omega-3 free fatty acid formulations in particular, is widespread among patients with inflammatory bowel disease. This may be due, in part, to dissemination of the positive results obtained in [a trial by Belluzzi et al]. Given the negative results observed in the EPIC trials and in [a trial by Lorenz-Meyer et al], we do not endorse this practice, since patients with Crohn disease who are at risk for relapse would be better served by taking medications of known efficacy,” the authors write.
(JAMA. 2008;299[14]:1690-1697. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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JAMA REPORTS
VIDEO: Windows Media | Quicktime
LOWER BLOOD PRESSURE AND CHOLESTEROL TARGETS FOR DIABETICS MAY REDUCE THEIR RISK OF HEART ATTACKS AND STROKES
INTRO:
Diabetics are at an increased risk when it comes to developing heart attacks and strokes. A new study finds lowering suggested targets for blood pressure and cholesterol levels beyond national guidelines may help prevent certain risk factors. Jennifer Mitchell explains in this week’s JAMA Report.
VIDEO:
B-ROLL
People on crowded street
Patient having blood pressure taken
AUDIO:
MILLIONS OF AMERICANS BATTLE DIABETES. NATIONAL RECOMMENDED GUIDELINES ARE IN PLACE TO HELP PATIENTS CONTROL THEIR BLOOD PRESSURE AND CHOLESTEROL. BUT ARE THOSE GUIDELINES SUFFICIENT?
VIDEO:
SOT/FULL
Super @: 12
Barbara Howard, Ph.D.
MedStar Research Institute
Runs :11
AUDIO:
“We know now that it’s important to control risk factors for heart disease in people with diabetes yet we don’t know how far to aim.”
VIDEO:
B-ROLL
Researcher talks at table
Study documents
FULL SCREEN GRAPHIC:
Group 1
Blood pressure – 130 or lower
LDL cholesterol – 100 or lower
Group 2
Blood pressure – 115 or lower
LDL cholesterol – 70 or lower
AUDIO:
DOCTOR BARBARA HOWARD IS AN EPIDEMIOLOGIST AT MEDSTAR RESEARCH INSTITUTE IN MARYLAND. SHE AND HER COLLEAGUES ANALYZED NEARLY FIVE HUNDRED NATIVE AMERICAN MEN AND WOMEN WITH TYPE TWO DIABETES. THEY RANDOMLY ASSIGNED PATIENTS INTO TWO GROUPS AND FOLLOWED THEM FOR THREE YEARS. ONE GROUP WAS TREATED TO THE CURRENT STANDARD, A SYSTOLIC BLOOD PRESSURE OF ONE HUNDRED AND THIRTY OR LOWER AND LDL CHOLESTEROL OF ONE HUNDRED OR LOWER. THE OTHER GROUP HAD LOWER TARGETS. A SYSTOLIC BLOOD PRESSURE OF ONE HUNDRED FIFTEEN OR LOWER AND LDL CHOLESTEROL OF SEVENTY OR LOWER.
VIDEO:
SOT/FULL
Barbara Howard, Ph.D.
MedStar Research Institute
Runs :15
AUDIO:
“The aggressive group actually had a reduction in the thickness of the neck vessels, an actual reduction in what we see as an indicator of plaque buildup, and that has not been seen in most studies.”
VIDEO:
B-ROLL
Echo cardiogram video here
Doctors look at echo heart images on monitor
GFX/ JAMA COVER
AUDIO:
USING ULTRASOUND RESEARCHERS ALSO MEASURED THE SIZE OF THE MAIN PUMPING CHAMBER OF THE HEART. IT DECREASED IN ALL PATIENTS BUT IT DECREASED MORE IN THOSE WHO REACHED LOWER BLOOD PRESSURE AND CHOLESTEROL TARGETS. THE STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
Barbara Howard, Ph.D.
MedStar Research Institute
Runs:13
AUDIO:
“We could infer that these changes that we see if more people were treated longer would then result in a difference in the numbers of heart attacks and strokes.”
VIDEO:
B-ROLL
Patient having blood taken
Patients and nurse talking
AUDIO:
RESEARCHERS SAY THE FINDINGS INDICATE HOW IMPORTANT IT IS FOR DIABETICS TO ACHIEVE AND MAINTAIN EVEN STARDARD TARGETS. THEY RECOMMEND TALKING TO YOUR DOCTOR ABOUT CHOLESTEROL AND BLOOD PRESSURE LEVELS THAT ARE RIGHT FOR YOU BASED ON YOUR OWN RISK FACTORS. JENNIFER MITCHELL, THE JAMA REPORT.
TAG:
Study participants were all Native Americans, a population with a high rate of diabetes. Researchers say additional studies are needed to determine if changes in national guidelines for blood pressure and cholesterol levels for diabetics are necessary. For more information about this study you can log on to www.jama.com.
