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January 29, 2008

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, January 29, 2008)


JAMA NEWS RELEASES

>   COMMON DRUG-RELEASING CORONARY STENTS APPEAR TO HAVE SIMILAR CLINICAL OUTCOMES

>   SECONDHAND SMOKE EXPOSURE IS ASSOCIATED WITH WORSENING OF LUNG FUNCTION FOR PERSONS WITH CYSTIC FIBROSIS

>   EXPRESSION PATTERNS OF MICRORNAS APPEAR ALTERED IN COLON CANCER, AND ASSOCIATED WITH POOR OUTCOMES

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   GENE MUTATION MAY HELP EXPLAIN DIFFERENCE IN LUNG FUNCTION AMONG CYSTIC FIBROSIS PATIENTS

INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.

TV Note: This week's JAMA Report video is on the effect of secondhand smoke for persons with cystic fibrosis. The report will be fed Tuesday, January 29, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 26 (formerly Intelsat America 6) C-Band, Transponder 14, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.

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.

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

Embargoed for Release: 3:00 p.m. CT, Tuesday, January 29, 2008
Media Advisory: To contact Anders M. Galløe, M.D., email: anders{at}galloe.dk. To contact editorial co-author David J. Moliterno, M.D., call Beth Goins at 859-257-1754.

COMMON DRUG-RELEASING CORONARY STENTS APPEAR TO HAVE SIMILAR CLINICAL OUTCOMES

CHICAGO—A comparison of use of the first two commercially available drug-releasing coronary stents (for the medications sirolimus and paclitaxel) among patients in "everyday clinical practice" indicates no significant differences for outcomes such as heart attack or cardiac death, according to a study in the January 30 issue of JAMA.

Drug-releasing (eluting) stents are used for percutaneous coronary interventions (PCI) to help reduce the rate of re-narrowing of a coronary artery, according to background information in the article. Approval of drug-eluting coronary stents was based on results of relatively small trials of selected patients; however, in routine practice, stents are used in a broader spectrum of patients.

Anders M. Galløe, M.D., of the University of Copenhagen, Denmark, and colleagues compared the efficacy and safety of sirolimus-eluting and paclitaxel-eluting stents in a study designed to reflect everyday clinical practice. The SORT OUT II trial included 2,098 men and women treated with PCI and randomized to receive either sirolimus-eluting (n = 1,065) or paclitaxel-eluting (n = 1,033) stents at five university hospitals in Denmark. The patients were initially treated for ST-segment elevation myocardial infarction (STEMI; a certain pattern on an electrocardiogram following a heart attack), non-STEMI or unstable angina pectoris, and stable angina.

The researchers found that the proportion of patients experiencing major adverse cardiac events, such as cardiac death, heart attack, target lesion revascularization, or target vessel revascularization, were 98 (9.3 percent) for the sirolimus-eluting stent group and 114 (11.2 percent) for the paclitaxel-eluting stent group. The stent thrombosis rates were 27 (2.5 percent) in the sirolimus-eluting stent group and 30 (2.9 percent) in the paclitaxel-eluting stent group.

"In conclusion, the SORT OUT II trial found no statistical significant differences in the primary or secondary end points between the sirolimus-eluting stent and paclitaxel-eluting stent in everyday clinical practice among patients undergoing PCI for ST-segment elevation myocardial infarction, non–ST-segment elevation myocardial infarction or unstable angina pectoris, and stable angina. The rates of serious adverse events, cardiac death, acute myocardial infarction, and stent thrombosis were low, suggesting that, at least when considering 18 months of follow-up, the use of drug-eluting stents in the general population may be safe," the authors write.
(JAMA. 2008;299[4]:409-416. 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: EFFECTIVENESS OF DRUG-ELUTING STENTS IN REAL-WORLD PATIENTS

In an accompanying editorial, Debabrata Mukherjee, M.D., and David J. Moliterno, M.D., of the University of Kentucky, Lexington, comment on the findings of Galløe and colleagues regarding the comparison of stents.

"In 2008, clinicians will have additional choices of drug-eluting stents with the availability of second-generation devices—namely, the everolimus-eluting stent, which yielded similar or fewer major adverse cardiac events among patients as compared with the paclitaxel-eluting stent, and the zotarolimus-eluting stent, which was shown to be noninferior to the paclitaxel-eluting stent. The ongoing choice of a drug-eluting stent will likely depend on multiple factors that will include safety, effectiveness, deliverability, and—given recent cuts in reimbursement—cost of the device."

"The current literature for drug-eluting stents can be challenging to interpret because of differing criteria for study enrollment, definitions for acute stent thrombosis and other clinical end points, and varied intervals of dual antiplatelet therapy and follow-up after stent implantation. Similarly, current real-world registries are usually limited by lack of valid control groups and often use historical controls. A large longitudinal database for patients receiving these various drug-eluting stents with open entry to fully capture all procedures may help determine the safest and most effective revascularization practice possible and should help guide future recommendations," they write.
(JAMA. 2008;299[4]:454-455. 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, January 29, 2008
Media Advisory: To contact corresponding author Garry R. Cutting, M.D., call Audrey Huang at 410-614-5105.

SECONDHAND SMOKE EXPOSURE IS ASSOCIATED WITH WORSENING OF LUNG FUNCTION FOR PERSONS WITH CYSTIC FIBROSIS

CHICAGO—Exposure to secondhand smoke is associated with adverse effects on lung function among persons with cystic fibrosis, with this effect being worse for persons with certain gene variations, according to a study in the January 30 issue of JAMA.

Cystic fibrosis (CF) is a fatal disorder that affects more than 30,000 individuals in the United States, with the major cause of illness and death being progressive obstructive lung disease. "Despite public health warnings, including a recent U.S. surgeon general’s report stating that there is no risk-free level of secondhand smoke exposure, substantial numbers of individuals with CF are exposed to secondhand smoke. Unfortunately, published studies have been inconsistent in associating poorer clinical outcomes in patients with CF with secondhand smoke exposure," the authors write.

J. Michael Collaco, M.D., of Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted a study examining several issues including whether secondhand smoke exposure is associated with worse lung disease and other outcomes in individuals with CF, and if the gene-environment interactions between the CF-causing gene (CFTR) or the transforming growth factor ß1 (TGFß1) gene influence the effect of secondhand smoke exposure on lung function. The researchers analyzed data from the U.S. Cystic Fibrosis Twin and Sibling Study, with missing data supplemented by the Cystic Fibrosis Foundation Data Registry. Of the 812 participants with data concerning secondhand smoke exposure in the home, 188 (23.2 percent) were exposed. Of the 780 participants with data showing their mother’s smoked during pregnancy, 129 (16.5 percent) were exposed.

The researchers found that secondhand smoke exposure was associated with decreased lung function for all measures of lung function studied. Also, socioeconomic status did not worsen the relationship between secondhand smoke exposure and reduced lung function. They also found that certain mutations in the CFTR gene determines the magnitude of the effect of secondhand smoke exposure on lung function in patients with CF.

"...CF may be a good model for uncovering gene-environment interactions that are detrimental to lung function. This study also raises the specter that healthy children bearing certain genetic variants may be at much higher risk for worse outcomes as a result of secondhand smoke exposure. Demonstration that genetically defined subsets of patients with CF exposed to secondhand smoke in the home have a substantial lifetime reduction in lung function provides potent justification for eradication of cigarette smoke exposure for all individuals with this life-limiting disorder," the authors conclude.
(JAMA. 2008;299[4]:417-424. 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.

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, January 29, 2008
Media Advisory: To contact corresponding author Curtis C. Harris, M.D., call Mike Miller at 301-496-6641.

EXPRESSION PATTERNS OF MICRORNAS APPEAR ALTERED IN COLON CANCER, AND ASSOCIATED WITH POOR OUTCOMES

CHICAGO—Preliminary research has found an association between certain microRNA expression patterns and poor survival and treatment outcomes for colon cancer, according to a study in the January 30 issue of JAMA.

Colon cancer is a major cause of cancer death worldwide. Colorectal cancer is the third most common and second leading cause of cancer death in the United States. "Even though 5-year mortality rates have modestly declined over the last 3 decades, there is still a need to identify new prognostic biomarkers and therapeutic targets for this disease," the authors write. They add that microRNAs have potential as diagnostic biomarkers and therapeutic targets in cancer.

MicroRNAs are 18 to 25 nucleotide, noncoding RNA (ribonucleic acid) molecules that have been found to regulate a variety of cellular processes and may also have a role in the development of cancer cells. The prognostic potential of microRNAs has been demonstrated for chronic lymphocytic leukemia, lung cancer and pancreatic cancer, according to background information in the article. No study has evaluated the association between microRNA expression patterns and colon cancer prognosis or therapeutic outcomes.

Aaron J. Schetter, Ph.D., M.P.H., and Curtis C. Harris, M.D., of the National Cancer Institute, National Institutes of Health, Bethesda, Md., and colleagues evaluated microRNA profiles of colon tumors and paired nontumorous tissue to study their potential role in tumor formation, diagnosis and therapeutic outcome in colon cancer. The study included 84 patients from Maryland; associations were validated in a second, independent group of 113 patients from Hong Kong.

Thirty-seven microRNAs were differentially expressed in tumor tissues by microRNA microarray analysis in the Maryland test cohort. Expression patterns of five tested microRNAs were validated in the Hong Kong cohort. "The discriminatory power of 5 microRNAs to differentiate between tumor and nontumorous tissue suggests that predictable and systematic changes of microRNA expression patterns may occur during tumorigenesis and may be representative of sporadic colon adenocarcinomas," the authors write.

"...we found systematic differences in microRNA expression patterns between colon tumors and paired nontumorous tissue. Tumors with high expression of miR-21 [a microRNA] was associated with poor survival outcome and poor response to adjuvant chemotherapy in 2 independent cohorts, independent of staging and other clinical covariates suggesting that miR-21 may be a useful diagnostic biomarker for colon adenocarcinomas and survival prognosis including response to therapy."

"Additional studies are required to demonstrate a causal link with miR-21 and the progression of colon cancer to determine the potential of miR-21 as either a biomarker or therapeutic target," the researchers write.
(JAMA. 2008;299[4]:425-436. 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.

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

GENE MUTATION MAY HELP EXPLAIN DIFFERENCE IN LUNG FUNCTION AMONG CYSTIC FIBROSIS PATIENTS

INTRO:
Approximately thirty thousand people in the United States have cystic fibrosis, a life-threatening disease that often leads to lung damage. The severity of the disease can vary greatly between patients. Some die young while others make it into adulthood. New research suggests a gene mutation may be one reason why some cystic fibrosis patients do worse than others. Jennifer Mitchell explains in this week’s JAMA Report.

VIDEO:
B-Roll
Patient using breathing machine
Tight on lips
Picture - sister Chrissy
B-Roll – Stacy at table

AUDIO:
BREATHING TREATMENTS ARE ROUTINE FOR STACY DANKO (dane-ko). SHE WAS DIAGNOSED WITH CYSTIC FIBROSIS DURING CHILDHOOD. NOW IN HER FORTIES SHE WONDERS WHY HER SISTER CHRISSY DIED FROM CYSTIC FIBROSIS AT AGE TWELVE, AND WHY HER OWN DISEASE NEVER SEEMED AS SEVERE.

VIDEO:
SOT/FULL
@ :18
Super: Stacy Danko
Cystic Fibrosis Patient
Runs :05

AUDIO:
"I think everyday why, why am I so fortunate?"

VIDEO:
B-ROLL
Researcher and colleagues
Cutaways to colleagues
In lab looking at slides
Smoking video –
Lab work

AUDIO:
DR. GARRY CUTTING AND HIS COLLEAGUES AT JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE HAVE BEEN LOOKING INTO WHY THIS OCCURS. THEY COLLECTED DATA FROM THE U.S. CYSTIC FIBROSIS TWIN AND SIBLING STUDY AND COMPARED EXPOSURE TO SECOND HAND SMOKE IN THE HOME WITH A GENE ABNORMALITY CARRIED BY SOME PATIENTS.

VIDEO:
SOT/FULL
@ :39
Super: Garry Cutting, M.D.
Johns Hopkins University School of Medicine
Runs: 06

AUDIO:
"What we really wanted to know is what makes one patient or helps one patient do better than another."

VIDEO:
B-ROLL
FULL SCREEN GXF
CYSTIC FIBROSIS STUDY (have each line reveal)

  • 812 patients studied
  • Exposure to Secondhand Smoke
  • 10% loss in lung function
  • Exposure + Gene Abnormality
  • 20% loss in lung function

AUDIO:
OUT OF ABOUT 800 CYSTIC FIBROSIS PATIENTS STUDIED, THOSE EXPOSED TO SECOND HAND SMOKE LOST, ON AVERAGE, TEN PERCENT OF THEIR LUNG FUNCTION COMPARED TO THOSE NOT EXPOSED. WHEN THOSE PATIENTS ALSO CARRIED A SPECIFIC GENE ABNORMALITY THEIR LOSS OF LUNG FUNCTION DOUBLED TO ABOUT 20 PERCENT SUGGESTING THE GENE MUTATION MAY BE PART OF THE REASON THE DISEASE IS MORE SEVERE FOR SOME THAN OTHERS.

VIDEO:
SOT/FULL
Garry Cutting, M.D.
Johns Hopkins University School of Medicine
Runs :08

AUDIO:
"For the first time we now see that other genes play a role in how bad that effect is on the lungs of cystic fibrosis patients."

VIDEO:
B-ROLL
GFX/ JAMA COVER
B-Roll of Stacy
B-Roll boyfriend smoking
Tight cigarette

AUDIO:
THE STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. STACY DANKO AND HER SISTER WERE BOTH EXPOSED TO SECONDHAND SMOKE AS CHILDREN AND HER BOYFRIEND SMOKES. SHE WOULD LIKE TO KNOW IF SHE CARRIES THE GENE.

VIDEO:
SOT/FULL
Stacy Danko
Cystic Fibrosis Patient
Runs :12

AUDIO:
"If you know you carry the gene that is going to make it affect you more then you’re going to be that much more careful. You’re going to be more open with individuals smoking around you. You’ll just avoid it."

VIDEO:
B-ROLL
Lab video
Walk with boyfriend
Walking away

AUDIO:
RESEARCHERS SAY WITH FURTHER STUDY, THE FINDINGS MAY APPLY TO OTHER CHRONIC RESPIRATORY PROBLEMS. IN THE MEANTIME, STACY REMAINS HOPEFUL FOR A CURE AND TRIES TO PROTECT THE FORTY PERCENT LUNG FUNCTION SHE STILL HAS LEFT. JENNIFER MITCHELL, THE JAMA REPORT.

TAG:
The findings do not recommend genetic testing. Researchers say further studies are still needed and regardless of whether cystic fibrosis patients carry the gene, it is always best to avoid the negative effects of secondhand smoke. The study was conducted in the United States from 2000 to 2006. For more information, visit www.jama.com.

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