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 of 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 CONTENTS
ARCHIVES OF INTERNAL MEDICINE NEWS RELEASES
(Embargoed Until: 3 P.M. (CT), Monday, March 24, 2008)
CANCER TREATMENTS IN PHASE 3 TRIALS SUCCESSFUL UP TO HALF OF THE TIME
HOSPITALS THAT PARTICIPATE IN CLINICAL TRIALS MAY PROVIDE BETTER PATIENT CARE
PARENTS' HIGH BLOOD PRESSURE ASSOCIATED WITH INCREASED RISK OF HYPERTENSION THROUGHOUT LIFE IN MEN
AFRICAN AMERICANS LESS LIKELY THAN WHITES TO UNDERGO COLONOSCOPY SCREENINGS DESPITE FAMILY HISTORY OF COLON CANCER
DIETING AND MEDICATION MAY REDUCE BLOOD PRESSURE IN PATIENTS WITH HYPERTENSION
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 24, 2008
Media Advisory: To contact Benjamin Djulbegovic, M.D., Ph.D., call Nancy Johnson at 813-745-1478.
CANCER TREATMENTS IN PHASE 3 TRIALS SUCCESSFUL UP TO HALF OF THE TIME
CHICAGO—About one-fourth to one-half of new cancer treatments that reach assessment in phase 3 randomized clinical trials are eventually proven successful, according to a report in the March 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Cancer remains the second leading cause of death in the United States, but continuous improvements have been made in survival and other outcomes, according to background information in the article. "To a large extent, this has occurred through the introduction of new treatments tested in clinical trials, with randomized controlled trials (RCTs) widely considered to be the most reliable method of assessing differences between the effects of health care interventions," the authors write. "Cancer is the only disease for which the National Institutes of Health has consistently funded a cooperative clinical trial infrastructure. Despite this investment, little is known about the proportion of clinical trials that have led to the discovery of successful new treatments."
Benjamin Djulbegovic, M.D., Ph.D., of the H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa, and colleagues extracted data from all completed phase 3 randomized clinical trials conducted by the National Cancer Institute cooperative groups since their inception in 1955. A total of 624 trials involving 216,451 patients were analyzed.
Overall, 30 percent of the trials had statistically significant results; in 80 percent of those cases, new treatments were superior to established protocols. The original researchers reported that the risk-benefit ratio favored new treatments in 41 percent of comparisons, while standard treatments were favored in 59 percent of comparisons.
"The real effects of new treatments compared with standard treatments in terms of patient outcomes such as survival is best measured by quantitative pooling of data," the authors write. "When done this way, new treatments are, on average, found to be slightly superior to standard treatments, with a 5 percent relative reduction in the death rate. This, of course, should not be understood as the average effects of new discoveries being equally spread among all patients." In 15 percent of the trials, breakthrough therapies were discovered; in 2 percent of the cases, these reduced the death rate by more than 50 percent.
"In conclusion, society has received a good return on its investment in the cooperative oncology group system," which funds the trials, the authors write. "The public can expect that about 25 percent to 50 percent of new cancer treatments that reach the stage of assessment in randomized clinical trials will prove to be successful. This pattern of successes has become more consistent over time. However, our results also indicate that the absolute number of discoveries might be improved if the proportion of inconclusive trials is reduced."
(Arch Intern Med. 2008;168[6]:632-642. Available to the media pre-embargo at www.jamamedia.org)
Editor's Note: Co-author Dr. Bennett received consulting fees and grant support from Sanofi-Aventis and AMGEN. Co-author Dr. Bepler received consulting fees and grant support from Eli Lilly and Company and Sanofi-Aventis. This study was supported by the Research Program on Research Integrity, Office of Research Integrity and National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 24, 2008
Media Advisory: To contact Sumit R. Majumdar, M.D., M.P.H., call Jo-anne Nugent at 780-492-9651.
HOSPITALS THAT PARTICIPATE IN CLINICAL TRIALS MAY PROVIDE BETTER PATIENT CARE
CHICAGO—Hospitals that participate in clinical trials appear to provide better care for patients with heart attacks or other acute heart events and have lower death rates than hospitals that do not participate in clinical trials, according to a report in the March 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Quality of care for common conditions such as acute coronary syndromes has slowly improved after the implementation of clinical guidelines, performance measurement and quality improvement efforts. Recent studies suggest that physician leadership, presence of shared goals, administrative support and credible feedback are associated with better hospital performance. Three of these characteristics are also believed to be important in successfully conducting hospital-based clinical trials. "We hypothesized that these same elements required for hospitals to participate in trials could induce beneficial changes in the hospital environment, thereby leading to better processes and outcomes of care for patients treated outside the trial setting," the authors write.
Sumit R. Majumdar, M.D., M.P.H., of the University of Alberta, Canada, and colleagues analyzed data from 174,062 patients with two specific types of heart conditions, high-risk non–ST-segment elevation acute coronary syndrome with unstable angina and non–ST-segment elevation myocardial infarction. The patients were admitted to 494 hospitals participating in Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE)—an ongoing, voluntary, observational data collection and quality improvement initiative—from Jan. 1, 2001 to June 30, 2006. Process-of-care and in-hospital outcome data were collected. Patients were split into three groups: those treated at hospitals with no trial participation (29,984 patients), low trial participation (93,705 patients) and high trial participation (50,373 patients).
In total, 4,590 patients (2.6 percent) were enrolled in clinical trials, with 145 hospitals having no enrollment, 226 hospitals having a midpoint of 1 percent enrollment and 123 hospitals having a midpoint of 4.9 percent enrollment.
The overall (composite) median (midpoint) guideline adherence scores increased with increasing levels of trial participation, from 76.9 percent among hospitals with no trial enrollment, 78.3 percent for hospitals with low trial enrollment and 81.1 percent among hospitals with high trial enrollment. "In-hospital mortality decreased with increasing trial participation: 5.9 percent vs. 4.4 percent vs. 3.5 percent," the authors write. "Patients treated at hospitals that participated in trials had significantly lower mortality than patients treated at non-participating hospitals."
"In conclusion, patients treated at hospitals that participate in clinical trials seem to receive better quality of care and seem to have significantly better outcomes than patients treated at hospitals that do not participate in trials-at least in the setting of acute coronary syndrome," the authors conclude. "For policy makers and physicians, our findings should assuage some of the concerns related to the possible opportunity costs and potential downsides of participating in the clinical research enterprise."
(Arch Intern Med. 2008;168[6]:657-662. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This study was supported by CRUSADE, a National Quality Improvement Initiative of the Duke Clinical Research Institute, which was funded by Schering Plough Corporation, Bristol Myers Squibb/Sanofi Aventis Pharmaceuticals Partnership and Millenium Pharmaceuticals. Dr. Majumdar receives salary support awards from the Alberta Heritage Foundation for Medical Research (Health Scholar) and the Canadian Institutes of Health Research (New Investigator). Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 24, 2008
Media Advisory: To contact Nae-Yuh Wang, Ph.D., call Christen Brownlee at 410-955-7832.
PARENTS' HIGH BLOOD PRESSURE ASSOCIATED WITH INCREASED RISK OF HYPERTENSION THROUGHOUT LIFE IN MEN
CHICAGO—Individuals who have one or two parents with hypertension appear to have a significantly increased risk of developing elevated blood pressure throughout their adult lives, according to a report in the March 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Hypertension, or high blood pressure, often clusters in families, according to background information in the article. Researchers estimate that between 35 percent and 65 percent of high blood pressure is heritable.
Nae-Yuh Wang, Ph.D., and colleagues at the Johns Hopkins University, Baltimore, assessed hypertension in 1,160 men who first filled out study questionnaires in 1947, when they were medical students. At that time, the participants underwent medical examinations and reported their medical history, health habits and dietary habits. Each year for 54 years of follow-up, they completed annual questionnaires regarding their blood pressure and the diagnosis and treatment of hypertension in themselves and their parents.
At the beginning of the study, 264 (23 percent) of the medical students reported at least one parent with hypertension, including 20 with both parents who had hypertension. During follow-up, 583 new cases of parental hypertension occurred, so that 701 (60 percent) of the group had at least one parent with high blood pressure and 166 (14 percent) had two. Men with one or two parents with hypertension had higher average systolic (top number) and diastolic (bottom number) blood pressure at the beginning of the study and were also more likely to develop hypertension at some point during adulthood than those whose parents never developed hypertension.
"Men with both parents with hypertension or men with one parent who was hypertensive before the age of 55 years had a much higher risk of developing hypertension, especially at a younger age," the authors write. Early-onset hypertension in both parents was associated with a 6.2-fold higher risk of hypertension at any point in adulthood and a 20-fold higher risk of developing hypertension by age 35.
"Our findings emphasize the importance of asking patients about parental hypertension to identify those who are at high risk of developing hypertension, especially at a young age, for both population-based and individual-level interventions," the authors conclude. "They also underscore the importance of primary prevention and blood-pressure monitoring early in life in men with parental hypertension, especially those who have a parent with early-onset hypertension."
(Arch Intern Med. 2008;168[6]:643-648. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This work was supported in part by grants from the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 24, 2008
Media Advisory: To contact Harvey J. Murff, M.D., M.P.H., call Craig Boerner at 615-322-4747.
AFRICAN AMERICANS LESS LIKELY THAN WHITES TO UNDERGO COLONOSCOPY SCREENINGS DESPITE FAMILY HISTORY OF COLON CANCER
CHICAGO—African Americans who have multiple first-degree relatives with colon cancer are less likely than whites with affected relatives to undergo recommended screening procedures, according to a report in the March 24 issue of the JAMA/Archives journals.
Family history increases risk for colon cancer, especially if multiple first-degree relatives develop the condition or if one immediate family member is diagnosed before age 60, according to background information in the article. Most clinical guidelines recommend that individuals with these family history factors begin undergoing screening for colorectal cancer at age 40 years, as opposed to age 50 for the general population. A colonoscopy every five years is the screening method of choice.
Harvey J. Murff, M.D., M.P.H., of Vanderbilt University, Nashville, Tenn., and colleagues analyzed screening behavior in 41,830 individuals (32,265 African Americans and 9,565 whites) age 40 to 79 years. Demographic characteristics, family cancer history, tobacco and alcohol use, medical history, physical activity level and medication use were assessed at initial interviews, conducted between 2002 and 2006. Participants were also asked whether they had undergone sigmoidoscopy or colonoscopy for colon cancer screening.
A total of 538 African Americans (1.7 percent) reported either multiple first-degree relatives with colon cancer or a first-degree relative diagnosed before age 50, compared with 255 whites (2.7 percent). Of those, 27.3 percent of African Americans and 43.1 percent of whites reported having a colonoscopy within the past five years, as recommended. Also in this group, African Americans were less likely than whites (19.7 percent vs. 46.9 percent) to report a personal diagnosis of colorectal polyps, precursors to colorectal cancer.
"For both African Americans and whites with family histories of colon cancer, the most common reason given for not having had a colonoscopy or flexible sigmoidoscopy was the lack of a recommendation from their health care provider, and this reason was more commonly reported by African Americans," the authors write.
"In conclusion, in this disadvantaged population, colonoscopy procedures in individuals with family histories of colon cancer are underused," they continue. "Physicians and other health care providers need to elicit family history information for all patients and ensure that African Americans with affected relatives appropriately receive colon cancer screening."
(Arch Intern Med. 2008;168[6]:625-631. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This article was supported in part by grants from the National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For more information, contact JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, March 24, 2008
Media Advisory: To contact Karl Horvath, M.D., e-mail:karl.horvath{at}meduni-graz.at.
DIETING AND MEDICATION MAY REDUCE BLOOD PRESSURE IN PATIENTS WITH HYPERTENSION
CHICAGO—Adults with hypertension may be able to lower their weight and their blood pressure by following a weight-loss diet or using the medication orlistat, according to a meta-analysis of previously published studies reported in the March 24 issue of the JAMA/Archives journals.
High blood pressure (hypertension) is a major risk factor for cardiovascular disease and is responsible for approximately 7 million deaths worldwide each year, according to background information in the article. Lowering blood pressure levels in those with hypertension has been shown to reduce cardiovascular risk, with corresponding decreases in illness and death. "Weight reduction is recommended in major guidelines as an initial intervention in the treatment of hypertensive patients," the authors write. "Among the possible means of reducing body weight are lifestyle modifications and pharmacologic and invasive interventions."
Karl Horvath, M.D., of the Medical University of Graz, Australia, and colleagues performed a meta-analysis of 48 articles that were published before March 2007 and analyzed weight-loss interventions for patients with hypertension. Of those studies, 38 assessed diet and 10 focused on medications for weight loss, including five evaluating orlistat and five assessing sibutramine. No relevant articles were located regarding the weight loss drug rimonabant or evaluating surgical weight reduction.
"Patients assigned to weight loss diets, orlistat or sibutramine reduced their body weight more effectively than did patients in the usual care/placebo groups," the authors write. "Reduction of blood pressure was higher in patients treated with weight loss diets or orlistat." Sibutramine treatment, however, did not lower overall blood pressure and appeared to increase systolic (top number) blood pressure.
"A reduction in body weight of approximately 4 kilograms [8.8 pounds] was necessary to achieve a reduction of approximately 6 milligrams of mercury in systolic blood pressure with dietary treatment and of approximately 2.5 milligrams of mercury with orlistat," the authors write. "None of the studies provided data to answer the question whether risk of mortality [death] or other patient-relevant end points can be lowered by weight reduction."
(Arch Intern Med. 2008;168[6]:571-580. Available to the media pre-embargo 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 JAMA/Archives media relations at 312/464-JAMA (5262) or e-mail mediarelations{at}jama-archives.org.
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