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November 24, 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 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, November 24, 2008)

>   MAMMOGRAMS MAY DETECT SOME CANCERS THAT WOULD HAVE OTHERWISE REGRESSED

>   HIGH BLOOD PRESSURE IN THE DOCTOR'S OFFICE MAY NOT PREDICT HEART RISKS

>   DIABETES MEDICATIONS IN SAME CLASS CARRY DIFFERENT RISKS OF HEART FAILURE, DEATH

>   TELEPHONE COUNSELING MAY BE AS EFFECTIVE AS FACE-TO-FACE COUNSELING IN WEIGHT LOSS MAINTENANCE

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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, November 24, 2008
Media Advisory: To contact corresponding author H. Gilbert Welch, M.D., M.P.H., call Betty Acheson at 802-295-9363, ext. 5391. To contact editorialist Robert M. Kaplan, Ph.D., call Sarah Anderson at 310-267-0440. To contact editorialist Franz Porzsolt, M.D., Ph.D., e-mail: franz.porzsolt{at}uniklinik-ulm.de.

MAMMOGRAMS MAY DETECT SOME CANCERS THAT WOULD HAVE OTHERWISE REGRESSED

CHICAGO—Breast cancer rates increased significantly in four Norwegian counties after women there began undergoing mammography every two years, according to a report in the November 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Rates among regularly screened women remained higher than rates among women of the same age who were screened only once after six years, suggesting that some of the cancers detected by mammography may have spontaneously regressed had they not been discovered and treated.

Throughout Europe, the start of screening mammography programs has been associated with increased incidence of breast cancer, according to background information in the article. "If all of these newly detected cancers were destined to progress and become clinically evident as women age, a fall in incidence among older women should soon follow," the authors write. "The fact that this decrease is not evident raises the question: What is the natural history of these additional screen-detected cancers?"

Per-Henrik Zahl, M.D., Ph.D., of the Norwegian Institute of Public Health, Oslo, and colleagues examined breast cancer rates among 119,472 women age 50 to 64 who were all invited to participate in three rounds of screening mammograms between 1996 and 2001 as part of the Norwegian Breast Cancer Screening Program. They compared these to rates among a control group of 109,784 women age 50 to 64 in 1992, who would have been invited for screening if the program had existed at that time. Cancers were tracked for six years using a national registry, and at the end of that time all participants were invited to undergo a one-time screening to assess breast cancer prevalence.

As anticipated, breast cancer rates were higher among screened women than among the control group before the final prevalence screening. "Even after prevalence screening in controls, however, the cumulative incidence of invasive breast cancer remained 22 percent higher in the screened group," the authors write. Of every 100,000 screened women, 1,909 had breast cancer during the six-year period, compared with 1,564 of every 100,000 in the control group. Screened women were more likely to have breast cancer at every age.

"Because the cumulative incidence among controls never reached that of the screened group, it appears that some breast cancers detected by repeated mammographic screening would not persist to be detectable by a single mammogram at the end of six years," the authors write. "This raises the possibility that the natural course of some screen-detected invasive breast cancers is to spontaneously regress."

"Although many clinicians may be skeptical of the idea, the excess incidence associated with repeated mammography demands that spontaneous regression be considered carefully," they continue. "Spontaneous regression of invasive breast cancer has been reported, with a recent literature review identifying 32 reported cases. This is a relatively small number given such a common disease. However, as some observers have pointed out, the fact that documented observations are rare does not mean that regression rarely occurs. It may instead reflect the fact that these cancers are rarely allowed to follow their natural course."

The findings do not answer the question of whether mammograms prevent deaths from breast cancer, the authors note. "Instead, our findings simply provide new insight on what is arguably the major harm associated with mammographic screening, namely, the detection and treatment of cancers that would otherwise regress," they conclude.
(Arch Intern Med. 2008;168[21]:2311-2316. Available to the media pre-embargo at www.jamamedia.org)

Editor's Note: This study was supported in part by a Research Enhancement Award from the Department of Veterans Affairs. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

EDITORIAL: RESULTS EMPHASIZE OUR LACK OF KNOWLEDGE REGARDING CANCER’S NATURAL HISTORY

"Despite the appeal of early detection of breast cancer, uncertainty about the value of mammography continues," write Robert M. Kaplan, Ph.D., of the University of California, Los Angeles, and Franz Porzsolt, M.D., Ph.D., of Clincal Economics University of Ulm, Germany, in an accompanying editorial. "In this issue of the Archives, Zahl et al use a clever study design in an attempt to estimate the value of screening."

"Perhaps the most important concern raised by the study by Zahl et al is that it highlights how surprisingly little we know about what happens to untreated patients with breast cancer," Drs. Kaplan and Porzsolt continue. "In addition to not knowing the natural history of breast cancer for younger women, we also know very little about the natural history for older women. We know from autopsy studies that a significant number of women die without knowing that they had breast cancer (including ductal carcinoma in situ). The observation of a historical trend toward improved survival does not necessarily support the benefit of treatment."

"If the spontaneous remission hypothesis is credible, it should cause a major re-evaluation in the approach to breast cancer research and treatment. Certainly it is worthy of further evaluation," they conclude.
(Arch Intern Med. 2008;168[21]:2302-2303. Available to the media pre-embargo at www.jamamedia.org)

Editor's Note: Please see the article for additional information, including 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, November 24, 2008
Media Advisory: To contact Gil F. Salles, M.D., Ph.D., e-mail gilsallse{at}hucff.ufrj.br.

HIGH BLOOD PRESSURE IN THE DOCTOR’S OFFICE MAY NOT PREDICT HEART RISKS

CHICAGO—Continuously measuring blood pressure may help predict heart disease and related deaths among individuals with treatment-resistant hypertension, while blood pressure readings taken in a medical office do not appear to predict future heart risks, according to a report in November 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

About 10 percent to 30 percent of individuals with high blood pressure have a condition known as resistant hypertension, according to background information in the article. For these patients, blood pressure remains high despite treatment with at least three antihypertensive drugs, always including a diuretic (medication that increases urine output). Ambulatory blood pressure monitoring, or measuring blood pressure at regular intervals throughout the day, is increasingly important in managing patients with this condition because of the possibility of a white-coat effect (when an individual only has high blood pressure at the physician’s office).

Gil F. Salles, M.D., Ph.D., studied 556 patients with resistant hypertension who attended an outpatient clinic between 1999 and 2004. Participants underwent a clinical examination and had their blood pressure monitored continuously during a 24-hour period (every 15 minutes throughout the day and every 30 minutes at night). They were followed up at least three to four times a year until December 2007.

After a median (midpoint) follow-up period of 4.8 years, 109 (19.6 percent) of participants had a cardiovascular event or died of cardiovascular disease. This included 44 strokes, 21 heart attacks, 10 new cases of heart failure and five sudden deaths. Seventy patients (12.6 percent) died, including 46 (8.3 percent) of cardiovascular causes.

Blood pressure measured in the office did not predict any of these events, whereas higher average ambulatory blood pressures (both systolic or top-number and diastolic or bottom-number) were associated with the occurrence of fatal and non-fatal heart events. This association remained after controlling for office blood pressure and other risk factors for heart disease. When considered separately, nighttime blood pressure was superior to daytime blood pressure in predicting heart events. If nighttime systolic blood pressure increased by 22 millimeters of mercury, risk for future heart events increased by 38 percent, whereas an increase of 14 millimeters of mercury in diastolic blood pressure increased heart risks by 36 percent.

"This study has important clinical implications," the authors write. "First, it reinforces the importance of ambulatory blood pressure monitoring performance in resistant hypertensive patients. Furthermore, ambulatory blood pressure monitoring should be performed during the whole 24 hours, with separate analyses of the daytime and nighttime periods, because it seems that nighttime blood pressures are better cardiovascular risk factors than are daytime blood pressures."

"Second, it raises the question of whether therapeutic interventions directed specifically at controlling nighttime hypertension will be able to improve cardiovascular prognosis compared with the traditional approach of controlling daytime blood pressure levels," they conclude. "This important clinical question should be addressed in future prospective interventional studies."
(Arch Intern Med. 2008;168[21]:2340-2346. Available to the media pre-embargo at www.jamamedia.org)

Editor's Note: This study was supported in part by a grant from PETROBRAS-FINEP and by research grants from the Brazilian National Research Council. 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, November 24, 2008
Media Advisory: To contact Wolfgang C. Winkelmayer, M.D., Sc.D., call Holly Brown-Ayers at 617-534-1603.

DIABETES MEDICATIONS IN SAME CLASS CARRY DIFFERENT RISKS OF HEART FAILURE, DEATH

CHICAGO—Older adults who take the diabetes medication rosiglitazone appear to have a higher risk of death and heart failure than those taking the related medication pioglitazone, according to a report in the November 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

In 1997, a new class of oral medications known as thiazolidinediones expanded the available options for diabetes treatment, according to background information in the article. These drugs offered several clinical benefits, including decreased insulin resistance, better control of blood sugar and, for some patients, a delay in beginning insulin therapy. Two agents in this class, rosiglitazone maleate and pioglitazone hydrochloride, were approved and marketed beginning in 1999. Not long after, it became apparent that these drugs had important adverse effects, including heart failure and heart attack. A black box warning was recently added to both drugs cautioning against their use in patients with existing heart failure.

Recent meta-analyses have suggested that the risks associated with rosiglitazone may be higher than those associated with pioglitazone. To compare cardiovascular outcomes and death rates between the two therapies, Wolfgang C. Winkelmayer, M.D., Sc.D., and colleagues at Brigham and Women’s Hospital and Harvard Medical School, Boston, used medical claims data to study 28,361 patients older than 65 years who began taking either rosiglitazone or pioglitazone between 2000 and 2005. Of these, 14,260 (50.3 percent) began treatment with pioglitazone and 14,101 (49.7 percent) with rosiglitazone.

After an average of 380 days taking pioglitazone or 369 taking rosiglitazone, 1,869 patients died. After adjusting for other factors, individuals taking rosiglitazone had a 15 percent higher rate of death and a 13 percent greater risk of heart failure compared with those taking pioglitazone. However, there were no differences in heart attack or stroke risk between the two groups.

"This study confirms the safety concerns that have been raised for rosiglitazone compared with pioglitazone, which, in turn, also cannot be considered a very safe drug given its well-documented effect on the risk of congestive heart failure," the authors write. "Although previous studies have indicated that the increased risk with rosiglitazone use resides predominantly in cardiovascular outcomes, the present study suggests that differences in all-cause mortality [death] risk may be even more important to consider in elderly patients."
(Arch Intern Med. 2008;168[21]:2368-2375. Available to the media pre-embargo at www.jamamedia.org).

Editor's Note: This study was supported by a Scientist Development Grant from the American Heart Association; a Norman S. Coplon Extramural Research Program Award from Satellite Healthcare Inc.; and investigator-initiated grants from Amgen, Fresenius Medical Care and GlaxoSmithKline. 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, November 24, 2008
Media Advisory: To contact Michael G. Perri, Ph.D., call Jill Pease at 352-273-5816.

TELEPHONE COUNSELING MAY BE AS EFFECTIVE AS FACE-TO-FACE COUNSELING IN WEIGHT LOSS MAINTENANCE

CHICAGO—Face-to-face and telephone follow-up sessions appear to be more effective in the maintenance of weight loss for women from rural communities compared with weight loss education alone, according to a report in the November 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. In addition, telephone counseling appears to be just as effective as face-to-to face counseling for weight loss management.

"Rural counties in the United States have higher rates of obesity, sedentary lifestyle and associated chronic diseases than nonrural areas, yet treatment of obesity in the rural population has received little research attention," according to background information in the article. Studies have shown that diet, exercise and behavior changes can produce significant weight loss and that extended care programs such as clinic-based follow-up sessions can improve weight loss maintenance. "However, in rural communities, distance to health care centers represents a significant barrier to ongoing care."

Michael G. Perri, Ph.D., of the University of Florida, Gainesville, and colleagues conducted a randomized trial involving 234 obese women (age 50 to 75) who completed a six-month weight loss program in six medically underserved rural communities. The women were randomly assigned to three different extended-care programs consisting of 26 biweekly sessions for one year; 72 participants received telephone counseling, 83 received face-to-face counseling and 79 received biweekly newsletters containing weight loss maintenance tips. Estimated program costs were also assessed.

Average weight at the beginning of the study was 96.4 kilograms (212.5 pounds). The average weight lost during the six-month intervention was 10 kilograms (22 pounds). One year after the randomization of the women into the three different programs, "participants in the telephone and face-to-face extended-care programs regained less weight [an average of 1.2 kilograms (2.6 pounds) for each group] than those in the education control group [an average 3.7 kilograms (8.2 pounds)]," the authors write.

"The beneficial effects of extended-care counseling were mediated by greater adherence to behavioral weight management strategies, and cost analyses indicated that telephone counseling was less expensive than face-to-face intervention," the authors note.

"Our findings highlight the benefits of extended-care interventions and indicate that telephone counseling represents an effective and cost-efficient approach to the management of obesity in underserved rural settings," the authors conclude.
(Arch Intern Med. 2008;168[21]:2347-2354. Available to the media pre-embargo at www.jamamedia.org).

Editor's Note: Dr. Perri and Dr. Limacher have received grant support from Orexigen Therapeutics. This study was supported by a Demonstration and Dissemination Grant from the National Heart, Lung and Blood Institute. 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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