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
For Immediate Release:
ADVERSE DRUG EVENTS REPORTED TO FDA APPEAR TO HAVE INCREASED MARKEDLY
Embargoed Until 3 P.M. (CT), Monday, September 10, 2007:
VITAMIN D SUPPLEMENTS APPEAR TO BE ASSOCIATED WITH LOWER RISK OF DEATH
BEING OVERWEIGHT MAY INDEPENDENTLY INCREASE RISK FOR HEART DISEASE EVENTS
ARCHIVES OF NEUROLOGY NEWS RELEASES
Embargoed Until 3 P.M. (CT), Monday, September 10, 2007:
MEDICATION APPEARS HELPFUL FOR TREATMENT OF ERECTILE DYSFUNCTION IN MEN WITH SPINAL CORD INJURIES
DECLINE IN BLOOD PLATELET COUNT ASSOCIATED WITH INCREASED RISK OF HIV-RELATED DEMENTIA
ARCHIVES OF OPHTHALMOLOGY NEWS RELEASES
Embargoed Until 3 P.M. (CT), Monday, September 10, 2007:
ORGANISMS FOUND ON CONTACT LENSES CAN PROVIDE CLUES TO CAUSE OF CORNEAL EYE INFECTION
NUTRIENTS LUTEIN AND ZEAXANTHIN ASSOCIATED WITH REDUCED RISK FOR AGE-RELATED EYE DISEASE
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, September 10, 2007
Media Advisory: To contact Philippe Autier, M.D., e-mail autierp{at}iacr.fr. To contact editorialist Edward Giovannucci, M.D., Sc.D., call Todd Datz at 617-432-3952.
VITAMIN D SUPPLEMENTS APPEAR TO BE ASSOCIATED WITH LOWER RISK OF DEATH
CHICAGO—Individuals who take vitamin D supplements appear to have a lower risk of death from any cause over an average follow-up time of six-years, according to a meta-analysis of 18 previously published studies in the September 10 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Past studies have suggested that deficiencies in vitamin D might be associated with a higher risk of death from cancer, heart disease and diabetes—illnesses that account for 60 percent to 70 percent of deaths in high-income nations, according to background information in the article. "If the associations made between vitamin D and these conditions were consistent, then interventions effectively strengthening vitamin D status should result in reduced total mortality," the authors write.
Philippe Autier, M.D., of the International Agency for Research on Cancer, Lyon, France, and Sara Gandini, Ph.D., of the European Institute of Oncology, Milano, Italy, searched for randomized controlled trials of vitamin D supplements published before November 2006. They analyzed 18 separate trials that included 57,311 participants and evaluated doses of vitamin D ranging from 300 to 2,000 international units, with an average dose of 528 international units. Most commercially available supplements contain between 400 and 600 international units.
Over an average follow-up period of 5.7 years, 4,777 of the participants died. Individuals who took vitamin D had a 7 percent lower risk of death than those who did not. In the nine trials that collected blood samples, those who took supplements had an average 1.4- to 5.2-fold higher blood level of vitamin D than those who did not.
"Mechanisms by which vitamin D supplementation would decrease all-cause mortality are not clear," the authors write. Vitamin D could inhibit some mechanisms by which cancer cells proliferate, or it may boost the function of blood vessels or the immune system, they note.
"In conclusion, the intake of ordinary doses of vitamin D supplements seems to be associated with decreases in total mortality rates," the authors write. "The relationship between baseline vitamin D status, dose of vitamin D supplements and total mortality rates remains to be investigated. Population-based, placebo-controlled randomized trials in people 50 years or older for at least six years with total mortality as the main end point should be organized to confirm these findings."
(Arch Intern Med. 2007;167(16):1730-1737. 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.
EDITORIAL: VITAMIN D AND TOTAL MORTALITY
The meta-analysis "adds a new chapter in the accumulating evidence for a beneficial role of vitamin D on health," writes Edward Giovannucci, M.D., Sc.D., of the Harvard School of Public Health, Boston, in an accompanying editorial.
"Research on vitamin D should be continued to clearly elucidate the specific benefits and optimal intakes and levels of vitamin D," Dr. Giovannucci writes. "Nonetheless, based on the total body of evidence of health conditions associated with vitamin D deficiency, abetted with the results from this meta-analysis, a more proactive attitude to identify, prevent and treat vitamin D deficiency should be part of standard medical care. From a broader public health perspective, the roles of moderate sun exposure, food fortification with vitamin D and higher-dose vitamin D supplements for adults need to be debated."
(Arch Intern Med. 2007;167(16):1709-1710. 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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FOR IMMEDIATE RELEASE
Media Advisory: To contact Thomas J. Moore, A.B., call Renee Brehio at 704-831-8822.
ADVERSE DRUG EVENTS REPORTED TO FDA APPEAR TO HAVE INCREASED MARKEDLY
CHICAGO—The number of serious adverse drug events reported to the U.S. Food and Drug Administration (FDA) more than doubled between 1998 and 2005, as did deaths associated with adverse drug events, according to a report in the September 10 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
A serious adverse drug event, as defined by the FDA, means an adverse event that resulted in death, a birth defect, disability, hospitalization, or was life-threatening or required intervention to prevent harm, according to background information in the article. Such events are voluntarily reported to the FDA through its Adverse Event Reporting System (AERS) and known as "MedWatch" reports. The reports come to the FDA directly or through drug manufacturers, who are then required to forward them.
Thomas J. Moore, A.B., of the Institute for Safe Medication Practices, Huntingdon Valley, Penn., and colleagues analyzed serious adverse drug events reported to the FDA through AERS from 1998 through 2005.
During this period, a total of 467,809 serious adverse events were reported. The annual number of reports increased 2.6-fold between 1998 and 2005, from 34,966 to 89,842. The number of fatal adverse drug events increased from 5,519 to 15,107 in the same time frame, a 2.7-fold increase.
"The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion," the authors write.
A total of 1,489 drugs were associated with adverse events, but a subset of 51 drugs that each had 500 or more reports in any year accounted for 203,957 or 43.6 percent of the total adverse event reports in the study.
"Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time," the authors write. In the subset of 51 drugs with 500 or more reports in a year, the percentage of reported events associated with drugs related to safety withdrawals declined from 26 percent in 1999 to less than 1 percent in 2005. "Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system."
"These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period," they conclude. "The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs."
(Arch Intern Med. 2007;167(16):1752-1759. 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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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, September 10, 2007
Media Advisory: To contact Rik P. Bogers, Ph.D., e-mail rik.bogers{at}rivm.nl.
BEING OVERWEIGHT MAY INDEPENDENTLY INCREASE RISK FOR HEART DISEASE EVENTS
CHICAGO—Being moderately overweight or obese appears to increase the risk for developing coronary heart disease events independent of traditional cardiovascular risk factors, according to a meta-analysis of previously published studies in the September 10 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.
Nearly two-thirds of U.S. adults are overweight and therefore at higher risk for heart disease, other illnesses and death, according to background information in the article. "Because of the high prevalence of overweight and the expected future increases, it is essential to gain precise insight into the consequences of overweight for health and into the metabolic pathways that link the two," the authors write.
Rik P. Bogers, Ph.D., of the Centre for Prevention and Health Services Research, National Institute for Public Health and the Environment, Bilthoven, the Netherlands, and colleagues combined data from 21 previous studies of overweight and heart disease that included a total of 302,296 participants.
A total of 18,000 heart events or deaths occurred among these participants during the studies. After the researchers factored in age, sex, physical activity levels and smoking, moderately overweight individuals had a 32 percent increased risk of heart disease compared those who were not overweight. Obesity increased their risk 81 percent over those of normal weight.
The researchers then adjusted the figures further for blood pressure and cholesterol levels. This reduced the excess risk associated with being moderately overweight by 47 percent, to 17 percent, and with obesity by 40 percent, to 49 percent. For every five units an individual’s body mass index increased, the risk for heart disease increased 29 percent before adjusting for blood pressure and cholesterol and 16 percent after adjustment.
"Hence, the present study indicates that adverse effects of overweight on blood pressure and cholesterol levels could account for about 45 percent of the increased risk of coronary heart disease, and that there is still a significantly increased risk of coronary heart disease that is independent of these effects," the authors write. "This implies that, even under the theoretical scenario that optimal treatment would be available against hypertension and hypercholesterolemia in overweight persons, they would still have an elevated risk of coronary heart disease."
They propose several other mechanisms by which being overweight could increase the risk of heart disease, including constant low-grade inflammation, problems with blood vessel function or an imbalance in blood chemicals that could lead to more clotting.
(Arch Intern Med. 2007;167(16)1720-1728. 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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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, September 10, 2007
Media Advisory: To contact Francois Giuliano, M.D., Ph.D., e-mail giuliano{at}cyber-sante.org.
MEDICATION APPEARS HELPFUL FOR TREATMENT OF ERECTILE DYSFUNCTION IN MEN WITH SPINAL CORD INJURIES
CHICAGO—The drug tadalafil appears to improve erectile function in men with spinal cord injuries, according to an article posted online today that will appear in the November 2007 print issue of Archives of Neurology, one of the JAMA/Archives journals.
Between 10.4 and 83 individuals per million worldwide experience spinal cord injuries every year, according to background information in the article. "Throughout the world, spinal cord injury occurs most often in young men, resulting in negative physical, social and psychological consequences," the authors write. "Erectile dysfunction, defined as the inability to attain and maintain penile erection sufficient for satisfactory sexual performance, is a common complication in men with spinal cord injury." Only 25 percent of men with spinal cord injuries are able to have erections that are adequate for having intercourse.
Francois Giuliano, M.D., Ph.D., of the Raymond Poincare Hospital, Garches, France, and colleagues, conducted a randomized, double-blind study of tadalafil in 197 men with spinal cord injuries (average age 38). After a four-week period during which none of the men received treatment, 142 were randomly assigned to the tadalafil treatment group and 44 to the placebo group. During the 12-week treatment phase, the participants were instructed to take the medication as needed before the potential for sexual activity, with a maximum of one dose daily. Those assigned to take tadalafil were given a 10-milligram dose at first and were evaluated every four weeks, at which time patients were switched to a 20-milligram dose based on their response to the treatment.
At the beginning of the study, the men’s average score on the International Index of Erectile Function—a 15-item questionnaire on which a score of 25 or lower indicates erectile dysfunction—was 13.4. After 12 weeks of treatment, men taking tadalafil had an average score of 22.6 (indicating mild erectile dysfunction) and men taking placebo had an average score of 13.6 (indicating moderate erectile dysfunction). Men taking tadalafil were, on average, successful 75.4 percent of the times they attempted penetration and 47.6 percent of the times they attempted intercourse, compared with a 41.1 success rate for penetration and 16.8 percent for intercourse among men taking placebo.
"Tadalafil was safe and well tolerated with few treatment-emergent side effects," the authors write. Fifty (35 percent) of patients in the tadalafil group and 15 (34 percent) of those in the placebo group experienced at least one adverse effect. Among those taking tadalafil, the most common side effects were headache (8.5 percent of patients) and urinary tract infection (7.7 percent of patients).
"As in other erectile dysfunction studies that include patients who were difficult to treat owing to pre-existing conditions (e.g., prostatectomy, diabetes mellitus), tadalafil was efficacious for the treatment of erectile dysfunction after a traumatic spinal cord injury," the authors write. "On-demand treatment with tadalafil (10 milligrams or 20 milligrams) may help improve the sex lives of patients with erectile dysfunction and spinal cord injury and their partners."
(Arch Neurol. 2007;64(11):(doi:10.1001/archneur.64.11.nct70001).
Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: Funding for this study was provided by Lilly ICOS LLC, Bothell, Wash., and Indianapolis, Ind. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, September 10, 2007
Media Advisory: To contact corresponding author Justin C. McArthur, M.B.B.S., M.P.H., call Christen Brownlee at 410-955-7832.
DECLINE IN BLOOD PLATELET COUNT ASSOCIATED WITH INCREASED RISK OF HIV-RELATED DEMENTIA
CHICAGO—HIV patients with declining platelet counts appear to be at increased risk for HIV–associated dementia, according to a report in the September issue of Archives of Neurology, one of the JAMA/Archives journals.
"Human immunodeficiency virus–associated dementia (HIV-D) is a syndrome encompassing a spectrum of cognitive, behavioral and motor deficits that usually has an insidious onset and a chronic progressive course," the authors write as background information in the article. Therapies leading to longer life for HIV patients have paradoxically increased the prevalence of this condition. Identifying biological markers for the development of HIV–associated dementia is critical both for diagnosing the disorder and for understanding its underlying mechanisms.
Lynn M. Wachtman, D.V.M., M.P.H., of Bloomberg School of Public Health, The Johns Hopkins University School of Medicine, Baltimore, and colleagues studied 396 patients with advanced HIV who were recruited for this prospective study between 1998 and 2003. Participants were examined every six months and completed mental and physical evaluations. Blood samples were also collected and assessed for platelet count (the number of clotting cells in the blood), hemoglobin levels, CD4 lymphocyte count (a measure of certain types of white blood cells, which reflects the state of the immune system) and plasma HIV RNA levels (which indicate the amount of "viral load," and predict HIV progression).
After a median (midpoint) follow-up of 31.1 months, 40 participants developed HIV–associated dementia. A decline in platelet count from baseline was associated with the development of dementia within six to 12 months. "Those HIV-infected individuals with a decline in platelets from baseline values at this lagged time point had a two-fold increased risk of dementia" in several different analyses, the authors write. The specific timing of the association indicates that the levels of circulating platelets fluctuate as HIV–associated dementia develops, they note.
"Further analyses indicated that decline from baseline platelet levels was associated with a five- to six-fold increased risk of dementia during the first two years of follow-up, but it was not associated with an increased risk of dementia after two years," the authors continue. "It is possible that individuals who do not progress rapidly to neurologic compromise differ in respect to immune activation, treatment adherence or virologic control relative to those who develop dementia more rapidly."
"Because CD4 cell counts and HIV RNA levels have proven not to be predictive of HIV–associated dementia, it is important to investigate alternative serum and hematologic markers," the authors conclude. "Should these markers be routinely measured in a clinical setting, such as platelet counts, they may prove useful for patient management. This study identifies a significant association between platelet decline and incident HIV–associated dementia." Further study of platelet levels during HIV–associated dementia may lead both to a specific marker for the development of HIV–associated dementia and a better understanding of how the disease develops.
(Arch Neurol. 2007;64(9):1264-1272.
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.
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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, September 10, 2007
Media Advisory: To contact corresponding author Rasik B. Vajpayee, M.S., F.R.C.S., e-mail rasikv{at}unimelb.edu.au.
ORGANISMS FOUND ON CONTACT LENSES CAN PROVIDE CLUES TO CAUSE OF CORNEAL EYE INFECTION
CHICAGO—Cultures of contact lenses may sometimes identify the organisms involved in cases of corneal eye infection, according to a report in the September issue of Archives of Ophthalmology, one of the JAMA/Archives journals.
"Contact lens wear is associated with a significant risk of microbial keratitis [corneal eye infection] leading to severe sight-threatening complications," the authors write. "Microbial keratitis has been seen in all types of lenses, including rigid gas-permeable lenses, hard or poly-methylmethacrylate lenses and high-and-low-oxygen transmissibility soft lenses, as well as with all modes of wear, including daily wear, extended wear, therapeutic wear and continuous wear." Patients using soft contact lenses are more likely to develop the infection than those using other lenses.
Sujata Das, M.S., F.R.C.S., of the Center for Eye Research Australia, University of Melbourne and Royal Victorian Eye and Ear Hospital, Melbourne, Australia, and colleagues reviewed the records of 49 patients (average age 34) with contact lens-related microbial keratitis between January 2001 and December 2004 to study the association between cultures of contact lenses and cultures of corneal scrapings. Age, sex, symptoms, results and predisposing factors were reported.
Among the 49 patients, there were 50 eyes with microbial keratitis. Seventeen corneal scrapings (34 percent) and 35 contact lenses (70 percent) were found to have organisms growing on them. In 13 eyes, identical organisms were growing in the cultures taken from the corneal scrapings and from the contact lenses. Different organisms were found in the corneal eye scrapings and the contact lenses in two eyes. Only corneal scrapings were found to be culture positive in two eyes.
Serratia marcescens was the most common organism found in both the corneal scrapings and the contact lenses.
"Our study highlights the fact that contact lens culture may help in identification of the causative organism in many cases of contact lens-related microbial keratitis," the authors conclude. "Also, contact lens culture may give a clue regarding the identity of the causative organism in situations in which the corneal scraping is culture negative and may help in choosing the appropriate antimicrobial agent." However, the cultures found on contact lenses cannot replace those found in corneal scrapings.
(Arch Ophthalmol. 2007;125(9):1182-1185. 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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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, September 10, 2007
Media Advisory: To contact the Age-Related Eye Disease Study Research Group, call Traci E. Clemons, Ph.D., at 301-251-1161, ext. 212.
NUTRIENTS LUTEIN AND ZEAXANTHIN ASSOCIATED WITH REDUCED RISK FOR AGE-RELATED EYE DISEASE
CHICAGO—Consuming higher levels of the yellow plant pigments lutein and zeaxanthin may be associated with a lower risk for age-related macular degeneration, according to a report in the September issue of Archives of Ophthalmology, one of the JAMA/Archives journals.
Age-related macular degeneration (AMD) occurs when the macula, the area at the back of the retina that produces the sharpest vision, deteriorates over time. It is a leading cause of irreversible blindness among elderly people of European descent, according to background information in the article.
The Age-Related Eye Disease Study Research Group assessed 4,519 individuals who were age 60 to 80 when they enrolled in 1992 through 1998. At that time, photographs were taken of their retinas to determine if they had AMD, and if so, to which of four stages the condition had progressed. The participants also completed a food frequency questionnaire that measured how often they consumed foods rich in certain vitamins, minerals and other nutrients. These included lutein, zeaxanthin, beta-carotene, lycopene and vitamins C and E.
The participants were divided into five groups based on the amount of each nutrient they consumed. Those who had the highest levels of lutein and zeaxanthin were significantly less likely than those in the group with the lowest levels to have advanced AMD. They were also less likely to have large or numerous intermediate drusen, yellow or white deposits on the retina or optic nerve head that are a sign of AMD. No associations were seen with any of the other nutrients.
Lutein and zeaxanthin, also called carotenoids and found in yellow and dark leafy vegetables, may affect processes through which light and oxygen damage the eyes, the authors note. "Lutein and zeaxanthin have the capacity to filter short-wavelength light associated both with photochemical damage and the generation of reactive oxygen species that attack cellular lipids, proteins and nuclear material; these carotenoids also have the capacity to reduce the potency of nascent reactive oxygen species," which damage cells, they write.
"If these cross-sectional results can be confirmed in prospective samples and experimental studies, lutein and zeaxanthin may be considered as useful agents in food or supplement-based interventions designed to reduce the risk of AMD," the authors conclude.
(Arch Ophthalmol. 2007;125(9):1225-1232. Available to the media pre-embargo at www.jamamedia.org).
Editor's Note: This study was supported by contracts from the National Eye Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Md., with additional support from Bausch and Lomb, Rochester, N.Y. 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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