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September 14, 2009


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, September 14, 2009)

>   Implantable Defibrillators Not Associated With Reduced Risk of Death in Women With Heart Failure

>   Active Older Adults Live Longer, Have Better Functional Status

>   Web-Based Screening and Intervention May Reduce Drinking in University Students

ARCHIVES OF NEUROLOGY NEWS RELEASES

(Embargoed Until: 3 P.M. (CT), Monday, September 14, 2009)

>   On-the-Job Pesticide Exposure Associated With Parkinson's Disease

>   Difficulties With Daily Activities Associated With Progression To Dementia

>   Study Examines Stroke Risk Among Patients Undergoing Cardiac Surgery

ARCHIVES OF OPHTHALMOLOGY NEWS RELEASES

(Embargoed Until: 3 P.M. (CT), Monday, September 14, 2009)

>   Steroid Injections May Help Restore Vision in Some Patients With Blocked Eye Veins


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EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, September 14, 2009
Media Advisory: To contact corresponding author Christian Machado, M.D., call Brian Taylor at 586-753-0726 or e-mail Brian.Taylor{at}providence-stjohnhealth.org. To contact editorial author Rita F. Redberg, M.D., call Kate Schoen at 415-476-3024 or e-mail kate.schoen{at}ucsf.edu.

Implantable Defibrillators Not Associated With Reduced Risk of Death in Women With Heart Failure

CHICAGO—Implantable cardioverter-defibrillators do not appear to be associated with a reduced risk of death in women with advanced heart failure, according to a meta-analysis of previously published research in the September 14 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Heart failure affects about 5.3 million Americans, almost half of them women, according to background information in the article. Patients with heart failure are six to nine times more likely than the general population to experience sudden cardiac death. In addition to medication, treatment for heart failure involves preventing sudden cardiac death through the implantation of a cardioverter-defibrillator. This therapy is supported by numerous clinical trials, the authors note. However, questions remain regarding the benefits in certain patient subgroups, including women.

Hamid Ghanbari, M.D., and colleagues at Providence Hospital Heart Institute and Medical Center, Southfield, Mich., searched for randomized clinical trials of implantable defibrillator therapy for heart failure patients published between 1950 and 2008 that included data on the risk of death for female patients. Five eligible trials that included 934 women were identified.

None of the five trials demonstrated a significant benefit of defibrillator implantation over medical therapy for women. When the researchers pooled the data and performed a meta-analysis, the implantable cardioverter-defibrillator was not associated with decreased all-cause mortality in women. Among the 3,810 men in the studies, however, a statistically significant decrease in death rate was found in each of the five trials alone and in the combined meta-analysis.

There are several possible reasons for the sex differences in these results, the authors note. Among patients with heart disease, women have about one-fourth the risk of sudden cardiac death as men. This may be because women have different patterns of arrhythmias and also because they have more co-occurring illnesses that may increase their risk of death from other causes. Therefore, a larger study population may be needed to show any benefit of defibrillator implantation in women.

"Most clinical trials have been heavily weighted toward men; therefore, generalization of the results to women remains questionable. The best answer to this problem would be to perform a clinical trial that specifically targets women with heart failure to test the hypothesis of whether implantable cardioverter-defibrillator implantation reduces their overall mortality [death] rate," the authors write. Because clinical guidelines already recommend defibrillator treatment to prevent sudden cardiac death, such a trial may be difficult to propose, they note. "However, on the basis of our findings it seems that a trial targeting women is needed, and a meta-analysis such as ours may be an appropriate first step to explore this hypothesis."
(Arch Intern Med. 2009;169[16]:1500-1506. 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: What's Good for the Gander May Not Be Good for the Goose

"Approximately 30 percent of implantable cardioverter-defibrillator recipients are women. However, data supporting the efficacy of implantable cardioverter-defibrillators for primary prevention in women is sparse," writes Rita F. Redberg, M.D., of University of California, San Francisco, and editor of Archives of Internal Medicine, in an accompanying editorial. "In other words, implantable cardioverter-defibrillators are being implanted in hundreds of thousands of women without substantial evidence of benefit, apparently based on the assumption that, to paraphrase the old saying, 'What's good for the gander is good for the goose.'"

"It is important to know the benefits of implantable cardioverter-defibrillator use in women, especially considering the known risks of morbidity and mortality," Dr. Redberg continues. "Ghanbari et al rightly conclude that further studies are needed. Part of the reason for the lack of sex-specific data for devices may be related to the lack of Food and Drug Administration guidance in this area. There is reason to be optimistic that this deficit will start to be corrected in the near future."

"Until then, meta-analyses such as the one by Ghanbari et al are the best way to determine if the goose is doing as well as the gander," she concludes.
(Arch Intern Med. 2009;169[16]:1460-1461. 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, September 14, 2009
Media Advisory: To contact corresponding author Jeremy M. Jacobs, M.B.B.S., e-mail jacobsj{at}haddasah.org.il.

Active Older Adults Live Longer, Have Better Functional Status

CHICAGO—Older adults who continue or begin to do any amount of exercise appear to live longer and have a lower risk of disability, according to a report in the September 14 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

"Physical activity is a modifiable behavior associated with health, functional status and longevity, and encouraging a physically active lifestyle has become an accepted public health goal," the authors write as background information in the article. However, most research on the benefits of physical activity has focused on middle-aged populations.

Jochanan Stessman, M.D., and colleagues at Hebrew University Medical Center and Hebrew University Hadassah Medical School, Jerusalem, studied 1,861 individuals born in 1920 and 1921. Participants underwent assessments in their homes at ages 70, 78 and 85 years, during which they were asked about their physical activity levels. Those who performed less than four hours per week of physical activity were considered sedentary, while those who exercised about four hours weekly, performed vigorous activities such as jogging or swimming at least twice weekly or who engaged in regular physical activity (for example, walking at least an hour daily) were considered physically active.

The proportion of participants who were physically active was 53.4 percent at age 70, 76.9 percent at age 77 and 64 percent at age 85. When compared with those who were sedentary, individuals who were physically active were 12 percent less likely to die between ages 70 and 78, 15 percent less likely to die between ages 78 and 85 and 17 percent less likely to die between ages 85 and 88; were more likely to remain independent and experienced fewer declines in their ability to perform daily tasks; and reported fewer new instances of loneliness (12.2 percent vs. 22.6 percent from ages 70 to 78 and 26.5 percent vs. 44.1 percent from ages 78 to 85) and poor self-rated health (77.3 percent vs. 63.3 percent from ages 70 to 78 and 63.8 percent vs. 82.6 percent from ages 78 to 85).

The benefits associated with physical activity were observed not only in those who maintained an existing level of physical activity, but also in those who began exercising between ages 70 and 85.

"Although the mechanism of the survival benefit is most likely multifactorial, one important finding was the sustained protective effect of physical activity against functional decline," the authors write. Physical activity may delay the spiral of decline that begins with inability to perform daily activities and continues through illness and death by improving cardiovascular fitness, slowing loss of muscle mass, reducing fat, improving immunity and suppressing inflammation.

"Despite the increasing likelihood of comorbidity, frailty, dependence and ever-shortening life expectancy, remaining and even starting to be physically active increases the likelihood of living longer and staying functionally independent," the authors write. "The clinical ramifications are far reaching. As this rapidly growing sector of the population assumes a prominent position in preventive and public health measures, our findings clearly support the continued encouragement of physical activity, even among the oldest old. Indeed, it seems that it is never too late to start."
(Arch Intern Med. 2009;169[16]:1476-1483. Available to the media pre-embargo at www.jamamedia.org).

Editor's Note: The Jerusalem Longitudinal Study has received funds from the Ministry of Labor and Social Affairs of the State of Israel; ESHEL, the Association for the Planning and Development of Services for the Aged in Israel; the National Insurance Institute; and various private, charitable donors. 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 14, 2009
Media Advisory: To contact Kypros Kypri, Ph.D., e-mail kypros.kypri{at}newcastle.edu.au.

Web-Based Screening and Intervention May Reduce Drinking in University Students

CHICAGO—Web-based screening and personalized interventions for alcohol use may reduce drinking in undergraduate students, according to a report in the September 14 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Unhealthy alcohol use is becoming more prevalent among young adults in many countries, according to background information in the article. "Young people at university have a particularly high prevalence of unhealthy alcohol use and have been found to drink more heavily and to exhibit more clinically significant alcohol-related problems than their non-student peers."

Kypros Kypri, Ph.D., of the University of Newcastle, Callaghan, New South Wales, Australia and the University of Otago, New Zealand, and colleagues analyzed results from a 2007 Web-based Alcohol Use Disorders Identification Test taken by 7,237 undergraduate university students (ages 17 to 24) in Australia. The test consisted of an online questionnaire covering items such as demographics, drinking in the last year, largest number of drinks consumed on one occasion within the last four weeks, duration of drinking episode, secondhand effects such as being pushed, hit or assaulted, opinions on alcohol beverage labeling, smoking history, height and weight.

Participants who scored in the hazardous/harmful drinking range were placed in either a Web-based intervention group, which received motivational assessments and personalized feedback or a control group, which received no feedback. The personalized motivational interventions included information about reducing the associated health risk, an estimated blood alcohol concentration for the respondent's heaviest episode, monetary expenditure, comparison to other students' drinking and hyperlinks to smoking cessation and help with drinking problems. Follow-ups were conducted one and six months after screening.

In total, 2,435 participants scored in the hazardous/harmful drinking range. Of these, 1,251 were randomized to the Web-based motivational feedback group and 1,184 were to the control group. "After one month, participants receiving intervention drank less often, smaller quantities per occasion and less alcohol overall than did controls," the authors write. "Differences in alcohol-related harms were nonsignificant. At six months, intervention effects persisted for drinking frequency and overall volume but not for other variables."

"Given the scale on which proactive Web-based electronic screening and brief intervention (e-SBI) can be delivered and its acceptability to student drinkers, we can be optimistic that a widespread application of this intervention would produce a benefit in this population group," the authors conclude. "The e-SBI, a program that is available free for nonprofit purposes, could be extended to other settings, including high schools, general practices and hospitals."
(Arch Intern Med. 2009;169[16]:1508-1514. Available to the media pre-embargo at www.jamamedia.org).

Editor's Note: This study was funded in part by a grant from the Western Australian Health Promotion Foundation. 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 14, 2009
Media Advisory: To contact Caroline M. Tanner, M.D., Ph.D., call Jonathan Friedman at 408-542-5606 or e-mail jfriedman{at}thepi.org.

On-the-Job Pesticide Exposure Associated With Parkinson's Disease

CHICAGO—Individuals whose occupation involves contact with pesticides appear to have an increased risk of having Parkinson's disease, according to a report in the September issue of Archives of Neurology, one of the JAMA/Archives journals.

The development of Parkinson's disease related to chemical exposure was identified in the late 20th century, according to background information in the article. Since then, occupations such as farming, teaching and welding have all been proposed to increase the risk of Parkinson's disease. However, associations have been inconsistent and few previous studies have evaluated the direct relationship between occupational chemical exposure and disease risk.

Caroline M. Tanner, M.D., Ph.D., of the Parkinson's Institute, Sunnyvale, Calif., and colleagues studied 519 individuals with Parkinson's disease and 511 controls who were the same age and sex and lived in the same location. Participants were surveyed about their occupational history and exposure to toxins, including solvents and pesticides.

Working in agriculture, education, health care or welding was not associated with Parkinson's disease, nor was any other specific occupation studied after adjustment for other factors.

Among the patients with Parkinson's disease, 44 (8.5 percent) reported pesticide exposure compared with 27 (5.3 percent) of controls, such that occupational pesticide exposure was associated with an increased risk of the disease. "Growing evidence suggests a causal association between pesticide use and parkinsonism. However, the term 'pesticide' is broad and includes chemicals with varied mechanisms," the authors write. "Because few investigations have identified specific pesticides, we studied eight pesticides with high neurotoxic plausibility based on laboratory findings. Use of these pesticides was associated with higher risk of parkinsonism, more than double that in those not exposed."

Three individual compounds—an organochloride (2,4-dichlorophenoxyacetic acid), an herbicide (paraquat) and an insecticide (permethrin)—were associated with a more than three-fold increased risk of Parkinson's disease. All three have been shown to have effects on dopaminergic neurons—affected by Parkinson's disease—in the laboratory.

"This convergence of epidemiologic and laboratory data from experimental models of Parkinson's disease lends credence to a causative role of certain pesticides in the neurodegenerative process," the authors conclude. "Other pesticide exposures such as hobby gardening, residential exposure, wearing treated garments or dietary intake were not assessed. Because these exposures may affect many more subjects, future attention is warranted."
(Arch Neurol. 2009;66[9]:1106-1113. Available to the media pre-embargo at www.jamamedia.org)

Editor's Note: This study was supported by an unrestricted grant from a group of current and former manufacturers of welding consumables awarded to The Parkinson's Institute. Co-author Dr. Hauser has received fees for providing expert testimony in cases related to Parkinson's disease in welders. 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 14, 2009
Media Advisory: To contact Sarah Tomaszewski Farias, Ph.D., call Phyllis Brown at 916-734-9023 or e-mail phyllis.brown{at}ucdmc.ucdavis.edu.

Difficulties With Daily Activities Associated With Progression To Dementia

CHICAGO—Among individuals with mild cognitive impairment, often considered a transitional state between normal cognitive function and Alzheimer's dementia, those who have more difficulties performing routine activities appear more likely to progress quickly to dementia, according to a report in the September issue of Archives of Neurology, one of the JAMA/Archives journals.

Mild cognitive impairment is recognized as a risk factor for dementia and an important public health issue, according to background information in the article. "Annual conversion rates [from mild cognitive impairment to dementia] often range from 10 percent to 15 percent in clinic samples. Conversion rates in community-based studies are often substantially lower (i.e., 3.8 percent to 6.3 percent per year)," the authors write. "Clearly patients with mild cognitive impairment compose a heterogeneous group, of whom not all rapidly convert to dementia. As such, it is important to identify risk factors for progressing rapidly among individuals diagnosed with mild cognitive impairment."

Sarah Tomaszewski Farias, Ph.D., of the University of California, Davis, and colleagues studied 111 individuals with mild cognitive impairment. Of these, 46 percent (51) were recruited from patients referred to a university-based memory disorders clinic on suspicion of cognitive decline, and 54 percent (60) were recruited directly through community outreach. All participants underwent annual clinical evaluations, diagnostic imaging, routine laboratory tests and neuropsychological evaluations.

During an average of 2.4 years of follow-up, 28 individuals progressed from mild cognitive impairment to dementia, including 23 from the clinic and five from the community. Annually, 13 percent of the clinic-based group and 3 percent of the community group converted into dementia.

Other than recruitment source, the only factor associated with conversion from mild cognitive impairment to dementia was the degree of functional impairment at the beginning of the study—no demographic, cognitive or neuroimaging variables predicted this progression.

"Thus, regardless of whether an individual was a clinic patient or recruited directly from the community, more functional impairment at baseline was an important risk for future conversion to dementia," the authors write. "The greater functional impairment at baseline within the clinically recruited group appears to account for their increased risk of conversion."

The results suggest that "in an educationally and ethnically diverse population, those with more functional impairment at their baseline evaluation—regardless of whether they are actively seeking an evaluation for a neurodegenerative disease—are at increased risk for conversion to dementia even within a relatively short follow-up period," they conclude.
(Arch Neurol. 2009;66[9]:1151-1157. Available to the media pre-embargo at www.jamamedia.org)

Editor's Note: This work was supported by grants from the National Institute on Aging, by the California Department of Health Services and by the Veterans Affairs Northern California Health Care System. 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 14, 2009
Media Advisory: To contact corresponding author John E. Castaldo, M.D., call Brian Downs at 610-402-0825 or e-mail brian.downs{at}lvh.com. To contact editorial author Louis R. Caplan, M.D., call Bonnie Prescott at 617-667-7306 or e-mail bprescot{at}bidmc.harvard.edu.

Study Examines Stroke Risk Among Patients Undergoing Cardiac Surgery

CHICAGO—Among patients undergoing cardiac surgery, post-operative stroke occurred in approximately 2 percent, was not correlated with significant carotid artery narrowing, but was more common among patients who had combined cardiac and carotid procedures, according to a report in the September issue of Archives of Neurology, one of the JAMA/Archives journals.

Complications involving the blood vessels leading to the brain—most often resulting in stroke—are a major source of illness and death following heart surgery, according to background information in the article. Factors causing postoperative stroke may include carotid artery stenosis (narrowing of the artery in the neck supplying blood to the brain), low blood pressure, irregular heartbeat, atherosclerosis or plaque buildup in the aorta (the body's largest artery) and a temporarily increased tendency for blood to clot.

"The presence of multiple co-existing causes makes studying the mechanism of stroke challenging. Significant carotid stenosis has been recognized as a positive predictor of postoperative stroke in patients receiving cardiac surgical procedures. However, studies directly addressing the role of severe carotid stenosis are lacking," the authors write. "Despite this lack of evidence, combined carotid and cardiac surgical procedures are performed frequently in an effort to reduce the incidence of postoperative stroke."

Yuebing Li, M.D., Ph.D., John E. Castaldo, M.D., and colleagues at Lehigh Valley Health Network, Allentown, Penn., studied 4,335 patients undergoing coronary artery bypass grafting, aortic valve replacement or both between 2001 and 2006. Of those, 3,942 (90.9 percent) underwent ultrasonography to evaluate the carotid artery before their procedure.

A total of 76 patients (1.8 percent) had a clinically definitive stroke following surgery. Stroke was more common in individuals with carotid stenosis than in individuals without (7.5 percent vs. 1.8 percent); however, most strokes (76.3 percent) occurred in patients without significant carotid stenosis, and 60 percent of strokes were not confined to a single carotid artery. "According to clinical data, in 94.7 percent of patients, stroke occurred without direct correlation to significant carotid stenosis," the authors write.

In a subgroup of 53 patients who had significant carotid stenosis (artery narrowed by 70 percent or more) before surgery and underwent combined cardiac and carotid procedures, eight patients had postoperative strokes (15.1 percent). Among 51 patients who had a similar level of carotid stenosis but did not undergo a combined procedure, zero had a postoperative stroke.

"Multiple causes other than carotid stenosis could account for postoperative stroke in patients undergoing cardiac procedures," the authors write. "For example, coexistence of aortic atherosclerosis has been demonstrated to be a significant determinant of postoperative stroke. In some studies, clamping and manipulation of the aorta or heart could account for more than 60 percent of emboli [clots or masses that block blood vessels]." In addition, particles released from the cardiopulmonary bypass pump used during surgery could contribute to stroke, as could postoperative heart rhythm disorders.

"We confirmed a higher incidence of stroke in the subgroup of patients with significant carotid stenosis," the authors conclude. "However, most strokes have no direct causal relationship with the diseased carotid artery. Combined carotid and cardiac procedures result in a significantly higher incidence of post-operative stroke and should be avoided. Pre-operative studies such as echocardiography or computed tomography or magnetic resonance imaging of the heart and aorta could identify disease-free areas for manipulation and clamping to prevent postoperative strokes."
(Arch Neurol. 2009;66[9]:1091-1096. 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: Research on Heart Surgery Complications Should be Put Into Action

"The report in this issue of the Archives by Li et al that describes the results of more than 4,000 coronary artery bypass graft procedures at one hospital provides an opportunity to review what is known about the neurological complications of elective coronary artery surgery and, more important, to editorialize about how the results should be translated into action," writes Louis R. Caplan, M.D., of Beth Israel Deaconess Medical Center, Boston, in an accompanying editorial.

"I suggest that patients and pre-operative information should be reviewed before surgery by a team approach that includes a cardiologist who will observe the patients throughout their hospitalization and the cardiac surgeon who will perform the operation. This should be done at a time when further studies can be scheduled and reviewed before surgery."

"I believe that carrying out these recommendations will save brain tissue and lives by reducing the frequency and severity of adverse neurological outcomes and may even save some money," Dr. Caplan concludes.
(Arch Neurol. 2009;66[9]:1062-1064. 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, September 14, 2009
Media Advisory: To contact SCORE study chair Michael S. Ip, M.D., call Susan Lampert Smith at 608-262-7335 or e-mail SSmith5{at}uwhealth.org. To contact corresponding author Paul C. VanVeldhuisen, Ph.D., call Janet Van Dyke at 301-251-1161, ext 272, or e-mail jvandyke{at}emmes.com. To contact editorial author Rajendra S. Apte, M.D., Ph.D., call Jim Dryden at 314-286-0110 e-mail jdryden{at}wustl.edu.

Steroid Injections May Help Restore Vision in Some Patients With Blocked Eye Veins

CHICAGO—Injecting the eye with the corticosteroid triamcinolone appears effective in improving the vision of some patients with retinal vein occlusion, an important cause of vision loss that results from blockages in the blood vessels in the retina, according to two reports in the September issue of Archives of Ophthalmology, one of the JAMA/Archives journals. A 1-milligram dose of triamcinolone may be a treatment option for certain patients with blockages in the main portion of the retinal vein, whereas existing laser therapies appear superior for those with blockages in smaller branches of the vein.

Retinal vein occlusion is an important cause of vision loss in the United States and worldwide, according to background information in the articles. The condition frequently occurs in individuals with diabetes and leads to macular edema, or fluid buildup in the retina. Grid photocoagulation, or a laser treatment of the retina, has shown a benefit in improving the vision of patients with branch retinal vein occlusion (blockages in smaller branches of the retinal vein). However, there is presently no proven, effective therapy for vision loss associated with macular edema after central retinal vein occlusion (blockage in the main portion of the retinal vein, at the optic nerve).

In one paper, the SCORE (Standard Care vs. Corticosteroid for Retinal Vein Occlusion) Study Research Group reports the results of a randomized clinical trial involving 271 participants with macular edema from central retinal vein occlusion. Of these, 92 were assigned to receive 1 milligram of intravitreal (injected into the eye) triamcinolone, 91 received a 4-milligram dose and 88 were assigned to an observation group that did not receive treatment.

Participants were evaluated every four months for 12 months, and those in the triamcinolone group received additional injections at each follow-up visit unless there was a specific reason not to re-treat them (for instance, adverse events or apparent success of the treatment). Additional follow-up data were collected annually through 36 months, although complete 24- and 36-month outcome assessments were not available for analysis.

After one year, vision improved significantly in 7 percent of those in the observation group, 27 percent of those in the 1-milligram triamcinolone group and 26 percent of those in the 4-milligram triamcinolone group. The odds of reaching a predetermined level of visual improvement were five times greater among individuals receiving either dose of triamcinolone than those not receiving treatment.

Cataracts and elevated intraocular pressure (pressure within the eyeball), potential adverse events associated with corticosteroid treatment, were similar for the observation and 1-milligram group but higher for the 4-milligram group. "The superior safety profile of the 1-milligram dose compared with the 4-milligram dose, particularly with respect to glaucoma and cataract, renders it the preferred dose," the authors write.

Based on the results, "intravitreal triamcinolone in a 1-milligram dose and following the retreatment criteria used in this study should be considered for up to one year, and possibly two years, in patients with vision loss associated with macular edema secondary to central retinal vein occlusion who have characteristics similar to the participants studied in this trial," they conclude.

In a second study, the same research group compared the safety and efficacy of triamcinolone with standard care (grid photocoagulation in eyes without hemorrhage, or deferring photocoagulation until hemorrhage clears) for 411 patients with macular edema from branch retinal vein occlusion. A group of 137 was assigned to receive standard care, 136 to receive a 1-milligram dose of intravitreal triamcinolone and 138 to receive a 4-milligram dose. Similar to the central retinal occlusion trial, participants were evaluated and re-treated as indicated every four months.

After one year, 29 percent of participants in the standard care group, 26 percent in the 1-milligram triamcinolone group and 27 percent in the 4-milligram group experienced improved vision.

"The rates of adverse events with respect to cataract surgery and elevated intraocular pressure were similar between the standard care and 1-milligram groups, but the potential for added risks of procedure-related complications in the 1-milligram group (as exemplified by the one case of endophthalmitis [inflammation inside the eye] reported in the 4-milligram group) suggests a superior safety profile for the standard care group," the authors write. Adverse event rates were higher in the 4-milligram group.

"Thus, current study results (up to 12 months and possibly up to 36 months) support grid photocoagulation as the continued standard of care for patients with decreased visual acuity associated with macular edema secondary to branch retinal vein occlusion who have similar characteristics to the cohort in this clinical trial," the authors conclude. "The results of this trial also support the idea that grid photocoagulation, as applied in the current study, should be the benchmark against which other treatments for vision loss associated with macular edema secondary to branch retinal vein occlusion are compared in clinical trials."
(Arch Ophthalmol. 2009;127[9]:1101-1114, 1115-1128. Available to the media pre-embargo at www.jamamedia.org).

Editor's Note: These studies were supported by grants from the National Eye Institute and in part by Allergan Inc. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Studies Will Influence Treatment of Common Eye Disease

"Retinal venous occlusive disease, including branch retinal vein occlusion and central retinal vein occlusion, is the second most common cause of severe vision loss in the United States," writes Rajendra S. Apte, M.D., Ph.D., of Washington University School of Medicine, St. Louis, in an accompanying editorial.

The results of the SCORE studies "provide valuable evidence regarding the role of laser photocoagulation and intravitreal triamcinolone in the management of macular edema associated with venous occlusive disease," Dr. Apte concludes. "These studies also provide important ocular safety information that confirms the previously reported associations of intraocular triamcinolone with intraocular pressure elevation and cataract development and progression. These well-designed studies will influence future research, treatment paradigms and clinical practice patterns for years to come."
(Arch Ophthalmol. 2009;127[9]:1203-1204. Available to the media pre-embargo at www.jamamedia.org).

Editor's Note: Dr. Apte is or has been a consultant and speaker for Eyetech and Genentech and a consultant for Ophthotech, Allergan and Synergetics. 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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