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May 19, 2009JAMA 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
JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT Tuesday, May 19, 2009)
JAMA REPORT (VIDEO SCRIPT)
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED. JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ON-LINE. Go to www.jamamedia.org for more information and to apply for access. SAVE THE DATE: JAMA will present new research from a theme issue on Child Health at a media briefing on Tuesday, June 2, from 10 a.m. – 12:15 p.m., at the Hilton New York, 1335 Avenue of the Americas. To register, go to www.jamamedia.org and click on the Events tab, or call 312-464-JAMA. Program information will be included in a future email. TV Note: This week's JAMA Report video is on therapies to treat insomnia. The report will be fed Tuesday, May 19, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 28 (C-Band), Transponder 19, downlink frequency: 4080 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA. Please Note: The FOR THE MEDIA website now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 19, 2009
Medication Used to Treat Urination Difficulties for Men Associated With Higher Risk of Ophthalmic Complications Following Cataract Surgery
CHICAGO—Use of the medication tamsulosin to treat male urination difficulties within two weeks of cataract surgery is associated with an increased risk of serious postoperative ophthalmic adverse events such as retinal detachment or lost lens, according to a study in the May 20 issue of JAMA. Benign prostatic hyperplasia (BPH; enlarged prostate) affects nearly 3 of 4 men by the age of 70 years, with symptoms of BPH including urination difficulties. A commonly prescribed medication for BPH is tamsulosin, which accounted for more than $1 billion in sales in 2007, according to background information in the article. Some research has suggested that this drug may increase the risk of complications, such as intraoperative floppy iris syndrome (IFIS) during cataract surgery, a procedure that approximately 5 percent of elderly U.S. residents undergo every year. "However, few studies have been large enough to assess the connection between tamsulosin exposure and postoperative complications," the authors write. Chaim M. Bell, M.D., Ph.D., of St. Michael's Hospital, Toronto, Canada, and colleagues conducted a large, population-based analysis of postoperative adverse events experienced by patients who were prescribed tamsulosin or other alpha-blockers at the time of cataract surgery. Using linked health care databases from Ontario, Canada, the study included 96,128 men, age 66 years or older, who had cataract surgery between 2002 and 2007. Of the patients in the study, 3,550 (3.7 percent) had recent (within 14 days of cataract surgery) exposure to tamsulosin and 1,006 (1.1 percent) had previous (more than 14 days before cataract surgery) exposure to tamsulosin. There were 7,426 patients (7.7 percent) who had recent exposure to other alpha-blocking medications and 1,683 (1.1 percent) who had previous exposure. The researchers identified 284 case patients (0.3 percent) who experienced an adverse event in the 14 days after surgery. Of these 284 cases, 175 had a procedure for lost lens or lens fragment, 35 for retinal detachment, and 26 had both. One hundred had suspected endophthalmitis (inflammation within or around the eye). Of the 284 cases, 280 were matched to 1,102 control patients. In the analysis of adverse events following cataract surgery, patients who received tamsulosin in the 14 days before surgery had a 2.3 times higher risk of a serious adverse event (7.5 percent vs. 2.7 percent of controls). For patients prescribed other alpha-blockers, 7.5 percent of case patients and 8.0 percent of control patients received the medication in the 14 days preceding surgery. Those who had previous exposure to tamsulosin were not at elevated risk for complications, as where patients who had previous exposure to other alpha-blockers.
"We believe that this is the first large study with an adequate study design to describe this effect [that tamsulosin exposure is associated with an increased risk of postoperative complications] and provide a population-based risk estimate (something that can only be done using population-based observational research). It is unclear whether drug discontinuation prior to surgery reduces this risk. Because the combination of cataract surgery and tamsulosin exposure is relatively common, patients should be properly appraised of the risks of drug therapy and preoperative systems should focus on the identification of tamsulosin use by patients. In this way, surgeons can plan and prepare for a potentially more complicated procedure or refer to someone with more experience," the authors conclude.
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. Editorial: Tamsulosin and the Intraoperative Floppy Iris Syndrome
In an accompanying editorial, Alan H. Friedman, M.D., of the Mount Sinai School of Medicine, New York, comments on the findings of Bell and colleagues.
"Cataract surgery is the most commonly performed operation in the United States today. With nearly 2 million cataract operations performed in the United States each year, the magnitude of IFIS associated with tamsulosin cannot be underestimated. Although the prescribing information for tamsulosin includes IFIS as a 'general precaution,' the data on the risk of this complication should be reassessed to determine whether a 'black box' warning should be issued to caution the ophthalmic surgeon and the general public (men in particular) of danger to the eye of taking alpha1-adrenergic blocking agents before cataract surgery."
Editor's Note: Please see the article for additional information, including 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. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 19, 2009
Bone Marrow Cell Therapy May Be Beneficial For Patients With Ischemic Heart Disease
CHICAGO—The injection of bone marrow cells into the heart of patients with chronic myocardial ischemia (reduced blood flow to some areas of the heart) was associated with modest improvements in blood flow and function of the left ventricle, according to a study in the May 20 issue of JAMA. Bone marrow cell therapy is currently being investigated as a new therapeutic option for patients with ischemic heart disease. Two small-sized studies assessed the effect of this therapy in patients with chronic myocardial ischemia, but with varying results, according to background information in the article. Jan van Ramshorst, M.D., of Leiden University Medical Center, the Netherlands, and colleagues assessed the effect of intramyocardial (within the heart wall) bone marrow cell injection on myocardial perfusion (the flow of blood to the heart muscle) and left ventricular (LV) function in patients with chronic ischemia who were not eligible for conventional treatment. The trial included 50 patients (average age, 64 years; 43 men), who were randomized to receive about 8 injections of either bone marrow cells or placebo solution. At 3-month follow-up, when the two groups were compared, the improvement in summed stress score (a measure of myocardial perfusion) was significantly greater in the bone marrow-cell treated patients as compared with placebo-treated patients. Magnetic resonance imaging indicated that the absolute increase in left ventricular ejection fraction (LVEF; a measure of how well the left ventricle of the heart pumps with each contraction) was significantly larger in bone marrow cell-treated patients. A quality-of-life score increased at 3 and 6 months in bone marrow cell-treated patients, compared with a smaller increase in the placebo group. There was also greater improvement in exercise capacity in the bone marrow cell group.
"In summary, the results of this randomized, double-blind, placebo-controlled trial demonstrate that intramyocardial bone marrow cell injection in patients with chronic ischemia is associated with significant improvements in anginal symptoms, myocardial perfusion, and LV function," the authors write.
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. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 19, 2009
Substance Abuse Appears To Be an Important Factor in Increased Risk of Violent Crime By Persons With Schizophrenia
CHICAGO—The increased risk of persons with schizophrenia committing violent crime may be largely mediated by co-existing substance abuse problems, according to a study in the May 20 issue of JAMA. Many studies have reported on the association between major mental disorder and violence, including some that specifically have examined the relationship with schizophrenia. "These reports typically find that schizophrenia is related to a 4- to 6-fold increased risk of violent behavior, which has led to the view that schizophrenia and other major mental disorders are preventable causes of violence and violent crime," the authors write. They add that considerable uncertainty exists as to what is the cause of this elevated risk. Some studies have indicated that substance abuse may play a role. Seena Fazel, M.D., of the University of Oxford, Warneford Hospital, Oxford, England, and colleagues examined the relationship of schizophrenia with violent crime and the possible role of substance abuse. The study included data from nationwide Swedish registers of hospital admissions and criminal convictions from 1973-2006. Risk of violent crime in patients after diagnosis of schizophrenia (n = 8,003) was compared with that among general population controls (n = 80,025). Potential confounders (factors that can influence outcomes; age, sex, income, and marital and immigrant status) and mediators (intervening factors such as substance abuse) were measured at the beginning of the study. To study familial confounding, the researchers also investigated risk of violence among unaffected siblings (n = 8,123) of patients with schizophrenia. The researchers found that among patients with schizophrenia, 1,504 (13.2 percent) had at least 1 violent offense compared with 4,276 (5.3 percent) of general population controls (adjusted odds ratio, 2.0). The rate of violent crime in individuals diagnosed as having schizophrenia and substance abuse (27.6 percent) was significantly higher than in those without substance abuse (8.5 percent), which resulted in adjusted odds ratios of 4.4 for violent crime in schizophrenia with substance abuse and 1.2 in schizophrenia without substance abuse. The risk increase among those with substance abuse was significantly less pronounced when unaffected siblings were used as controls (28.3 percent of those with schizophrenia had a violent offense compared with 17.9 percent of their unaffected siblings), suggesting significant familial (genetic or early environmental) confounding of the association between schizophrenia and violence.
"We demonstrate that the risk of violent crime in schizophrenia in patients without comorbid substance abuse is only slightly increased. In contrast, the risk is substantially increased among patients with comorbidity and suggests that current practice for violence risk assessment and management in schizophrenia may need review," the authors conclude.
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. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 19, 2009
Combination Therapy Appears Helpful for Short-Term Treatment of Insomnia; Cognitive Behavior Therapy May Be Better for Long-Term
CHICAGO—For patients with persistent insomnia, a combination of cognitive behavior therapy (CBT) and the medication zolpidem for 6 weeks was associated with modest improvement in sleep, although for a longer treatment period CBT alone was more beneficial, according to a study in the May 20 issue of JAMA. Insomnia is a prevalent public health problem affecting large segments of the population on a situational, recurrent, or chronic basis. "Persistent insomnia is associated with significant impairments of daytime functioning, reduced quality of life, and when persistent insomnia is not treated, it heightens the risks for major depression and hypertension," the authors write. CBT and some sleep medications are effective for short-term treatment of insomnia, but few patients achieve complete remission with any single treatment. It has been unclear whether combined therapies would improve outcomes. Charles M. Morin, Ph.D., of the Universite Laval, Quebec, Canada, and colleagues evaluated the short- and long-term effects of CBT, singly and combined with the medication zolpidem, for persistent insomnia, and compared treatment strategies to optimize long-term outcomes. The trial included 160 adults, who were randomized to receive either CBT alone or CBT plus 10 mg/d (taken at bedtime) of zolpidem for an initial 6-week therapy, followed by extended 6-month therapy. The CBT included recommendations on how to improve sleep and education regarding faulty beliefs and misconceptions about sleep. The researchers found that CBT used singly or in combination with zolpidem produced significant improvements in the amount of time that it took to fall asleep, time awake after falling to sleep, and sleep efficiency during initial therapy. A larger increase of sleep time was obtained with the combined approach. After six weeks, the proportion of patients who responded to treatment of CBT alone (60 percent) or CBT plus zolpidem (61 percent) were similar, as were treatment remissions (39 percent for the CBT alone group; 44 percent for the CBT plus zolpidem group). "The best long-term outcome was obtained with patients treated with combined therapy initially, followed by CBT alone, as evidenced by higher remission rates at the six-month follow-up compared with patients who continued to take zolpidem during extended therapy (68 percent vs. 42 percent)," the authors write.
"Although the present findings are promising, there is currently no treatment that works for every patient with insomnia and additional studies are needed to develop treatment algorithms to guide practitioners in the clinical management of insomnia."
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. EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), Tuesday, May 19, 2009
Better Cardiorespiratory Fitness Related to Lower Risk of Death, Cardiovascular Disease
CHICAGO—Persons with higher levels of cardiorespiratory fitness have a lower risk of all-cause death and coronary heart disease and cardiovascular disease compared to persons with lower levels of cardiorespiratory fitness, according to an analysis of previous studies appearing in the May 20 issue of JAMA. Physical fitness is typically expressed as cardiorespiratory fitness (CRF) and is assessed by exercise tolerance testing; however, it is rare for clinicians to consider CRF when evaluating future risk of coronary heart disease (CHD). "A major reason for lack of consideration of CRF as a marker of CHD risk may be that the quantitative association of CRF for cardiovascular risk is not well established. The degree of risk reduction associated with each incremental higher level of CRF, the criteria for low CRF, and the magnitude of risk associated with low CRF have been inconsistent among studies," the authors write. Satoru Kodama, M.D., Ph.D., of the University of Tsukuba Institute of Clinical Medicine, Ibaraki, Japan, and colleagues conducted a meta-analysis to systematically review the quantitative relationship between CRF and all-cause mortality and CHD or cardiovascular disease (CVD) events in healthy individuals. The researchers identified 33 studies for inclusion in the analysis, which included: all-cause mortality, 102,980 participants and 6,910 cases; CHD/CVD, 84,323 participants and 4,485 cases. CRF was estimated as maximal aerobic capacity (MAC) expressed in metabolic equivalent (MET; measured via oxygen consumption) units. Participants were categorized as low CRF (less than 7.9 METs), intermediate CRF (7.9 – 10.8 METs), or high CRF (10.9 METs or greater). Compared with participants with high CRF, those with low CRF had a 70 percent higher risk for all-cause death and a 56 percent higher risk for CHD/CVD events. Compared with participants with intermediate CRF, those with low CRF had a 40 percent higher risk for all-cause death and a 47 percent increased risk for CHD/CVD events. "These analyses suggest that a minimal CRF of 7.9 METs may be important for significant prevention of all-cause mortality and CHD/CVD," the researchers write. They add that expressed in terms of walking speed, men around 50 years of age must be capable of continuous walking at a speed of 4 m.p.h. and women, 3 m.p.h. "It is possible that consideration of low CRF as a major coronary risk factor could be put into practical use in the clinical setting through identification of low exercise tolerance by exercise stress testing or in daily life by the speed at which a person can walk before experiencing exhaustion," the researchers write. The analysis also indicated that a 1-MET higher level of MAC (corresponding to 0.6 mile/hour higher running/jogging speed) was associated with a decrease of 13 percent in risk of all-cause mortality, and a 15 percent decrease in risk of CHD/CVD.
"Based on the findings of our meta-analysis, we suggest for future research (1) further development of a CHD prediction algorithm (e.g., Framingham Scores) that would consider both CRF and the classical coronary risk factors to allow physicians to use CRF as a major risk factor in clinical settings; (2) cost-effectiveness of exercise testing for assessing CRF from the viewpoint of primary prevention of all-cause mortality and CHD; and (3) a clinical trial to determine whether an intervention that improves CRF by exercise reduces the risk of all-cause mortality and CHD," the authors write.
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.
JAMA REPORTS
VIDEO: Windows Media | Quicktime
THERAPY TO CHANGE BAD SLEEP HABITS IS FOUND TO HELP PEOPLE WITH INSOMNIA GET A BETTER NIGHT'S SLEEP
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