From Medscape Medical News
Caroline Cassels
January 15, 2010 — A traditional or whole diet characterized by vegetables, fruit, whole grains, and high-quality meat and fish may help prevent mental illness — specifically, depression and anxiety. Conversely, a Western diet high in refined or processed foods and saturated fats may increase the risk of depression, new research suggests.
A large, cross-sectional study conducted by investigators at the University of Melbourne in Australia shows that women who regularly consume a so-called traditional diet were more than 30% less likely to have major depression, dysthymia, and anxiety disorders compared with their counterparts who consume a Western diet. In addition, the Western diet was associated with a 50% increased likelihood of depression.
"Simply put, if you habitually eat a healthy diet that includes fruit, vegetables, whole grains, and high-quality lean meat, then you may cut your risk of depression and anxiety," principal investigator Felice Jacka, PhD, told Medscape Psychiatry.
But one caveat here, said Dr. Jacka, is high-quality meat, which is difficult to come by in the United States. This is because most of the cattle in North America are raised — from birth to death — in feed lots, where they are fed a corn-based diet.
This method of raising cattle may have a "profound impact" on the quality of the meat, said Dr. Jacka. "It increases saturated fat and decreases very important good fatty acids. Whereas in Australia, red meat, such as beef and lamb, comes from pasture-raised animals, so it has a much healthier fatty acid profile," she said.
One of the findings that was not published in the article is that people who consumed more beef or lamb within Australia's recommended dietary guidelines (not more than 4 times per week) were less likely to have depression and anxiety.
According to Dr. Jacka, recent Australian studies show that a good proportion of individuals' dietary intake of omega-3 fatty acids actually comes from red meat.
"We've traditionally thought of omega-3s as only coming from fatty fish, but actually good-quality red meat, that is, naturally raised, has very good levels of omega-3 fatty acids, whereas red meat that comes from feedlots tends to be higher in omega-6 fatty acids — a fatty acid profile that is far less healthy and may in fact be associated with more mental health problems," she said.
The study was published online January 4 in the American Journal of Psychiatry.
Lack of Evidence
According to the investigators, unlike many medical conditions, most notably cardiovascular disease, psychiatric disorders lack evidence-based primary prevention and treatment strategies based on dietary modification. Previous studies that have looked at a potential link between diet and depressive illness have focused on individual nutrients or food groups, but they note that none has looked at the impact of a whole diet.
However, they add, that limiting studies to individual nutrients or foods may provide an incomplete picture of the relationship between diet and mental health. "We don't eat individual nutrients, we eat a whole diet," said Dr. Jacka.
"Up until very recently there really haven't been any studies that have looked at the impact of whole diet on common mental disorders, which is really interesting since over the past 10 years or so there's been a real burgeoning in the literature regarding the impact of diet on cardiovascular disease, diabetes, and the metabolic syndrome," she added.
Interestingly, many of the same underlying mechanisms that influence some of these conditions, such as immune dysfunction and subsequent inflammation, have also been shown to influence depression, Dr. Jacka pointed out.
To assess the association between individuals' regular diet and the prevalence of mental health disorders, the investigators used data from the Geelong Osteoporosis Study, a large epidemiologic study.
Unexpected Finding
The study included 1046 women ages 20 to 93 years. Participants' diets were assessed using the Cancer Council Victoria dietary questionnaire, a comprehensive food frequency tool that reports on 74 foods and 6 alcoholic beverages during the preceding 12 months on a 10-point frequency scale.
To diagnose current mental disorders, participants were assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) Research Version, Non-Patient Edition. In addition, psychological symptoms were measured with the 12-item version of the General Health Questionnaire (GHQ-12). Scores on the GHQ-12, major depressive disorder, dysthymia, and anxiety disorders were the study's primary outcomes.
After adjustment for age, socioeconomic status, education, and health behaviors, the results revealed that a traditional or whole food diet was associated with a reduction in depression and anxiety risk, with respective odds ratios (ORs) of 0.65 (95% confidence interval [CI], 0.43 – 0.98; P < .05) and 0.68 (95% CI, 0.47 – 0.99; P < .05).
In contrast, those who consumed a Western diet of processed or fried foods, refined grains, sugary products, and beer had higher GHQ-12 scores. Those who scored higher on the Western-type or processed food diet tended to be approximately 50% more like to have depression (OR, 1.52; 95% CI, 0.96 – 2.41). However the researchers found no link between the Western diet and an increased risk of anxiety.
In an unexpected finding, the researchers also found a tendency for a so-called modern diet — which consisted of foods such as fruits, salads, fish, tofu, beans, nuts, yogurt, and red wine — was associated with a higher, rather than lower, likelihood for depression among younger, more educated women.
The researchers speculate that this may be due to reverse causality. "We think these women may have been attempting to improve their depressive symptoms by consuming a healthier diet," said Dr. Jacka.
Growing Public Awareness
Dr. Jacka pointed out that recent research conducted in primary care practices in Australia show that up to 30% of individuals with depression change their dietary habits as a way of improving their depressive symptoms, a finding she views as an indication of a growing public awareness about the potential relationship between diet and mental health.
Although primary care physicians often encourage their patients to improve their diets and increase their exercise level to help improve cardiovascular risk factors, the field of psychiatry "is just not there yet," said Dr. Jacka.
In large part, she said, this is due to a lack of evidence to support the hypothesis that a healthy diet can help prevent and/or treat mental illness, but the tide is turning, said Dr. Jacka. Two recent studies published late in 2009 [Br J Psychiatry. 2009;195:408-413, Arch Gen Psychiatry. 2009;66:1090-1098] also support the link between diet and mental health and depression risk.
"The good thing about these studies is that they were able to rule out reverse causality as an explanation for their findings. In other words, they found if you had a poorer-quality diet you were more likely to develop depression over the ensuing years, which supports what we found in our cross-sectional study, but depression itself did not lead to a poorer diet," said Dr. Jacka.
Public Policy Implications?
"The data are fairly consistent, and I do think it's time we started a conversation about public health messages about the potential role of diet in prevention as well as the treatment of depression particularly and mental health in general," said Dr. Jacka.
She added that her group currently has a paper in press investigating a link between diet and depression in a cohort of adolescents that shows "a very clear" relationship between diet quality and the presence of depression.
"My feeling is that the negative impact of the processed food industry is really going to make itself felt [in terms of the physical and mental health] on the younger generation," she said. She pointed out that nutrition has an impact on the developing brain, adding that 75% of psychiatric illnesses begin before the age of 25 years.
"I believe that these dietary studies support the hypothesis that diet is causally related to depression, but we need to do more research to be sure that these just aren't chance findings. We also need to test whether [dietary] interventions in the early stages of depression may be of use," said Dr. Jacka.
Diet's 'Profound Impact'
Commenting on the study for Medscape Psychiatry, Fernando Gómez-Pinilla, PhD, at University of California Los Angeles' Neurotrophic Research Laboratory, said the study is impressive and makes an important contribution to the literature.
"This is a very well-controlled study and demonstrates the importance of a whole diet, not only on physical health, but also mental health," Dr. Gómez-Pinilla said.
Animal research by Dr. Gómez-Pinilla and colleagues has demonstrated that diet has a significant and rapid impact on brain-derived neurotrophic factor (BDNF), which plays a key role in psychiatric illness in general and depression in particular.
Boosting levels of neurotrophins appears to be one of the main ways antidepressant medications work. Dr. Gómez-Pinilla 's group has shown that feeding rats a Western diet high in refined sugars and saturated fats has a very immediate and obvious impact in reducing BDNF level, which has a resulting impact on learning and memory.
Like Dr. Jacka, Dr. Gómez-Pinilla said the psychiatric community has been somewhat reticent about advocating diet as a preventive and/or treatment strategy for mental illness. However, he said, this research, as well as other recent studies, may help convince clinicians about the "profound impact" diet can have on mood and psychiatric disorders in general and perhaps help shift clinical practice.
Dr. Jacka reports she has receive travel funding from Sanof-Synthelabo Australia and Organon and research support from an unrestricted educational grant from Eli Lilly. Disclosures of the other authors can be found in the original article.
Am J Psychiatry. Published online January 4, 2010.
Thursday, January 28, 2010
Same Weight Loss, Better BP With Low-Carb Diet vs Drug/Diet Combo
From Heartwire
Shelley Wood
January 25, 2010 (Durham, North Carolina) — A new randomized trial comparing a low-carbohydrate diet with a low-fat diet in combination with the weight-loss drug orlistat has found that both strategies produced meaningful weight loss among hospital outpatients over a one-year period [1]. Strikingly, however, the low-carb diet appeared to produce significant improvements in blood pressure.
According to Dr William S Yancy Jr (Duke University, Durham, NC), lead author on the study, this is the first time the low-carb diet has been pitted against a diet drug in combination with a different diet. It is also one of the first studies to compare weight-loss strategies in patients who also have other known medical problems, including high blood pressure, diabetes, arthritis, etc.
Yancy et al's findings are published in the January 25, 2010 issue of the Archives of Internal Medicine.
Almost 10% Weight Loss at One Year
Yancy et al's study randomized 146 overweight or obese outpatients (mean age 52, mean body-mass index [BMI] 39.3) to either a low-carbohydrate, ketogenic diet, or to orlistat (120 mg, three times daily) and a low-fat diet over 48 weeks, with regular group meetings to boost diet adherence. At the end of the study period, weight loss was similar in both groups, at roughly 10% (approximately 20 to 25 pounds). Of note, almost 80% of the low-carb group and almost 90% of the orlistat/low-fat group completed the full 48-week follow-up.
Improvements in HDL and triglycerides were seen in both groups, LDL levels improved in the orlistat/low-fat diet group only, while glucose, insulin, and HbA1c levels improved in the low-carb group only, although none of these differences were statistically meaningful. By contrast, both systolic and diastolic blood-pressure levels declined in the low-carb group only, a statistically significant difference between weight-loss groups.
"It's not surprising that the blood pressure improved," Yancy told heartwire , adding that improvements in blood pressure are common in weight-loss trials. "But it was surprising that, with similar weight loss, blood pressure would improve more in one group than the other."
While there are a number of explanations for the blood-pressure differences between weight-loss strategies, Yancy speculated that it might be related to the known diuretic effect of low-carb diets.
"We've looked at that in the past, and it seems to occur in the first couple weeks of the diet and doesn't seem to be a big factor after that, but that could contribute to the differences seen here. The other thing is that low-carb diets are thought to reduce insulin levels more so than a high-carb diet. There are several different mechanisms that insulin has with the vascular system that might cause increased blood pressure, so if you decrease insulin your blood pressure might decrease as well."
No Significant Differences in Lipid Changes
Other low-carb diet studies have also reported improvements in lipid parameters compared with low-fat diets: something that was not seen in the current study to a statistically significant degree. Yancy attributes this in part to an aggressive attempt on the part of investigators to include as many patients as possible at the 48-week follow-up.
"A big criticism of other weight-loss trials is there are a lot of lost or missing data," he explained. "We tried to avoid that as much as possible, and as a result, some of these folks who came back for their final measurements who hadn't really been following their diets kind of watered down the results."
For example, in the paper, the authors report differences in heart-disease risk factors at interim time points and note that, out to 36 weeks, the two interventions "appeared to have differential effects on fasting serum lipid and lipoprotein levels over the first 36 weeks," but that "these differences converged by 48 weeks."
In another important finding, Yancy et al point out that while a small number of study participants initiated hypertension or diabetes medications over the course of the study in both diet groups, a much higher number actually decreased or discontinued their dosages, with a higher proportion of patients discontinuing or lowering their dosages in the low-carb group.
Referring to the blood-pressure effects of the low-carb diet, Yancy pointed out that investigators "don't really know the full effect of the diet intervention because patients were actually taking less medication."
Options for Patients
The key message from the paper is not that one diet is superior to another, Yancy concluded. "Different interventions appeal to different people," he told heartwire . "We have a big weight problem in our society, and this study gives us two different options, both of which worked quite well. And if you happen to have blood-pressure problems and you are trying to kill two birds with one stone, the low-carb option might be a better option than the orlistat option."
Of note, he added, orlistat is not associated with increases blood pressure, although other diet drugs are, including sibutramine, for which the FDA recently released an updated warning on CVD risks.
Yancy, as well as second author Dr Eric C Westman (Duke University Medical Center) disclosed having received clinical research grants from the Robert C Atkins Foundation.
References
Shelley Wood
January 25, 2010 (Durham, North Carolina) — A new randomized trial comparing a low-carbohydrate diet with a low-fat diet in combination with the weight-loss drug orlistat has found that both strategies produced meaningful weight loss among hospital outpatients over a one-year period [1]. Strikingly, however, the low-carb diet appeared to produce significant improvements in blood pressure.
According to Dr William S Yancy Jr (Duke University, Durham, NC), lead author on the study, this is the first time the low-carb diet has been pitted against a diet drug in combination with a different diet. It is also one of the first studies to compare weight-loss strategies in patients who also have other known medical problems, including high blood pressure, diabetes, arthritis, etc.
Yancy et al's findings are published in the January 25, 2010 issue of the Archives of Internal Medicine.
Almost 10% Weight Loss at One Year
Yancy et al's study randomized 146 overweight or obese outpatients (mean age 52, mean body-mass index [BMI] 39.3) to either a low-carbohydrate, ketogenic diet, or to orlistat (120 mg, three times daily) and a low-fat diet over 48 weeks, with regular group meetings to boost diet adherence. At the end of the study period, weight loss was similar in both groups, at roughly 10% (approximately 20 to 25 pounds). Of note, almost 80% of the low-carb group and almost 90% of the orlistat/low-fat group completed the full 48-week follow-up.
Improvements in HDL and triglycerides were seen in both groups, LDL levels improved in the orlistat/low-fat diet group only, while glucose, insulin, and HbA1c levels improved in the low-carb group only, although none of these differences were statistically meaningful. By contrast, both systolic and diastolic blood-pressure levels declined in the low-carb group only, a statistically significant difference between weight-loss groups.
"It's not surprising that the blood pressure improved," Yancy told heartwire , adding that improvements in blood pressure are common in weight-loss trials. "But it was surprising that, with similar weight loss, blood pressure would improve more in one group than the other."
While there are a number of explanations for the blood-pressure differences between weight-loss strategies, Yancy speculated that it might be related to the known diuretic effect of low-carb diets.
"We've looked at that in the past, and it seems to occur in the first couple weeks of the diet and doesn't seem to be a big factor after that, but that could contribute to the differences seen here. The other thing is that low-carb diets are thought to reduce insulin levels more so than a high-carb diet. There are several different mechanisms that insulin has with the vascular system that might cause increased blood pressure, so if you decrease insulin your blood pressure might decrease as well."
No Significant Differences in Lipid Changes
Other low-carb diet studies have also reported improvements in lipid parameters compared with low-fat diets: something that was not seen in the current study to a statistically significant degree. Yancy attributes this in part to an aggressive attempt on the part of investigators to include as many patients as possible at the 48-week follow-up.
"A big criticism of other weight-loss trials is there are a lot of lost or missing data," he explained. "We tried to avoid that as much as possible, and as a result, some of these folks who came back for their final measurements who hadn't really been following their diets kind of watered down the results."
For example, in the paper, the authors report differences in heart-disease risk factors at interim time points and note that, out to 36 weeks, the two interventions "appeared to have differential effects on fasting serum lipid and lipoprotein levels over the first 36 weeks," but that "these differences converged by 48 weeks."
In another important finding, Yancy et al point out that while a small number of study participants initiated hypertension or diabetes medications over the course of the study in both diet groups, a much higher number actually decreased or discontinued their dosages, with a higher proportion of patients discontinuing or lowering their dosages in the low-carb group.
Referring to the blood-pressure effects of the low-carb diet, Yancy pointed out that investigators "don't really know the full effect of the diet intervention because patients were actually taking less medication."
Options for Patients
The key message from the paper is not that one diet is superior to another, Yancy concluded. "Different interventions appeal to different people," he told heartwire . "We have a big weight problem in our society, and this study gives us two different options, both of which worked quite well. And if you happen to have blood-pressure problems and you are trying to kill two birds with one stone, the low-carb option might be a better option than the orlistat option."
Of note, he added, orlistat is not associated with increases blood pressure, although other diet drugs are, including sibutramine, for which the FDA recently released an updated warning on CVD risks.
Yancy, as well as second author Dr Eric C Westman (Duke University Medical Center) disclosed having received clinical research grants from the Robert C Atkins Foundation.
References
Guidance for Relief Workers and Others Traveling to Haiti for Earthquake Response
Psychological/Emotional Difficulties
http://www.medscape.com/viewarticle/715475_5
As a first responder or relief worker, you may encounter extremely stressful situations, such as witnessing a tremendous loss of life, serious injuries, missing and separated families, and destruction of whole areas. It is important to recognize that these experiences may cause you psychological or emotional difficulties.
Normal Reactions to a Disaster Event
Profound sadness, grief, and anger are common.
You may not want to leave the scene until the work is finished.
You will likely try to override stress and fatigue with dedication and commitment.
You may deny the need for rest and recovery time.
Ways to Help Manage Your Stress
Limit on-duty work time to no more than 12 hours per day.
Rotate work assignments between high stress and lower stress functions.
Drink plenty of water and eat healthy snacks and other energy foods.
Take frequent, brief breaks from the scene when you are able.
Keep an object of comfort with you such as a family photo, favorite music, or religious material.
Stay in touch with family and friends.
Pair up with another responder so that you can monitor one another's stress.
To learn about mental health resources, see:
Mental Health in Aid Workers Fact Sheet
Self-Care Tips for Stress
Download Podcasts on stress management for first responders: Stress Management for Emergency Responders - What Responders Can Do
NIOSH: Traumatic Incident Stress: Information for Emergency Response Workers
NIOSH: Estrés por sucesos traumáticos: Información para el personal de Emergencia
After You Come Home
If you are not feeling well, you should see your doctor and mention that you have recently returned from response and relief work in Haiti. Also tell your doctor if you were bitten or scratched by an animal while traveling.
Symptoms of malaria can develop up to one year after travel, so be alert for fever or flu-like symptoms.
Approximately one-third of aid workers report depression shortly after returning home, and more than half of returned aid workers have reported feeling predominantly negative emotions on returning home, even though many reported that their time overseas was positive and fulfilling. You might want to see a professional counselor to help you adjust back into your home environment.
More Information
Haiti destination page on the Travelers' Health website
Haiti country specific information from the US Department of State
United Nations Relief Web
Page last reviewed: January 16, 2010
Page last updated: January 16, 2010
Page created: January 14, 2010
Division of Global Migration and Quarantine National Center for Preparedness, Detection, and Control of Infectious Diseases
Centers for Disease Control and Prevention 1600 Clifton Rd. Atlanta, GA 30333, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, 24 Hours/Every Day - cdcinfo@cdc.gov
http://www.medscape.com/viewarticle/715475_5
As a first responder or relief worker, you may encounter extremely stressful situations, such as witnessing a tremendous loss of life, serious injuries, missing and separated families, and destruction of whole areas. It is important to recognize that these experiences may cause you psychological or emotional difficulties.
Normal Reactions to a Disaster Event
Profound sadness, grief, and anger are common.
You may not want to leave the scene until the work is finished.
You will likely try to override stress and fatigue with dedication and commitment.
You may deny the need for rest and recovery time.
Ways to Help Manage Your Stress
Limit on-duty work time to no more than 12 hours per day.
Rotate work assignments between high stress and lower stress functions.
Drink plenty of water and eat healthy snacks and other energy foods.
Take frequent, brief breaks from the scene when you are able.
Keep an object of comfort with you such as a family photo, favorite music, or religious material.
Stay in touch with family and friends.
Pair up with another responder so that you can monitor one another's stress.
To learn about mental health resources, see:
Mental Health in Aid Workers Fact Sheet
Self-Care Tips for Stress
Download Podcasts on stress management for first responders: Stress Management for Emergency Responders - What Responders Can Do
NIOSH: Traumatic Incident Stress: Information for Emergency Response Workers
NIOSH: Estrés por sucesos traumáticos: Información para el personal de Emergencia
After You Come Home
If you are not feeling well, you should see your doctor and mention that you have recently returned from response and relief work in Haiti. Also tell your doctor if you were bitten or scratched by an animal while traveling.
Symptoms of malaria can develop up to one year after travel, so be alert for fever or flu-like symptoms.
Approximately one-third of aid workers report depression shortly after returning home, and more than half of returned aid workers have reported feeling predominantly negative emotions on returning home, even though many reported that their time overseas was positive and fulfilling. You might want to see a professional counselor to help you adjust back into your home environment.
More Information
Haiti destination page on the Travelers' Health website
Haiti country specific information from the US Department of State
United Nations Relief Web
Page last reviewed: January 16, 2010
Page last updated: January 16, 2010
Page created: January 14, 2010
Division of Global Migration and Quarantine National Center for Preparedness, Detection, and Control of Infectious Diseases
Centers for Disease Control and Prevention 1600 Clifton Rd. Atlanta, GA 30333, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, 24 Hours/Every Day - cdcinfo@cdc.gov
Sunday, January 24, 2010
Iraq Cabinet Approves Draft Law to Protect Doctors
From Reuters Health Information
BAGHDAD (Reuters) Jan 18 - Iraqi doctors would be allowed to carry weapons under a law approved by the cabinet on Sunday to help protect physicians subjected to kidnapping, murder and tribal demands for blood money from relatives of dead patients.
The law, which must still be passed by parliament, could help prevent doctors from fleeing war-shattered Iraq and encourage those abroad to come back.
Many doctors, particularly in the south, complain about a tribal tradition where the family of a patient who dies while in a doctor's care demands payment.
The draft law foresees a possible prison sentence of three years or a fine of no less than 10 million Iraqi dinars (around $8,000) against anyone who demands a tribal settlement from a doctor.
"The draft law is a gesture from the Iraqi government for doctors and specialists... to protect them from attacks and the tribal demands resulting from their medical work," government spokesman Ali al-Dabbagh said in a statement.
Doctors fled Iraq by the thousands during the explosion of violence between majority Shi'ites and minority Sunni Arabs in the years following the 2003 U.S.-led invasion that toppled Saddam Hussein.
Considered among the elite of Iraqi society, medical specialists became a target for insurgents, militias and kidnappers in search of rich ransoms. Hundreds have been killed since 2003.
The law would also allow the government to lift Iraq's usual retirement age of 63 and let doctors work until 70 if they are needed, and to build residential compounds for physicians near hospitals and other health institutions.
BAGHDAD (Reuters) Jan 18 - Iraqi doctors would be allowed to carry weapons under a law approved by the cabinet on Sunday to help protect physicians subjected to kidnapping, murder and tribal demands for blood money from relatives of dead patients.
The law, which must still be passed by parliament, could help prevent doctors from fleeing war-shattered Iraq and encourage those abroad to come back.
Many doctors, particularly in the south, complain about a tribal tradition where the family of a patient who dies while in a doctor's care demands payment.
The draft law foresees a possible prison sentence of three years or a fine of no less than 10 million Iraqi dinars (around $8,000) against anyone who demands a tribal settlement from a doctor.
"The draft law is a gesture from the Iraqi government for doctors and specialists... to protect them from attacks and the tribal demands resulting from their medical work," government spokesman Ali al-Dabbagh said in a statement.
Doctors fled Iraq by the thousands during the explosion of violence between majority Shi'ites and minority Sunni Arabs in the years following the 2003 U.S.-led invasion that toppled Saddam Hussein.
Considered among the elite of Iraqi society, medical specialists became a target for insurgents, militias and kidnappers in search of rich ransoms. Hundreds have been killed since 2003.
The law would also allow the government to lift Iraq's usual retirement age of 63 and let doctors work until 70 if they are needed, and to build residential compounds for physicians near hospitals and other health institutions.
Green Vegetables Protect Smokers From Genetic Changes Associated With Lung Cancer Risk
From Medscape Medical News
Jacquelyn K. Beals, PhD
January 19, 2010 — A questionnaire on food intake combined with an analysis of DNA from the sputum of smokers shows that intake of leafy green vegetables, folate, and multivitamins protects smokers against the methylation of several genes often silenced in lung cancer. Methylation, the addition of methyl groups to cytosine bases of DNA, prevents a gene from being transcribed, essentially blocking its function.
Published in the January 15 issue of Cancer Research, this study leads to new conceptions of lung cancer prevention based on the influence of diet on the epigenome of patients' respiratory epithelium.
Although lung cancer most frequently results from the carcinogenic effects of tobacco, changes leading to cancer occur over the course of several decades. The 8 genes analyzed in this study are frequently "turned off" in lung cancer by promoter methylation, associated in previous studies with greater risk of developing the disease. Thus, higher methylation levels are associated with increased risk.
Of these 8 genes, 7 "are tumor suppressor genes, and the eighth is a gene involved in DNA repair," said senior author Steven A. Belinsky, PhD, director of the Lung Cancer Program, Lovelace Respiratory Research Institute, Albuquerque, New Mexico, in his email to Medscape Oncology. "Most notably, one of the genes is p16, a critical gene for regulating cell cycle control."
Participants were drawn from the Lovelace Smokers Cohort. Cohort members are former and current smokers between 40 and 75 years old with at least 15 pack-years of smoking history. Individuals from the cohort filled out the Harvard University Food Frequency Questionnaire Dietary Assessment form to indicate their intake frequency of approximately 150 food items. After excluding individuals with caloric intakes exceeding sex-specific ranges, 1101 participants remained.
Foods with established or suspected connections with methylation or lung cancer were considered most carefully. The assessments included animal fat; vitamins C, E, and B9 (folate), among others; alcohol; cod liver oil; and multivitamins. Foods analyzed included 6 groups of potential relevance: yellow vegetables, leafy green vegetables (a major source of folate), cruciferous vegetables, tomatoes, fruit, and red or processed meats. The hypothesis was that animal fat and red and processed meats would be associated with greater methylation, whereas fruit, vegetable, and vitamin intake would be associated with lower methylation status.
The 8 genes — p16, MGMT, DAPK, RASSF1A, PAX5α, PAX5β, GATA4, and GATA5 — had previously established associations with the risk for lung cancer. DNA was obtained from cells isolated from each participant's sputum samples, and polymerase chain reaction was used to identify methylated forms of the genes of interest. Patients were "scored" by the number of methylated genes and were grouped into those having fewer than 2 genes methylated (low) and those with 2 or more genes methylated (high).
Significant Links Between Methylation Status and Dietary Variables
Statistical analysis found significant associations between methylation status and specific dietary variables. Intake of leafy green vegetables was associated with decreased risk for high methylation (odds ratio [OR], .84; 95% confidence interval [CI], .74 - .93; P < .001). Folate intake yielded similar results (OR, .84; 95% CI, .72 - .99; P = .04). Even current multivitamin use was significantly associated with methylation status: current use (OR, .57; 95% CI, .40 - .83; P = .01).
"There was a dose response with consumption of vegetables and sustained vitamin use, and increased duration was associated with better protection," observed Dr. Belinsky. "Multivitamins and leafy green vegetables have things other than folate, although that is the common link, and...the amount of folate varies by multivitamin and vegetable, so I don't know that there is a simple yes or no answer [regarding dose dependence]," he said.
The report summarizes their findings: "Green leafy vegetables were the only food item in this analysis to exhibit protection against methylation status." In addition, the use of multivitamins, which supply many of the same substances as leafy green vegetables, had a significant protective effect.
Should all smokers be told to increase their intake of spinach and kale? "Our findings certainly support yes for smokers," said Dr. Belinsky. "Most cancers arise through inactivating genes by methylation, so I don't think consumption of leafy green vegetables and a multivitamin would do anything negative, and it could help." He noted, however, that further studies are needed to validate their findings.
"Adequate folate intake is essential, because folate is a crucial cofactor in one-carbon metabolism and has an important role in DNA synthesis and replication," said Margaret R. Spitz, MD, MPH, clinical professor of epidemiology, University of Texas M.D. Anderson Cancer Center, Houston, in her email replying to Medscape Oncology's request for independent commentary. "Also remember that folate deficiency is associated with...an established risk factor for cardiovascular disease.
"I do not think we can make any clinical recommendations yet," said Dr. Spitz. With folate-fortified foods in the United States, many adults achieve their recommended allowance of folate from those sources alone. Nevertheless, "All smokers should be advised to quit, and everyone should follow common-sense dietary principles," Dr. Spitz concluded.
Dr. Belinsky is a consultant and has licensed intellectual property with Oncomethylome Sciences. Dr. Spitz has disclosed no relevant financial relationships.
Cancer Res. 2010;70(2):568-574. Abstract
.
Jacquelyn K. Beals, PhD
January 19, 2010 — A questionnaire on food intake combined with an analysis of DNA from the sputum of smokers shows that intake of leafy green vegetables, folate, and multivitamins protects smokers against the methylation of several genes often silenced in lung cancer. Methylation, the addition of methyl groups to cytosine bases of DNA, prevents a gene from being transcribed, essentially blocking its function.
Published in the January 15 issue of Cancer Research, this study leads to new conceptions of lung cancer prevention based on the influence of diet on the epigenome of patients' respiratory epithelium.
Although lung cancer most frequently results from the carcinogenic effects of tobacco, changes leading to cancer occur over the course of several decades. The 8 genes analyzed in this study are frequently "turned off" in lung cancer by promoter methylation, associated in previous studies with greater risk of developing the disease. Thus, higher methylation levels are associated with increased risk.
Of these 8 genes, 7 "are tumor suppressor genes, and the eighth is a gene involved in DNA repair," said senior author Steven A. Belinsky, PhD, director of the Lung Cancer Program, Lovelace Respiratory Research Institute, Albuquerque, New Mexico, in his email to Medscape Oncology. "Most notably, one of the genes is p16, a critical gene for regulating cell cycle control."
Participants were drawn from the Lovelace Smokers Cohort. Cohort members are former and current smokers between 40 and 75 years old with at least 15 pack-years of smoking history. Individuals from the cohort filled out the Harvard University Food Frequency Questionnaire Dietary Assessment form to indicate their intake frequency of approximately 150 food items. After excluding individuals with caloric intakes exceeding sex-specific ranges, 1101 participants remained.
Foods with established or suspected connections with methylation or lung cancer were considered most carefully. The assessments included animal fat; vitamins C, E, and B9 (folate), among others; alcohol; cod liver oil; and multivitamins. Foods analyzed included 6 groups of potential relevance: yellow vegetables, leafy green vegetables (a major source of folate), cruciferous vegetables, tomatoes, fruit, and red or processed meats. The hypothesis was that animal fat and red and processed meats would be associated with greater methylation, whereas fruit, vegetable, and vitamin intake would be associated with lower methylation status.
The 8 genes — p16, MGMT, DAPK, RASSF1A, PAX5α, PAX5β, GATA4, and GATA5 — had previously established associations with the risk for lung cancer. DNA was obtained from cells isolated from each participant's sputum samples, and polymerase chain reaction was used to identify methylated forms of the genes of interest. Patients were "scored" by the number of methylated genes and were grouped into those having fewer than 2 genes methylated (low) and those with 2 or more genes methylated (high).
Significant Links Between Methylation Status and Dietary Variables
Statistical analysis found significant associations between methylation status and specific dietary variables. Intake of leafy green vegetables was associated with decreased risk for high methylation (odds ratio [OR], .84; 95% confidence interval [CI], .74 - .93; P < .001). Folate intake yielded similar results (OR, .84; 95% CI, .72 - .99; P = .04). Even current multivitamin use was significantly associated with methylation status: current use (OR, .57; 95% CI, .40 - .83; P = .01).
"There was a dose response with consumption of vegetables and sustained vitamin use, and increased duration was associated with better protection," observed Dr. Belinsky. "Multivitamins and leafy green vegetables have things other than folate, although that is the common link, and...the amount of folate varies by multivitamin and vegetable, so I don't know that there is a simple yes or no answer [regarding dose dependence]," he said.
The report summarizes their findings: "Green leafy vegetables were the only food item in this analysis to exhibit protection against methylation status." In addition, the use of multivitamins, which supply many of the same substances as leafy green vegetables, had a significant protective effect.
Should all smokers be told to increase their intake of spinach and kale? "Our findings certainly support yes for smokers," said Dr. Belinsky. "Most cancers arise through inactivating genes by methylation, so I don't think consumption of leafy green vegetables and a multivitamin would do anything negative, and it could help." He noted, however, that further studies are needed to validate their findings.
"Adequate folate intake is essential, because folate is a crucial cofactor in one-carbon metabolism and has an important role in DNA synthesis and replication," said Margaret R. Spitz, MD, MPH, clinical professor of epidemiology, University of Texas M.D. Anderson Cancer Center, Houston, in her email replying to Medscape Oncology's request for independent commentary. "Also remember that folate deficiency is associated with...an established risk factor for cardiovascular disease.
"I do not think we can make any clinical recommendations yet," said Dr. Spitz. With folate-fortified foods in the United States, many adults achieve their recommended allowance of folate from those sources alone. Nevertheless, "All smokers should be advised to quit, and everyone should follow common-sense dietary principles," Dr. Spitz concluded.
Dr. Belinsky is a consultant and has licensed intellectual property with Oncomethylome Sciences. Dr. Spitz has disclosed no relevant financial relationships.
Cancer Res. 2010;70(2):568-574. Abstract
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Friday, January 22, 2010
High-Intensity Aerobics Improves Cognitive Performance in MCI, Especially for Women
From Medscape Medical News
Pam Harrison
January 21, 2010 — A high-intensity, supervised aerobic exercise program improves cognitive performance in older adults with mild cognitive impairment (MCI), a new study suggests. The effects are most pronounced in women despite comparable gains in cardiorespiratory fitness and body fat reduction in both sexes.
The results, published in the January issue of the Archives of Neurology, showed that a 6-month aerobic exercise program improved performance on multiple tests of executive function in women with MCI. The same exercise regimen also improved insulin sensitivity and reduced stress hormones in women but had much less effect in men.
"What we know is that generally with age or disease, we use glucose less efficiently and then we see cognitive problems," Laura Baker, PhD, University of Washington School of Medicine, Seattle, told Medscape Neurology. "So if we can increase the efficacy of glucose metabolism, we may be improving the efficacy with which glucose gets to the brain and therefore improve cognition. This happened for women but not for men."
Aerobics vs Stretching
For the study, 33 adults, of whom 17 were women, with amnestic MCI were randomized to either a high-intensity aerobic exercise program or a stretching control group. "The aerobic group exercised under the supervision of a fitness trainer at 75% to 85% of heart rate reserve for 45 to 60 minutes per day, 4 days per week for 6 months," the investigators note.
The control group followed the same schedule during which they performed supervised stretching activities but maintained their heart rate at or below 50% of their heart rate reserve. Glucometabolic and treadmill tests were done before and after the study on all participants, and blood was collected and the cognitive test administered at baseline and again at months 3 and 6.
The first 8 sessions were supervised by the trainer, and thereafter, the trainer supervised 1 session per week per participant. "Six months of controlled aerobic exercise vs stretching improved cardiorespiratory fitness indexed by exercise treadmill test measures of VO2 peak ... treadmill grade ... and treadmill time to exhaustion," the investigators report.
The same aerobic regimen also improved executive control processes of multitasking, cognitive flexibility, information processing efficiency, and selective attention. When sex was included in the model as a predictor variable, they write, "a significant interaction indicated that this treatment effect differed for men and women, [whereas] for women, increasing VO2 peak was associated with improved executive function."
Favorable effects of aerobic exercise were also apparent for Symbol-Digit Modalities and Verbal Fluency, measures of cognitive function, with analyses again revealing that the effect size was larger for women than for men on both tasks. Sex differences were also observed on the Stroop test, with aerobic exercise having no effect in men. The aerobic group was also faster to complete the Trails B test compared with baseline than the stretching control group; here, the effect was similar for women and men.
"Aerobic exercise was [also] associated with sex-specific improvements in glucoregulation and insulin sensitivity," the study authors note, "and for women, 6-month changes in insulin sensitivity predicted VO2 peak and executive function."
A sex-specific effect of aerobic exercise was again observed for plasma cortisol levels, increasing for women in the stretching control group over the study interval but not for women in the aerobic group. In men, cortisol levels decreased over time for those in the stretching group, whereas they remained stable for the aerobic group.
Aerobic exercise also reduced brain-derived neurotrophic factor (BDNF) in women but not in men.
Initiate and Organize
As Dr. Baker observes, the first cognitive ability to be affected in patients with MCI is their ability to initiate and to organize. "Generally, it's the little things like cleaning up or finishing off projects, and exercise is no different than any other task." Patients with MCI are also afraid to exercise, and they have no confidence that if they exercise they might do it right.
Thus, these people need help to "get the ball rolling," she adds. Once a structure is in place, however, and they get started on an exercise regimen, "they are really fine." Indeed, after the first 6 weeks of their exercise regimen during which patients were worked up to their target heart rate very slowly, "we were exercising them at a pretty high level, and by week 6, many of them were going over their target [heart rate]," Dr. Baker notes.
"Evidence already shows that there is a benefit from exercise for normal older adults with no specific memory problems, and our hope is that prolonged exercise may slow progression in cognitive decline in patients with MCI because even if we can't reverse cognitive decline altogether, if we can give someone a better quality of life for many months, that would be a huge accomplishment," Dr. Baker observes.
In a related but separate study published in the same issue of Archives of Neurology by Yonas Geda, MD, and colleagues at the Mayo Clinic in Rochester, Minnesota, moderate exercise done during mid or even later in life reduced the risk of MCI by 39% in adults with normal cognitive function at baseline.
Findings in this study were consistent among both men and women.
Important Gap
Art Kramer, PhD, University of Illinois at Urbana-Champaign, told Medscape Neurology that the study begins to fill an important gap toward a better understanding of the potential impact exercise may have in MCI patients. "There are many exercise studies with relatively healthy older individuals but very few with MCI or Alzheimer's disease, and rigorously controlled trials are important."
In their own meta-analysis of fitness and cognition (Psychol Sci. 2003;14:125-130), Dr. Kramer and colleagues also found that fitness positively affects cognition.
"Consistent across the many studies, the effect of exercise was larger for women than it is for men," he adds. On the other hand, the current study, although well controlled, still involves only a small sample and perhaps the lack of effect from aerobic exercise in men may be explained by the limited numbers of patients in the study overall.
"As the authors themselves suggest, this is preliminary data and it needs to be replicated ideally in a larger randomized controlled trial of MCI patients and perhaps even those further along with Alzheimer's disease," Dr. Kramer observes. Still, he adds, "the study attempts to relate the effects of exercise on cortisol and BDNF to animal work in which we have more physiological and neurological measures, which is a good step."
The study was supported by the Department of Veterans Affairs and the Alzheimer’s Association. The authors have disclosed no relevant financial relationships. Dr. Kramer has disclosed no relevant financial relationships.
Arch Neurol. 2010;67:71-79, 80-86.
Pam Harrison
January 21, 2010 — A high-intensity, supervised aerobic exercise program improves cognitive performance in older adults with mild cognitive impairment (MCI), a new study suggests. The effects are most pronounced in women despite comparable gains in cardiorespiratory fitness and body fat reduction in both sexes.
The results, published in the January issue of the Archives of Neurology, showed that a 6-month aerobic exercise program improved performance on multiple tests of executive function in women with MCI. The same exercise regimen also improved insulin sensitivity and reduced stress hormones in women but had much less effect in men.
"What we know is that generally with age or disease, we use glucose less efficiently and then we see cognitive problems," Laura Baker, PhD, University of Washington School of Medicine, Seattle, told Medscape Neurology. "So if we can increase the efficacy of glucose metabolism, we may be improving the efficacy with which glucose gets to the brain and therefore improve cognition. This happened for women but not for men."
Aerobics vs Stretching
For the study, 33 adults, of whom 17 were women, with amnestic MCI were randomized to either a high-intensity aerobic exercise program or a stretching control group. "The aerobic group exercised under the supervision of a fitness trainer at 75% to 85% of heart rate reserve for 45 to 60 minutes per day, 4 days per week for 6 months," the investigators note.
The control group followed the same schedule during which they performed supervised stretching activities but maintained their heart rate at or below 50% of their heart rate reserve. Glucometabolic and treadmill tests were done before and after the study on all participants, and blood was collected and the cognitive test administered at baseline and again at months 3 and 6.
The first 8 sessions were supervised by the trainer, and thereafter, the trainer supervised 1 session per week per participant. "Six months of controlled aerobic exercise vs stretching improved cardiorespiratory fitness indexed by exercise treadmill test measures of VO2 peak ... treadmill grade ... and treadmill time to exhaustion," the investigators report.
The same aerobic regimen also improved executive control processes of multitasking, cognitive flexibility, information processing efficiency, and selective attention. When sex was included in the model as a predictor variable, they write, "a significant interaction indicated that this treatment effect differed for men and women, [whereas] for women, increasing VO2 peak was associated with improved executive function."
Favorable effects of aerobic exercise were also apparent for Symbol-Digit Modalities and Verbal Fluency, measures of cognitive function, with analyses again revealing that the effect size was larger for women than for men on both tasks. Sex differences were also observed on the Stroop test, with aerobic exercise having no effect in men. The aerobic group was also faster to complete the Trails B test compared with baseline than the stretching control group; here, the effect was similar for women and men.
"Aerobic exercise was [also] associated with sex-specific improvements in glucoregulation and insulin sensitivity," the study authors note, "and for women, 6-month changes in insulin sensitivity predicted VO2 peak and executive function."
A sex-specific effect of aerobic exercise was again observed for plasma cortisol levels, increasing for women in the stretching control group over the study interval but not for women in the aerobic group. In men, cortisol levels decreased over time for those in the stretching group, whereas they remained stable for the aerobic group.
Aerobic exercise also reduced brain-derived neurotrophic factor (BDNF) in women but not in men.
Initiate and Organize
As Dr. Baker observes, the first cognitive ability to be affected in patients with MCI is their ability to initiate and to organize. "Generally, it's the little things like cleaning up or finishing off projects, and exercise is no different than any other task." Patients with MCI are also afraid to exercise, and they have no confidence that if they exercise they might do it right.
Thus, these people need help to "get the ball rolling," she adds. Once a structure is in place, however, and they get started on an exercise regimen, "they are really fine." Indeed, after the first 6 weeks of their exercise regimen during which patients were worked up to their target heart rate very slowly, "we were exercising them at a pretty high level, and by week 6, many of them were going over their target [heart rate]," Dr. Baker notes.
"Evidence already shows that there is a benefit from exercise for normal older adults with no specific memory problems, and our hope is that prolonged exercise may slow progression in cognitive decline in patients with MCI because even if we can't reverse cognitive decline altogether, if we can give someone a better quality of life for many months, that would be a huge accomplishment," Dr. Baker observes.
In a related but separate study published in the same issue of Archives of Neurology by Yonas Geda, MD, and colleagues at the Mayo Clinic in Rochester, Minnesota, moderate exercise done during mid or even later in life reduced the risk of MCI by 39% in adults with normal cognitive function at baseline.
Findings in this study were consistent among both men and women.
Important Gap
Art Kramer, PhD, University of Illinois at Urbana-Champaign, told Medscape Neurology that the study begins to fill an important gap toward a better understanding of the potential impact exercise may have in MCI patients. "There are many exercise studies with relatively healthy older individuals but very few with MCI or Alzheimer's disease, and rigorously controlled trials are important."
In their own meta-analysis of fitness and cognition (Psychol Sci. 2003;14:125-130), Dr. Kramer and colleagues also found that fitness positively affects cognition.
"Consistent across the many studies, the effect of exercise was larger for women than it is for men," he adds. On the other hand, the current study, although well controlled, still involves only a small sample and perhaps the lack of effect from aerobic exercise in men may be explained by the limited numbers of patients in the study overall.
"As the authors themselves suggest, this is preliminary data and it needs to be replicated ideally in a larger randomized controlled trial of MCI patients and perhaps even those further along with Alzheimer's disease," Dr. Kramer observes. Still, he adds, "the study attempts to relate the effects of exercise on cortisol and BDNF to animal work in which we have more physiological and neurological measures, which is a good step."
The study was supported by the Department of Veterans Affairs and the Alzheimer’s Association. The authors have disclosed no relevant financial relationships. Dr. Kramer has disclosed no relevant financial relationships.
Arch Neurol. 2010;67:71-79, 80-86.
Sibutramine Now Contraindicated in Patients With a History of Cardiovascular Disease
From Medscape Medical News > Medscape Alerts
Emma Hitt, PhD
January 21, 2010 — Sibutramine, marketed as Meridia in the United States by Abbott, (Reductil in UK) is now contraindicated in patients with a history of cardiovascular disease, the US Food and Drug Administration (FDA) announced today.
According to an alert posted today by MedWatch, the FDA's safety information and adverse event reporting program, the announcement is a follow-up to an ongoing safety review of preliminary results reported in November 2009, which first raised concerns about this issue.
According to the FDA, the drug label already warns against the use of sibutramine in patients with cardiovascular disease. "However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label," stating that sibutramine should not be used in patients with a history of cardiovascular disease, including patients with a:
History of coronary artery disease (eg, myocardial infarction, angina)
History of stroke or transient ischemic attack
History of heart arrhythmias
History of congestive heart failure
History of peripheral arterial disease
Uncontrolled hypertension (eg, >145/90 mm Hg)
The safety review was based on data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT), which enrolled more than 10,000 overweight or obese patients with diabetes or a history of coronary artery disease, peripheral vascular disease, or stroke, along with other cardiovascular risk factors.
An analysis of the trial's primary end point — a composite of myocardial infarction, stroke, resuscitated cardiac arrest, or death — found the rate to be 11.4% for patients receiving sibutramine and 10% for those receiving placebo.
The current review found that the risk for cardiovascular events with sibutramine was significantly increased only in patients with a history of cardiovascular disease (P = .023).
Healthcare professionals should regularly monitor blood pressure and heart rate in patients taking sibutramine, the FDA notes.
"If sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued," according to the FDA. "Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first 3 to 6 months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk."
The full study report for SCOUT is expected in March 2010, at which time an open public advisory committee meeting will be convened to determine whether additional regulatory actions should be taken to ensure the safe use of sibutramine.
EMEA
Meanwhile, the European Medicines Agency (EMEA) also announced the results of its safety review of drugs containing sibutramine, citing the SCOUT data. According to a press release issued today, the EMEA concluded, "the risks of these medicines are greater than their benefits."
Sibutramine-containing brands in the United Kingdom and Europe include Reductil, Reduxade, and Zelium, among others.
The agency now "recommend[s] the suspension of marketing authorizations for these medicines across the European Union."
The EMEA statement goes on to say that physicians should no longer prescribe sibutramine-containing agents, pharmacists should no longer dispense them, and patients taking them should make an appointment to see their physicians "at the next convenient time."
More information is available on the FDA's MedWatch Web site and on the EMEA Web site.
Adverse events related to sibutramine should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Emma Hitt, PhD
January 21, 2010 — Sibutramine, marketed as Meridia in the United States by Abbott, (Reductil in UK) is now contraindicated in patients with a history of cardiovascular disease, the US Food and Drug Administration (FDA) announced today.
According to an alert posted today by MedWatch, the FDA's safety information and adverse event reporting program, the announcement is a follow-up to an ongoing safety review of preliminary results reported in November 2009, which first raised concerns about this issue.
According to the FDA, the drug label already warns against the use of sibutramine in patients with cardiovascular disease. "However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label," stating that sibutramine should not be used in patients with a history of cardiovascular disease, including patients with a:
History of coronary artery disease (eg, myocardial infarction, angina)
History of stroke or transient ischemic attack
History of heart arrhythmias
History of congestive heart failure
History of peripheral arterial disease
Uncontrolled hypertension (eg, >145/90 mm Hg)
The safety review was based on data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT), which enrolled more than 10,000 overweight or obese patients with diabetes or a history of coronary artery disease, peripheral vascular disease, or stroke, along with other cardiovascular risk factors.
An analysis of the trial's primary end point — a composite of myocardial infarction, stroke, resuscitated cardiac arrest, or death — found the rate to be 11.4% for patients receiving sibutramine and 10% for those receiving placebo.
The current review found that the risk for cardiovascular events with sibutramine was significantly increased only in patients with a history of cardiovascular disease (P = .023).
Healthcare professionals should regularly monitor blood pressure and heart rate in patients taking sibutramine, the FDA notes.
"If sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued," according to the FDA. "Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first 3 to 6 months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk."
The full study report for SCOUT is expected in March 2010, at which time an open public advisory committee meeting will be convened to determine whether additional regulatory actions should be taken to ensure the safe use of sibutramine.
EMEA
Meanwhile, the European Medicines Agency (EMEA) also announced the results of its safety review of drugs containing sibutramine, citing the SCOUT data. According to a press release issued today, the EMEA concluded, "the risks of these medicines are greater than their benefits."
Sibutramine-containing brands in the United Kingdom and Europe include Reductil, Reduxade, and Zelium, among others.
The agency now "recommend[s] the suspension of marketing authorizations for these medicines across the European Union."
The EMEA statement goes on to say that physicians should no longer prescribe sibutramine-containing agents, pharmacists should no longer dispense them, and patients taking them should make an appointment to see their physicians "at the next convenient time."
More information is available on the FDA's MedWatch Web site and on the EMEA Web site.
Adverse events related to sibutramine should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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