ADA Issues New Clinical Practice Recommendations

December 31, 2007 (SunHerald) - The American Diabetes Association (ADA) today issued its annual Clinical Practice Recommendations to help health care providers treat people with diabetes using the most current evidence available.

This year, one notable change occurs in the Medical Nutrition Therapy section dealing with weight loss. Until now, the ADA did not recommend low carbohydrate diets because of lack of sufficient scientific evidence supporting their safety and effectiveness. The 2008 Recommendations include a statement recognizing the increasing evidence that weight-loss plans that restrict carbohydrate or fat calorie intake are equally effective for reducing weight in the short term (up to one year). The "Standards of Medical Care in Diabetes--2008" document reviews the growing evidence for the effectiveness of either approach to weight loss. In addition, there is now evidence that the most important determinant of weight loss is not the composition of the diet, but whether the person can stick with it, and that some individuals are more likely to adhere to a low carbohydrate diet while others may find a low fat calorie-restricted diet easier to follow.

As it has in the past, the ADA continues to emphasize the importance of sustained, moderate weight loss and increased physical activity for people who are overweight or obese and at risk for diabetes or living with diabetes.

"The risks of overweight and obesity are well known. We recognize that people are looking for realistic ways to lose weight," said Ann Albright, PhD, RD, President, Health Care & Education, American Diabetes Association. "The evidence is clear that both low-carbohydrate and low-fat calorie restricted diets result in similar weight loss at one year. We're not endorsing either of these weight-loss plans over any other method of losing weight. What we want health care providers to know is that it's important for patients to choose a plan that works for them, and that the health care team support their patients' weight loss efforts and provide appropriate monitoring of patients' health."

Because people following low carbohydrate diets may replace calories from carbohydrate with fat or protein, the recommendations also include monitoring the lipid profile (blood fats, including cholesterol and triglycerides) of patients on such diets. High protein diets may also worsen kidney problems.

Therefore, it is also recommended that patients with kidney disease be counseled about appropriate intake of protein and that their kidney functions be monitored carefully.

"Short-term weight loss is beneficial, but what is most important for health is keeping the weight off long-term," said Albright. "We also want to continue to emphasize the importance of regular physical activity, both to aid weight loss from calorie-restricted diets, and also for the positive health gains associated with exercise that are independent of weight loss."

Being overweight or obese and inactive are major contributing factors to the onset of type 2 diabetes.

Overweight and obesity also complicate the treatment of diabetes (both type 1 and type 2) and can contribute to the development of other health problems, such as heart disease and cancer. In the United States, rates of type 2 diabetes in adults and children have risen dramatically in recent years, along with the national epidemic of obesity.

This year's revisions also include:

-- Recommendations that adults who are overweight or obese and have one or more diabetes risk factor be tested for pre-diabetes and diabetes
-- New treatment guidelines for older adults
-- Recommendations for preparing and maintaining disaster kits for diabetes self-management
-- Structural changes to make the documents more "user-friendly," incorporating an Executive Summary, screening recommendations and diagnostic cut-point tables, along with general treatment information.

For more information about the ADA's 2008 Clinical Practice Recommendations, which are published as a supplement to the January issue of Diabetes Care, please visit diabetes.org. Diabetes Care, published by the American Diabetes Association, is the leading peer-reviewed journal of clinical research into the nation's fifth leading cause of death by disease. Diabetes also is a leading cause of heart disease and stroke, as well as the leading cause of adult blindness, kidney failure, and non-traumatic amputations. For more information about diabetes, visit the American Diabetes Association Web site http://diabetes.org or call 1-800-DIABETES (1-800-342-2383).

SOURCE American Diabetes Association

Posted by dlifenews at 11:28 AM | Comments (0)

Vitamin A Suppresses Type 1 Diabetes in Animal Study

December 28, 2007 (USDA) - Pumpkin pie, sweet potatoes and many other holiday favorites are rich in vitamin A, a nutrient essential for good health. Now a study by Agricultural Research Service (ARS) nutrition scientists has shown, for the first time, that high levels of vitamin A can suppress development of type 1 diabetes in laboratory mice prone to that disease.

Type 1 diabetes, which affects more than 750,000 Americans, occurs when the immune system mistakenly attacks and destroys the pancreas' insulin-producing beta cells. Scientists already know that vitamin A and antioxidants—such as those in the freeze-dried grape powder also tested in the study—can regulate the immune system.

However, apparently no one had shown the suppressive effect of either vitamin A or grape powder on type 1 diabetes in either lab mice or humans, according to ARS physiologist Charles B. Stephensen.
He collaborated with molecular biologist Susan J. Zunino for the investigation, conducted in their laboratories at the ARS Western Human Nutrition Research Center in Davis, Calif. They reported their findings earlier this year in the Journal of Nutrition.

Blood sugar levels of the 45 mice in the experiment were taken regularly to determine onset of diabetes. At about seven months, only 25 percent of those mice eating a high-vitamin-A feed, and 33 percent of those eating grape-powder-enriched feed, had developed type 1 diabetes, while 71 percent of those on non-enriched feed had became diabetic.

Differences in levels of a protein called tumor necrosis factor-alpha, or TNF-alpha, linked in other studies to type 1 diabetes, were notable. TNF-alpha production by immune cells of mice fed the vitamin A- or grape-powder-enriched feed was significantly lower than that in cells of mice fed standard feed.
The study is part of ongoing research at the nutrition center to discover more about the potential of vitamin A and other nutrients to help prevent diabetes, cancer, asthma and other diseases of the immune system.

ARS, the U.S. Department of Agriculture's chief scientific research agency, and the National Institutes of Health of the U.S. Department of Health and Human Services funded the research.

Posted by dlifenews at 01:59 PM | Comments (1)

High Triglycerides, Other Cholesterol Raise Risk of Stroke

December 27, 2007 (EurekAlert) – People with high triglycerides and another type of cholesterol tested but not usually evaluated as part of a person’s risk assessment have an increased risk of a certain type of stroke, according to research published in the December 26, 2007, online issue of Neurology®, the medical journal of the American Academy of Neurology. “LDL or ‘bad’ cholesterol has been the primary target for reducing the risk of stroke, but these results show that other types of cholesterol may be more strongly linked with stroke risk,” said study author Bruce Ovbiagele, MD, of UCLA Medical Center in Los Angeles, CA, and member of the American Academy of Neurology.

The researchers analyzed the records of 1,049 people admitted to a university hospital with a stroke or mini-stroke over four years. Of those, 247 people had a large artery atherosclerotic stroke. This is a type of ischemic stroke caused by a blockage of blood flow to the brain. People with this type of stroke have blockage in the large arteries leading to the brain.

Those with high triglycerides and elevated “non-high density lipoprotein cholesterol” were more likely to have a large artery atherosclerotic stroke than those with low levels of these fats in the blood.

Those with the highest triglycerides were 2.7 times more likely to have this type of stroke than those with the lowest level. Triglycerides are fatty acids and are the most common type of fat in the blood. Those with the greatest non-high density lipoprotein cholesterol, which is neither the “good” nor the “bad” cholesterol, were 2.4 times more likely to have a large artery stroke.

“Because this type of cholesterol is included in the test that is normally ordered, and triglycerides are already reported, it would not be difficult to start paying closer attention to these factors in people at risk for large artery stroke,” Ovbiagele said.

The study found that people with high “bad” cholesterol did not have an increased risk of this type of stroke. Ovbiagele noted that it is still important to monitor bad cholesterol levels to reduce risk of heart disease and other types of stroke.

Posted by dlifenews at 01:56 PM | Comments (0)

The Devil in the Dark Chocolate

December 21, 2007 (EurekAlert) - Eating dark chocolate rich in flavanols* might be good for your heart, but gaining this potential health benefit can be tricky, according to an Editorial in this week’s issue of The Lancet.

Last month, a study in Circulation showed that dark chocolate that is rich in flavanols induced coronary vasodilatation and improved coronary vascular function in 11 heart-transplant recipients compared with patients taking a cocoa-free control chocolate. Other studies have also shown that dark chocolate has cardiovascular benefits.

But before we all rush to buy our festive supplies of dark chocolate, “there is a catch” states the editorial. Some chocolate manufacturers remove the flavanols, which are bitter, from the darkened cocoa solids, so that even dark-looking chocolate can have no flavanol, and thus no health benefit. Consumers are also kept in the dark about the flavanol content of chocolate because manufacturers rarely label their products with this information. Moreover, even if falvanols are present the editorial warns, “the devil in the dark chocolate is the fat, sugar, and calories it contains.” To gain any health benefit those who eat a moderate amount of flavanol-rich dark chocolate would have to balance the calories by reducing their intake of other foods, claims the editorial.

But after all Christmas is nearly upon us , and The Lancet wouldn’t want to disappoint. The editorial concludes: “Of course some would say that, in terms of food intake, the best and simplest health message would be to stay away from the chocolate and eat a healthy, balanced diet, low in sugar, salt, and fat, and full of fresh fruit and vegetables. We say: ‘Bah, humbug to that. Pass the chocolates.’”

Posted by dlifenews at 11:45 AM | Comments (0)

Test Strip Recall for CONTOUR TS

December 21, 2007 (Bayer) - Bayer Diabetes Care has initiated a voluntary market recall of test strips (sensors) used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Company identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of our product specifications. Test results may demonstrate results 5 -17% higher.

This issue is unrelated in any way to the Contour TS meter itself and pertains only to certain test strips used with the meter. Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems.

The affected Contour TS strips were produced during the initial manufacturing process on new manufacturing equipment designed for the new Contour TS strips. The root cause of the problem has been identified, and corrective actions implemented including additional quality control measures to prevent recurrence. The quality of our products and the results our customers receive are very important to Bayer and, as such, we are notifying regulatory authorities, healthcare professionals and customers in the countries where Contour TS is marketed – France, Austria, Turkey, Korea, Mexico, India and predominantly through mail order channels in the United States.

Healthcare providers, retailers, patients and other customers who use Contour TS are advised to check the lot number on the bottles of Contour TS strips and to contact Bayer Diabetes Care for information regarding return and replacement of strips. The lot numbers can be found on the bottom of the box and on the side of the bottle containing the strips. The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). Only bottles of test strips with the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence are affected. Bottles with a lot number including 7J through 7M after WK are not affected and need not be returned. Additional information can be found at www.bayerdiabetes.com. Please call your Bayer customer service phone number (in the U.S., call 1-800-348-8100) to return any affected bottle of strips and to get a replacement.

Posted by dlifenews at 10:51 AM | Comments (1)

Mental Health Linked to Amputation Risk in Diabetic Veterans

December 20, 2007 (EurekAlert) – For U.S. veterans with diabetes, lower scores on a test of mental health functioning are associated with an increased risk of major amputations, reports a study in the November/December issue of the journal General Hospital Psychiatry.

"Our findings suggest that foot care programs need to assess individuals for mental health functioning as a risk factor and to develop appropriate interventions to counteract this higher risk of major amputation," write the study authors, led by Chin-Lin Tseng, Dr.P.H., of the VA New Jersey Health Care System, East Orange, N.J.

Dr. Tseng and colleagues analyzed a database of nearly 115,000 patients with diabetes who received care at Veterans Health Administration clinics from 1998 to 2000. All of the veterans were asked to complete a measure of mental health functioning.

Scores for mental health functioning were evaluated as a risk factor for diabetes-related amputations of the foot and leg. During 2000, "major" amputations (ankle or above) were required in 450 patients, while 431 underwent "minor" amputations (toes to ankle).

Veterans with lower scores for mental health functioning were at increased risk for amputations. This was so even when other important risk factors—including poor control of diabetes, smoking, less-frequent health care, and obesity—were taken into account. The overall rate of major amputations was 0.5 percent in veterans with below-average mental health scores, compared to 0.3 percent in those with above average scores and 0.2 percent for those at the highest level of mental health functioning.

On analysis including all risk factors, each five-point increase in mental health score was associated with a five percent decrease in the risk of major amputations. After adjustment, mental health functioning was no longer a significant risk factor for minor amputations.

Mental health scores were higher for veterans who had above a high school education, who were not obese, and who were not considered poor.

Amputations are a major complication of diabetes. Most studies of amputation risk factors have focused on medical conditions—for example, foot problems such as ulcers or infections or control of diabetes. Although some research has suggested that mental health care may affect the risk of diabetes-related amputations, the new study is the first to address this issue directly.

The results suggest that poor mental health functioning is an important risk factor for major amputations in diabetic veterans. Although the study cannot prove any cause-and-effect relationship, Dr. Tseng and colleagues believe that problems with mental health may interfere with needed diabetes care, including foot care.

The researchers urge medical professionals and patients to be aware of the possible link between mental health and amputation risk. They conclude, "Identifying patients who are at higher risk for major amputations due to poor mental health functioning may allow the dedication of resources and services to more closely supervise and manage their podiatric needs, perhaps leading to fewer amputations."

Posted by dlifenews at 11:41 AM | Comments (0)

Cancer and Arthritis Therapy May be Promising Treatment for Diabetes

December 19, 2007 (EurekAlert) - An antibody used to treat certain cancers and rheumatoid arthritis appears to greatly delay type 1 diabetes in mice, Yale School of Medicine researchers report in the Journal of Clinical Investigation.

“Even better, the beneficial effects of the antibody continue to be observed long after the antibody is no longer administered,” the researchers said.

The antibody, rituximab (anti-CD20), depletes B cells. Experimental evidence in mutant mice indicates that B cells play a role in autoimmune diseases by interacting with T cells of the immune system. It is T cells that destroy insulin-producing cells directly in the pancreas, leading to type 1 diabetes.

“Our paper shows, for the first time, that after successful B cell depletion, regulatory cells emerge that can continue to suppress the inflammatory and autoimmune response even after the B cells return,” said Li Wen, senior research scientist in the division of endocrinology. “Even more strikingly, we found that these regulatory cells include both B and T cells.”

To determine if B cell depletion would work as a therapy for type 1 diabetes, Wen and her colleague at Yale, Mark Shlomchik, M.D., professor of laboratory medicine and immunobiology, developed a mouse model. They engineered mice that were predisposed to diabetes and had the human version of CD20, the molecule rituximab targets, on the surface of their B cells.

The researchers tested a mouse version of the drug to deplete B cells in mice either before diabetes onset, or within days of diagnosis with diabetes. The drug treatment significantly delayed diabetes onset in pre-diabetic mice. This translated to a 10- to 15-week delay in developing diabetes compared to mice given a “sham” treatment. The equivalent period for humans would be approximately 10 to 15 years. Of the 14 mice that already had diabetes, five stopped needing insulin for two to five months while all the sham-treated mice remained diabetic.

“These studies suggest that B cells can have dual roles in diabetes and possibly other autoimmune diseases. The B cells might promote disease initially, but after being reconstituted following initial depletion with rituximab, they actually block further disease,” Shlomchik added. “This means that multiple rounds of medication to deplete the B cells might not be necessary or even advisable.”

Posted by dlifenews at 11:38 AM | Comments (0)

New Consumer Guides on Oral Diabetes Medications

December 17, 2007 (Newswise) — A pair of plain-language guides that outline the latest scientific evidence on the effectiveness and safety of oral medications for adults with type 2 diabetes are now available from HHS’ Agency for Healthcare Research and Quality.

AHRQ's analysis is the first to summarize evidence on the effectiveness and adverse events for all commonly used type 2 diabetes medications. As new classes of oral diabetes medications have become available, patients and clinicians have faced a growing list of treatment options and choices. The guides for consumers and clinicians are tools to help patients, their families, and health care providers make informed decisions about treating a condition that affects more than 15 million Americans.

The consumer-targeted guide, called Pills for Type 2 Diabetes: A Guide for Adults, includes information on:

· Types of diabetes pills commonly available for adults
· How well they work
· Possible side effects
· Medication costs

The clinician’s guide, called Comparing Oral Medications for Adults With Type 2 Diabetes, includes more detail on those topics and “confidence ratings” for evidence to support research conclusions.

Type 2 diabetes is an increasingly common chronic disease that occurs in people who have too much glucose in their blood either because their cells are resistant to insulin (a hormone that helps convert glucose into energy) or because their pancreas does not produce enough insulin. Excessive glucose levels can cause severe problems with the heart, eyes, kidneys and nerves. Obesity increases the risk of developing diabetes.

The diabetes guides are part of a series of informational products created by the Agency’s Effective Health Care program. Online and audio versions are available at http://effectivehealthcare.ahrq.gov/index.cfm. Free print versions can also be ordered.

Posted by dlifenews at 09:44 AM | Comments (0)

Pioglitazone Lowers Cardiovascular Risk in Diabetic Patients with Kidney Disease

December 12, 2007 (Newswise) — A new study confirms that chronic kidney disease (CKD) increases the already-high risk of serious cardiovascular events in diabetic patients with damage to the large blood vessels and suggests that treatment with the anti-diabetic drug pioglitazone may help to lower this risk, reports the January Journal of the American Society of Nephrology.

"The data confirm that chronic kidney disease is an independent risk factor for major adverse cardiovascular events and death, even amongst a very high-risk population of patients with diabetes and pre-existing macrovascular disease," comments Dr. Christian A. Schneider of University of Cologne, Germany. "In these patients with moderate to severe renal disease, pioglitazone reduced all-cause death, myocardial infarction, and stroke, independently of renal function."

The study was based on data from PROactive, a large-scale study of over 5,000 patients with type 2 diabetes who were at high cardiovascular risk because of macrovascular complications of diabetes. ("Macrovascular" disease means damage to the large blood vessels, such as the coronary arteries and the arteries supplying the legs.) In PROactive, patients were randomly assigned to treatment with the anti-diabetic drug pioglitazone or an inactive placebo.

Dr. Schneider and colleagues focused on 597 patients who had moderate to severe CKD in addition to diabetes and macrovascular disease. "It is well known that patients with diabetes and CKD are at particularly high risk for cardiovascular disease," Dr Schneider explains. "However, the impact of CKD on recurrent cardiovascular events among patients with diabetes and established macrovascular disease has not been studied previously." The CKD patients treated with pioglitazone versus placebo were compared for their rates of death or cardiovascular disease events, such as myocardial infarction (heart attack) and stroke.

Overall, 27.5 percent of diabetic patients with CKD died or experienced a cardiovascular event—significantly higher than the 19.6 rate among patients with normal kidney function. "In a high cardiovascular risk group of patients with type 2 diabetes and pre-existing macrovascular disease, CKD appears to identify a subpopulation of patients at even higher risk for cardiovascular disease," comments Dr. Schneider.

Within the CKD group, patients assigned to pioglitazone had a significantly lower risk of death or cardiovascular events. Overall, the rate of death, myocardial infarction, or stroke was reduced by one-third in patients taking pioglitazone, compared with placebo. Most of the reduction occurred among patients with lower levels of kidney function.

Dr. Schneider concludes, "Our analysis from PROactive suggests that patients with diabetes, macrovascular disease, and CKD (moderate to severe renal failure) can be treated effectively to reduce the occurrence of major cardiovascular endpoints." The researchers warn that their conclusions do not necessarily apply to diabetic patients at lower cardiovascular risk. Dr. Schneider adds, "These benefits of pioglitazone in patients with CKD must be viewed with caution until confirmatory data of our findings are provided."

The study is available online at http://jasn.asnjournals.org/ and in print in the January issue of the Journal of the American Society of Nephrology (JASN).

The study was funded by Takeda Pharmaceutical Company and was designed by the International Steering Committee, who approved the protocol and amendments. Conflicts of interest for the authors involved in the study are available within the printed/online study.

The ASN is a not-for-profit organization of 10,500 physicians and scientists dedicated to the study of nephrology and committed to providing a forum for the promulgation of information regarding the latest research and clinical findings on kidney diseases.

Posted by dlifenews at 09:50 AM | Comments (0)

Smoking Associated With Increased Risk of Diabetes

December 11, 2007 (Newswise) — A review of previous studies indicates that people who currently smoke have an increased risk of developing type 2 diabetes, compared with non-smokers, according to an article in the December 12 issue of JAMA.

A number of studies have examined the association between smoking and incidence of glucose abnormalities, and have suggested that smoking could be independently associated with glucose intolerance, impaired fasting glucose and type 2 diabetes, which could make smoking a modifiable risk factor for type 2 diabetes. However, it appears the quality and clinical features of these studies have not been fully assessed regarding this possible association.

Carole Willi, M.D., of the University of Lausanne, Switzerland, and colleagues conducted a systematic review and meta-analysis of studies describing the association between active smoking and the incidence of diabetes or other glucose metabolism irregularities. A search of databases yielded 25 studies, which were published between 1992 and 2006. The number of participants per study ranged from 630 to 709,827, for a total of 1.2 million participants. A total of 45,844 new cases of diabetes were reported during a study follow-up period ranging from 5 to 30 years.

Analysis of the data indicated that active smokers have a 44 percent increased risk of developing type 2 diabetes compared with non-smokers. Further analyses suggested a dose-response relationship between smoking and diabetes, with the association stronger for heavy smokers (20 or more cigarettes/day; 61 percent increased risk) compared with lighter smokers (29 percent increased risk).

The association also was weaker for former smokers (23 percent increased risk) than it was for active smokers.

“… we conclude that the relevant question should no longer be whether this association exists, but rather whether this established association is causal,” the authors write.

They add that observational primary studies cannot prove causality, but that the studies in this review do meet several recommended criteria for causation. “First, there is an appropriate temporal relationship: the cigarette smoking preceded diabetes incidence in all studies. Second, the findings are consistent with a dose-response relationship, with stronger associations for heavy smokers relative to lighter smokers and for active smokers relative to former smokers. … Third, there is theoretical biological plausibility for causality, in that smoking may lead to insulin resistance or inadequate compensatory insulin secretion responses according to several but not all studies.”

“Conversely, there are also possible non-causal explanations for this association. Smoking is often associated with other unhealthy behaviors that favor weight gain and/or diabetes, such as lack of physical activity, poor fruit and vegetable intake, and high alcohol intake,” the researchers write.

“Considering the consistent finding of increased diabetes incidence associated with active cigarette smoking across a large number of studies, we believe that there is no need for further cohort studies to test this hypothesis. However, there is a need for studies that include detailed measurement and adjustment for potential confounding factors such as socioeconomic status, education, and exercise with a goal of establishing whether the association with smoking is causal. We recommend that future studies focus on plausible causal mechanisms or mediating factors such as obesity, lack of physical activity, dietary habits, and stress levels.”

Posted by dlifenews at 09:55 AM | Comments (0)

Most Adults With Conditions that Increase Cardiovascular Disease Risk Have High Blood Pressure

December 11, 2007 (Newswise) — Nearly three-fourths of American adults with conditions such as coronary heart disease, stroke, diabetes or others that raise their risk for cardiovascular complications also have hypertension (high blood pressure), according to a report in the December 10/24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Although about 75 percent of these individuals are being treated for hypertension, only one-third to one-half are reaching blood pressure goals.

Blood pressure control remains a problem in the United States and around the world, according to background information in the article. “Recent estimates indicate little change in the prevalence of hypertension, and, although there seem to be some recent improvements in treatment and control rates, hypertension in many persons remains inadequately controlled,” the authors write.

Nathan D. Wong, Ph.D., of the University of California, Irvine, and colleagues analyzed data from adults participating in the National Health and Nutrition Examination Survey, a nationally representative survey conducted by the Centers for Disease Control and Prevention. In 2003 and 2004, 4,646 adults (representing 192 million nationwide) provided demographic and socioeconomic information and underwent laboratory and physiological testing (including blood pressure measurements).

A total of 1,671 (31.4 percent) of the participants had hypertension, defined as a systolic (top number) blood pressure of at least 140 milligrams of mercury (130 milligrams of mercury in those with diabetes or chronic kidney disease) or a diastolic (bottom number) blood pressure of at least 90 milligrams of mercury (80 milligrams of mercury in those with diabetes or chronic kidney disease), or as reporting use of a blood pressure–lowering medication. The condition was more common in older and black adults. A total of 68.5 percent of those with hypertension were being treated and 52.9 percent of those had their hypertension under control.

High blood pressure was found in most persons with cardiovascular diseases and related problems, including:

• 76.8 percent of those with diabetes
• 81.8 percent of those with chronic kidney disease
• 69.5 percent of those with stroke
• 71.4 percent of those with congestive heart failure, which occurs when the heart can’t pump enough blood to the rest of the body
• 73.7 percent of those with peripheral artery disease, or narrowed veins or arteries
• 73 percent of those with coronary artery disease
• 76.9 percent of those with two or more of these diseases

Among individuals with these conditions, 75 percent or more were being treated for hypertension, but only one-third to one-half of those in treatment reached goal levels for blood pressure (140/90 milligrams of mercury for most patients, or 130/80 milligrams of mercury for patients with diabetes or chronic kidney disease). Goal attainment rates were particularly low for persons with stroke (34.9 percent), heart failure (48.8 percent), peripheral arterial disease (46.7 percent) and coronary artery disease (50.3 percent).

With the lower goal for persons with diabetes and chronic kidney disease, only 35 percent and 23 percent, respectively, were controlled for their blood pressure. Those who were uncontrolled had systolic blood pressure that averaged at least 20 higher than the goal. “Poor control rates of systolic hypertension remain a principal problem that further compromises the already high cardiovascular disease risk” in these individuals, the authors write. “Moreover, given recently released recommendations to reduce the blood pressure goal to less than 130/80 milligrams of mercury for persons with coronary artery disease and other high-risk conditions, our hypertension control rates would be even lower and a greater distance from the goal for these persons if the new criteria are applied.”

“These high-risk persons with low rates of hypertension control represent an urgent need for intensified efforts to achieve blood pressure control,” they conclude.

(Arch Intern Med. 2007;167(22):2431-2436. Available pre-embargo to the media at http://www.jamamedia.org.)

Editor’s Note: This study was supported by a contract from Bristol-Myers Squibb to the University of California, Irvine. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Posted by dlifenews at 09:38 AM | Comments (0)

Use of Diabetes Medication by Older Adults Associated With Increased Risk of Serious Heart Problems, Death

December 11, 2007 (Newswise) — Older patients treated with the diabetes medications known as thiazolidinediones (which include rosiglitazone) had a significantly increased risk of heart attack, congestive heart failure and death, compared with the use of other hypoglycemic drugs, according to a study in the December 12 issue of JAMA. The authors suggest that these results provide further evidence that this class of medication may cause more harm than good.

The thiazolidinediones (TZDs) rosiglitazone and pioglitazone are oral hypoglycemic agents used to treat type 2 diabetes and have been shown to improve glycemic control. “While improved glycemic control has been linked to better clinical outcomes in diabetes and TZDs have been suggested as having potential cardiovascular benefits, recent concerns have arisen regarding adverse cardiac effects of these drugs,” the authors write.

Some research has indicated that both rosiglitazone and pioglitazone may increase the risk of congestive heart failure (CHF), and that rosiglitazone may be associated with an increased risk of acute myocardial infarction (AMI; heart attack) and death. “These findings prompted a recent hearing by a U.S. Food and Drug Administration advisory panel regarding the safety of rosiglitazone; however the panel voted against removing rosiglitazone from the market because of insufficient data.”

Lorraine L. Lipscombe, M.D., M.Sc., of the Institute for Clinical Evaluative Sciences, Toronto, and colleagues evaluated the risks of CHF, heart attack, and all-cause death associated with the use of TZDs, compared with other oral hypoglycemic agents among patients age 66 years or older with diabetes. This older patient population has often been under-represented in trials of TZDs, even though they have a high prevalence of diabetes, and may be at greater risk of medication-related harms. The researchers analyzed data from health care databases in Ontario that included 159,026 individuals with diabetes who were treated with oral hypoglycemic agents and were followed for a median (midpoint) of 3.8 years, through March 2006. During this time, 7.9 percent of patients had a hospital visit for congestive heart failure (n = 12,491), 7.9 percent had a hospital visit for a heart attack (n = 12,578), and 19 percent died (n = 30,265).

Compared to oral hypoglycemic agent combination therapy users, current users of TZD monotherapy had a 60 percent increased risk of congestive heart failure; had a 40 percent increased risk of heart attack; and had a 29 percent increased risk of death. These increased risks associated with TZD use appeared limited to rosiglitazone.

“Our findings argue against current labeling of TZDs that warns against use only in persons at high risk of CHF, as we did not identify any subgroup of older diabetes patients who may be protected from adverse effects of TZDs,” the authors write. “These findings provide evidence from a real-world setting and support data from clinical trials that the harms of TZDs may outweigh their benefits, even in patients without obvious baseline cardiovascular disease.”

“Further studies are needed to better quantify the risk-benefit tradeoffs associated with TZD therapy and to explore whether the hazards associated with these agents are specific to rosiglitazone. In the interim, treatment decisions must remain individualized, with clinicians weighing the potential benefits and harms of TZD treatment, especially among high-risk elderly populations.”

Posted by dlifenews at 09:33 AM | Comments (0)

Abdominal Fat Distribution Predicts Heart Disease

American Heart Association rapid access journal report

December 10, 2007 (EurekAlert) - Abdominal obesity is a strong independent risk factor for heart disease, and using the waist-hip ratio rather than waist measurement alone is a better predictor of heart disease risk among men and women, researchers reported in a study published in Circulation: Journal of the American Heart Association.

In the study, researchers also looked at whether the association between fat distribution and heart disease risk was independent of body mass index (BMI), which assesses body weight relative to height, as well as other heart disease risk factors, such as high blood pressure and high cholesterol.

“The size of the hips seems to predict a protective effect,” said Dexter Canoy, M.Phil., M.D., Ph.D., lead author of the study and a research fellow in epidemiology and public health at the University of Manchester in the United Kingdom. “In other words, a big waist with comparably big hips does not appear to be as worrisome as a big waist with small hips.”

The research was based on 24,508 men and women ages 45 to 79 in the United Kingdom who participated in the European Prospective Investigation into Cancer cohort study (EPIC-Norfolk) which is based at the University of Cambridge in the UK. Researchers measured participants’ weight, height, waist circumference, hip circumference and other heart disease risk factors from 1993 to 1997. They then followed up with participants for an average 9.1 years.

During the follow-up, 1,708 men and 892 women developed coronary heart disease. When they divided the men and women into five groups, according to waist-hip ratio, researchers found that those with the highest waist-to-hip ratio had the highest heart disease risk. Among the findings:

• Men in the top one-fifth of the distribution (those with the biggest waists in relation to their hips) had a 55 percent higher risk of developing coronary heart disease compared to men in the bottom one-fifth of the distribution (those with the smallest waists in relation to their hips).
• Women in the top one-fifth, or the highest waist-to-hip ratio group, were 91 percent more likely to develop heart disease than women with the smallest waists in relation to their hips.
• Waist-only measurements underestimated heart disease risk by 10 percent to 18 percent when compared to risk estimates for waist measurements when hip is considered (waist-to-hip ratio).
• When waist-only, body mass index and coronary heart disease risk factors are considered, for every 6.4 centimeter (cm) increase in hip circumference in men and for every 9.2 cm hip circumference increase in women, there is a 20 percent lower risk for developing heart disease.

The study’s results are definitive for predicting risk in relatively healthy men and women in the general population, Canoy said. More research is needed on whether abdominal fat distribution is an independent risk factor for heart disease among people who have chronic and other diseases at baseline.

“People whose abdominal fat puts them at higher risk for heart disease do not always appear overweight or obese,” Canoy said. “However, the overriding message from this and other studies about heart disease risk is that, despite the different measures and risk estimates, the bottom line is that many of us need to lose excess weight. Doctors should start looking beyond weight, height, simple waist circumference and BMI to assess heart disease. A simple waist-hip ratio measurement is a strong predictor of heart disease.”

Posted by dlifenews at 12:17 PM | Comments (0)

Most Adults with Conditions That Increase Cardiovascular Disease Risk Have High Blood Pressure

December 10, 2007 (EurekAlert) - Nearly three-fourths of American adults with conditions such as coronary heart disease, stroke, diabetes or others that raise their risk for cardiovascular complications also have hypertension (high blood pressure), according to a report in the December 10/24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. Although about 75 percent of these individuals are being treated for hypertension, only one-third to one-half are reaching blood pressure goals.

Blood pressure control remains a problem in the United States and around the world, according to background information in the article. “Recent estimates indicate little change in the prevalence of hypertension, and, although there seem to be some recent improvements in treatment and control rates, hypertension in many persons remains inadequately controlled,” the authors write.

Nathan D. Wong, Ph.D., of the University of California, Irvine, and colleagues analyzed data from adults participating in the National Health and Nutrition Examination Survey, a nationally representative survey conducted by the Centers for Disease Control and Prevention. In 2003 and 2004, 4,646 adults (representing 192 million nationwide) provided demographic and socioeconomic information and underwent laboratory and physiological testing (including blood pressure measurements).

A total of 1,671 (31.4 percent) of the participants had hypertension, defined as a systolic (top number) blood pressure of at least 140 milligrams of mercury (130 milligrams of mercury in those with diabetes or chronic kidney disease) or a diastolic (bottom number) blood pressure of at least 90 milligrams of mercury (80 milligrams of mercury in those with diabetes or chronic kidney disease), or as reporting use of a blood pressure–lowering medication. The condition was more common in older and black adults. A total of 68.5 percent of those with hypertension were being treated and 52.9 percent of those had their hypertension under control.

High blood pressure was found in most persons with cardiovascular diseases and related problems, including:

• 76.8 percent of those with diabetes
• 81.8 percent of those with chronic kidney disease
• 69.5 percent of those with stroke
• 71.4 percent of those with congestive heart failure, which occurs when the heart can’t pump enough blood to the rest of the body
• 73.7 percent of those with peripheral artery disease, or narrowed veins or arteries
• 73 percent of those with coronary artery disease
• 76.9 percent of those with two or more of these diseases

Among individuals with these conditions, 75 percent or more were being treated for hypertension, but only one-third to one-half of those in treatment reached goal levels for blood pressure (140/90 milligrams of mercury for most patients, or 130/80 milligrams of mercury for patients with diabetes or chronic kidney disease). Goal attainment rates were particularly low for persons with stroke (34.9 percent), heart failure (48.8 percent), peripheral arterial disease (46.7 percent) and coronary artery disease (50.3 percent).

With the lower goal for persons with diabetes and chronic kidney disease, only 35 percent and 23 percent, respectively, were controlled for their blood pressure. Those who were uncontrolled had systolic blood pressure that averaged at least 20 higher than the goal. “Poor control rates of systolic hypertension remain a principal problem that further compromises the already high cardiovascular disease risk” in these individuals, the authors write. “Moreover, given recently released recommendations to reduce the blood pressure goal to less than 130/80 milligrams of mercury for persons with coronary artery disease and other high-risk conditions, our hypertension control rates would be even lower and a greater distance from the goal for these persons if the new criteria are applied.”

“These high-risk persons with low rates of hypertension control represent an urgent need for intensified efforts to achieve blood pressure control,” they conclude.

Posted by dlifenews at 12:13 PM | Comments (0)

Monotherapy BYETTA® Showed Significant Improvement in Glucose Control and Weight Loss in Adults with Type 2 Diabetes

FDA Submission Planned in First Half of 2008

December 6, 2007 (PRNewswire-FirstCall via COMTEX News Network) -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced study results from a 24-week study of monotherapy, or stand-alone, BYETTA (exenatide) injection taken twice daily in drug-naive patients with type 2 diabetes. Study participants taking 5 mcg or 10 mcg of monotherapy BYETTA twice daily showed significant reductions in A1C (a measure of average blood sugar over 3 months) by 0.7 percentage points and 0.9 percentage points, respectively, from an average baseline A1C ranging from 7.8 to 7.9 percent. In addition, approximately 60 percent of study participants on either 5 mcg or 10 mcg of monotherapy BYETTA at the conclusion of the study had an A1C of 7 percent or less, a common target for good glucose control. The companies plan a regulatory submission to the U.S. Food and Drug Administration (FDA) in the first half of 2008.

In this 24-week, randomized, placebo-controlled study, 232 drug-naive people with type 2 diabetes were treated with monotherapy BYETTA or placebo. More than 85 percent of study participants in the 5 mcg and 10 mcg arms completed the study. Weight loss from baseline was significant and similar to that observed in previous BYETTA studies.

"The American Diabetes Association's (ADA) clinical guidelines for the treatment of patients with type 2 diabetes are to achieve target glucose control, as well as weight loss in overweight or obese patients," said James Malone, M.D., Global Medical Director, Eli Lilly and Company. "These data are robust and are consistent with data from other trials that support the use of BYETTA before starter insulin. If approved for monotherapy, BYETTA may provide an additional treatment option for physicians to consider earlier in the continuum of care."

There was a low incidence of nausea reported in both treatment arms of the study of approximately 3 and 13 percent in the 5 mcg and 10 mcg arms, respectively. There were no instances of severe hypoglycemia in this study. Overall hypoglycemia observed was similar to that seen in studies where BYETTA was used in conjunction with metformin only.

BYETTA -- the first and only FDA-approved incretin mimetic -- was approved in April 2005 and has been used by more than 700,000 patients since its introduction. BYETTA is indicated as an add-on therapy for use twice a day in adults with type 2 diabetes who are unsuccessful at controlling their blood sugar levels using common oral diabetes medications. This study was conducted following receipt of an approvable letter for a monotherapy indication from the FDA in 2005.

Study Design
The 24-week, randomized study included 232 people with type 2 diabetes who were not achieving adequate glucose control using diet and exercise without previous use of antidiabetes agents. Study participants were randomized to receive subcutaneous injections of placebo, 5 mcg exenatide, or 10 mcg exenatide twice daily without taking any oral antidiabetes agents. Patients randomized to 10 mcg exenatide received 5 mcg injections for the first 4 weeks, and increased to 10 mcg injections for the final 20 weeks.

Full study results will be included in future scientific publications.

Posted by dlifenews at 12:26 PM | Comments (0)

Mental Health Treatment Extends Lives of Older Patients with Diabetes and Depression

First study to examine relationship between diabetes, depression, and mortality

December 5, 2007 (EurekAlert) – Researchers at the University of Pennsylvania School of Medicine report that older adults with diabetes and depression are half as likely to die over a 5-year period when they receive depression care management than depressed patients with diabetes who do not receive depression care management. The first known study to examine the relationship between diabetes and mortality in a depression intervention trial appears in the December issue of Diabetes Care.

“Depression is common among people with diabetes and contributes to issues with medication and diet adherence, and also leads to an overall reduced quality of life,” says lead author, Hillary R. Bogner, MD, MSCE, Assistant Professor, Department of Family Practice and Community Medicine at Penn.

The multi-site, practice-randomized controlled trial was conducted in 20 primary care practices in New York City, Philadelphia, and Pittsburgh. A total of 584 participants 60 – 94 years of age were identified through a depression screening, and of these participants, 123 reported a history of diabetes. The practices were randomly assigned to usual care, or a depression care management intervention, which involved a depression care manager who worked with the primary care provider to recommend treatment for depression and assist patients with treatment adherence.

At follow-up, 110 depressed patients had died. Depressed, older adults with diabetes who were in practices randomized to depression care management were less likely to have died at the end of the 5-year follow-up than were depressed, older adults with diabetes who received usual care. The authors note that they believe these findings support the integration of depression evaluation and treatment with diabetes management in primary care.

Posted by dlifenews at 09:47 AM | Comments (0)

Quality-Improvement Initiatives Lead to Progress in Diabetes Care

December 3, 2007 (Newswise) — Two major initiatives designed to improve primary care treatment of type 2 diabetes have yielded significant benefits in largely minority, disadvantaged populations, according to a pair of studies in the December issue of Medical Care, published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, pharmacy and the pharmaceutical industry.

One study finds that patients treated at clinics that follow the "Chronic Care Model" have lower rates of diabetes-related coronary artery disease, while another finds that the "Health Disparities Collaboratives" initiative has improved diabetes care at U.S. community health centers.

In both studies, outcomes appeared better when care more closely followed the research-based quality improvement programs. "Patients are better off when we use what we know; the more reliably we use it, the better off they are," writes Dr. Donald M. Berwick of the Institute for Healthcare Improvement, Cambridge, Mass., in an accompanying editorial. "That's the simple, affirming conclusion of both of these papers."

Dr. Michael Parchman and colleagues of the South Texas Veterans Health Care System, San Antonio, evaluated an approach called the Chronic Care Model (CCM), which outlines specific organizational characteristics believed to lead to improved outcomes for patients with chronic diseases such as type 2 diabetes. Using data on diabetic patients treated at twenty Texas primary care clinics, the researchers looked at how closely diabetes care followed the CCM approach, and whether CCM care led to reductions in the risk of coronary heart disease—a major complication of diabetes.

Just fifteen percent of patients in the study met target levels for three critical risk factors: hemoglobin A1c (which measures long-term control of blood sugar levels), blood pressure, and lipid levels (including cholesterol). The overall coronary risk over 10 years was 16.2 percent—nearly one-third of this risk (5.0 percent) could be explained by poor control of risk factors.

At clinics that followed the CCM approach more closely, the percentage of CHD risk explained by poor risk factor control was significantly reduced. For example, at a clinic that closely followed the CCM, just 1.7 percent of CHD risk was explained by poor risk factor control, compared to 5.0 percent at a clinic that only partially followed the CCM approach. "These findings contribute to the growing body of evidence documenting a relationship between how care is provided in primary care clinic settings and patient outcomes," Dr. Parchman and colleagues conclude.

The second study, led by Dr Marshall H. Chin of University of Chicago, evaluated the impact of a Health Resources and Services Administration initiative, the Health Disparities Collaborative (HDC). The goal of the HDC was to institute a quality improvement program for diabetes care for patients treated at community health centers.

Using nationwide data, the researchers found that health centers where staff were trained in the HDC approach achieved significant improvements in several measures of diabetes care, including reductions in hemoglobin A1c level and "bad" cholesterol levels. Centers receiving a more intensive form of the HDC approach had only slightly better improvement. It may be that the "standard" HDC approach is adequate, or that even stronger interventions will be needed to achieve greater improvements.

New approaches to improving care for patients with chronic diseases such as diabetes are urgently needed—particularly in medically "under-served" populations at increased risk of poor health outcomes. However, it can be difficult to translate research-proven management approaches into "real-world" health care settings.

The new studies show that research-based initiatives such as CCM and HDC can improve diabetes care for disadvantaged populations, at both the patient and organizational levels. Dr. Berwick writes, "Both papers seek to build a bridge between two important worlds of endeavor: the world of study and assessment of medical practices, and the world of action to put that knowledge to work on behalf of patients."

Posted by dlifenews at 10:25 AM | Comments (0)

New Study in the Journal Sleep Finds That Sleep Duration Raises the Risk for Diabetes

December 1, 2007 (EurekAlert) – The most common factors believed to contribute to diabetes are a decreased amount of physical activity and access to highly palatable processed foods. However, there is growing evidence that another aspect of our modern lifestyle, short sleep duration, is also contributing toward the “diabetes epidemic”, according to a study published in the December 1 issue of the journal SLEEP.

The study, authored by James E. Gangwisch, PhD, of Columbia University in New York, explored the relationship between sleep duration and the diagnosis of diabetes over an eight-to-10-year follow-up period between 1982 and 1992 among 8,992 subjects who participated in the Epidemiologic Follow-Up Studies of the first National Health and Nutrition Examination Survey. The subjects’ ages ranged from 32 to 86 years.
According to the results, subjects who reported sleeping five or fewer hours and subjects who reported sleeping nine or more hours were significantly more likely to have incident diabetes over the follow-up period than were subjects who reported sleeping seven hours, even after adjusting for variables such as physical activity, depression, alcohol consumption, ethnicity, education, marital status, age, obesity and history of hypertension.
The effect of short sleep duration on diabetes incidence is likely to be related in part to the influence of short sleep duration upon body weight and hypertension, said Dr. Gangwisch. Experimental studies have shown sleep deprivation to decrease glucose tolerance and compromise insulin sensitivity by increasing sympathietic nervous system activity, raising evening cortisol levels and decreasing cerebral glucose utilization. The increased burden on the pancreas from insulin resistance can, over time, compromise â-cell function and lead to type two diabetes, warned Dr. Gangwisch.

“If short sleep duration functions to increase insulin resistance and decrease glucose tolerance, then interventions that increase the amount and improve the quality of sleep could potentially serve as treatments and as primary preventative measures for diabetes,” said Dr. Gangwisch.

It is unknown as to how long sleep duration contributes to diabetes, although increased time in bed to compensate for poor sleep quality is one possible explanation, noted Dr. Gangwisch.

Recent estimates show that at least 171 million people worldwide suffer from diabetes, and that, by the year 2030, this number is projected to double.

Lawrence Epstein, MD, medical director of Sleep HealthCenters, an instructor of medicine at Harvard Medical School, a past president of the American Academy of Sleep Medicine (AASM) and a member of the AASM board of directors, said that this study is one of several large studies that have shown that people who don’t get enough sleep have higher rates of diabetes.

“Restricting sleep to four hours a night for only a few days causes abnormal glucose metabolism, suggesting the mechanism for increased rates of diabetes in sleep deprived individuals,” said Dr. Epstein. “Additionally, sleep disorders that disrupt sleep, such as obstructive sleep apnea, also increase the likelihood of developing diabetes. Treating the sleep disorders improves glucose metabolism and diabetes control. These studies underscore the fact that sleep is integral to good health.”

On average, most adults need seven to eight hours of sleep each night to feel alert and well-rested. Adolescents should sleep about nine hours a night, school-aged children between 10-11 hours a night and children in pre-school between 11-13 hours a night.

The AASM offers the following tips on how to get a good night’s sleep:

• Follow a consistent bedtime routine.
• Establish a relaxing setting at bedtime.
• Get a full night’s sleep every night.
• Avoid foods or drinks that contain caffeine, as well as any medicine that has a stimulant, prior to bedtime.
• Do not go to bed hungry, but don’t eat a big meal before bedtime either.
• Avoid any rigorous exercise within six hours of your bedtime.
• Make your bedroom quiet, dark and a little bit cool.
• Get up at the same time every morning.

Posted by dlifenews at 10:17 AM | Comments (0)