October 1, 2009 (Newswise) - A regular tai chi exercise program can help people better control their diabetes and lower glucose levels, according to a University of Florida study.In a study of adults diagnosed with type 2 diabetes, those who participated in a supervised tai chi exercise program two days a week with three days of home practice for six months significantly lowered their fasting blood glucose levels, improved their management of the disease, and enhanced their overall quality of life, including mental health, vitality and energy.

"Tai chi really has similar effects as other aerobic exercises on diabetic control. The difference is tai chi is a low-impact exercise, which means that it's less stressful on the bones, joints and muscles than more strenuous exercise," said Beverly Roberts, Ph.D., R.N., the Annabel Davis Jenks endowed professor at the UF College of Nursing.

Roberts, with Rhayun Song, Ph.D., R.N., of Chungham National University, studied tai chi's effect on older Korean residents. The research was featured in the June issue of The Journal of Alternative and Complementary Medicine.

About 23.6 million children and adults in the United States, or 7.8 percent of the population, have diabetes. It occurs when the body does not produce or properly use insulin, a hormone that is needed to convert sugar, starches and other food into energy needed for daily life.

Risk factors include obesity, sedentary lifestyle, unhealthy eating habits, high blood pressure and cholesterol, a history of gestational diabetes and increased age, many of which can be reduced through exercise.

"People assume that for exercise to be beneficial you have to be huffing and puffing, sweating and red-faced afterward," Roberts said. "This may turn people off, particularly older adults. However, we have found that activities like tai chi can be just as beneficial in improving health."

Tai chi is an ancient Chinese martial art that combines deep breathing and relaxation with slow, gentle circular movements. This low impact exercise uses shifts in body position and stepping in coordination with arm movements.

Sixty-two participants, mostly Korean women, took part in the study. Half the group participated in at least 80 percent of two supervised sessions one hour per week, with three days of home practice for six months, and the other half served as a control group. Those who completed the sessions had significantly improved glucose control and reported higher levels of vitality and energy.

"Those who participated in the tai chi sessions actually had lower blood glucose at three and six months," Roberts said. "Those individuals also had lower hemoglobin A1c, which means they had better diabetic control."

In addition to improved blood glucose levels, participants also reported significantly improved mental health. This was very encouraging especially since people with less depression are typically more active and independent, Roberts said.

Tai chi has also been used for people with arthritis and disabilities to increase balance, muscle strength and mobility and to reduce the risk of falls. It is worth investigating its effects in other conditions, especially in older people, Roberts said.

"Tai chi provides a great alternative for people who may want the benefits of exercise on diabetic control but may be physically unable to complete strenuous activities due to age, condition or injury," Roberts said. "Future studies could examine if tai chi could similarly benefit conditions such as osteoporosis or heart disease."

Since tai chi is an exercise that involves so many parts of the body and also helps to relax the mind, it is more likely participants will adhere to the exercise, said Paul Lam, M.B.B.S., a lecturer with the University of South Wales School of Public Health and Community Medicine and a practicing family physician in Sydney, Australia.

"This study shows that tai chi can have a significant effect on the management and treatment of diabetes - a significant and growing health challenge for all Western countries," Lam said.

September 30, 2009 (Newswise) - Treating pregnant women for mild gestational diabetes resulted in fewer cesarean sections and other serious birthing problems associated with larger than average babies, according to a study conducted in part at the University of North Carolina at Chapel Hill.'This study is important because it clearly indicates the value to mothers and their newborns of screening for and treatment of diabetes-like conditions provoked by pregnancy," said John M. Thorp, M.D., McAllister distinguished professor of obstetrics and gynecology at the UNC School of Medicine and a co-author of the study.

"Our work resolves a 40-year controversy in women's health and should be immediately helpful to both pregnant women and the clinicians caring for them."

The study is published in the Oct. 1 issue of the New England Journal of Medicine. The lead author and principal investigator is Mark B. Landon, M.D. of Ohio State University. It was conducted at 14 sites that are part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network.

About 4 percent of all pregnant women in the U.S. develop gestational diabetes, resulting in about 135,000 cases each year, Thorp said. Because these women have high blood sugar levels, their babies receive more blood glucose than they need, and the extra energy is stored as fat. These babies tend to be larger and fatter than average at birth and thus are more likely to be affected by problems associated with larger babies, such as the need for cesarean delivery, damage to their shoulders during birth and a greater risk of becoming obese as children and developing type 2 diabetes as adults.

There has been a longstanding controversy among physicians on the question of whether treating pregnant women with gestational diabetes for their high blood sugar levels would provide worthwhile benefits. Several professional organizations advocate screening, but the 2008 guidelines of the U.S. Preventive Services Task Force concluded there is insufficient evidence to support screening for and treatment of gestational diabetes.

Against this background, the MFMU Network launched a clinical trial to determine if treating mothers for mild gestational diabetes would reduce infant deaths and birth-related complications. A total of 958 women between 24 and 31 weeks of pregnancy were randomized, with 485 receiving treatment (including dietary changes, self blood glucose monitoring and insulin if necessary) and 473 in the untreated group.

There were no infant deaths in the study and no significant differences between the two groups in terms of babies born with problems such as hypoglycemia, hyperbilirubinemia, neonatal hyperinsulinemia and birth trauma.

However, there were significantly fewer babies in the treatment group to experience unusually large size (7.1 percent vs. 14.5 percent), high birth weight (5.9 percent vs. 14.3 percent), shoulder damage during birth (1.5 percent vs. 4.0 percent) or to require cesarean delivery (26.9 percent vs. 33.8 percent).

In addition, Thorp said, "It's especially intriguing that mothers in the treatment arm gained less weight during pregnancy, experienced fewer preterm births and had fewer cases of preeclampsia than mothers in the untreated group." Preeclampsia is a syndrome marked by a sudden increase in the blood pressure of a pregnant woman after the 20th week of pregnancy, which can be fatal or lead to long-term health problems for mother and baby.

The study concludes that "these findings confirm a benefit to the identification and treatment of women with mild carbohydrate intolerance during pregnancy."

September 10, 2009 (EurekAlert) - When it comes to assessing risk for type 2 diabetes, not only do waistlines matter to women, but so does the size of their fat cells. This new discovery by a team of Swedish researchers was just published online in the FASEB Journal (http://www.fasebj.org) and helps explain why some women of normal weight develop type 2 diabetes, despite not having any known risk factors."Increased knowledge of the link between enlarged fat cells and the development of type 2 diabetes may give rise to new preventive and therapeutic alternatives," said Malin Lönn, co-author of the study and associate professor in the department of clinical chemistry at Sahlgrenska University Hospital in Gothenburg, Sweden. "Our research also identifies the ratio waist-to-height, waist circumference divided by body height, as a simple tool that can be used to identify women at risk of developing type 2 diabetes."

The data for this discovery were obtained as part of the "Prospective Study of Women in Gothenburg," performed in Sweden and started in 1968 by Professor Emeritus Calle Bengtsson. For this study, a team of Swedish researchers invited women to free health examinations over the course of 25 years. In 1974-1975, scientists collected abdominal fat biopsies from some of the women and tracked who developed type 2 diabetes. They found that the number of abdominal fat cells remained relatively constant in women after adolescence, but the size of fat cells could change considerably throughout life and were larger in women with type 2 diabetes. In addition, they found that waist-to-height ratio may also be a good indicator of diabetes risk.

"Despite notions to the contrary, size does matter to women-at least when it comes to her fat cells, her waist-to-height-ratio and her risk for type 2 diabetes," said Gerald Weissmann, M.D., Editor-in-Chief of the FASEB Journal. "This is a remarkable study that should lead to preventive measures for this most common of serious diseases."

According to the U.S. Centers for Disease Control and Prevention, type 2 diabetes may account for 90 to 95 percent of all diagnosed cases of diabetes. The disease begins as insulin resistance, and as the need for insulin rises, the pancreas gradually loses its ability to produce insulin. Type 2 diabetes often is associated with older age, but is increasingly being diagnosed in children. Obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity also play a role in whether or not someone develops the disease. In particular, African Americans, Hispanic/Latino Americans, American Indians/Native Americans, and some Asian Americans and Native Hawaiians or Other Pacific Islanders are at high risk for type 2 diabetes.

September 3, 2009 (EurekAlert) - Pregnant women who develop marked increased blood sugar levels during pregnancy can reduce the risk of certain birth complications if they receive treatment. This is a prerequisite for offering all pregnant women routine screening for gestational diabetes. However, potential disadvantages of this type of routine screening have not been thoroughly researched. This is the conclusion of the Institute for Quality and Efficiency in Health Care (IQWiG) in its final report published on 3 September 2009.Even today, most pregnant women in Germany are unsystematically offered a blood sugar test to identify those women whose blood sugar levels rise too much during pregnancy. However, the women often have to pay for this test themselves. In a project commissioned by the Federal Joint Committee (G-BA), IQWiG has investigated whether this screening should be routinely offered free of charge to all pregnant women insured with a statutory health insurance fund.

Although the Institute has found an indication in its final report on assessing benefit that such a test can reduce the risk of complications in birth, certain test requirements must be met, which has not always been the case in Germany. According to Prof. Dr. med. Peter T. Sawicki, the director of IQWiG, "We cannot be certain that the tests as currently carried out in the doctor's surgery yield more benefit than harm."

Gestational diabetes is a question of definition

During pregnancy it is normal that a woman's metabolic rate changes and sugar takes longer to be absorbed by the body. In May 2008 an international study confirmed that rising blood sugar levels increase the risk, for example, of a Caesarean section or birth injuries. However, there is disagreement over when increased blood sugar levels should be treated, as there is no threshold where these risks increase dramatically.

Nevertheless, it should be noted that a diagnosis of gestational diabetes has far-reaching consequences for a pregnant woman. Not only does she have to accept the unpleasant news that something is not right, she also has to adapt her diet and take more physical exercise. In addition, blood sugar levels have to be measured several times a day and, if they do not drop to the prescribed targets within a short time, daily insulin injections have to be administered.

Treatment can have positive effects

In order to evaluate the benefit of a therapy, the Institute analysed a total of 25 studies. This yielded an indication that treatment reduces the risk of certain rare birth complications in pregnant women with a marked metabolic disorder. One such complication is shoulder dystocia. This is the name given to a delay in the birth with the attendant risk of the baby suffering a lack of oxygen. As midwives and doctors then quickly take countermeasures, injuries to mother and child may occur more frequently.

Potential disadvantages of routine screening have not been researched

Even if there is an indication of benefit from treatment, this does not automatically mean that routine screening is also useful for identifying pregnant women with gestational diabetes. Although some professional associations have been recommending this type of screening for many years, potential harms have not yet been sufficiently investigated. IQWiG could not find any studies which directly showed that routine screening was of more benefit than harm.

In view of this uncertainty, the Institute considered a long list of potential disadvantages. However, the potential risks were not assessed as being so serious that they might cancel out the potential benefit. Thus, the Institute has indirectly deduced an indication that routine screening for gestational diabetes leads to a reduction in perinatal complications.

Two-step test strategy

However, this deduction presupposes that routine screening takes place according to the selection and diagnosis of participants in the relevant therapy studies. Professor Sawicki explains, "We only obtained an indication of benefit from treatment in the case of women who were diagnosed in a particular way."

Experts around the world are not agreed on how women with a metabolic disorder should be routinely identified.

To date, three main options have been under discussion: The first proposal is that all pregnant women should undergo an oral glucose tolerance test (oGTT), which measures the metabolic reaction to the rapid absorption of an larger amount of sugar.

For this test, the pregnant woman has to attend her doctor's surgery in the morning, having fasted overnight, and drink a concentrated glucose solution. Three blood samples are subsequently taken within 2 hours. The diagnosis is confirmed if at least one of the blood sugar level measurements is too high.

Some experts consider this test of several hours' duration to be too cumbersome to be introduced for all pregnant women. They propose a pre-selection process. Consequently, the second proposal for a test strategy is that only those women undergo an oGTT who display specific risk factors for gestational diabetes, such as older age, overweight or diabetes in the family.

The third proposal is to introduce a short version of the glucose tolerance test in the pre-selection. As part of a routine appointment, the pregnant woman would drink a smaller amount of glucose solution and have only one blood sample taken after 1 hour. Only those women whose blood sugar levels were then above a pre-determined threshold would be given an appointment for a full tolerance test.

Other screening strategies were directly compared in studies

One result of the report is that those pregnant women for whom the relevant therapy studies have shown a benefit were selected by undergoing a short glucose test as the first step. "As long as good screening studies are lacking, we find it difficult to recommend other strategies", says Sawicki.

Consequently, many tests for gestational diabetes that are already being offered to pregnant women should be viewed critically. "These tests label many pregnant women as being at risk, without it being clear whether they would actually profit from having treatment", explains Sawicki. A harm is particularly likely if a woman with a mild metabolic disorder during pregnancy is recommended to have treatment which is too strong.

In IQWiG's opinion, therefore, a study that directly compares the advantages and disadvantages of different screening strategies for mother and child is overdue. According to Sawicki, "In view of the number of pregnancies per year in Germany (more than 600,000), such a study could be carried out relatively quickly."

Report preparation procedure

IQWiG published the preliminary results in the form of the preliminary report in January 2009 and interested parties were invited to submit comments. When the comments stage ended, the preliminary report was revised and sent as a final report to the contracting agency, the Federal Joint Committee, at the end of June 2009. Documentation of the written comments and minutes of the oral debate are published in a separate document simultaneously with the final report. The report was produced in collaboration with external experts.

The Institute is awaiting further information on the benefit of treatment from a US study, whose results are expected to be published in the near future. IQWiG then intends to supplement the final report.

June 11, 2009 (EurekAlert) - The benefits of alcohol are all about moderation. Low to moderate drinking - especially of red wine - appears to reduce all causes of mortality, while too much drinking causes multiple organ damage. A mini-review of recent findings on red wine's polyphenols, particularly one called resveratrol, will be published in the September issue of Alcoholism: Clinical & Experimental Research; the review is also available at Early View."Reports on the benefits of red wine are almost two centuries old," said Lindsay Brown, associate professor in the School of Biomedical Sciences at The University of Queensland and corresponding author for the study. "The media developed the more recent story of the French paradox in the early 1990s. However, studies on the actions of resveratrol, one of the active non-alcoholic ingredients, were uncommon until research around 1997 showed prevention of cancers. This led to a dramatic interest in this compound." (See attached figure.)

Red wine contains a complex mixture of bioactive compounds, including flavonols, monomeric and polymeric flavan-3-ols, highly colored anthocyanins, as well as phenolic acids and the stilbene polyphenol, resveratrol. Brown said that some of these compounds, particularly resveratrol, appear to have health benefits.

"The breadth of benefits is remarkable - cancer prevention, protection of the heart and brain from damage, reducing age-related diseases such as inflammation, reversing diabetes and obesity, and many more," said Brown. "It has long been a question as to how such a simple compound could have these effects but now the puzzle is becoming clearer with the discovery of the pathways, especially the sirtuins, a family of enzymes that regulate the production of cellular components by the nucleus. 'Is resveratrol the only compound with these properties?' This would seem unlikely, with similar effects reported for other components of wine and for other natural products such as curcumin. However, we know much more about resveratrol relative to these other compounds."

Stephen Taylor, professor of pharmacology at the University of Queensland, agreed that resveratrol is the "compound du jour."

"I think that red wine has both some mystique and some historical symbolism in the west," said Taylor, "and of course, some various pleasures attached to its ingestion, all of which give it a psychological advantage edge, food-wise. Not many of us can or will eat a couple of cups of blueberries a day for years on end, but if we could do a population study for a decade or so on such a group, you might actually see similar results."

Key points of the review include:

Resveratrol exhibits therapeutic potential for cancer chemoprevention as well as cardioprotection.
"It sounds contradictory that a single compound can benefit the heart by preventing damage to cells, yet prevent cancer by causing cell death, said Brown. "The most likely explanation for this, still to be rigorously proved in many organs, is that low concentrations activate survival mechanisms of cells while high concentrations turn on the in-built death signals in these cells."

Resveratrol may aid in the prevention of age-related disorders, such as neurodegenerative diseases, inflammation, diabetes, and cardiovascular disease.
"The simplest explanation is that resveratrol turns on the cell's own survival pathways, preventing damage to individual cells," said Brown. "Further mechanisms help, including removing very reactive oxidants in the body and improving blood supply to cells."

Low doses of resveratrol improve cell survival as a mechanism of cardio- and neuro-protection, while high doses increase cell death.
"The key difference is probably the result of activation of the sirtuins in the nucleus," said Brown. "Low activation reverses age-associated changes, while high activation increases the process of apoptosis or programmed cell death to remove cellular debris. Similar changes are seen with low-dose versus high-dose resveratrol: low-dose resveratrol produces cellular protection and reduces damage, while high-dose resveratrol prevents cancers."

In summary, noted Brown, current scientific research is starting to explain reports from the last 200 years that drinking red wine improves health. "It is a cliché that 'nature is a treasure trove of compounds,' but studies with resveratrol show that this is correct! We need to understand better the vast array of compounds that exist in nature, and determine their potential benefits to health."

"There is one particular point that deserves fleshing out," added Taylor. "Resveratrol is largely inactivated by the gut or liver before it reaches the blood stream, where it exerts its effects - whatever they may be - good, bad, or indifferent. Thus, most of the reseveratrol in imbibed red wine does not reach the circulation. Interestingly, absorption via the mucous membanes in the mouth can result in up to around 100 times the blood levels, if done slowly rather than simply gulping it down. Of course, we don't know if these things matter yet, but issues like this are real and generally ignored by all."

June 11, 2009 (EurekAlert) - If you are pregnant and your mate complains your frequent snoring is rattling the bedroom windows, you may have bigger problems than an annoyed, sleep-deprived partner.A new study from researchers at the Northwestern University Feinberg School of Medicine has found that women who reported frequent snoring during their pregnancy were more likely to develop gestational diabetes -- a condition than can cause health problems for the mother and baby. The study also found pregnancy increases the likelihood that a woman will snore.

This is the first study to report a link between snoring and gestational diabetes.

For the study, 189 healthy women completed a sleep survey at the time of enrollment (six to 20 weeks gestation) and in the third trimester.

Pregnant women who were frequent snorers had a 14.3 percent chance of developing gestational diabetes, while women who did not snore had a 3.3 percent chance. Even when researchers controlled for other factors that could contribute to gestational diabetes such as body mass index, age, race and ethnicity, frequent snoring was still associated with the disease.

Principal investigator Francesca Facco, M.D., a fellow at Northwestern's Feinberg School, will present her findings at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies June 11.

"Sleep disturbances during pregnancy may negatively affect your cardiovascular system or metabolism," said Facco, who in August will become an assistant professor of obstetrics and gynecology at the Feinberg School and a maternal and fetal medicine physician at Northwestern Memorial Hospital.

"Snoring may be a sign of poor air flow and diminished oxygenation during sleep that can cause a cascade of events in your body," Facco said. "This may activate your sympathetic nervous system, so your blood pressure rises at night. This can also provoke inflammatory and metabolic changes, increasing the risk of diabetes or poor sugar tolerance."

The study also showed more women became frequent snorers as their pregnancies progressed. Early in pregnancy, 11 percent of women in the study reported frequent snoring; by the third trimester, the number rose to 16.5 percent. Frequent snoring was defined as snoring three or more nights a week.

Facco said snoring during pregnancy may be triggered by weight gain and edema (a buildup of fluid), which can increase airway resistance. Exactly how the snoring is linked to gestational diabetes is not yet known.

About 4 percent of pregnant women develop gestational diabetes, a condition in which women without previously diagnosed diabetes develop high blood sugar levels during pregnancy. Babies born to mothers with gestational diabetes are at increased risk of problems such as being large for gestational age, which may lead to delivery complications. These babies may also have low blood sugar levels and are at increased risk of becoming obese or developing impaired sugar tolerance or metabolic syndrome later in life.

While gestational diabetes usually resolves after pregnancy, women who develop it are at higher risk for type 2 diabetes later in life.

Facco said further studies are needed to understand the association between snoring and gestational diabetes and to develop interventions to treat sleep disorders during pregnancy.

"If snoring is bothering a woman who is pregnant, she should seek a consultation with a sleep specialist," Facco said.

In related study, also to be presented at the SLEEP 2009 meeting, Facco found sleep disturbances such as restless legs syndrome and insomnia increase significantly during pregnancy.

April 4, 2009 (EurekAlert) - A new study by NYU dental researchers has uncovered evidence that pregnant women with periodontal (gum) disease face an increased risk of developing gestational diabetes even if they don't smoke or drink, a finding that underscores how important it is for all expectant mothers - even those without other risk factors - to maintain good oral health.The study, led by Dr. Ananda P. Dasanayake, Professor of Epidemiology & Health Promotion at New York University College of Dentistry in collaboration with the Faculty of Dental Sciences at the University of Peradeniya, Sri Lanka, eliminated smoking and alcohol use among a group of 190 pregnant women in the South Asian island nation of Sri Lanka, where a combination of cultural taboos and poverty deter the majority of women from smoking and drinking. The findings support an earlier study led by Dr. Dasanayake that found evidence that pregnant women with periodontal disease are more likely to develop gestational diabetes than pregnant women with healthy gums.

That study, which followed 256 women at New York's Bellevue Hospital Center through their first six months of pregnancy, showed that 22 of the women developed gestational diabetes. Those women had significantly higher levels of periodontal bacteria and inflammation than the other women in the study. The findings were published in the April 2008 issue of the Journal of Dental Research.

More than one-third of the women in the new study, which was conducted over the course of one year, reported having bleeding gums when they brushed their teeth. The women were given a dental examination and a glucose challenge test, which is used specifically to screen for gestational diabetes. According to Dr. Dasanayake, those women found to have the greatest amount of bleeding in their gums also had the highest levels of glucose in their blood. Dr. Dasanayake, who presented the findings today at the annual meeting of the International Association for Dental Research in Miami, said that he expected the final data to show that between 20 and 30 of the women had developed gestational diabetes.

Gestational diabetes is characterized by an inability to transport glucose -- the main source of fuel for the body -- to the cells during pregnancy. The condition usually disappears when the pregnancy ends, but women who have had gestational diabetes are at a greater risk of developing the most common form of diabetes, known as Type 2 diabetes, later in life. Asians, Hispanics, and Native Americans are at the highest risk for developing gestational diabetes. All of the women in the Sri Lanka study were of Asian origin, while 80 percent of the New York study subjects were Hispanic.

"In addition to its potential role in preterm delivery, evidence that gum disease may also contribute to gestational diabetes suggests that women should see a dentist if they plan to get pregnant, and after becoming pregnant," Dr. Dasanayake said. "Treating gum disease during pregnancy has been shown to be safe and effective in improving women's oral health and minimizing potential risks."

April 3, 2009 (EurekAlert) - It has so far not been proven that long-acting insulin analogues (LAIAs) have an advantage over conventional human insulin in the treatment of patients with type 2 diabetes. Even though the results of a 5-year study are available for one of the two LAIAs assessed (insulin glargine), the potential long-term benefits and harms of this drug class have still not been sufficiently investigated. This is the conclusion of a report by the German Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, which was published in March 2009 and for which an English-language summary is now available.

The final report is part of a comprehensive commission package awarded by the Federal Joint Committee, by means of which key therapy options for people with diabetes are to be assessed. The reports on rapid-acting insulin analogues in diabetes mellitus type 1 and 2 have already been completed.Only one study lasting longer than 12 months was available

For the assessment of the LAIAs, IQWiG searched for studies that either compared one of the two currently approved LAIAs for the treatment of type 2 diabetes (insulin glargine and insulin detemir) with human insulin, or compared the benefits of the two LAIAs with each other. A precondition for study inclusion was that patients had been randomly allocated to one of the treatment groups and that the treatment period had lasted at least 24 weeks, as the aim of the project was to assess the potential benefits and harms of long-term therapy.

A database search and queries to the manufacturers resulted in the retrieval of a total of 18 studies for inclusion in the evaluation. Of these studies, 15 (glargine: 9; detemir: 6) compared an LAIA with neutral protamine Hagedorn (NPH) insulin, a longer-acting (intermediate-acting) insulin based on human insulin. The other 3 studies compared the two LAIAs with each other. In 11 studies, insulin was used in addition to oral antidiabetics, in 6 studies within the framework of intensified insulin therapy. One study investigated various treatment schemes. This study on insulin glargine lasted 5 years; all the other studies lasted a maximum of 12 months.

It is notable that in 7 of the 9 studies comparing insulin glargine and human insulin, the drugs were not used as normally used in Germany. The study participants only injected the drugs once daily, even though in daily practice they are often injected more frequently. The relevance of these studies is therefore limited.

Conclusions about late complications of diabetes are hardly possible

It is not possible to draw reliable conclusions about the long-term advantages and disadvantages of the drugs investigated, solely due to the short duration of most studies. Even the 5-year study on insulin glargine, the results of which were not available at the time of the preparation of the preliminary report, only allows limited conclusions about late complications of diabetes. Regarding heart disease, the comparison with NPH insulin does not provide indications of a difference between treatment options. Similarly, the data do not provide indications that insulin glargine is associated with a higher risk of damage to the ocular fundus. This suspicion had prompted the US regulatory authority FDA (Food and Drug Administration) to request a long-term study from the manufacturer (Sanofi-Aventis). This study has now been completed and is assessed in the IQWiG report.

Data provide an indication of less frequent severe hypoglycaemia in patients using insulin glargine

The data do not prove short-term advantages of LAIAs, either. However, the data do provide some indications: in certain treatment schemes, non-severe hypoglycaemia seems to occur less frequently with insulin detemir, in consideration of the individual lowering of HbA1c levels. However, this only applies to the use as basal insulin (once or twice daily) in patients who also use oral antidiabetics. In addition, the 5-year study provides an indication that in patients using insulin glargine, severe hypoglycaemia occurs less frequently than in those using NPH insulin.

In the direct comparison of the two LAIAs, neither drug was clearly better than the other. However, study participants who used insulin detemir discontinued the study more often due to adverse events than those using insulin glargine. On average, patients in the detemir group put on less weight than those in the glargine group. However, the differences were small (0.9-1.3 kg). As the studies only lasted 6-12 months, it is unclear anyway whether this effect is long term.

Manufacturers provide previously unpublished data

Both manufacturers of LAIAs, Sanofi-Aventis (insulin glargine) and Novo Nordisk (insulin detemir), agreed to provide IQWiG with previously unpublished data during the preparation of the report. Data subsequently requested by IQWiG were supplied. These data referred in part to studies still completely unpublished and in part to additional information (clinical study reports) on comparative clinical trials already published. In addition, the manufacturers agreed that all of these data could be documented in the final report. A large amount of previously unpublished data could thus be incorporated in the final report.

During the course of the hearing procedure on the preliminary report, the manufacturers also supplied further analyses based on individual patient data (IPD). However, these data only changed the conclusions of the preliminary report in a few cases.

Procedure of report production

The preliminary results (preliminary report) were published by IQWiG at the end of March 2008 and interested parties were invited to submit comments. Following the commenting procedure, the preliminary report was revised and the final report sent to the contracting agency, the Federal Joint Committee, in January 2009. The documentation of the written comments, as well as the meeting minutes of the oral scientific debate, will be published in a separate document simultaneously with the final report.

November 9, 2008 (Press Release) - New data from the JUPITER study demonstrated that CRESTOR® (rosuvastatin calcium) 20 mg significantly reduced major cardiovascular (CV) events (defined in this study as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by a dramatic 44% compared to placebo (p<0.001) among men and women with elevated hsCRP but low to normal cholesterol levels.Results also showed that for patients in the trial taking rosuvastatin:

*
the combined risk of heart attack, stroke or CV death was reduced by nearly half (47%, p<0.001).
*
risk of heart attack was cut by more than half (54%, p<0.001).
*
risk of stroke was cut by nearly half (48%, p=0.002).
*
total mortality was significantly reduced by 20% (p=0.02).

These results were accompanied by a median LDL-C reduction of 50% (p<0.001) resulting in an on-treatment median LDL-C of 55 mg/dL.

On the basis of the data, if the results are projected over a period of 5 years, 25 patients would need to be treated to prevent one major cardiovascular event (NNT=25).

The JUPITER results will be presented today at the American Heart Association Scientific Sessions and were simultaneously published online by the New England Journal of Medicine.

"These results provide new information about Crestor's effects on CV risk. The JUPITER trial confirmed that CRESTOR dramatically reduces LDL-C cholesterol levels and has now demonstrated a nearly 50% reduction in the risk of heart attack and stroke in a population of patients who had elevated hsCRP but low to normal cholesterol levels," said Howard Hutchinson, Chief Medical Officer for AstraZeneca. "As is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients."

As previously guided, AstraZeneca expects to file a regulatory submission including the JUPITER data in the first half of 2009 and if approved, will begin promotional activities within the approved labeling.

Rosuvastatin is not indicated for the prevention of cardiovascular events. Rosuvastatin should be used according to the prescribing information, which contains recommendations for initiating and titrating therapy according to the individual patient profile. In most countries, the usual recommended starting dose of rosuvastatin is 10 mg.

Rosuvastatin 20 mg was well tolerated in nearly 9,000 patients during the course of the study. There was no difference between treatment groups for major adverse events, including cancer or myopathy. There was a small increase in physician reported diabetes consistent with data from other large placebo controlled statin trials.

ABOUT JUPITER:
JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a long-term, randomized, double-blind, placebo-controlled, large-scale study of 17,802 patients designed to determine if rosuvastatin 20 mg decreases the risk of heart attack, stroke and other major cardiovascular events in patients with low to normal LDL-C but at increased cardiovascular risk as identified by elevated high-sensitivity C-reactive protein (hsCRP) and age. The majority of patients had at least one other risk factor including hypertension, low HDL-C, family history of premature coronary heart disease (CHD) or smoking. hsCRP is a recognized marker of inflammation which is associated with an increased risk of atherosclerotic cardiovascular events.

JUPITER is a part of AstraZeneca's extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.

ABOUT CRESTOR (ROSUVASTATIN):
Studies have previously shown that CRESTOR was the most effective statin at lowering LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.

CRESTOR has now received regulatory approval in over 95 countries. Nearly 15 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.

November 6, 2008 (EurekAlert) - Children born to mothers with pregnancy-related diabetes run twice the risk of language development problems, according to a research team directed by Professor Ginette Dionne of Université Laval's School of Psychology. Details of this discovery are published in the most recent issue of the scientific journal Pediatrics.Researchers compared the vocabulary and grammar skills of 221 children whose mothers were diagnosed with gestational diabetes to those of 2,612 children from a control group. These tests were conducted at different intervals between ages 18 months and 7 years.

Results showed that children born to mothers with gestational diabetes achieve poorer scores on tests of spoken vocabulary and grammar than children of healthy mothers. The differences between the two groups are probably due to the effects of gestational diabetes on the brain development of babies. The study shows that these effects persist even after the children start school.

This study is the first to isolate the effect of gestational diabetes from other factors including family socioeconomic status, alcohol and tobacco consumption as well as maternal hypertension during pregnancy.

However, the study suggests that the impact of pregnancy-related diabetes on language development is not inevitable, as children of more educated mothers appear less affected. "This protection may be the result of the more stimulating environment in which children of more highly educated mothers develop, but it could also be due to genes that could make some babies less vulnerable," explains Ginette Dionne. "For the moment, we cannot isolate the two factors, but ongoing studies should allow us to answer that question," she continued.

Between 2% and 14% of children are born to mothers who suffer from gestational diabetes. Risk factors for this complication during pregnancy include the mother's age and her body mass index. "As mothers are having their children at a later age and the incidence of obesity in the population is on the rise, the rate of gestational diabetes is clearly increasing," underlined Professor Dionne. "The risk to babies' language development needs to be taken into account," she concludes.