Clinical Trial Shows Islet Transplantation is a Promising Procedure

September 27th, 2006 (NIAID) - The first international, multicenter trial of the Edmonton Protocol--a standardized approach to the transplantation of insulin-producing islets--demonstrates that this may be an appropriate therapy that can dramatically benefit certain patients with severe complications of Type 1 diabetes mellitus.

As described in the September 28, 2006 issue of The New England Journal of Medicine, 36 adult volunteers at nine clinical trial sites in North America and Europe received up to three infusions of islets, which are non-functioning in people with Type 1 diabetes. The trial was designed to gauge how well the transplanted islets would function in regulating blood sugar levels.

Led by James Shapiro, M.D., Ph.D., of the University of Alberta, Edmonton, Canada, and involving an international team of islet transplant researchers, this trial was conducted by the Immune Tolerance Network (ITN). Headquartered at the University of California, San Francisco, the ITN is an international consortium of clinical investigators supported by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Juvenile Diabetes Research Foundation (JDRF). NIAID and NIDDK are both components of the National Institutes of Health (NIH).

"The results of the trial show the feasibility and reproducibility of islet transplantation using the Edmonton Protocol and has promising implications for the future of treating Type 1 diabetes," says NIH Director Elias A. Zerhouni, M.D.
A year after the final treatment, 44 percent of the transplant recipients no longer needed insulin injections, and an additional 28 percent had partial islet function, which was associated with resolution of hypoglycemic unawareness--a severe complication of diabetes in which people can no longer recognize early symptoms of low blood sugar. Insulin independence did not persist indefinitely in most cases, and less than a third of the people who had been freed from insulin injections after one year remained so by two years. However, individuals with functioning islets had improved control of their diabetes, even though they still needed to take insulin shots. Further research will be needed to improve and prolong the beneficial effects of the procedure, the researchers say.

"Dr. Shapiro and the ITN research team have improved our understanding of the potential of islet transplantation for certain patients with Type 1 diabetes," says NIAID Director Anthony S. Fauci, M.D. "Ongoing studies will further define the clinical utility of this approach."

"This really shows that islet transplantation can be tremendously successful in protecting against hypoglycemic unawareness," says Dr. Shapiro.

About five to ten percent of the estimated 21 million Americans with diabetes have Type 1 diabetes--an autoimmune disease in which the body loses its ability to make insulin due to destruction of islets. Islets are clusters of cells in the pancreas that produce insulin, a hormone the body requires to use glucose (sugar) as a source of energy. This is different from the more common Type 2 diabetes, in which the body produces insulin but has a reduced ability to use it properly. Without insulin, very high levels of glucose accumulate in the blood, causing injury to nerves and blood vessels; at the same time, the glucose is unable to enter cells where the body can use it. Without insulin shots, this condition is fatal. Even with insulin shots, people with Type I diabetes cannot achieve perfectly normal control of their blood sugar. As a result, most people with Type 1 diabetes eventually develop one or more complications, such as heart disease and damage to the eyes, nerves and kidneys.

Healthy individuals and most people with Type 1 diabetes know when their blood sugar is low. Over time, however, some people with Type 1 diabetes develop hypoglycemic unawareness. This condition may make them vulnerable to sudden and severe confusion, fainting and even death if untreated. People with this condition may be unable to perform routine tasks such as driving.

In the last few decades, doctors have been able to treat Type 1 diabetes with pancreas transplantation. The transplanted pancreas senses blood sugar and produces insulin. Many people with diabetes who have taken daily insulin injections for years have achieved total insulin independence after pancreas transplantation--often for years after the transplant. About 1,500 pancreas or pancreas/kidney transplants are performed every year in the United States, and nearly 20,000 of these operations have been performed in the last two decades.

Despite this success, pancreas transplants are not routinely done in patients with Type 1 diabetes because it is a major surgery that carries associated surgical and anesthetic risks. Even without complications, it requires several weeks of recovery at home. In addition, a transplant recipient must stay on immunosuppressive drugs to prevent rejection of the transplanted pancreas. These drugs can have serious side effects, such as kidney damage and vulnerability to infection. For these reasons, pancreas transplantation is almost always reserved for patients who are already undergoing kidney transplantation.

Since the 1970s, doctors have been experimenting with a less invasive procedure, islet transplantation. Islets can be isolated from the pancreas of a deceased donor and then infused into a patient's portal vein, a large vessel that carries blood into the liver. Once in the liver, the islets settle in small blood vessels and begin sensing blood sugar content and producing insulin to control it. This is a safer procedure than a pancreas transplant and can be done in a few hours. Islet transplantation is not as effective as pancreas transplantation, however, in eliminating the need for insulin shots.

In 2000, Dr. Shapiro and his colleagues reported data on seven patients who achieved insulin independence after islet transplantation following a standardized procedure that he designed, which became known as the Edmonton Protocol. The Edmonton Protocol standardizes the procedure for preparing high-quality islets for infusion, testing the function of these islets and transplanting them into the recipient. It also makes use of a regimen of newer immunosuppressants that are less toxic to islets than some older drugs. However, toxicity remains a problem. Some patients in the trial stopped taking their immunosuppressants because of side effects, and as a result, they lost their transplanted islets.

The 36 participants in the clinical trial (mean age 41) had lived with diabetes for an average of 27 years. Each received between one and three infusions of islets. The majority of them had at least partial islet function one year after their final islet infusion, and almost all who did had resolution of hypoglycemic unawareness even if they were not freed from daily insulin injections.

"Even a small number of functioning islets seems sufficient for them to be able to detect low blood sugar and be cured of hypoglycemic unawareness," says Nancy D. Bridges, M.D., chief of the Transplant Immunobiology Branch at NIAID.

Posted by dlife at 04:42 PM | Comments (0)

Walgreens and Joslin Diabetes Center Form Broad Alliance to Improve Diabetes Outcomes

Program to Feature Access to First-in-Class Pharmacy-Based Resources for People With Diabetes and Those at Risk for Diabetes and Related Conditions

DEERFIELD, IL, and BOSTON, MA, Sept. 21, 2006 - Walgreens, the nation's largest drugstore chain, and Joslin Diabetes Center, the global leader in diabetes research, care and education, have formed a sweeping alliance to improve health outcomes for Americans with diabetes. Over the next five years, Walgreens and Joslin, an affiliate of Harvard Medical School, will develop and deliver awareness, wellness, prevention and education programs nationally to reach the estimated 21 million Americans with diabetes and the additional 41 million Americans at risk for the disease. Walgreens also will open a specialty pharmacy on the Joslin campus under a separate lease arrangement.

"Diabetes in America continues to grow at epidemic proportions, and there are too few endocrinologists to handle that many patients," said Ron Weinert, vice president of patient services for Walgreens Health Services, the managed care division of Walgreen Co. "The burden of care is falling to primary care physicians and ultimately the patients, many of whom are our customers. We know the Joslin approach to education, outreach and disease management improves outcomes for people with diabetes, and our alliance is specifically designed to increase access to Joslin's model for everyone we reach."

The alliance will leverage all of Joslin's expertise in diabetes awareness, prevention and management. This expertise will be applied across Walgreens consumer channels, including its nationwide network of pharmacies, Walgreens.com and Walgreens Health Initiatives (a pharmacy benefit manager).

"This alliance represents a new model of care, powered by Joslin's deep research and extensive clinical knowledge, and distributed 'from bench to bedside' to the community through Walgreens pharmacies," said C. Ronald Kahn, M.D., President of Joslin and the Mary K. Iacocca Professor of Medicine at Harvard Medical School. "The incomparable reach of Walgreens and its deep commitment to the health of its customers make it our ideal alliance partner as Joslin strives to deliver our model of patient empowerment and the aggressive identification and prevention of complications across the country."

Pharmacy-Based Resources for People with Diabetes

A cornerstone of the program will be the creation of pharmacy-based resources for diabetes prevention and care. Working together, Walgreens and Joslin will design and build enhanced training curricula, continuing education programs, and practical support tools that pharmacists can use to address the most important needs of patients, from managing medication regimens to understanding key individual health measures like blood pressure and A1C scores.

"Our joint vision is for the Walgreens pharmacist to be a true partner for customers with diabetes and their physicians, and to enable them to work together toward demonstrable and measurable changes in behavior and health outcomes," said Alan M. Jacobson, M.D., Senior Vice President, Joslin Strategic Initiatives Division. "Joslin will design approaches and then assess and report on their impact on Walgreens customers, and we will continually enhance and add to the program over time."

In the first months of the alliance, Walgreens and Joslin will launch initial patient education campaigns delivered through the Walgreens pharmacy that carefully target critical aspects of day-to-day diabetes management and the prevention of complications. The campaigns will include education handouts, tips and tools tailored to specific patient audiences, including the elderly and different ethnic groups disproportionately affected by diabetes. Aspects of the campaign will be visible on pharmacy prescription inserts, Walgreens.com, Walgreens Diabetes &You Magazine, and other communication vehicles.

Joslin and Walgreens are also jointly committed to developing breakthrough approaches over the long term that increase access to innovative health services for people with diabetes. The alliance will explore the possibility of installing the Joslin Vision Network TM (JVN) in select locations across the Walgreens chain. The JVN is the most thoroughly validated diagnostic retinal imaging service offering patients a pain-free and non-dilated diabetic eye evaluation that facilitates further examination by eye care specialists to treat diabetic retinopathy and other pathologies. The JVN is already in use at more than 50 clinical sites in 15 states.

"Diabetes is the leading cause of vision loss and blindness among working age adults in the United States, and yet most patients do not receive recommended care," continued Jacobson, who also directs Joslin's Behavioral Research Program and Clinic and is Professor of Psychiatry at Harvard Medical School. "Our Walgreens alliance may allow us to bring Joslin's proven techniques in managing eye disease to the millions of Americans across the country at risk of losing their vision from diabetic retinopathy."

New Flagship Pharmacy on Joslin Campus in Boston

Walgreens also intends to open, on the Joslin Campus in Boston's Longwood Medical Area, a specialty pharmacy designed to meet the needs of people with diabetes. "We see this pharmacy as the flagship of our presence in the Harvard medical community," said Weinert. "We expect the pharmacy to open in the first quarter of 2007.

Posted by dlife at 10:15 AM | Comments (2)

Hope for Significant New Diabetes Treatment in Stanford Discovery

STANFORD, CA Sept. 20, 2006 (EurekAlert) - Certain immune-suppressing drugs, such as those taken by patients who have had organ transplants, greatly increase the risk of developing diabetes. These drugs are known to put a stranglehold on a protein called calcineurin.

So it's not exactly a surprise that Seung Kim, MD, PhD, assistant professor of developmental biology at the Stanford University School of Medicine, chose to study why calcineurin inhibition leads to the disease. What is surprising is just how central calcineurin turns out to be in the health and happiness of the insulin-producing pancreatic beta cells. His findings, to be published in the Sept. 21 issue of Nature, could shake up diabetes research, lead to new classes of diabetes drugs and aid in efforts to develop stem cell treatments for diabetes.

"This work has the potential to be big," said Scott Campbell, PhD, vice president of research for the American Diabetes Association. He said that drugs based on this research could potentially expand the numbers of the few beta cells that remain in diabetics and make those cells perform better. "That would have a major impact on the lives of people with diabetes."

In diabetes, the beta cells produce too little insulin or none at all, which prevents cells of the body from being able to take in sugar after a meal. Sugar accumulates in the blood, damaging the blood vessels, kidneys and eyes. Diabetics are also prone to nerve damage. In the United States, 20.8 million people, or 7 percent of the population, have diabetes.

Knowing the potential link between calcineurin-inhibiting drugs and diabetes, Kim and MD/PhD graduate student Jeremy Heit collaborated with Gerald Crabtree, MD, professor of pathology, in a series of experiments to clarify the connection. They worked with mice that had been bred to produce calcineurin in the pancreas only until they were born. After birth, the pancreas in each mouse stopped producing the protein. By 12 weeks of age, the mice, which had been born with a normal number of beta cells, were severely diabetic.

Squelching calcineurin prevented the beta cells from increasing their numbers as the mice grew - more body mass requires more beta cells to keep blood sugar in check. It also reduced the amount of insulin made by the existing beta cells. What's more, calcineurin was found to regulate 10 genes that already had been associated with diabetes.

"This work has led us and others to think in entirely new ways about diabetes," Heit said. Until now people had identified individual genes or processes that were involved in diabetes. The new findings show that these lines of research are connected through a common regulator in calcineurin.

Heit and Kim used further genetic trickery to bypass calcineurin by artificially activating its protein sidekick, called NFAT. Beta cells lacking calcineurin but with active NFAT behaved normally, multiplying as the mice aged and producing normal amounts of insulin.

The implications of these findings are many:

* Drugs that enhance the activity of calcineurin or NFAT could become a new treatment for type-2, or adult-onset diabetes, in which the beta cells don't produce enough insulin.

* Drugs that inhibit calcineurin or NFAT could treat diseases in which the beta cells produce too much insulin, such as hypoglycemia or some pancreatic tumors.

* Treating isolated beta cells with drugs that enhance calcineurin could make those cells divide, producing more cells for transplantation.

* Activating calcineurin could help Kim in his efforts to direct embryonic stem cells to become insulin-producing cells.

Kim, whose work in diabetes includes the development of islet cells, identifying new drug targets and potential stem cell treatments, said the calcineurin findings have wide-ranging implications. "The finding that the calcineurin pathway regulates other pathways in the beta cell makes it highly relevant to many areas of diabetes research," he said.

Campbell said the next step is to verify that the findings in mice also hold true in humans. "This is a step in the right direction and a major leap forward, but now we need to take it into to humans," he said.

Posted by dlife at 10:09 AM | Comments (0)

Prostate Cancer Drug Raises Heart, Diabetes Risk

WASHINGTON, September 19, 2006 (Reuters) - "For men who do require this treatment, physicians may want to talk with their patients about strategies, such as exercise and weight loss, which may help to lower risk of diabetes and heart disease," Dr. Matthew Smith of Massachusetts General Hospital said in a statement.

Prostate cancer is the most common cancer among men, with more than 234,000 new cases diagnosed in the United States every year. It will kill 27,350 this year, according to the American Cancer Society.

On Tuesday, the Prostate Cancer Coalition released a report showing that deaths from prostate cancer have fallen by 32.5 percent in 10 years in the United States.

It said the mortality rate for black men is the lowest since 1977, but it is still 2.36 times the rate for white men.

The mortality rate was 39.34 per 100,000 in 1993 and dropped to 26.55 per 100,000 in 2003, mostly due to better screening but also because of better treatments, according to the coalition and the American Cancer Society.

Posted by dlife at 10:20 AM | Comments (0)

Insufficient Sleep Associated with Poorer Blood Glucose Control in African-Americans with Diabetes

September 18, 2006 (Newswise) — Getting fewer hours of sleep or lower-quality sleep may be associated with poorer blood glucose control among African-Americans with diabetes, according to an article in the September 18 issue of Archives of Internal Medicine, a theme issue on sleep.

Many individuals in modern society experience a chronic lack of adequate sleep, either because they voluntarily stay up late or because they have difficulty sleeping, according to background information in the article. Accumulating evidence suggests that restricting sleep may affect the ability of the body to process sugar (glucose) into energy, thereby increasing risk for the development of diabetes. Additional studies indicate that the reverse may be true, and that type 2 diabetes—which occurs when the body loses the ability to respond to the insulin that converts glucose into energy—may contribute to sleep problems.

Kristen L. Knutson, Ph.D., of the University of Chicago, and colleagues conducted a study of 161 African-Americans with type 2 diabetes, including 42 men and 119 women who had an average age of 57.3. During a 30- to 45-minute interview, participants answered questions about sleep quality and quantity, their diabetes and any complications, and whether or not they took insulin. Their waist-hip ratio was measured, and the patients reported their height and weight, from which body mass index (BMI) was calculated. Each individual was given a sleep quality score that ranged from zero to 21, with scores of greater than five indicating poor sleep quality. In addition, the researchers calculated a perceived sleep debt for each individual, described as the difference between the number of hours of sleep participants said they got on a typical weekday and the amount of sleep they said they wanted to get. Hemoglobin A1c (HbA1c) levels, which measure the control of blood glucose over time, were obtained from patients’ medical charts. A level of 7 percent or lower is the recommended optimal level for HbA1c.

The individuals in the study reported that they slept an average of six hours per night—22 percent averaged at least seven hours and only 6 percent at least eight hours. About 71 percent had sleep quality ratings of greater than five, indicating poor sleep quality. The average HbA1c level was 8.3 percent; 26 percent had a level below the recommended 7 percent.

Thirty-nine patients reported that their sleep was frequently disrupted by pain; these individuals were excluded from further analyses. Among the remaining 35 men and 87 women, 67 percent had poor sleep quality. Higher HbA1c levels were associated with lower sleep quality, less sleep and a larger perceived sleep debt, even after researchers controlled for sex, age, BMI, complications and use of insulin. Participants were then classified based on whether or not they had complications from diabetes and whether or not they used insulin. “In patients without complications, perceived sleep debt but not subjective sleep quality was associated with lnHbA1c levels,” authors write. “In contrast, in patients with at least one complication, [sleep quality] score, but not perceived sleep debt, was a significant predictor after controlling for covariates.”

The results do not indicate whether diabetes control impacts sleep—for instance, excessive urination at night resulting from high blood glucose levels could interrupt sleep—or whether insufficient or poor-quality sleep could contribute to poor glucose control. “Additional research is needed to determine whether optimizing sleep duration and quality may improve glucose control in patients with type 2 diabetes,” conclude Dr. Knutson and colleagues. “Sleep curtailment has become increasingly prevalent in modern society, and it cannot be excluded that this behavior has contributed to the current epidemic of type 2 diabetes.”

Posted by dlife at 10:06 AM | Comments (0)

Avandia® Reduces Risk of Progression from Pre-Diabetes to Type 2 Diabetes by 62 Percent in Largest Ever Diabetes Prevention Trial

Pre-diabetes estimated to affect 300 million people globally2

LONDON, September 15, 2006 - In the largest diabetes-prevention trial ever conducted, Avandia® (rosiglitazone maleate) reduced the risk of developing type 2 diabetes by 62 percent relative to placebo among people at high risk of developing type 2 diabetes. This highly statistically significant reduction of 62 percent (p<0.0001) was additive to standard counselling on healthy eating and exercise. The results of the landmark study are being reported today both in The Lancet and at the 42nd annual meeting of the European Association for the Study of Diabetes (EASD).1

The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial evaluated the likelihood of progression to type 2 diabetes over a three-year median follow-up period among 5,269 people with a condition known as “pre-diabetes.”1 In pre-diabetes, blood sugar levels are higher than normal, but not yet high enough for a diagnosis of type 2 diabetes.3 Patients included in the study were randomised to rosiglitazone (8 mg daily) or placebo and to ramipril (15 mg daily) or placebo and were assessed every six months for three to five years to determine if rosiglitazone or ramipril can reduce the risk of developing type 2 diabetes in pre-diabetic patients, when added to healthy eating and exercise counselling.1 The DREAM study was not designed as a direct comparison between rosiglitazone and ramipril. Results from the ramipril arm of the study, which increased regression to normoglycemia but did not reduce the risk of diabetes or death, are also being reported at EASD and published separately in the New EnglandJournal of Medicine.4

In this study, designed and conducted by the Population Health Research Institute at McMaster University, 10.6 percent of people receiving rosiglitazone progressed to type 2 diabetes versus 25 percent of people treated with placebo.1 In the composite primary endpoint of development of diabetes or death from any cause, rosiglitazone demonstrated a 60 percent risk reduction relative to placebo (p<0.0001).1

“The DREAM findings are particularly significant as we are in the midst of an epidemic of type 2 diabetes with global implications. It is also noteworthy that the damaging complications of type 2 diabetes can often precede the diagnosis of this condition by several years," said Dr. Bernard Zinman, DREAM Steering Committee Member, director of the Diabetes Centre, Mount SinaiHospitaland professor of medicine, University of Toronto, Canada. "By demonstrating that rosiglitazone significantly reduced the risk of developing type 2 diabetes, these data provide important evidence that it may be possible to alter the course of rising blood sugar levels and its consequences."

Over the three-year median follow-up period of the trial, 51 percent of the people receiving rosiglitazone returned to normal blood sugar levels compared to 30 percent of people receiving placebo; thus, people taking rosiglitazone were about 70 percent (p<0.0001) more likely than those taking placebo to return to normal blood sugar levels. As might be expected, people in the placebo group with higher Body Mass Index (BMI), an indicator of obesity, were more likely than those with lower BMIto progress to diabetes. However, the risk of developing diabetes did not increase with BMIin the group randomised to rosiglitazone. These findings suggest that rosiglitazone may reduce the increased risk of developing diabetes that is attributable to obesity.1

“GSKis committed to groundbreaking research for the treatment of pre-diabetes and type 2 diabetes in order to improve patient outcomes. We believe the long awaited findings from the DREAM trial will lead to a better understanding of type 2 diabetes and its treatment,” said Dr. Lawson Macartney, senior vice president, Cardiovascular and Metabolic Medicine Development Centre, GlaxoSmithKline. “The DREAM trial is the largest diabetes prevention trial conducted to date and provides the first body of evidence that rosiglitazone can reduce the risk of progression from pre-diabetes to type 2 diabetes in high risk patients.”

In the study, rosiglitazone was generally well tolerated. There was no significant difference between the rosiglitazone and placebo groups in withdrawal from study medication before study end, or in the secondary composite endpoint of cardiovascular (CV) events that included myocardial infarction, stroke, CV death, confirmed heart failure, new angina and revascularisation procedures (2.9 percent in the rosiglitazone group [75 events]; 2.1 percent in the placebo group [55 events], p=0.15). There was a low number of deaths in the trial and no significant difference between the two groups (1.1 percent in the rosiglitazone group [30 deaths] versus 1.3 percent in the placebo group [33 deaths], p=0.7). The most commonly reported CV event in the study was revascularisation procedures. More events of confirmed heart failure were reported in people who received rosiglitazone as compared to those who received placebo (0.5 percent in people randomized to rosiglitazone [14 events] versus 0.1 percent in people randomized to placebo [2 events], p=0.01). Data presented by McMasterUniversityshowed that all cases of heart failure were treated effectively during the trial. Information about the potential for heart failure can be found in rosiglitazone prescribing information. At the conclusion of the study, mean bodyweight in the rosiglitazone group had increased slightly (2.2 kg) more than the placebo group.1,5

Rosiglitazone belongs to the thiazolidinedione class of drugs and is an approved treatment for type 2 diabetes that improves blood sugar control, enabling people to reach recommended blood sugar levels. No agent including rosiglitazone is currently approved for the treatment of pre-diabetes.5

About the DREAM Study

DREAM is an international, multi-centre, randomised, double-blind, 2x2 factorial trial involving 5,269 patients from 21 countries with impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG), also known as pre-diabetes, who are therefore at high risk of developing type 2 diabetes. The DREAM study was conducted by the Population Health Research Institute at the Michael G. DeGroote School of Medicine at McMasterUniversityand Hamilton Health Sciences in Hamilton, Ontario. DREAM was funded by a peer-reviewed grantfrom the Canadian Institutes of Health Research (CIHR) via the CIHR/Rx&D Collaborative Research Program aswell as by GlaxoSmithKline, sanofi-aventis and King Pharmaceuticals.1

About Pre-diabetes and Type 2 Diabetes

The International Diabetes Federation (IDF) estimates a potential increase in pre-diabetes from 300 million people worldwide in 2003 to approximately 500 million by 2025.2 While not everyone with pre-diabetes develops type 2 diabetes, large clinical outcomes trials have demonstrated that without intervention between 29 and 55 percent of people with pre-diabetes develop type 2 diabetes over the course of three years.6-8 As type 2 diabetes naturally progresses, the combined effects of core defects of the disease, namely insulin resistance and beta-cell dysfunction, can make it increasingly difficult for physicians to help patients control blood sugar levels.9

Pre-diabetes is considered a key stage in the development of type 2 diabetes – a chronic, progressive illness often linked to premature death that affects approximately 230 million individuals worldwide and is expected to affect 350 million people globally by 2025.3,10 Complications from diabetes can include eye disease, kidney disease, nerve damage, heart disease, stroke and peripheral vascular disease.11-14 In fact, more than three million people die from diabetes-related causes each year – one death every 10 seconds.15

Important Information regarding Avandia (rosiglitazone maleate)

Globally, prescribing information varies therefore please refer to the product label in your country for complete information.

Important Information for Avandia (rosiglitazone maleate) in Europe

Rosiglitazone, along with diet and exercise, helps improve blood sugar control. It may be taken alone by diabetic patients who cannot take metformin, in combination with metformin or a sulphonylurea, or with both metformin and a sulphonylurea. It is contraindicated for use in combination with insulin.

Rosiglitazone is also contraindicated for patients with cardiac failure and may cause fluid retention. Patients with sudden rapid increase in weight, increasing edema or shortness of breath should consult their doctor.

Patients with liver impairment should not take rosiglitazone. Blood tests should be used to check for liver problems before starting treatment, and periodically after that according to clinical appropriateness.

Caution is advised when using rosiglitazone in patients with significant renal impairment.

Rarely, some people have experienced vision changes due to swelling in the back of the eye while taking rosiglitazone

When used in combination therapy, particularly with sulphonylurea, hypoglycaemia may occur. Dose reduction of concomitant diabetes therapy may be required.

Rosiglitazone may increase the likelihood of pregnancy. Where appropriate, patients should seek contraceptive advice from their doctor prior to commencing therapy.

Rosiglitazone is contraindicated while breast feeding

Avandiacontains lactose so should not be used by patients with rare hereditary problems associated with lactose intolerance.

For full prescribing information please consult the current rosiglitazone summary of product characteristics.

About GlaxoSmithKline

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit http://www.gsk.com.

References:

1. The DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomized controlled trial. The Lancet. Published Online September 15, 2006. DOI:10.1016/S0140-6736(06)69420-8.

2. International Diabetes Federation. Fact Sheet: Impaired Glucose Tolerance ( IGT ). Available at: http://www.idf.org/home/index.cfm?node=1224. Accessed on August 3, 2006.

3. Gluco-Forum. What is pre-diabetes. Available at: http://www.glucoforum.org/glucoforum/front/Controller?controller=InterligoController&action=loadPage&codeRubrique=10&codePage=31. Accessed on August 3, 2006.

4. International Diabetes Federation. Fact Sheet: Impaired Glucose Tolerance ( IGT ) .Available at: http://www.idf.org/home/index.cfm?node=1224. Accessed on August 3, 2006.

5. Avandia Prescribing Information

6. Gluco-Forum. Preventing diabetes. Available at: http://www.glucoforum.org/glucoforum/front/Controller?controller=InterligoController&action=loadPage&codeRubrique=7. Accessed on August 3, 2006.

7. Diabetes Prevention Program Research Group. Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin. NEJM. 2002; 346:393-403.

8. Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006;49:289-297.

9. Gerich JE. Redefining the clinical management of type 2 diabetes: Matching therapy to pathophysiology. Eur J Clin .Invest. 2002;32 (Supplement 3):46– 53.

10. Unite for Diabetes. The Global Epidemic of the 21st Century. Available at: http://www.unitefordiabetes.org/assets/files/About_diabetes.pdf. Accessed on August 16, 2006.

11. Molitch ME, DeFronzo RA, Franz MJ, et al. Diabetic nephropathy. Diabetes Care. 2003;26 (Supplement 1):S94–S98.

12. Fong DS, Aiello L, Gardner TW, et al. Diabetic retinopathy. Diabetes Care. 2003;26 (Supplement 1):S99–S102.

13. Mayfield JA, Reiber GE, Sanders LJ, et al. Preventive foot care in people with diabetes. Diabetes Care. 2003;26 (Supplement 1):S78–S79.

14. Kannel WB, D'Agostino RB, Wilson PW, et al. Diabetes, fibrinogen, and risk of cardiovascular disease: the Framinghamexperience. Am Heart J. 1990;120:672–676.

15. International Diabetes Federation. Did You Know? Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed on August 3, 2006.

Posted by dlife at 10:02 AM | Comments (0)

Exubera Effective in Diabetes Patients who Have Respiratory Infections or are Exposed to Passive Cigarette Smoke, New Analyses Show

COPENHAGEN, Denmark, Sept. 14 (Pfizer PR) -- Adult patients with diabetes who took Exubera® (insulin human [rDNA origin]) inhalation powder were able to safely maintain good blood sugar control even if they developed a respiratory infection or were exposed to passive (second-hand) cigarette smoke. These analyses were presented today at the 42nd European Association for the Study of Diabetes.

In addition, according to a retrospective analyses of 14 Exubera phase 2 and 3 clinical studies, Exubera was well tolerated and efficacious, even during respiratory illness in adults with type 1 or type 2 diabetes.

Another new study found that while passive smoke exposure could result in decreased absorption, Exubera could be used by patients who were exposed to a smoky environment.

"This information is important for healthcare providers who have prescribed or are considering prescribing Exubera to their patients," said Professor Philippe Camus, lead investigator from the University Medical Center, Dijon, France. "It shows that the efficacy and tolerability of Exubera remain unchanged even if patients develop a cold or the flu. Also, studies showed patients taking Exubera are no more likely to develop a respiratory infection than patients using injectable insulin."

Exubera should not be used by people who smoke or have smoked in the past six months, or by people who have underlying lung diseases such as asthma or chronic obstructive pulmonary disease.

An analysis of a previously reported study showed that Exubera has the potential to encourage twice as many people with uncontrolled Type 2 diabetes to try insulin (44 percent choosing insulin with Exubera availability versus 17 percent choosing insulin without Exubera availability). This held true even in countries where insulin pens are commonly used to administer insulin. Past studies have shown that people avoid or delay starting insulin therapy, for example due to the fear and pain of injection, even when suffering from devastating complications brought about by uncontrolled blood sugar levels.

"This finding contradicts the perception that insulin pens can overcome peoples' resistance to using insulin. If Exubera can get more people to accept insulin at all and to accept it earlier than they ordinarily might, we would expect that more people could get their blood sugars under control," said Professor Nick Freemantle, professor of clinical epidemiology and biostatistics from the University of Birmingham, U.K. "This is incredibly important in helping people to reduce their chances of suffering from the serious complications of uncontrolled diabetes such as blindness and amputations as well as for healthcare systems responsible for reducing diabetes related morbidity and mortality."

In addition, an analysis of five clinical trials showed that people with either Type 1 or Type 2 diabetes who used Exubera gained less weight than those using injectable insulin. Type 2 patients gained less than half with Exubera (0.7 kg vs. 1.6 kg), while the difference was even greater for Type 1 patients (0.2 kg with Exubera vs. 1.1 kg with injected insulin).

"Many of my patients worry about weight gain with insulin," said Dr. Priscilla Hollander, lead investigator from Baylor University Medical Center, Dallas, U.S. "This analysis reassures me that people who need insulin will not gain as much weight if they use Exubera. This may be another reason for physicians and their patients to consider Exubera to control blood sugar levels."

Posted by dlife at 09:52 AM | Comments (0)

Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Biphasic Insulin Aspart

Patients on exenatide lost weight, while insulin aspart patients gained weight

COPENHAGEN, DENMARK, September 14, 2006 - Eli Lilly and Company and Amylin Pharmaceuticals, Inc. today announced results from a study indicating that exenatide improves blood sugar levels as effectively as biphasic insulin aspart 30/70 (NovoMix 30(R), NovoNordisk) for people with type 2 diabetes failing to achieve acceptable blood sugar control on both metformin and a sulfonylurea, two common oral diabetes medications.

This long-term clinical trial is the second study conducted at European clinical centers demonstrating that exenatide can control blood sugar as effectively as insulin.(1)

During the one year (52-week) study, patients using exenatide showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose, and hemoglobin A1C (HbA1C). Exenatide treatment also resulted in an average reduction in body weight.

Thirty-two percent of study participants using exenatide reached target HbA1C of 7% or less. HbA1C measures a person's average glucose level over a three-month period and is often used by health care providers to assess blood glucose management.

The American Diabetes Association (ADA) recommends a target HbA1C of less than 7%. When measured against the International Diabetes Federation (IDF) recommended target HbA1C of 6.5% or less, 18% of patients in the exenatide group achieved this level compared to 9% in the biphasic insulin aspart group. These findings were presented at the 42nd annual meeting of the European Association of the Study of Diabetes (EASD) in Copenhagen, Denmark.

Patients on exenatide lost an average of 2.5 kg (5.5 pounds), while those receiving biphasic insulin aspart gained an average of 2.9 kg (6.4 pounds). Weight gain is a common side effect of insulin therapy. In addition, exenatide reduced peak blood sugar levels after meals. Both treatments were associated with low rates of daytime and nighttime hypoglycemia (low blood sugar).

"This comparator study demonstrates that exenatide has similar blood glucose control to the conventional treatment with insulin," said Professor Dr. Michael Nauck, Director of the Diabetes Centre in Bad Lauterberg, Germany, and a lead author of the study. "These data show that exenatide, without the inconvenience of dose titration, is a potential alternative to biphasic insulin aspart for the treatment of patients with type 2 diabetes not adequately treated with metformin and a sulfonylurea, commonly used oral antidiabetic agents."

Exenatide is the first in a new class of medicines known as incretin mimetics and was approved for use in the United States by the U.S. Food and Drug Administration in April 2005 for the treatment of type 2 diabetes. Exenatide is injected twice daily. The U.S. is the first country that has received regulatory approval for exenatide. In late 2005, Lilly submitted exenatide for approval in the European Union.

Key Findings

A1C reduction:

* Both treatment groups achieved similar HbA1C reductions. Exenatide lowered HbA1C by 1.04% while biphasic insulin aspart lowered HbA1C by 0.89%.

* When measured against the target HbA1C of less than or equal to 7%, 32% of patients in the exenatide group achieved this level compared to 24% in the biphasic insulin aspart group.

* When measured against the target HbA1C of less than or equal to 6.5%, 18% of patients in the exenatide group achieved this level compared to 9% in the biphasic insulin aspart group.

Glucose measurements:

* As measured by patient self-glucose monitoring, exenatide reduced postprandial excursions, the rise of glucose after meals, following breakfast and dinner. Biphasic insulin aspart reduced mainly pre-meal glucose.

* The fasting blood glucose at endpoint was decreased in patients treated with exenatide by 1.8 mmol/L and by 1.6 mmol/L in patients treated with biphasic insulin aspart.

Weight change:

* Weight loss in the exenatide arm: Patients treated with exenatide experienced an average weight reduction of 2.5 kg (5.5 pounds).

* Weight gain in the biphasic insulin aspart: On average, patients treated with insulin gained 2.9 kg (6.4 pounds).

* After 52 weeks, the total weight difference between treatments was -5.4 kg (11.9 pounds).

Hypoglycemia:

* Both exenatide and biphasic insulin aspart had low rates of daytime and nighttime hypoglycemia.

* No severe hypoglycemia was reported in either the exenatide or the biphasic insulin aspart arm.

Other adverse events:

* The most common adverse event for exenatide was nausea (33.2% exenatide, 0.4% biphasic insulin aspart), which was generally mild-to- moderate and tended to decrease in frequency and severity over time. Four% of exenatide-treated patients discontinued due to nausea.

Study Design/Protocol
501 patients were enrolled in the 52-week, multi-center, open-label, randomized trial. The trial was designed to determine if exenatide can be used as safely and effectively as biphasic insulin aspart in patients with type 2 diabetes inadequately treated with metformin plus a sulfonylurea.

Study participants were randomized into two treatment arms. The first group received a dose of exenatide (5 micrograms twice-a-day for first four weeks, then 10 micrograms twice-a-day for the remainder of the study), in conjunction with metformin and a sulfonylurea. The second group received biphasic insulin aspart (titrated to achieve an optimal balance between glycemic control and risk of hypoglycemia as dictated by best clinical practice), again with metformin and a sulfonylurea. The average HbA1C at baseline was 8.6% in both treatment groups.

About Exenatide
Exenatide is the first incretin mimetic, a new class of drugs for the treatment of type 2 diabetes. Exenatide exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.(2)

About Incretin Mimetics
Incretin mimetics are a distinct class of treatment in the fight against diabetes. An incretin mimetic works to mimic the anti-diabetic or glucose- lowering actions of naturally occurring human hormones called incretins. These actions include stimulating the body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing food intake. Exenatide is the first FDA-approved incretin mimetic.

About Diabetes
Diabetes affects an estimated 194 million adults worldwide(3) and around 48.4 million in Europe.(4) Approximately 90 to 95% of those are affected by type 2 diabetes, a condition characterized by failure of the pancreatic beta cells to adequately respond to the increased demands for insulin that occur as a result of obesity-related insulin resistance.(5) Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(4) In virtually every developed society, diabetes is ranked among the leading causes of blindness, renal failure and lower limb amputation, as well as death through its effects on cardiovascular disease (70-80% of people with diabetes die of cardiovascular disease)(6). The calculated estimates of the costs of diabetes care in Europe amount to 42.8 million International Dollars per year.(7)

About Lilly and Amylin

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier, and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients.

Lilly, a leading innovation-driven corporation is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin's research and development activities leverage the company's expertise in metabolism to develop promising therapies to treat diabetes, obesity and cardiovascular disease. Amylin is located in San Diego, California with over 1200 employees nationwide.

This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that future clinical trials may not replicate previous trial results; risks that exenatide may not prove to be an important new therapeutic option, European approval for exenatide or regulatory approval of additional indications for exenatide may not be received or exenatide may be affected by unexpected new data or technical issues. The potential for exenatide may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance and any issues related to manufacturing and supply. These and additional risks and uncertainties are described more fully in Amylin and Lilly's most recently filed SEC documents such as their Quarterly Reports on Form 10-Q. Amylin and Lilly disclaim any obligation to update these forward-looking statements.

P-LLY

REFERENCES:
(1) Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: A randomized trial. Annals of Internal Medicine. 2005; 143(8):559-69.
(2) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide) significantly reduces postprandial and fasting glucose in subjects with type 2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003; 88(7):3082-3089.
(3) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed April 12, 2005.
(4) The International Diabetes Federation, Prevalence / All diabetes. Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/.
(5) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
(6) The International Diabetes Federation, Complications. Available at http://www.eatlas.idf.org/Complications/.
(7) The International Diabetes Federation, Diabetes Atlas, Second edition. The Economic Impact of Diabetes. 2003:186.

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

ACTOS® (pioglitazone HCl) Demonstrates Significant Improvements in Cardiovascular Outcomes for High-Risk Patients with Type 2 Diabetes

Copenhagen, Denmark, September 14, 2006 – Several abstracts presented today at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD) indicated that ACTOS® (pioglitazone HCl), an oral antidiabetic medication, demonstrated significant cardiovascular benefits such as reducing the risk of heart attack and/or stroke and acute coronary syndrome in patients with type 2 diabetes. Cardiovascular disease (CVD) is the leading cause of premature death in patients with diabetes. An estimated 171 million people worldwide have diabetes, and CVD is responsible for 50% to 80% of deaths in people with diabetes.

“We are continuing to see the benefits of ACTOS beyond glycemic control,” said Erland Erdmann, M.D., chairman of the PROactive Executive Committee and director of the Clinic III for Internal Medicine, University of Cologne, Germany. “We know that patients with diabetes are two to four times more likely to develop heart disease or have a stroke than people without diabetes. The data presented at EASD showed that ACTOS can have a positive effect on several measures of cardiovascular disease outcomes in high-risk patients with type 2 diabetes.”

Reduced Occurrence of Major Adverse Cardiovascular Events (MACE)

Results from one of the studies showed that ACTOS significantly reduced the occurrence of major adverse cardiovascular events (MACE), such as heart attacks, nonfatal stroke, acute coronary syndrome and cardiovascular death in high-risk patients with type 2 diabetes. Compared to placebo, patients treated with ACTOS demonstrated statistically significant risk reductions of heart attacks (23 percent, P=0.046), the combined risk of cardiovascular death, nonfatal heart attack or nonfatal stroke (18 percent, P=0.020) and the combined risk of all-cause mortality, nonfatal heart attack, nonfatal stroke or acute coronary syndrome (17 percent, P=0.010). These results were part of the landmark PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study.

Decreased Incidence of Heart Attacks

Compared with the general population, individuals with type 2 diabetes have an increased incidence of myocardial infarction (MI), commonly known as a heart attack. In patients who had experienced a previous heart attack, ACTOS, on top of standard-of-care treatment, reduced the recurrence of fatal or non fatal (excluding silent MI) heart attacks by 28 percent (P=0.045).

Prevented Recurrent Strokes

Patients with diabetes have a markedly higher risk of stroke than those without. In fact, strokes occur twice as often in people with diabetes. Of the estimated 750,000 people in the U.S. who experience a stroke each year, 5 to 14 percent will have an additional stroke within one year. A recent analysis examined the effects of ACTOS on the risk of stroke and other cardiovascular outcomes in patients with type 2 diabetes with and without prior stroke. The results showed that:

• The incidence of recurrent stroke was reduced by 47 percent.
• The combined risk of CV death, MI or stroke was reduced by 28 percent.
• There was no effect of ACTOS on subsequent strokes in patients who had never experienced a stroke.

Improved Triglycerides & HDL-C

Additional data presented at the meeting showed that ACTOS improved components of diabetic dyslipidemia, a condition commonly found in people with type 2 diabetes and an important risk factor for CVD, the leading cause of death for people with type 2 diabetes. Diabetic dyslipidemia is characterized by increased trigylcerides and decreased HDL-C. People with diabetic dyslipidemia also tend to have normal levels of LDL-C (“bad” cholesterol), but smaller, denser LDL-C particles that are likely to contribute to cholesterol build-up in arteries. The data indicated that:

• ACTOS decreased triglycerides (a type of lipid or fat found in food and the body)
• ACTOS increased HDL-C (“good” cholesterol)

“All of the results seen from the PROactive trial significantly impact the lives of those with type 2 diabetes and cardiovascular disease. Because they are at higher risk, it is important to find solutions that impact not only glycemic control but overall cardiovascular health. These findings show the potential benefits ACTOS can have in managing diabetes and the risk factors that contribute to cardiovascular disease,” said Robert Spanheimer, M.D., senior medical director for Diabetes and Metabolism at Takeda Pharmaceuticals North America, Inc., in Lincolnshire, Illinois.

About the PROactive Study

PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) is a landmark study that prospectively looked at the impact in total mortality and macrovascular morbidity using ACTOS, a glucose-lowering agent. It was a randomized, double-blind, placebo-controlled outcome study of 5,238 patients with type 2 diabetes and macrovascular disease. Patients were randomized to receive either ACTOS or placebo in addition to standard-of-care treatment (including the routine use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose-lowering agents such as metformin, sulfonylureas and insulin; antiplatelet drugs such as aspirin, and lipid-modifying medicines such as statins and fibrates).

This study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events including both disease and procedural endpoints; and a principal secondary combination endpoint of death, heart attack and stroke.

As reported at the European Association for the Study of Diabetes (EASD) Annual Meeting in September 2005, the primary endpoint was reduced by 10 percent but had not reached statistical significance by study end (P=0.095). The principal secondary endpoint showed that ACTOS significantly reduced the combined risk of heart attacks, strokes and death by 16 percent (P=0.027) in high-risk patients with type 2 diabetes.

Posted by dlife at 09:48 AM | Comments (0)

New Analyses Show ACTOS® (pioglitazone HCl) Reduced Risk of Secondary Stroke by Almost 50 Percent in High-Risk Type 2 Diabetes Patients

Barcelona, Spain, September 3, 2006 — Results of new analyses found that ACTOS® (pioglitazone HCl), an oral antidiabetic medication, significantly reduced the risk of recurrent stroke in high-risk patients with type 2 diabetes. The findings were presented today in a late-breaker session at the World Congress of Cardiology in Barcelona.

“These results are very encouraging news for people with type 2 diabetes because they demonstrated that ACTOS reduced the incidence of strokes in patients who had already experienced a stroke from 10.2 percent down to 5.6 percent, translating to a risk reduction of almost 50 percent,” said Robert Wilcox, M.D., professor in the Department of Cardiovascular Medicine at Queen’s Medical Centre, University Hospital, Nottingham, United Kingdom.

These new analyses from the landmark PROactive Study examined the effects of ACTOS on the risk of stroke and other cardiovascular (CV) outcomes in high-risk patients with type 2 diabetes with and without prior stroke. Pre-specified study endpoints included all-stroke and CV disease death, myocardial infarction (MI, excluding silent MI) or stroke.

According to the results, there were statistically significant benefits of ACTOS in patients who had suffered a prior stroke. The incidence of recurrent stroke was reduced by 47 percent (P=0.008) and the combined risk of death, MI or stroke was reduced by 28 percent (P<0.05). There was no effect of ACTOS on subsequent strokes in patients who had never experienced a stroke.

Patients with diabetes are at an increased risk of stroke. In fact, the risk is two to four times higher for people with diabetes than the general population. Results from the PROactive Study demonstrated that an oral glucose-lowering medication could substantially impact the risk of some CV events, including the combined risk of death, MI and stroke in high-risk patients with type 2 diabetes.

About the PROactive Study
PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was a landmark study that prospectively looked at the impact in total mortality and macrovascular morbidity using ACTOS, a glucose-lowering agent. It was a randomized, double-blind, placebo-controlled outcome study of 5,238 patients with type 2 diabetes and macrovascular disease. Patients were randomized to receive either ACTOS or placebo in addition to standard-of-care treatment (including the routine use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose-lowering agents such as metformin, sulfonylureas and insulin; antiplatelet drugs such as aspirin, and lipid-modifying medicines such as statins and fibrates).

This study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events including both disease and procedural endpoints; and a principal secondary combination endpoint of death, heart attack and stroke.

As reported at the European Association for the Study of Diabetes (EASD) Annual Meeting in September 2005, the primary endpoint was reduced by 10 percent but had not reached statistical significance by study end (P=0.095). The principal secondary endpoint showed that ACTOS significantly reduced the combined risk of heart attacks, strokes and death by 16 percent (P=0.027) in high-risk patients with type 2 diabetes.

About ACTOS
ACTOS works by directly targeting insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. ACTOS is taken once daily as an adjunct to diet and exercise, and is approved for use for type 2 diabetes as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.

Additional Information
ACTOS is not for everyone. ACTOS can cause fluid retention that may lead to or worsen heart failure, so tell your doctor if you have a history of these conditions. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter.

Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood glucose.

Please visit the ACTOS Web site at www.actos.com for complete Prescribing Information.

Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc., is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.

ACTOS® (pioglitazone HCl) is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc.

Posted by dlife at 09:28 AM | Comments (1)