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Boxed Warning Additions to GlaxoSmithKline’s Anti-Diabetes Drug Avandia

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The U.S. Food and Drug Administration has announced that GalaxoSmithKline, the manufacturer of Avandia (rosiglitazone), has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks. Avandia is used to treat type 2 diabetes.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

"FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines."

Avandia, manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa., was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

According to the FDA, over the past year the agency has analyzed various sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

The FDA has concluded that there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, the agency has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia’s existing boxed warning—FDA’s strongest form of warning—includes the following statement:

A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.

GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

Source: FDA

Fat Cells Help Pancreas Secrete Insulin

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Research carried out at Washington University School of Medicine in St. Louis shows that the body’s fat cells help the pancreas secrete insulin, a finding which could lead to new methods in improving glucose metabolism in type 2 diabetics or insulin-resistant people.

In the November 7, 2007 issue of Cell Metabolism, scientists at the School of Medicine describe a study using laboratory mice where fat cells release a protein that aids insulin secretion from pancreatic beta cells, the sole source of insulin. The protein is an enzyme that the pancreatic cells produce in minimal amounts; the enzyme enhances glucosde-stimulated insulin secretion from pancreatic beta cells.

The enzyme secreted by fat cells is called Nampt (NMN) and is an important component of the insulin-secretion pathway. "We think this secretion process allows fat cells to communicate with the pancreas and aid its function," says senior author Shin-ichiro Imai, M.D., Ph.D., assistant professor of medicine and of molecular biology and pharmacology. "I suspect this process could be critical for compensating pancreatic beta cell function in the face of increasing insulin resistance." "Our work marks a conceptual breakthrough," continued Imai. "Nampt synthesizes a compound in the bloodstream, and when that compound reaches the pancreas it stimulates insulin secretion. This is a surprising mechanism by which a circulating metabolite modulates pancreatic function."

Imai believes that the compound produced by Nampt could be used to raise insulin secretion from pancreatic cells, and so improve the way the body handles sugar. NMN was measured in the bloodstreams of laboratory mice at a concentration sufficient to enhance insulin secretion from pancreatic cells; previously it not known that NMN circulated in the bloodstream.

In conjunction with the Office of Technology Management at the University, Imai has patented the use of Nampt and NMN for the prevention and treatment of metabolic complications, such as type 2 diabetes.

Source: Cell Metabolism, November 7, 2007.

Charcot Foot Condition on the Increase Among Diabetics

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With the number of diabetes cases growing nationwide, more diabetes patients are developing a somewhat rare, but dangerous foot complication called Charcot foot, according to a number of physicians with the American College of Foot and Ankle Surgeons.

Charcot foot is a sudden softening of the foot’s bones caused by severe neuropathy, or nerve damage, a common diabetic foot complication. It can cause joint loss, fractures, collapse of the arch, massive deformity, ulcers, amputation and even death. It cannot be reversed, but early detection can arrest its effects.

Symptoms, which appear suddenly, include warm and red skin, swelling and pain. A diabetic with a red, swollen foot or ankle requires emergency medical care because these symptoms can also indicate deep vein thrombosis, or an infection.

"More people with diabetes, their families and their care providers need to know about Charcot foot," says J.T. Marcoux, DPM, one of a few Massachusetts foot and ankle surgeons who perform Charcot foot reconstructions. "When I diagnose a patient with this complication, I telephone their primary care doctor and educate them about it as well."

Apathy and diabetic denial are major factors in preventing the treatment of Charcot foot among diabetics, say Keith Jacobson, DPM, and Dr. Marcoux. "I’ve had patients who are literally blind, on dialysis and neuropathic, who refuse to admit they have diabetes," says Jacobson. "I’ve seen horrific deformities with this condition."

Meanwhile Kim Schraeder, one patient who was successfully treated for Charcot foot by Dr. Jacobson, is back walking on both feet and is carefully watched by her children for any reoccurrence of the condition. "They’re all like hawks now." she says. "If I’m sitting here with bare feet, they’ll look to make sure they’re not red, hot or swollen."

Source: American College of Foot and Ankle Surgeons

Angry Men at Higher Risk for Heart Disease, Diabetes

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It’s not healthy to be hostile, according to a recent study from Duke University.

Steven Boyle, Ph.D., a researcher at Duke University Medical Center, says men who regularly exhibit strong feelings of anger or depression may face increased risk of coronary heart disease.

The study was conducted on 313 men who were given a standard psychological test that measures hostility, anger and depression.

Men whose psychological screening showed the highest level of hostility, depressive symptoms and anger had a 7.1 percent increase in levels of an immunity protein known as C3, while men with lower levels of hostility, depression and anger showed no during the decade-long study.

According to the study’s co-author, Edward Suarez, Ph.D., the lifestyle of individuals with a hostile attitude, "often leads to greater stress and possibly changes in the way the body functions that could lead to disease.”

The study appears in the August issue of the journal Brain, Behavior, and Immunity.

Source: Health Behavior News Service

FDA Panels to Evaluate Avandia Heart Risks

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Two Food and Drug Administration advisory panels will meet to discuss the results of a study done by Cleveland Clinic cardiovascular medicine chairman and a leading author, Steven Nissen, claiming that the popular diabetes drug "Avandia" may increase the risk of heart attack in patients.

Nissen’s study is based on 42 clinical trials. Results showed that people on Avandia were at 43% higher risk of having a heart attack.

Glaxo, the drug maker, reported a fall of 23% in Avandia sales after the study was published.
The advisory panel may recommend anything from no action to a black box label. However, Glaxo spokeswoman Mary Anne Rhyne maintains that these drugs are safe and the decline in sales is only in new prescriptions.

US Presidential Candidates Plan to Cure Diabetes

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US Presidential Candidates, Senator Chris Dodd (D-Connecticut) and former Governor Bill Richardson (D-New Mexico) seem to be showing a lot of interest in finding a permanent cure to diabetes.

Both of them indicated their intentions during Monday night’s debate.
While answering a question on fixing Medicare, Medicaid, and Social Security, Richardson responded that almost 33% of Medicare money is spent only on diabetes. He added that they need to put in bipartisan efforts to prevent diabetes and to find a cure for it.
Dodd although made his statement by mistake—while speaking about a video related to Alzheimer’s—he said that he will promote stem cell research to find a cure for diabetes.

Richardson, who made a stronger statement, has not included any plan about combating diabetes on his campaign website.

Source: Wired

Older Type 2 Diabetes Drugs Work Well

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While new diabetes drugs have been introduced on the market, recent studies have found that the older drugs, such as second generation sulfonylureas and metformin (sold under the brand names Glucophage, Diabex, Diaformin, Fortamet, Riomet, Glumetza, and others) work just fine in controlling blood glucose for most patients.

These older drugs are less expensive, and, according to researchers, a drug such as Metformin appears to have the best benefit, particularly when risk is accounted for.

Metformin was first approved by the FDA for diabetes treatment in 1994 and marketed in the United States for diabetes treatment in 1995 by Bristol Myers Squibb under the brand name Glucophage.

The study did not examine the effectiveness of the most recent class of anti-diabetes drugs called incretin mimetics, such as exenatide (Byetta) and sitagliptin (Januvia).

Clinical Study Seeks Relatives of Type 1 Diabetics

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Researchers have begun a clinical study of oral insulin to prevent or delay type 1 diabetes in at-risk people, the National Institutes of Health (NIH) announced today.

Type 1 Diabetes TrialNet, an NIH-funded network of researchers dedicated to the understanding, prevention, and early treatment of type 1 diabetes, is conducting the study in more than 100 medical centers across the United States, Canada, Europe, and Australia.

First- and second-degree relatives of people with type 1 diabetes who may be at risk are being screened through TrialNet’s natural history study, which is examining the immune and metabolic events that precede diabetes symptoms. Screening involves a simple blood test for the autoantibodies that signify diabetes risk.
Individuals enrolled in the natural history study are closely monitored for diabetes development and may be eligible to participate in the oral insulin trial or future studies that try to arrest the autoimmune process.

Gene Link Found for Type 1 Diabetes

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A research team, from the Children’s Hospital of Philadelphia and McGill University in Montreal has identified a single gene that may be a trigger for Type 1 diabetes.

The gene variant, called KIAA0350, greatly raises a child’s chances of developing the disease.
The study is published in the journal Nature.