I am diabetic

WEDNESDAY, Nov. 14 (HealthDay News) — The popular diabetes drug Avandia — which has been linked to the risk of heart failure and, more recently, heart attack — will carry a revised “black box” warning noting the heart attack risk, even though the research on heart attack is inconclusive, U.S. officials said Wednesday.

GlaxoSmithKline, the maker of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add the new warning to the existing black box warning on the drug’s label, according to U.S. Food and Drug Administration officials.

“We are announcing an update to the existing box warning on Avandia,” Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research, said during a midday teleconference. “A black box is the strongest form of warning, and we are adding another warning to that black box.”

Despite the revised warning label, the FDA said it isn’t seeking to have the drug withdrawn from the market, because the evidence for the increased heart-attack risk is not conclusive.

“We are keeping Avandia on the market, because we have concluded there isn’t enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments,” Woodcock said.

Woodcock said the FDA has asked GlaxoSmithKline to conduct a long-term study comparing Avandia with other type 2 diabetes drugs. The trial will most likely start in a year, and full results won’t be available until 2014.

Dr. Steven Nissen, chairman of the Cleveland Clinic’s department of cardiovascular medicine, first raised concerns about Avandia and heart-attack risk in a study published earlier this year. He said he welcomed “the addition of a black box warning for the risk of heart attack from Avandia,” but would have preferred a warning “written with greater clarity,” like the one used by Health Canada, the FDA’s counterpart in Canada.

The Canadian labels says Avandia is not to be used as the sole medication for type 2 diabetes except for patients who can not take another drug — metformin — that also lowers blood sugar. The label also states that Avandia is not to be used by any patient with heart failure.

“This is a much clearer statement than the FDA statement,” Nissen said.

Nissen said he was also bothered by the proposed trial that ends in 2014. “It really doesn’t solve the problem of what to do in the meantime,” he said. “I hope the appearance of a black box warning will be enough to keep people from being harmed.”

The new FDA-mandated labeling change follows recommendations made by the FDA’s Endocrine and Metabolic Advisory Committee and Drug Safety and Risk Management Advisory Committee. In July, the committees recommended keeping Avandia on the market, pending a review of additional data. The committees also said the drug’s label should carry a warning of the potential for increased risk of heart attacks.

Controversy over Avandia started in May, when a study by Nissen and colleague Kathy Wolski, published in the New England Journal of Medicine, found a 43 percent increased risk of heart attack among patients taking the drug. Nissen said he uncovered the risk after poring over data from 42 studies of Avandia.

Both the FDA and GlaxoSmithKline continue to say that the evidence for the risk of heart attack with Avandia is inconclusive.

“Avandia remains a safe and effective medicine for most patients with type 2 diabetes when used appropriately,” Dr. Ronald Krall, GlaxoSmithKline’s chief medical officer, said in a prepared statement. “Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine.”

The new warning states: “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 anti-diabetic 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 FDA is advising people with type 2 diabetes who have heart disease or are at risk of a heart attack to discuss their use of Avandia with their doctor to evaluate treatment options. The agency is also advising doctors to monitor patients who have cardiac risk and are taking the drug.

In August, Avandia’s warning label was changed, to state that the drug and others in its class may worsen heart failure — a condition in which the heart does not adequately pump blood — in some patients. The association between Avandia and increased risk for heart failure has been known since 1999, when the drug was first approved.

Woodcock noted that Avandia and the other oral anti-diabetes drugs, called thiazolidinediones, have not been shown to prevent cardiovascular risk as a byproduct of reducing blood sugar.

In light of this, the FDA is asking all manufacturers of approved oral anti-diabetes drugs to include a statement on their label saying that there is no data that the drugs have the ability to protect the heart.

HealthDay

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia

Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile

Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures

Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use

Older Diabetics Using Avandia Face Increased Death Risk

Diabetes Drug Avandia Could Weaken Bones

Avandia Label to Get Heart-Attack Warning

To buy AVANDIA click HERE: My Family Drugstore

SUNDAY, Dec. 2 (HealthDay News) — Avandia, a drug used by millions of diabetes patients, may contribute to bone loss, according to a new study conducted in mice.

Experts fear that, over the long term, Avandia (rosiglitazone) may speed osteoporosis, the thinning of the bones that can lead to dangerous and even fatal fractures.

The findings appear in the Dec. 2 online issue of Nature Medicine.

“Our study suggests that long-term rosiglitazone usage in the treatment of type II diabetes may cause osteoporosis due to both increased bone resorption and decreased bone formation,” said study senior author Ron Evans, a professor at the Salk Institute for Biological Studies in La Jolla, Calif. “Because Avandia is effective in controlling glucose and restoring the body’s sensitivity to insulin, we do not recommend that people stop their treatment. You must balance the benefits against the complications.”

“Anyone who is already at risk for osteoporotic fractures should consider an alternative anti-diabetic drug,” added Paul Brandt, an associate professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine, in College Station. “There are many alternatives, ” he said.

“It may [also] be possible to blunt some of Avandia’s effects with anti-osteoporosis drugs such as bisphosphonates, raloxifene, vitamin D and calcium,” Brandt added.

Earlier this year, Avandia and four other diabetes drugs from the same class were given a “black box” warning by the U.S. Food and Drug Administration. That warning advises users of an increased risk of heart failure while on the drug.

The black box message is the FDA’s strongest label warning.

With an estimated 3.5 million or more U.S. patients taking Avandia, the public health impact from the point of view of both heart failure and bone degradation could be substantial, experts say.

Avandia affects a key cellular protein called the peroxisome proliferator-activated receptor (PPAR-gamma). In their study, the California team discovered that, in mice, activating this receptor also stimulates the production of osteoclasts, cells whose key function is to degrade bone.

Proper bone health is maintained by a balance between osteoclasts and osteoblasts, the cells that build bone up.

If either side is out of whack, so to speak, bones become thinner, more fragile and prone to fracture.

The current results are particularly disturbing in light of prior studies, the experts said.

“It was previously known that Avandia mediates bone loss by inhibiting bone formation,” Evans explained. “Our work identified an additional mechanism, in which Avandia promotes bone resorption. These are the two parts of the checks-and-balance system that maintains bone in good shape. The drug weakens both sides of the balance mechanism, leading to an increased risk for osteoporosis.”

“Previous research showed that Avandia reduced osteoblasts,” Brandt added. “Combine the two, and you’re going to get thinning of the bone.”

HealthDay

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia

Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile

Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures

Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use

Older Diabetics Using Avandia Face Increased Death Risk

Diabetes Drug Avandia Could Weaken Bones

Avandia Label to Get Heart-Attack Warning

To buy AVANDIA click HERE: My Family Drugstore

Thiazolidinediones

Rosiglitazone (Avandia) and pioglitazone (ACTOS) are in a group of drugs called thiazolidinediones. These drugs help insulin work better in the muscle and fat and also reduce glucose production in the liver. The first drug in this group, troglitazone (Rezulin), was removed from the market because it caused serious liver problems in a small number of people. So far rosiglitazone and pioglitazone have not shown the same problems, but users are still monitored closely for liver problems as a precaution. Both drugs appear to increase the risk for heart failure in some individuals, and there is debate about whether rosiglitazone may contribute to an increased risk for heart attacks. Both drugs are effective at reducing A1C and generally have few side effects.

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia

Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile

Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures

Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use

Older Diabetics Using Avandia Face Increased Death Risk

FDA MedWatch Alerts: Avandia (rosiglitazone maleate)

Diabetes drugs dangers revealed

Misreading Avandia

To get more information about Avandia: AVANDIA MEDICATION.

To buy AVANDIA click HERE: My Family Drugstore

TUESDAY, Dec. 11 (HealthDay News) — Older patients using the diabetes drug Avandia faced an increased risk of heart attack, heart failure and even death, new research shows.According to the Canadian authors of the study, which is published in the Dec. 12 issue of the Journal of the American Medical Association, this is the first population-based look at the class of drugs to which Avandia belongs and the first report to find an increase in mortality rates.

“Our study looked at an older population in the real world who tend to be underrepresented in research trials and are at higher risk,” said study author Dr. Lorraine L. Lipscombe, a researcher with the Institute for Clinical Evaluative Sciences in Toronto. “While the overall risk versus benefit is difficult to interpret in all people, in older people, the risks may outweigh the benefit.”

“This is very striking data,” added Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation. “This and other studies are going to put tremendous pressure on the FDA [U.S. Food and Drug Administration] to act more forcefully with regard to Avandia.”

But the maker of Avandia (rosiglitazone), GlaxoSmithKline, took issue with the findings.

In a prepared statement, the company said the Canadian study “has significant limitations and generates misleading conclusions regarding acute myocardial infarction and death. These conclusions are inconsistent with a more robust body of evidence from large, long-term, prospective, well-designed clinical studies, including ADOPT and RECORD. These long-term trials in diabetic patients comparing rosiglitazone to other oral anti-diabetic medicines show no increased risk for cardiovascular events compared to other commonly used medications, other than the well-known risk of congestive heart failure with thiazolidinedione (TZDs).”

Nissen was the first scientist to publish concerns about Avandia and increased heart risks in a study last May.

After that and other research was released, the FDA added a “black box” warning to all drugs in the class. An FDA advisory panel voted against removing the drug from the market, citing inconclusive evidence.

The Canadian label for Avandia carries a stronger message: The drug is not to be used as the sole medication for type 2 diabetes unless the patient cannot take another drug to lower blood sugar and that the drug should not be used by any patient with heart failure.

People with type 2 diabetes are already at heightened risk for cardiovascular disease.

Thiazolidinediones including Avandia and Actos (pioglitazone) heighten the body’s sensitivity to insulin. Some 3.5 million U.S. patients take Avandia, which has also been linked to bone loss in some patients.

The current study involved an older (66 and over), “real-world” population consisting of more than 159,000 residents of Ontario in this age group who were treated with at least one oral diabetic medication. The patients were followed for about four years.

Compared to individuals taking more than one oral hypoglycemic agent, people using Avandia on its own had a 60 percent increased risk of congestive heart failure, a 40 percent increased risk of heart attack, and a 29 percent increased risk of dying.

The increased risks were associated with Avandia only, but fewer people in the study took Actos, so the results could be skewed, the researchers noted.

“It looks like the results were limited to Avandia, but 50 percent fewer people were on Actos, so you can’t rule out an increased or decreased risk with Actos,” Lipscombe said. “We need more studies.”

“It’s an observational study and, like all observational studies, this has strengths and weaknesses. These studies do not provide the strength of evidence of a prospective, randomized trial,” Nissen pointed out. “But as observational studies go, this one is very helpful, because it is quite large, and it is independent, not sponsored by any company. Remarkably, with Avandia, the increased risk of heart attack is very similar to what we reported in our meta-analysis last May.”

In related research appearing in the same issue of JAMA, a review of 25 studies found that current smokers have a 44 percent increased risk of developing type 2 diabetes compared with nonsmokers.

The degree of risk was linked to the level of smoking — there was a 61 percent increased risk for those smoking 20 or more cigarettes a day and a 29 percent increased risk for those who smoked less, said the Swiss researchers. Former smokers had a 23 percent increased risk.

HealthDay

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

Avandia Reduces Risk of Progresson from Pre-Diabetes to Type 2 Diabetes by 62 percent

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia

Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile

Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures

Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use

Diabetes Drug Avandia Could Weaken Bones

Avandia Label to Get Heart-Attack Warning

To buy AVANDIA click HERE: My Family Drugstore

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.”1In 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 England Journal 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 Sinai Hospital and 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 BMI to progress to diabetes. However, the risk of developing diabetes did not increase with BMI in the group randomised to rosiglitazone. These findings suggest that rosiglitazone may reduce the increased risk of developing diabetes that is attributable to obesity.1
“GSK is 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 McMaster University showed 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, 2×2 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 McMaster University and Hamilton Health Sciences in Hamilton, Ontario. DREAM was funded by a peer-reviewed grant from the Canadian Institutes of Health Research (CIHR) via the CIHR/Rx&D Collaborative Research Program as well 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.

Product Description

Most important information about Avandia

Pharmacokinetics

Possible Side Effects

More information about AVANDIA (Rosiglitazone):

AVANDIA (Rosiglitazone): What You Should Know

Can Avandia or other drugs prevent diabetes?

Actos beats Avandia in sugar, fat control: study

Avandia approved for combination with insulin in type 2 diabetes treatment

EMEA Statement on Recent Publication on Cardiac Safety of Rosiglitazone (Avandia, Avandamet, Avaglim)

GSK Revises US Labeling for Avandia

Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile

Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures

Texas Family Sues GlaxoSmithKline (GSK) Over Man’s Heart Attack Death Following Avandia Use

To buy AVANDIA click HERE: My Family Drugstore