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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