Type 2 diabetes patients who underwent bariatric surgery appear to require significantly less medication and incur considerably lower health costs, says a report published in this month’s issue of Archives of Surgery , a JAMA/Archives journal. Bariatric surgery is a surgical procedure on the stomach and/or intestines to help extremely obese people lose weight – it is an option for patients with a BMI ( body (more…)
Posts Tagged ‘Medications’
ACTOS (Pioglitazone)
Tuesday, January 1st, 2008Thiazolidinediones
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.
Most important information about Actos
More information about ACTOS (Pioglitazone):
Actos Benefits Recent Heart-Attack Patients with Diabetes
Actos found to improve glucose control and lipid profiles
Takeda Revises Actos (pioglitazone HCl) Prescribing Label
New Analyses Show Actos Reduced Risk of Secondary Stroke by Almost 50 Percent
ACTOS (Pioglitazone) Combination Therapy
Termination of Development of Fixed Dose Combination Product of Actos + TAK-536
Takeda Wins Patent Infringement Litigation on Appeal Against ANDA Filers for Generic Actos
Diabetes Drugs Increase Risk of Heart Failure, Research Shows
To get more information about Actos: ACTOS MEDICATION.
To buy ACTOS click HERE: My Family Drugstore
AVANDAMET (Rosiglitazone/Metformin)
Saturday, December 29th, 2007Thiazolidinediones
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.
Most important information about Avandamet
More information about AVANDAMET (Rosiglitazone/Metformin):
FDA Approves Avandamet as Initial Therapy for Type 2 Diabetes
Too Many Meds: Try Combinations
New Avandamet dosage strengths approved for treatment of type 2 diabetes
To get more information about Avandamet: AVANDAMET MEDICATION.
To buy AVANDAMET (Rosiglitazone/Metformin) click HERE: My Family Drugstore
AVANDIA (Rosiglitazone) Avandia Label to Get Heart-Attack Warning
Saturday, December 22nd, 2007WEDNESDAY, 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
Most important information about Avandia
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
GSK Revises US Labeling for Avandia
Data Affirms Avandia (Rosiglitazone maleate) Cardiovascular Safety Profile
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
ACTOS (Pioglitazone) Diabetes Drugs Increase Risk of Heart Failure, Research Shows
Saturday, December 22nd, 2007WINSTON-SALEM, N.C., July 27, 2007 – A class of drugs commonly used to treat type 2 diabetes may double the risk of heart failure, according to a new analysis by researchers at Wake Forest University School of Medicine and colleagues.
Based on a review of research studies and case reports involving more than 78,000 patients, the authors concluded that the risk of heart failure may be up to 100 percent higher (depending on the type of study) in patients taking thiazolinediones (which includes Avandia® and Actos®). These drugs are known to enhance insulin sensitivity. The authors estimated that one additional patient with type 2 diabetes would develop heart failure for every 50 patients taking the drugs over a 26-month period.
The results were published online in May 2007 by Diabetes Care and will appear in the August print issue.
“These drugs are currently used by more than 3 million diabetic patients in the U.S. alone, suggesting that several thousand could be harmed,” said Sonal Singh, M.D., lead author and an assistant professor in internal medicine at Wake Forest.
Earlier this year, one of the drugs in this class (Avandia®) was linked to an increased risk of heart attack and death from cardiovascular causes.
The current analysis looked at a potential link between the drugs and heart failure, which is the inability of the heart to meet the body’s demands. Heart failure is a very common condition in the elderly and one of the costliest to society. Common symptoms include shortness of breath and the inability to exercise including, in some cases, even to walk short distances.
The authors hypothesize that fluid retention caused by the drugs may trigger heart failure in susceptible people.
Heart failure occurred equally at high and low doses. In fact, heart failure even occurred in some patients who were taking doses below those commonly prescribed. The medium time for the onset of heart failure was 24 weeks after beginning drug therapy.
The adverse reaction was not limited to the elderly – one-quarter of cases occurred in people younger than 60. Heart failure occurred equally among men and women.
The product label for both drugs warns against their use in patients with more severe cases of heart failure. The label also cautions about the increased risk of heart failure if used in combination with insulin. However, the current analysis found that the risk wasn’t confined just to patients on insulin, and it occurred even among patients without any risk factors for heart failure. “Our findings support current efforts by the FDA to add a black box warning to the labeling for those agents,” said co-investigator Curt Furberg, M.D., Ph.D., from Wake Forest.
“The occurrence of heart failure several months after initiation of treatment suggests a long-term effect of the drugs, which may not be avoided by beginning with low doses,” said Singh.
The authors called for additional research to evaluate whether there are differences between drugs in the class and how to best manage patients who experience heart failure while on the drugs.
Product Description
Most important information about Actos
More information about ACTOS (Pioglitazone):
Actos Benefits Recent Heart-Attack Patients with Diabetes
Actos found to improve glucose control and lipid profiles
Takeda Revises Actos (pioglitazone HCl) Prescribing Label
New Analyses Show Actos Reduced Risk of Secondary Stroke by Almost 50 Percent
ACTOS (Pioglitazone) Combination Therapy
Termination of Development of Fixed Dose Combination Product of Actos + TAK-536
Takeda Wins Patent Infringement Litigation on Appeal Against ANDA Filers for Generic Actos
To buy ACTOS click HERE: My Family Drugstore