Actos | I am diabetic

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FROM THE BEGINING…

Saturday, October 4th, 2008

Do you have diabetes? Are you struggling to live with diabetes? Are you looking for information online about diabetes? Are you unsure as to what types of foods you should now be eating to help keep a check on your glucose levels? If you have answered yes to any of these questions this article may well be of interest and benefit to you.

Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life. The cause of diabetes continues to be a mystery, although both genetics and environmental factors such as obesity and lack of exercise appear to play roles.

There are 20.8 million children and adults in the United States, or 7% of the population, who have diabetes. While an estimated 14.6 million have been diagnosed with diabetes, unfortunately, 6.2 million people (or nearly one-third) are unaware that they have the disease.

In order to determine whether or not a patient has pre-diabetes or diabetes, health care providers conduct a Fasting Plasma Glucose Test (FPG) or an Oral Glucose Tolerance Test (OGTT). Either test can be used to diagnose pre-diabetes or diabetes.

With the FPG test, a fasting blood glucose level between 100 and 125 mg/dl signals pre-diabetes. A person with a fasting blood glucose level of 126 mg/dl or higher has diabetes.

In the OGTT test, a person’s blood glucose level is measured after a fast and two hours after drinking a glucose-rich beverage. If the two-hour blood glucose level is between 140 and 199 mg/dl, the person tested has pre-diabetes. If the two-hour blood glucose level is at 200 mg/dl or higher, the person tested has diabetes.

Major Types of Diabetes

Type 1 diabetes
Results from the body’s failure to produce insulin, the hormone that “unlocks” the cells of the body, allowing glucose to enter and fuel them. It is estimated that 5-10% of Americans who are diagnosed with diabetes have type 1 diabetes.

Type 2 diabetes
Results from insulin resistance (a condition in which the body fails to properly use insulin), combined with relative insulin deficiency. Most Americans who are diagnosed with diabetes have type 2 diabetes.

Medications for Type 2 Diabetes

Sulfonylureas:
- GLUCOTROL XL (Glipizide)
- AMARYL (Glimepiride)

Meglitinides:
- PRANDIN (Repaglinide)
- STARLIX (Nateglinide)

Biguanides:
- GLUCOPHAGE (Metformin)

Thiazolidinediones:
- ACTOS (Pioglitazone)
- ACTOPLUS MET (Pioglitazone/Metformin)
- AVANDIA (Rosiglitazone)
- AVANDAMET (Rosiglitazone/Metformin)

Other medications:
- KARELA and DIABECON

Gestational diabetes
Gestational diabetes affects about 4% of all pregnant women – about 135,000 cases in the United States each year.

Pre-diabetes
Pre-diabetes is a condition that occurs when a person’s blood glucose levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. There are 54 million Americans who have pre-diabetes, in addition to the 20.8 million with diabetes.

Additional Information

Recently Diagnosed
You or someone you love has just been diagnosed with diabetes — chances are you have a million questions running through your head. This area of our Web site can help ease your fears and teach you more about living with diabetes or caring for someone with diabetes, and connect you with others affected by diabetes who will listen and share their own experiences.

Diabetes Symptoms
Often diabetes goes undiagnosed because many of its symptoms seem so harmless. Learn what they are in this section.

Diabetes Risk Test
More than 20 million Americans have diabetes — nearly one in three does not know it! Take our diabetes risk test to see if you are at risk for having diabetes. Diabetes is more common in African Americans, Latinos, Native Americans, Asian Americans and Pacific Islanders.

Diabetes Myths
Find the truth about some of the most common myths about diabetes.

The Genetics of Diabetes
You’ve probably wondered how you got diabetes. You may worry that your children will get it too. Unlike some traits, diabetes does not seem to be inherited in a simple pattern. Yet clearly, some people are born more likely to get diabetes than others.

Tags: Begining
Posted in Actoplus Met, Actos, Amaryl, Avandamet, Avandia, Diabetes Myths, Diabetes Symptoms, Genetics, Gestational diabetes, Glucophage, Glucotrol XL, Medications, Prandin, Pre-diabetes, Recently Diagnosed, Starlix, Type 1 Diabetes, Type 2 Diabetes | 1 Comment »

Diabetes Drug Slows Clogging of Arteries

Wednesday, April 2nd, 2008

By Amanda Gardner
HealthDay Reporter Tuesday, Apr. 1, 2008; 4:00 AM
Copyright © 2008 ScoutNews, LLC. All rights reserved.

MONDAY, March 31 (HealthDay News) — The diabetes drug Actos is better than another diabetes drug, Amaryl, at slowing clogging of the arteries in patients with both type 2 diabetes and cardiovascular disease.

The Cleveland Clinic researchers behind the new findings say this is the first time that a diabetes medication has been shown to slow atherosclerosis, giving doctors new insight into which drugs may be most effective and safest for this group of patients.

“As we go forward, the study tells us that we must do comparative effectiveness trials looking at different diabetes strategies,” study author Steve Nissen, chairman of the department of cardiovascular medicine at Cleveland Clinic, said Monday. “We can’t just focus on pricking your finger, getting blood sugar down. The goal in diabetes therapy is to prevent complications, and the most feared complication is heart disease, which will kill 75 percent of all diabetics. I’m thrilled with results.”

Another expert hailed the results.

“The biggest news here is that pioglitazone [Actos] appears safe, does not increase cardiovascular risk, and may even reduce it,” said Dr. Robert Scott III, an assistant professor of internal medicine at the Texas A&M Health Science Center College of Medicine and senior staff cardiologist with Scott&White in Temple, Texas. “It looks safe to use in people with coronary artery disease, and it is well-tolerated. We may need another trial to see how it helps, but at least it doesn’t hurt, and that was our biggest concern.”

The findings are published in the April 2 issue of the Journal of the American Medical Association and were released Monday to coincide with a presentation at the American College of Cardiology annual meeting, in Chicago. The research was funded by Takeda Pharmaceuticals North America Inc., which makes Actos.

Individuals with type 2 diabetes are particularly susceptible to atherosclerosis, as evidenced by the fact that 75 percent of this group eventually die of cardiovascular disease.

Amaryl (glimepiride) belongs to a class of drugs known as sulfulonylureas, which have been prescribed for decades. Actos, along with its cousin Avandia, is a thiazolidinedione, a relatively new class of diabetes drugs.

Both Actos and Avandia appear to increase the risk of heart failure (the entire class now carries a black-box warning to that effect), but Avandia has been associated with an increased risk of heart attack, while Actos has been linked with a reduced risk of negative cardiovascular outcomes.

“Both are associated with heart failure, but there were increased deaths [with Avandia],” said Dr. Stanley Mirsky, an endocrinologist with Lenox Hill Hospital in New York City and co-author of the Diabetes Survival Guide.

For this study, 543 patients with both coronary disease and type 2 diabetes were randomized to receive either Amaryl or Actos for 18 months. Actos works by making the body more sensitive to insulin, while Amaryl works by spurring the body to produce more insulin. All participants were also taking medications for heart disease.

Progression of atherosclerosis was measured by intravascular ultrasonography in the 360 patients who actually completed the study.

One measure found a 0.73 increase in plaque in the Amaryl group versus a 0.16 decrease in the Actos group. A second measure found a 0.64 increase for Amaryl and a 0.06 decrease for Actos.

The study was not designed to measure actual clinical endpoints, meaning cardiovascular events or death.

The authors stated that the exact mechanisms for the decreases associated with Actos were unclear, although several biomarkers linked to atherosclerosis progression were impacted by the drug, including a 16 percent increase in HDL or “good” cholesterol, a 15 percent reduction in triglyceride levels, and a 45 percent drop in C-reactive protein (CRP) levels.

It’s also not clear if the benefits associated with Actos extend to other medications in that class of drugs.

An accompanying editorial found the results “reassuring.”

“You’ve got to take into consideration the benefit of preventing heart attacks may be greater than the few people who get heart failure,” Mirsky said.

If you want to buy Actos click here: http://www.myfamilydrugstore.com/item/anti_diabetic/actos.html

To buy Avandia: http://www.myfamilydrugstore.com/item/anti_diabetic/avandia.html

Amaryl: http://www.myfamilydrugstore.com/item/anti_diabetic/amaryl.html

Posted in Actos, Amaryl, Avandia, Cardiovascular disease, Medications, Type 1 Diabetes, Type 2 Diabetes | No Comments »

FDA to review diabetes drugs

Tuesday, March 4th, 2008

BOSTON (MarketWatch) — Food and Drug Administration advisory panels will be reviewing the applications of two potential blockbuster diabetes drugs later this week, Bristol-Myers Squibb’s Pargluva and Pfizer’s Exubera.

First up will be Pfizer’s Exubera, the first inhaled form of insulin to be considered by the government agency. Pfizer hopes that if approved, inhaled insulin will woo over thousands of diabetics who loathe injecting insulin or who should be taking insulin but fear needles.

While the drug appears to be just as effective in controlling blood sugar levels as injected insulin, the FDA panel will be scrutinizing the drug’s data that to see if long-term use can diminish lung capacity in any way.

Still, many Pfizer watchers believe the FDA will give Pfizer the go- ahead, given the spike in diabetes cases due to obesity and an aging population.

Although decisions made by advisory panels aren’t binding, the FDA almost always follows their recommendations.

Pfizer developed the drug with Nektar Therapeutics , a specialist in drug-delivery systems, and Sanofi-Aventis, one of the world’s largest suppliers of insulin. The insulin is delivered through a device that resembles a large asthma inhaler.

If approved, Exubera could have peak worldwide sales of up to $1.5 billion by 2010, according to Caris & Co. analyst Le Anne Zhao.

“I think Exubera’s chances are 70% to 80% of being approved,” said Zhao.

If it’s approved, Exubera could face strong competition down the road. Eli Lilly & Co. is currently in late-stage testing with drug-delivery developer Alkermes for their version of inhaled insulin. Novo Nordisk and delivery partner Aradigm are also in the game, along with niche drug developer Mannkind.

On Friday, the same FDA panel will review Bristol-Myers’ Pargluva, also known as muraglitazar, which is used to help control blood sugar and triglyceride levels in type 2 diabetics.

If approved, Bristol-Myers would be splitting any profits with partner Merck & Co., and Pargluva would also be in competition with two other drugs in its chemical class, Eli Lilly’s Actos and GlaxoSmithKline’s Avandia.

Zhao said that she estimates Pargluva could have peak worldwide sales of $3 billion by 2010.

However, analysts say that while Pargluva appears to be slightly more effective in treating diabetes than Actos and Avandia, the drug also has a higher incidence of causing cardiovascular problems such as edema.

Because of this, analysts add, the FDA, which is still stinging from accusations that it has dropped the ball on drug safety, may be wary of approving Pargluva.

“I give it a 50-50 chance,” said Zhao. “If the FDA does give the green light, it will require extensive Phase IV [postmarket] studies, and the drug will probably have a bold-faced warning on its label.”

Lehman Brothers’ Anthony Butler said he thinks the FDA will probably approve Pargluva, although he put the odds at “a little better than 50%.”

Butler added that while Pargluva performed “marginally better” than Actos or Avandia, “it also has marginally worse side effects at higher doses.”

Pargluva’s side effects are an issue, said Butler, in that many general practitioners tend to prescribe oral diabetic medications in very high amounts to patients who still don’t have their blood sugar levels under control.

But Butler added that if Pargluva is turned down on Friday, it would probably be with the caveat that the companies conduct additional safety and dosing studies.

“There’s clearly a need for improved glucose-control drugs,” said Butler. “I think they’ll get an approval because there’s a marginal benefit.”

Val Brickates Kennedy is a reporter for MarketWatch in Boston.

Posted in Actos, Avandia, Medications, Type 2 Diabetes | No Comments »

Diabetes drugs dangers revealed

Sunday, February 24th, 2008

Two popular drugs used to treat late-onset diabetes may double the risk of heart failure, according to a new study.

Researchers who analysed data on 78,000 patients who took Avandia or Actos to treat type II diabetes found that it increased the risk of heart failure by up to 100 percent, said the study released on Thursday.

The researchers estimate that for every 50 patients taking the medications over a period of 26 months, one person will develop heart failure.

The manufacturers cautioned from the beginning that the drugs were not suitable for patients at risk for – or with a history of – heart failure, and that patients who combined the drugs with insulin treatments were at increased risk for this complication.

But this analysis found that this adverse effect occurred in patients with no risk for heart failure, even in the absence of insulin. The study also showed that it occurred in young people and at high and low doses.

On average, patients who developed this complication did so 24 weeks after starting on the drug, the investigators report in the journal Diabetes Care.

“Our analysis quantifies the risk for the first time and it shows that nobody is immune,” said Sonal Singh, lead author of the study and an assistant professor in internal medicine at Wake Forest University Baptist Medical Center in Winston Salem, North Carolina.

Singh said the findings raise the question of whether doctors should revert to using older drugs such as Glucophage and or insulin injections.

The researchers did not evaluate whether the adverse effects were fatal, nor did they study what went wrong. They suggest that the drugs cause some people to retain fluid which can trigger heart failure, symptoms of which include shortness of breath and an inability to exercise.

GlaxoSmithKline, which has been marketing Avandia in the United States since 1999 and in Europe since 2000, downplayed the findings. Actos is made by Takeda Pharmaceutical.

“The risk of heart failure in diabetes patients and with use of these medicines is well recognized and is clearly identified in prescribing information to doctors,” the company said in a statement.

“GSK is confident in the overall safety profile of rosiglitazone when used appropriately.”

Rosiglitazone is the trade name for Avandia.

GSH’s blockbuster drug has also been linked with other problems. In May, a study in a US medical journal said people taking the drug had a 43 percent higher risk of heart attack.

The US Food and Drug Administration will consult with medical experts on Monday to see whether the data merits adding so-called “black box warnings” to the drug packaging that would alert consumers to the potential risk.

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)

To buy AVANDIA click HERE: My Family Drugstore

Tags: Actos, Avandia, Type 2 Diabetes
Posted in Actos, Avandia, Medications, Type 2 Diabetes | No Comments »

ACTOS (Pioglitazone)

Tuesday, January 1st, 2008

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 Actos

Pharmacokinetics

Side Effects

More information about ACTOS (Pioglitazone):

FDA Alert

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

Submission of an Application for an additional Indication of Actos in Japan; Concomitant Therapy with Biguanides for Type 2 Diabetes