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

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

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

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

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

The Appeals Court ruling affirmed the February 2006 decision upholding the ‘777 patent’s validity by the U.S. District Court for the Southern District of New York in a lawsuit brought by Takeda against the generic manufacturers Mylan Pharmaceuticals1 and Alphapharm Pty Ltd2.

Other U.S. patents covering certain methods of treatment using ACTOS® and certain compositions that include ACTOS® will expire in 2016.

“Takeda has always confidence in its patents,” said Mr. Seiji Hakoda, General Manager of Intellectual Property Dept. of Takeda. “Because innovation is critical to our company, we have a profound respect for the protection of intellectual property rights. We are very pleased with the ruling.”

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

Termination of Development of Fixed Dose Combination Product of Actos + TAK-536

Diabetes Drugs Increase Risk of Heart Failure, Research Shows

To buy ACTOS click HERE: My Family Drugstore

OSAKA, Japan, June 18, 2007 — Takeda Pharmaceutical Company Limited (“Takeda”) announced today that it has terminated the development of a fixed dose combination product of Actos®(pioglitazone HCl), a treatment for type 2 diabetes, and Takeda’s novel investigational drug TAK-536, an angiotensin receptor blocker. The phase 3 study of this combination product has been conducted in the U.S.

Takeda found out that an improvement in pharmaceutical formulation is needed for the fixed combination of Actos® and TAK-536, and has been reviewing its overall development projects in the franchises of cardiovascular and diabetes, while suspending that phase 3 study. As a result of this review, Takeda has reached a conclusion that it is optimal to prioritize projects other than Actos® + TAK-536 in order to provide novel treatment options as early as possible.

Takeda is continuously committed to enhance its cardiovascular and diabetes franchises by earliest possible launching of our investigational compounds such as SYR-322 for diabetes, TAK-475 for hypercholesterolemia, TAK-491 for hypertension and others, and by maximizing value of these investigational compounds as well as existing products such as Actos® and candesartan cilexitil (Blopress®, Amias®, Kenzen®, etc.).
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

Takeda Wins Patent Infringement Litigation on Appeal Against ANDA Filers for Generic Actos

Diabetes Drugs Increase Risk of Heart Failure, Research Shows

To buy ACTOS click HERE: My Family Drugstore

ACTOS directly targets insulin resistance, a condition where the body does not effectively use the insulin it produces, by improving the sensitivity to insulin mainly in the muscles, fat cells and the liver. Biguanides act primarily by reducing the amount of glucose produced by the liver, and are being used as the standard therapy for type 2 diabetes in Western countries and its use in Japan is now being expanded.

“In Japan, Actos is already approved for monotherapy, and concomitant therapies with sulfonylureas and alpha-glucosidase inhibitors respectively”, said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda.”Once this concomitant therapy of Actos with biguanides is approved, we can offer a variety of treatment option for patients with type 2 diabetes and also healthcare
providers who help them manage their blood glucose levels.”

Notes:
1. Currently available biguanides in Japan are metformin and buformin.
2. Approved indications of Actos in Japan:
Type 2 diabetes; Monotherapy in patients inadequately controlled by diet
and exercise,
Concomitant therapy with a sulfonylurea, in patients
inadequately controlled by diet and exercise plus the
single agent,
Concomitant therapy with an alpha-GI, in patients
inadequately controlled by diet and exercise plus the
single agent
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

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 buy ACTOS click HERE: My Family Drugstore