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BARCELONA, Spain, September 3, 2006 — Results of new analyses found that Actos (pioglitazone HCl), an oral antidiabetic medication, significantly reduced the risk of recurrent stroke in high-risk patients with type 2 diabetes. The findings were presented today in a late-breaker session at the World Congress of Cardiology in Barcelona.

“These results are very encouraging news for people with type 2 diabetes because they demonstrated that Actos reduced the incidence of strokes in patients who had already experienced a stroke from 10.2 percent down to 5.6 percent, translating to a risk reduction of almost 50 percent,” said Robert Wilcox, M.D., professor in the Department of Cardiovascular Medicine at Queen’s Medical Centre, University Hospital, Nottingham, United Kingdom.

These new analyses from the landmark PROactive Study examined the effects of Actos on the risk of stroke and other cardiovascular (CV) outcomes in high-risk patients with type 2 diabetes with and without prior stroke. Pre-specified study endpoints included all-stroke and CV disease death, myocardial infarction (MI, excluding silent MI) or stroke.

According to the results, there were statistically significant benefits of Actos in patients who had suffered a prior stroke. The incidence of recurrent stroke was reduced by 47 percent (P=0.008) and the combined risk of death, MI or stroke was reduced by 28 percent (P<0.05). There was no effect of Actos on subsequent strokes in patients who had never experienced a stroke.

Patients with diabetes are at an increased risk of stroke. In fact, the risk is two to four times higher for people with diabetes than the general population. Results from the PROactive Study demonstrated that an oral glucose-lowering medication could substantially impact the risk of some CV events, including the combined risk of death, MI and stroke in high-risk patients with type 2 diabetes.

About the PROactive Study

PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) was a landmark study that prospectively looked at the impact in total mortality and macrovascular morbidity using Actos, a glucoselowering agent. It was a randomized, double -blind, placebo-controlled outcome study of 5,238 patients with type 2 diabetes and macrovascular disease. Patients were randomized to receive either Actos or placebo in addition to standard-of-care treatment (including the routine use of anti-hypertensives such as ACE inhibitors and beta blockers; glucose-lowering agents such as metformin, sulfonylureas and insulin; antiplatelet drugs such as aspirin, and lipid-modifying medicines such as statins and fibrates).

This study focused on two key endpoints: a primary combination endpoint of seven different macrovascular events including both disease and procedural endpoints; and a principal secondary combination endpoint of death, heart attack and stroke.

As reported at the European Association for the Study of Diabetes (EASD) Annual Meeting in September 2005, the primary endpoint was reduced by 10 percent but had not reached statistical significance by study end (P=0.095). The principal secondary endpoint showed that Actos significantly reduced the combined risk of heart attacks, strokes and death by 16 percent (P=0.027) in high-risk patients with type 2 diabetes.

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

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 buy ACTOS click HERE: My Family Drugstore

Three 16-week, randomized, double-blind, placebo-controlled clinical studies and three 24-week randomized, double-blind, dose-controlled clinical studies were conducted to evaluate the effects of Actos on glycemic control in patients with type 2 diabetes who were inadequately controlled (HbA1c? 8%) despite current therapy with a sulfonylurea, metformin, or insulin. Previous diabetes treatment may have been monotherapy or combination therapy.

Actos Plus Sulfonylurea Studies

Two clinical studies were conducted with Actos in combination with a sulfonylurea. Both studies included patients with type 2 diabetes on a sulfonylurea, either alone or in combination with another antidiabetic agent. All other antidiabetic agents were withdrawn prior to starting study treatment. In the first study, 560 patients were randomized to receive 15 mg or 30 mg of Actos or placebo once daily for 16 weeks in addition to their current sulfonylurea regimen. When compared to placebo at Week 16, the addition of Actos to the sulfonylurea significantly reduced the mean HbA1c by 0.9% and 1.3% and mean FPG by 39 mg/dL and 58 mg/dL for the 15 mg and 30 mg doses, respectively.
In the second study, 702 patients were randomized to receive 30 mg or 45 mg of Actos once daily for 24 weeks in addition to their current sulfonylurea regimen. The mean reductions from baseline at Week 24 in HbA1c were 1.55% and 1.67% for the 30 mg and 45 mg doses, respectively. Mean reductions from baseline in FPG were 51.5 mg/dL and 56.1 mg/dL.
The therapeutic effect of Actos in combination with sulfonylurea was observed in patients regardless of whether the patients were receiving low, medium, or high doses of sulfonylurea.

Actos Plus Metformin Studies

Two clinical studies were conducted with Actos in combination with metformin. Both studies included patients with type 2 diabetes on metformin, either alone or in combination with another antidiabetic agent. All other antidiabetic agents were withdrawn prior to starting study treatment. In the first study, 328 patients were randomized to receive either 30 mg of Actos or placebo once daily for 16 weeks in addition to their current metformin regimen. When compared to placebo at Week 16, the addition of Actos to metformin significantly reduced the mean HbA1c by 0.8% and decreased the mean FPG by 38 mg/dL.
In the second study, 827 patients were randomized to receive either 30 mg or 45 mg of Actos once daily for 24 weeks in addition to their current metformin regimen. The mean reductions from baseline at Week 24 in HbA1c were 0.80% and 1.01% for the 30 mg and 45 mg doses, respectively. Mean reductions from baseline in FPG were 38.2 mg/dL and 50.7 mg/dL.
The therapeutic effect of Actos in combination with metformin was observed in patients regardless of whether the patients were receiving lower or higher doses of metformin.

Actos Plus Insulin Studies

Two clinical studies were conducted with Actos in combination with insulin. Both studies included patients with type 2 diabetes on insulin, either alone or in combination with another antidiabetic agent. All other antidiabetic agents were withdrawn prior to starting study treatment. In the first study, 566 patients receiving a median of 60.5 units per day of insulin were randomized to receive either 15 mg or 30 mg of Actos or placebo once daily for 16 weeks in addition to their insulin regimen. When compared to placebo at Week 16, the addition of Actos to insulin significantly reduced both HbA1c by 0.7% and 1.0% and FPG by 35 mg/dL and 49 mg/dL for the 15 mg and 30 mg dose, respectively.
In the second study, 690 patients receiving a median of 60.0 units per day of insulin received either 30 mg or 45 mg of Actos once daily for 24 weeks in addition to their current insulin regimen. The mean reductions from baseline at Week 24 in HbA1c were 1.17% and 1.46% for the 30 mg and 45 mg doses, respectively. Mean reductions from baseline in FPG were 31.9 mg/dL and 45.8 mg/dL. Improved glycemic control was accompanied by mean decreases from baseline in insulin dose requirements of 6.0% and 9.4% per day for the 30 mg and 45 mg dose, respectively.
The therapeutic effect of Actos in combination with insulin was observed in patients regardless of whether the patients were receiving lower or higher doses of insulin.

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

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 buy ACTOS click HERE: My Family Drugstore

DEERFIELD, Ill., June 06, 2007 /PRNewswire/ — Takeda Pharmaceuticals North America, Inc. (TPNA) today announced that the company will revise warnings related to congestive heart failure (CHF) in the prescribing label of its type 2 diabetes medication Actos (pioglitazone HCl). Takeda is working in conjunction with a request from the U.S. Food and Drug Administration (FDA) that a Boxed Warning be added to the label. The new Boxed Warning will heighten awareness of the risk of CHF.

“By giving the CHF guidance more prominence in the Actos label, we hope to ensure that this information is being attended to by treating physicians to optimize patient care,” said Robert Spanheimer, M.D., senior medical director, Diabetes and Metabolism, Takeda Pharmaceuticals North America. “Takeda remains confident in the safety and efficacy of Actos when used according to its label, and with this revision, we can heighten patient and physician awareness of an already known, but serious side effect.”

The Actos label has always contained information that the thiazolidinedione (TZD) class can cause fluid retention, which may lead to or exacerbate CHF, and Takeda has consistently emphasized the importance of physician education and patient monitoring involved in the use of Actos. Through its global system of surveillance, adverse event reports involving patients taking Actos are reviewed and reported to the FDA on an ongoing basis.

Actos Cardiovascular Safety Data

The Actos label was most recently updated in February 2007 to incorporate important cardiovascular safety data from the PROactive Study (PROspective PioglitAzone Clinical Trial In MacroVascular Events), a large outcomes trial. The updated Actos label confirmed that Actos was not associated with an increase in mortality or in total macrovascular events, including heart attacks and stroke. PROactive demonstrated that Actos, in addition to standard of care, has a proven safety profile in patients with type 2 diabetes who are at high risk for cardiovascular events.

PROactive was a prospective, randomized, double-blind, placebo-controlled outcomes study that investigated the effects of Actos on total mortality and macrovascular morbidity in 5,238 high-risk patients with type 2 diabetes. Patients were randomized to Actos or placebo in addition to diabetes and cardiovascular standard of care, and followed for up to 3.5 years. This landmark study is the first and only macrovascular outcomes trial with any thiazolidinedione (TZD).

While the incidence of serious heart failure (CHF) was higher for Actos- treated vs. placebo-treated patients (5.7% vs. 4.1%), there was no increase in the incidence of death subsequent to a report of serious heart failure (1.5% vs. 1.4%, respectively).

The Difference Between Heart Attack Events and CHF

“While physicians recognize the difference between heart failure and heart attacks, there remains significant confusion among patients,” says Dr. Spanheimer.

According to the American Heart Association, CHF is a known complication for people with type 2 diabetes in which inadequate pumping from the heart causes accumulation of fluid throughout the body including the lungs. The heart continues to work, but inefficiently.

Heart attacks, also known as myocardial infarctions, cause permanent damage to the heart muscle. This damage usually occurs when the supply of blood is blocked by plaque buildup due to atherosclerosis.

Cardiovascular disease is a major complication associated with type 2 diabetes. As a result, Takeda has always evaluated the safety and efficacy of Actos with a particular emphasis on cardiovascular health, and has conducted a robust clinical trial program in the area. Takeda continues to work with the FDA to educate patients and physicians on the latest data on the cardiovascular effects of Actos.

“We are confident in the scientific validity and important safety information from PROactive and that there was no increase in mortality or total macrovascular events with Actos,” added Dr. Spanheimer. “This PROactive cardiovascular safety information about heart attacks, in addition to the boxed CHF warning, are important data that will help physicians make the treatment decisions that are best for their patients.”

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

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 buy ACTOS click HERE: My Family Drugstore

LINCOLNSHIRE, ILL. — People with type 2 diabetes who are unable to adequately manage their blood glucose levels with insulin alone exhibited improved results when Actos (pioglitazone HCl) was added to their treatment regimen, according to a study published in the May issue of the International Journal of Clinical Practice.

Results from the clinical study show that Actos, used in combination with a stable insulin regimen, decreases fasting plasma glucose levels and improves blood glucose control as measured by glycosylated hemoglobin A1C (HbA1c), an estimate of blood glucose levels for a patient during the preceding 90 – 120 days.

Actos is an insulin resistance reducer, and the only thiazolidinedione (TZD) approved for use in combination with insulin. People with insulin resistance are unable to effectively use the insulin their bodies produce, which is a core metabolic defect of type 2 diabetes.

“The main goal in managing diabetes is maintaining appropriate blood glucose levels, and for some patients with type 2 diabetes, conventional insulin alone may not be sufficient,” said Julio Rosenstock, M.D., at the Dallas Diabetes and Endocrine Center in Texas, and the study’s lead investigator.

“We’re very encouraged by these study results because they present a viable option for patients who have hit a roadblock with their current conventional insulin treatment. The study required the insulin doses to remain unchanged to allow proper analysis of the specific effects of Actos. Further improvements in glycemic control could potentially be achieved if more dynamic and physiologic insulin regimens are used in clinical practice.”

The study also showed that Actos improved patients’ lipid profiles by increasing mean HDL (“good”) cholesterol and decreasing mean triglyceride levels. “The lipid improvements seen in this study are an important benefit, since diabetes tends to lower ‘good’ cholesterol and raise triglyceride levels, a common condition called diabetic dyslipidemia,” said Wendell Cheatham, M.D., vice president, medical and scientific affairs, Takeda Pharmaceuticals North America, Inc.

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

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 buy ACTOS click HERE: My Family Drugstore

November 26, 2005

Actos (pioglitazone) has been shown to reduce the risk of another heart attack among diabetic patients recovering from a heart attack. In a recent study, Actos added to standard therapy for glucose and lipid control proved superior in preventing repeat heart attacks.

Analysis of a data subset from 2,445 patients enrolled in the PROspective pioglitAzone Clinical Trial In macroVascular Events (PROACTIVE) trial revealed that taking Actos was associated with a 28% lower risk of recurrent myocardial infarction (MI; P=0.045), according to Erland Erdmann, MD, of the University of Köln in Germany.

Actos is in a class of drugs called thiazolidinediones. Thiazolidinediones raise the body’s sensitivity to insulin, by binding to and activating a receptor (the peroxisome proliferator-activated receptor-gamma).

Subset Analysis is Key

The subset analysis of data, presented at the American Heart Association (AHA) meeting in Dallas in November, provided a new perspective on Actos’s benefits for recent MI patients that had not been evident from the main PROACTIVE study results. In these results, revealed at the European Association for the Study of Diabetes last September, researchers mainly noted that the trial did not meet its primary endpoint.

All participants in the subset analysis had had an MI within 6 months before randomization. Participants received treatment according to European Association for the Study of Diabetes guidelines. A total of 55% of participants received statin therapy at baseline and 63% were receiving statins at the study’s end, Dr Erdmann said.

Actos was associated with a 37% relative decrease in the risk of acute coronary syndrome (P=0.035) and a 19% relative decrease in the composite endpoint of non-fatal MI, coronary revascularization, acute coronary syndrome and death (P=0.034).

The primary endpoint in the main PROACTIVE study was a 20% improvement during the time from randomization to the participant’s next cardiovascular event (i.e., a composite of all-cause mortality, non-fatal MI, stroke, acute coronary syndrome, coronary revascularization, limb revascularization or amputation above the ankle).

In the main PROACTIVE study, Actos was associated with only a 10% improvement , thus missing the primary endpoint. However, these results did confirm that Actos was associated with a 16% reduction in risk of death or recurrent heart attack.

PROACTIVE was conducted in 19 European countries and involved 5,238 diabetic participants with prior MI. Participants were randomized either to the highest tolerated dose of Actos (up to 45 mg) or placebo, on top of standard therapy (including insulin, when indicated). Patients were followed for an average of 2.8 years.

One problem with the earlier results was the issue of increased congestive heart failure among patients in the Actos arm, according to AHA president Robert H. Eckel, MD, an endocrinologist and professor of medicine at the University of Colorado Health Sciences Center in Denver.

Dr Erdmann noted that the subset analysis more clearly elucidates the heart failure question. In total, 63 of the 1,215 patients receiving placebo and 92 of the 1,230 patients receiving Actos were hospitalized for treatment of congestive heart failure.

“We know that patients with diabetes and heart failure have a particularly bad prognosis, but when we looked at mortality, in the control group exactly one-third of the congestive heart failure patients died, but in the [Actos] group 22 of the 92 patients died,” said Dr Erdmann, according to MedPage Today. “That was less than one-fourth.”

Because Actos promotes edema by directly stimulating sodium reabsorption in the kidney, the likely explanation for these results is that patients on the Actos arm were “misdiagnosed with congestive heart failure. They really had edema,” said Dr Erdmann. At any rate, he added, “there was no excessive death due to heart failure in the [Actos] arm.”

The PROACTIVE trial was funded by Takeda Pharmaceuticals, which markets Actos.
Product Description

Most important information about Actos

Pharmacokinetics

Side Effects

More information about ACTOS (Pioglitazone):

FDA Alert

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 buy ACTOS click HERE: My Family Drugstore