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James H. Nance S. Sammy Cacciatore John N. Hamilton

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Charles G. Barger James N. Nance Sammy M. Cacciatore

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& Bladder Cancer

Nance Cacciatore

Actos®

Legal Information

9 Nance Cacciatore Team

10 Common Questions about Legal Representation

Treatment Options

6 Treatments

7 Clinical Trials/ Follow-up Care/ Lifestyle Changes

8 Support Networks/ Other Resources

Bladder Cancer

4 Bladder Cancer/ Symptoms/ Types

5 Diagnosis/ Grade/

Invasiveness/ Staging

Actos Background

3 Actos Indication/

Type 2 Diabetes Mellitus/

Actos Function

Actos , Actoplus Met, Actoplus Met XR, Duetact

Table of Contents

Actos - along with Actoplus Met, Actoplus Met XR, & Duetact - are prescription medications that contain the active substance pioglitazone. They are diabetes medications produced by Takeda Pharmaceuticals.

Includes Takeda’s Actos, Actoplus Met, Actoplus Met XR, & Duetact

Actos (pioglitazone)

Actos was approved by the FDA in July of 1999 and became the market leader after a 2007 study showed a 43 percent increase in heart attacks from GlaxoSmithKline’s Avandia. (According to a study published last year in the American Heart Association journal, Circulation: Cardiovascular Quality and Outcomes, the heart risk from Actos is just as great as the risk posed by Avandia.) In the last year, the medication had global sales of $4.8 billion and accounted for 27% of Takeda’s revenue. In 2008, Actos was the tenth best selling medication in the United States. From January 2010 through October 2010, there were an estimated 2.3 million prescriptions filled by diabetic patients that had a pioglitazone containing product from pharmacies in the United States.

Actos Indication

Actos is used to treat type 2 diabetes in adults (18 and over), particularly those who are overweight. Actos is not generally used as a first-line therapy, instead it is used:

As monotherapy in adult patients nadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance,

As dual oral therapy in combination with Metformin, in adult patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin OR a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.

As triple oral therapy in combination with metformin and a sulphonylurea, in adult patients with insufficient glycaemic control despite dual oral therapy.

Actos can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.

Type 2 Diabetes Mellitus

Type 2 diabetes usually develops in adulthood and occurs when the body (the pancreas) does not produce enough insulin or cannot properly use the insulin it makes to control blood sugar. Insulin allows sugar to enter the cells of your body. Once inside the cells, sugar is used as a source of energy. If your body is resistant to the effects of insulin—a condition known as insulin resistance—and if it cannot make enough insulin to overcome that resistance, sugar builds up in the blood (hyperglycemia).

Actos Function

The active substance in Actos, pioglitazone is a thiazolidinedione (or "glitazone") that stimulates the nuclear receptor PPAR-³ (peroxisome proliferator-activated receptor gamma) and to a lesser extent PPAR-± (-alpha). Ittance in Actos, pioglitazone is a thiazolidinedione (or "glitazone") that stimulates the nuclear receptor PPAR-γ (peroxisome proliferator-activated receptor gamma) and to a lesser extent PPAR-α (-alpha). Its role is to modulate the transcription of the insulin-sensitive genes involved in the control of glucose and lipid metabolism in the muscle, adipose tissue, and the liver. As a result, pioglitazone reduces insulin resistance in the liver and peripheral tissues; increases the expense of insulin-dependent glucose, decreases withdrawal of glucose from the liver; and reduces the quantity of glucose, insulin and glycated hemoglobin in the bloodstream.

Essentially, pioglitazone makes fat, muscle and liver cells more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.

In 2003, due to preclinical studies of pioglitazone and the results of two 3-year controlled clinical studies of Actos, the U.S. Food & Drug Administration (FDA) requested a safety study to assess the risk of bladder cancer.

Meanwhile, drug regulators in France and Germany have ordered doctors to stop prescribing pioglitazone-containing medicines.

Actos & Bladder Cancer

Bladder Cancer

Bladder cancer is a disease in which abnormal cells multiply without control in the bladder. The bladder is a hollow, muscular organ in the pelvis whose main function is to store urine before it leaves the body. The most common type of bladder cancer begins in cells lining the inside of the bladder and is called transitional cell carcinoma (sometimes urothelial cell carcinoma). Cancer cells can then invade other tissue, where they begin to grow and form new tumors that replace normal tissue.

Symptoms

• Abdominal pain

• Blood in the urine (hematuria)

• Bone pain or tenderness

• Fatigue

• Painful urination (dysuria)

• Urinary frequency

• Urinary urgency

• Urine leakage (incontinence)

• Weight loss

Types of Bladder Cancer

Bladder tumors are grouped into several types by how their cells look under a microscope. The type of bladder cancer you have can affect your treatment options. This is because different types can respond differently to treatments such as radiation and chemotherapy.

The main types of cancers that affect the bladder are:

1. Transitional cell carcinoma (95%)

2. Squamous cell carcinoma (~1% - 2%)

3. Adenocarcinoma (~1%)

4. Small cell carcinoma ( ................
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