What is ACTOS ? [In treatment for Diabetes]

 [Extracted from the webpage of actos.com]


What is ACTOS ?

• ACTOS is a once-a-day prescription medication for type 2 diabetes that, along with healthy eating and physical activity, helps your body control blood sugar (glucose) levels.  
  
• ACTOS makes the cells in your body more sensitive to insulin, a hormone produced by the pancreas that allows the cells in your body to use blood sugar for energy.
  
• When the cells are more sensitive to insulin, the sugar that’s in your blood can pass more easily into the cells of your body where it’s really needed. So instead of remaining in the blood, where sugar can build up to dangerous levels, it passes into the cells and your blood sugar levels go down.
  
  
• ACTOS can be used by itself or in combination with certain other diabetes medications (sulfonylureas, metformin, or insulin) when your necessary efforts at healthy eating and physical activity do not control your blood sugar levels.
  
  
• ACTOS may improve HDL (good) cholesterol and triglycerides without consistent changes in LDL (bad) cholesterol or total cholesterol in patients with type 2 diabetes. However, ACTOS should not be substituted for cholesterol medicine.

ACTOS is a member of the type of oral diabetes prescription medications called thiazolidinediones (THIGH-ah-ZO-li-deen-DYE-owns; TZDs). These medications help reduce insulin resistance, which is one of the major problems in type 2 diabetes. Some of the benefits of therapy with ACTOS are :

• With diet and exercise, lowers blood sugar by helping your body use its own insulin more effectively.
  
• Convenient, once-a-day pill can be taken anytime.
  
• Can be taken with or without food.
  
• ACTOS may improve HDL (good) cholesterol and triglycerides without consistent changes in LDL (bad) cholesterol or total cholesterol in patients with type 2 diabetes. However, ACTOS should not be substituted for cholesterol medicine.
  
• Has not been associated with stomach upset when used alone.
  
• Can be used alone or in combination with certain other diabetes medicines such as sulfonylureas, metformin, or insulin. Taken alone, ACTOS is not likely to cause hypoglycemia (low blood sugar levels). However, if you take ACTOS with insulin or sulfonylureas, you may be at increased risk for hypoglycemia. Talk to your doctor about the signs and symptoms of hypoglycemia.
  
• ACTOS is available in three different dose levels so you and your health professional have more treatment options to consider.
  
  
• ACTOS is also available in convenient combination tablets :
  
  
  
  • ACTOplus met combines ACTOS and metformin in one tablet.
    
  • Duetact combines ACTOS and glimepiride in one tablet.
    
    
• ACTOS can often begin working right away, although it may take several weeks to see the full change.

The major underlying problems in type 2 diabetes are insulin resistance in muscle and fat, decreased insulin production by the pancreas, and increased sugar production by the liver. Other concerns include lipid problems, such as increased triglyceride levels (blood fats), low levels of HDL (good cholesterol), and high levels of LDL (bad cholesterol). Gastrointestinal (stomach) and kidney function are additional considerations.
The effect of these lipid changes has not been determined.

ACTOS and blood sugar (glucose)

The main goal of type 2 diabetes treatment is to keep your blood sugar level within a target range. The American Diabetes Association recommends the following blood sugar goals for people with diabetes :

• Before meals : Your premeal blood glucose should be between 70 mg/dL and 130 mg/dL.
  
• After meals : Your highest postmeal (1 to 2 hours after eating) blood glucose should be less than 180 mg/dL.
  
• Your average blood sugar for the last 2–3 months (A1C) : Your A1C should be less than 7%.
  

Reasons for high blood sugar levels

Healthy eating and physical activity are always essential to help meet these goals, but despite your best efforts, your blood sugar could end up out of control due to one or more of the following factors :

• Stress or illness.
• Change in diet.
• Limited physical activity.
• Need for medication or adjustment of medication.
• Forgetting to take diabetes medication as prescribed.

People with type 2 diabetes still produce insulin, but either their body doesn’t respond to insulin’s action (it’s resistant) or there isn’t enough insulin. ACTOS, along with healthy eating and physical activity, helps to lower your blood sugar by decreasing insulin resistance.

The major underlying problems in type 2 diabetes are insulin resistance in muscle and fat, decreased insulin production by the pancreas, and increased sugar production by the liver. Other concerns include lipid problems, such as increased triglyceride levels (blood fats), low levels of HDL (good cholesterol), and high levels of LDL (bad cholesterol). Gastrointestinal (stomach) and kidney function are additional considerations.
While ACTOS may provide some lipid benefits, ACTOS is not intended as a substitute for cholesterol medications. The effect of these lipid changes has not been determined.

ACTOS, cholesterol, and blood fats (triglycerides)

Low levels of HDL (good) cholesterol and high levels of triglycerides are often associated with type 2 diabetes. Cholesterol is a fatty substance that can be found in the body. The body needs cholesterol for making hormones and building cell walls. This combination of low HDL levels and high triglyceride levels can lead to health complications.

Fats in the blood

There are three types of fat in your blood :

• LDL (low-density lipoprotein) cholesterol is known as the “bad cholesterol” because it is the source of harmful fatty buildup in blood vessels.
  
  
• HDL (high-density lipoprotein) cholesterol is often called “good cholesterol” because it helps prevent cholesterol buildup in blood vessels by carrying cholesterol back to the liver, where it can be eliminated.
  
  
• Triglycerides are a form of fat carried through the bloodstream.
  

ACTOS has a positive change on HDL cholesterol and triglycerides

ACTOS may have a positive change on HDL (good) cholesterol and triglycerides (blood fats) without consistent changes in LDL (bad) cholesterol or total cholesterol in patients with type 2 diabetes. ACTOS has been shown to :

• Increase HDL cholesterol.
  
• Decrease triglycerides.
  
• Have no consistent effect on LDL or total cholesterol.

While ACTOS may provide some lipid benefits, ACTOS is not intended as a substitute for cholesterol medications. The effect of these lipid changes has not been determined.

If you have high cholesterol, you should ask your doctor what steps you can take to lower it. These may include :

• Changing eating habits to reduce intake of dietary saturated fat.
• Being more physically active.
• Maintaining your proper weight.

Your doctor may also prescribe a cholesterol-lowering medication in addition to these healthy lifestyle habits. ACTOS is not intended as a substitute for cholesterol medications.

Please see Important Safety Information, including warnings about heart failure and lactic acidosis, below.

The major underlying problems in type 2 diabetes are insulin resistance in muscle and fat, decreased insulin production by the pancreas, and increased sugar production by the liver. Other concerns include lipid problems, such as increased triglyceride levels (blood fats), low levels of HDL (good cholesterol), and high levels of LDL (bad cholesterol). Gastrointestinal (stomach) and kidney function are additional considerations.
There have been no clinical studies showing a decrease in the risk of macrovascular disease with ACTOS.

Is ACTOS right for you ?

Answer these questions and share them with your doctor to find out if ACTOS may be right for you :

1. Are your premeal blood sugar levels consistently above 130 mg/dL ?
   
2. Are you having problems managing your diabetes with healthy eating and physical activity alone ?
   
3. Are you having problems managing your diabetes with your current prescription medications ?
   
4. Do you prefer taking a prescription medication only once a day ?
   
5. Are you interested in a diabetes prescription medication that may provide some improvements in HDL (good) cholesterol and triglyceride levels in addition to helping to manage your blood sugar ?

While ACTOS may provide some lipid benefits, ACTOS is not intended as a substitute for cholesterol medications. The effect of these lipid changes has not been determined.

If you have type 2 diabetes and answered yes to any of these questions, ask your doctor if ACTOS is right for you. Remember, only your doctor can determine the best treatment for you.

How ACTOS works ?

Turning food into energy

• When you eat, food is broken down into different products that can be used by your body.
  
• One of those products is glucose, or sugar, the main source of energy for the body.
  
• In order to process glucose into energy, the pancreas produces insulin—a hormone that allows cells to absorb glucose (sugar).
  
• Insulin is produced by the pancreas and is needed to let sugar into the body’s cells so it can be processed into energy.

Insulin resistance in type 2 diabetes

• For people with type 2 diabetes, the body cannot produce enough insulin to properly use the sugar in their blood. In addition, their cells lose their sensitivity to insulin—a condition known as insulin resistance.
  
  
• Because some cells, such as muscle cells, are not sensitive to insulin, they cannot absorb blood sugar for the energy they need to function.
  
  
• The body responds to this situation by signaling the pancreas to produce more insulin, causing insulin levels in the blood to become too high. This condition is known as hyperinsulinemia. Unfortunately, even this extra insulin does not allow insulin-resistant cells to absorb blood sugar.
  
  
• Eventually, the pancreas can no longer produce enough insulin to compensate for insulin resistance. The cells in the liver also become insulin resistant and respond by making too much blood sugar.
  
  
• Because blood sugar is not absorbed by the cells, it stays in the blood, causing blood sugar levels to rise—a condition known as hyperglycemia.
  
  
• Over time, high levels of sugar in the blood can result in damage to parts of the body, such as the kidneys, eyes, nerves, and heart.
  

Reducing insulin resistance with ACTOS

• Along with healthy eating and physical activity, ACTOS works by reducing insulin resistance, which helps reduce the harmful buildup of sugar in the blood.
  
  
  
  • ACTOS increases the sensitivity of cells to insulin. When the cells in the body are more sensitive to insulin :
    
    
    
    • They can absorb blood sugar for the energy they need to function properly.
      
    • The amount of sugar in the blood goes down, because the sugar is absorbed by the cells rather than remaining in the blood.
   
  Indications and Usage
  
  ACTOS, ACTOplus met, ACTOplus met XR, and duetact are prescription medications used with diet and exercise to improve blood sugar (glucose) control in adults (≥18 years of age) with type 2 diabetes.
  
  Important Safety Information
  
  Warnings
  
  ACTOS, ACTOplus met, ACTOplus met XR, and duetact are not for everyone. Certain patients with heart failure should not start taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. These medications can cause new, or worsen, heart failure. Talk to your doctor immediately if you experience unusually fast weight gain, fluid retention (swelling), shortness of breath, unusual tiredness, or slow heartbeat.
  
  Warnings Specific to ACTOplus met and ACTOplus met XR
  
  Metformin, one of the medicines in ACTOplus met and ACTOplus met XR, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital. Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met and ACTOplus met XR should not be used in people with kidney disease or in people 80 years of age or older whose kidneys do not work properly. ACTOplus met and ACTOplus met XR should not be taken by people with metabolic acidosis or who drink excessive amounts of alcohol.
  
  Talk to your doctor if you are going to have an X-ray procedure using injectable dye and are taking ACTOplus met or ACTOplus met XR.
  
  ACTOS, ACTOplus met, ACTOplus met XR, and duetact are not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.
  
  Warning Specific to duetact : The chance of death from serious heart or blood vessel problems may be higher when using a sulfonylurea, an ingredient in duetact.
  
  Precautions
  
  ACTOS may cause low blood sugar when taken in combination with insulin or sulfonylureas. Lightheadedness, shakiness, dizziness, or hunger may mean that your blood sugar is too low. Talk to your doctor if low blood sugar is a problem for you.
  
  Some people taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact may experience mild-to-moderate swelling of legs and ankles, anemia, and weight gain.
  
  If you are of childbearing age, talk to your doctor before taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact, as this could increase your chance of becoming pregnant. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
  
  Do not take ACTOS, ACTOplus met, ACTOplus met XR, or duetact if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start therapy and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.
  
  Some patients have experienced visual changes while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact. If you experience vision problems, consult your doctor immediately.
  Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS, ACTOplus met, ACTOplus met XR, or duetact.
  
  Precaution Specific to duetact: Taking glimepiride along with having an inherited condition where you don’t produce enough of the enzyme G6PD (G6PD deficiency) can cause hemolytic anemia, which causes red blood cells to be destroyed too quickly.
  
  
  Other side effects of these products may include :
  
  
  
  
  • ACTOS: cold or flu-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat
    
    
  • ACTOplus met and ACTOplus met XR: cold or flu-like symptoms, diarrhea, nausea, headache, urinary tract infection, dizziness, and sinus infection
    
    
  • Duetact: cold or flu-like symptoms, headache, urinary tract infection, diarrhea, nausea, and limb pain