ACTOS provides significant and sustained benefits
- Directly reduces insulin resistance.
- Associated with improvements in beta-cell function.
- Significant long-term A1C reductions.
- Additional improvements in both triglycerides and HDL-C.
- No consistent mean changes in LDL-C and Total-C levels.
The prescription medication ACTOS is used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes. ACTOS is taken once daily either alone or in combination with insulin, sulfonylureas, or metformin.
ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen congestive heart failure. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath.
Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, and anemia. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Very rarely, some patients have experienced visual changes while taking ACTOS.
While ACTOS may confer some lipid benefits, ACTOS is not indicated to treat lipid disorders and should not be used as a substitute for lipid-lowering therapy.
The effects of these lipid changes on morbidity and mortality have not been determined.
Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise.
- Thiazolidinediones (TZDs), including ACTOS, cause or exacerbate congestive heart failure (CHF) in some patients. After initiation of ACTOS and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of ACTOS must beconsidered.
- ACTOS is not recommended in patients with symptomatic heart failure. Initiation of ACTOS in patients with established NYHA Class III or IV heart failure is contraindicated.
References:
1. Data on file, Takeda Pharmaceuticals North America, Inc.
2. ACTOS package insert, Takeda Pharmaceuticals America, Inc.
3. Miyazaki Y, Mahankali A, Matsuda M, et al. Improved glycemic control and enhanced insulin sensitivity in type 2 diabetic subjects treated with pioglitazone. Diabetes Care. 2001;24:710-719.
4. Miyazaki Y, Matsuda M, DeFronzo RA. Dose-response effect of pioglitazone on insulin sensitivity and insulin secretion in type 2 diabetes. Diabetes Care. 2002;25:517-523.
5. Tan MH, Baksi A, Krahulec B, et al, for the GLAL Study Group. Comparison of pioglitazone and gliclazide in sustaining glycemic control over 2 years in patients with type 2 diabetes. Diabetes Care. 2005;28:544-550.
