Managed Care - January 2008 - (Page Cover4) In type 2 diabetes ACTOS AT THE CORE AR EN F PATI T EXPE R SO CE IEN 8 YE #1 75 MI LLIO prescribed brand-name diabetes medication 1 N PRESC RIP T IO Indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. *IMS Health, NPATM, November 2, 2007. NS * Important Safety Information Boxed Warning: Congestive Heart Failure • 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 be considered.2 • 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.2 Cardiac considerations: Like other TZDs, ACTOS can cause fluid retention when used alone or in combination with other antidiabetic agents, including insulin. Fluid retention may lead to or exacerbate CHF. ACTOS should be used with caution in patients at risk for heart failure. Patients should be monitored for symptoms of heart failure or other adverse events related to fluid retention. In clinical trials, a small number of patients with a history of previously existing cardiac disease were reported to develop CHF when treated with ACTOS in combination with insulin. Reports of CHF have been received in postmarketing experience in patients with and without previously known heart disease.2 Hepatic safety: Reports of hepatitis and of hepatic enzyme elevations to three or more times the upper limit of Please see Brief Summary normal (ULN) have been received in postmarketing experience with of Prescribing Information pioglitazone. Very rarely, these reports have involved hepatic failure on adjacent pages. with or without fatal outcome, although causality has not been established. Liver enzymes, including serum ALT, should be evaluated References: 1. Data on file, Takeda in all patients at initiation of therapy with ACTOS, and periodically Pharmaceuticals North America, Inc. 2. ACTOS package insert, Takeda thereafter per the clinical judgment of the healthcare professional. Pharmaceuticals America, Inc. 3. Schinner S, If ALT >2.5X ULN at baseline or if the patient exhibits clinical evidence Scherbaum WA, Bornstein SR, Barthel A. Molecular mechanisms of insulin resistance. of active liver disease, do not initiate therapy with ACTOS.2 Other Diabet Med. 2005;22:674-682. 4. American considerations: ACTOS may also be associated with hypoglycemia, Diabetes Association. Dyslipidemia edema, anemia, weight gain, and/or ovulation in premenopausal, management in adults with diabetes. anovulatory women. Adequate contraception should be recommended Diabetes Care. 2004;27(suppl 1):S68-S71. American Diabetes Association. for premenopausal women. Macular edema has been reported in some 5. medical care in diabetes–2007. Standards of Diabetes diabetic patients receiving TZD therapy, although a causal relationship Care. 2007;30(suppl 1):S4-S41. is unknown. Persons with diabetes should have routine eye exams and be instructed to immediately report any visual changes to their healthcare provider. An increased incidence of bone fracture was noted in female patients taking ACTOS. The risk of fracture should be considered in the care of patients treated with ACTOS, particularly females, and attention should be given to assessing and maintaining bone health according to current standards of care.2 Well-tolerated therapy: In US placebo-controlled ACTOS monotherapy clinical trials, the most common adverse events (≥5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus, and pharyngitis.2 Indications and usage: ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. ACTOS is approved for use as monotherapy and in combination with sulfonylureas, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control.2 • ACTOS should not be used in patients with type 1 diabetes. Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise.2 • The major metabolic defects in type 2 diabetes are peripheral insulin resistance in muscle and fat, decreased pancreatic insulin secretion, and increased hepatic glucose output.3 Dyslipidemia in insulin resistance is represented by hypertriglyceridemia, decreased HDL levels, and increased small dense LDL particles.4 Renal and gastrointestinal function are also clinical considerations when prescribing an oral agent for type 2 diabetes.5
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