ACTOS® and DUETACTTM are trademarks of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc.
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
© 2006 Takeda Pharmaceuticals America, Inc.
05-1152 December 2008
WARNING: CONGESTIVE HEART FAILURE
- Thiazolidinediones, including pioglitazone, which is a component of DUETACT, cause or exacerbate congestive heart failure in some patients (see WARNINGS, Pioglitazone hydrochloride). After initiation of DUETACT, 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 the current standards of care. Furthermore, discontinuation of DUETACT must be considered.
- DUETACT is not recommended in patients with symptomatic heart failure. Initiation of DUETACT in patients with established NYHA Class III or IV heart failure is contraindicated (see CONTRAINDICATIONS and WARNINGS, Pioglitazone hydrochloride).
DUETACTTM (pioglitazone hydrochloride and glimepiride) tablets contain two oral antihyperglycemic agents used in the management of type 2 diabetes: pioglitazone hydrochloride and glimepiride. The concomitant use of pioglitazone and a sulfonylurea, the class of drugs that includes glimepiride, has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on a sulfonylurea. Additional efficacy and safety information about pioglitazone and glimepiride monotherapies may be found in the prescribing information for each individual drug. Pioglitazone hydrochloride is an oral antihyperglycemic agent that acts primarily by decreasing insulin resistance. Pioglitazone is used in the management of type 2 diabetes. Pharmacological studies indicate that pioglitazone improves sensitivity to insulin in muscle and adipose tissue and inhibits hepatic gluconeogenesis. Pioglitazone improves glycemic control while reducing circulating insulin levels. Pioglitazone (±)-5-[[4-[2-(5-ethyl-2-pyridinyl)ethoxy]phenyl]methyl]-2,4-thiazolidinedione monohydrochloride belongs to a different chemical class and has a different pharmacological action than the sulfonylureas, biguanides, or the α-glucosidase inhibitors. The molecule contains one asymmetric center, and the synthetic compound is a racemate. The two enantiomers of pioglitazone interconvert in vivo.
DUETACT is indicated as an adjunct to diet and exercise as a once-daily combination therapy to improve glycemic control in patients with type 2 diabetes who are already treated with a combination of pioglitazone and a sulfonylurea or whose diabetes is not adequately controlled with a sulfonylurea alone, or for those patients who have initially responded to pioglitazone alone and require additional glycemic control .
Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise. These efforts are important not only in the primary treatment of type 2 diabetes, but also to maintain the efficacy of drug therapy.
Published Studies Related to Duetact (Pioglitazone / Glimepiride)
Pioglitazone plus glimepiride: a promising alternative in metabolic control. [2007.06]
Current approaches to pharmacotherapy of type 2 diabetes focus on two key aspects of hyperglycaemia - insulin secretory dysfunction and insulin resistance... This review discusses the potential benefits of combining pioglitazone plus glimepiride on patient compliance, targeting the dual effects of insulin resistance and beta-cell dysfunction and affecting a number of metabolic and cardiovascular parameters.
Reports of Suspected Duetact (Pioglitazone / Glimepiride) Side Effects
Bladder Cancer (3),
Back Pain (1),
Bladder Cancer Stage II (1),
Bladder Transitional Cell Carcinoma (1),
NO Adverse Event (1),
Cardiac Failure (1)
Page last updated: 2008-01-02