WARNING: CONGESTIVE HEART FAILURE
Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions]. After initiation of AVANDARYL®, 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 AVANDARYL must be considered.
AVANDARYL is not recommended in patients with symptomatic heart failure. Initiation of AVANDARYL in patients with established NYHA Class III or IV heart failure is contraindicated. [See Contraindications (4), Warnings and Precautions .]
AVANDARYL contains 2 oral antidiabetic drugs used in the management of type 2 diabetes: rosiglitazone maleate and glimepiride.
Rosiglitazone maleate is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity.
AVANDARYL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use:
Due to its mechanism of action, rosiglitazone is active only in the presence of endogenous insulin. Therefore, AVANDARYL should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Coadministration of AVANDARYL with insulin is not recommended [see Warnings and Precautions (5.2, 5.3)].
Published Studies Related to Avandaryl (Rosiglitazone / Glimepiride)
Adherence to a fixed-dose combination of rosiglitazone/glimepiride in subjects switching from monotherapy or dual therapy with a thiazolidinedione and/or a sulfonylurea. [2010.05]
BACKGROUND: In 2005, a fixed-dose combination therapy (FDCT) of rosiglitazone maleate and glimepiride became available for treatment of type 2 diabetes mellitus. It is hypothesized that FDCTs increase adherence by decreasing the number of required tablets. OBJECTIVE: To assess changes in medication adherence and hemoglobin A(1c) (A1C) values in subjects switching from monotherapy with either a sulfonylurea or rosiglitazone or dual therapy with both to rosiglitazone/glimepiride FDCT... CONCLUSIONS: Switching to rosiglitazone/glimepiride FDCT, in comparison with switching to dual therapy, was associated with improvements in medication adherence and glycemic control.
Initial treatment with fixed-dose combination rosiglitazone/glimepiride in patients with previously untreated type 2 diabetes. [2008.08]
AIM: This study assessed the efficacy and safety of two different dosing regimens of fixed-dose combination (FDC) rosiglitazone (RSG) plus glimepiride (GLIM) compared with RSG or GLIM monotherapy in drug-naive subjects with type 2 diabetes mellitus (T2DM)... CONCLUSIONS: Compared with RSG or GLIM monotherapy, the RSG/GLIM FDC improved glycaemic control with no significant increased risk of hypoglycaemia. RSG/GLIM FDC provides an effective and well-tolerated treatment option for drug-naive individuals with T2DM.
Initial treatment with fixed-dose combination rosiglitazone/glimepiride in patients with previously untreated type 2 diabetes. [2007.07.21]
Aim: This study assessed the efficacy and safety of two different dosing regimens of fixed-dose combination (FDC) rosiglitazone (RSG) plus glimepiride (GLIM) compared with RSG or GLIM monotherapy in drug-naive subjects with type 2 diabetes mellitus (T2DM)... RSG/GLIM FDC provides an effective and well-tolerated treatment option for drug-naive individuals with T2DM.
Reports of Suspected Avandaryl (Rosiglitazone / Glimepiride) Side Effects
Myocardial Infarction (95),
Cardiac Failure Congestive (64),
Coronary Artery Disease (44),
Cerebrovascular Accident (42),
Cardiac Disorder (26),
Cardiovascular Disorder (17),
Chest Pain (13),
Acute Myocardial Infarction (12), more >>
Page last updated: 2010-10-05