Avandia (Rosiglitazone Maleate) - Summary

AVANDIA SUMMARY

AVANDIA

AVANDIA (rosiglitazone maleate) is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. AVANDIA is used in the management of type 2 diabetes mellitus (also known as non-insulin-dependent diabetes mellitus [NIDDM] or adult-onset diabetes). AVANDIA improves glycemic control while reducing circulating insulin levels.

AVANDIA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. AVANDIA is indicated as monotherapy. AVANDIA is also indicated for use in combination with a sulfonylurea, metformin, or insulin when diet, exercise, and a single agent do not result in adequate glycemic control. For patients inadequately controlled with a maximum dose of a sulfonylurea or metformin, AVANDIA should be added to, rather than substituted for, a sulfonylurea or metformin.

Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes, but also in maintaining the efficacy of drug therapy. Prior to initiation of therapy with AVANDIA, secondary causes of poor glycemic control, e.g., infection, should be investigated and treated.

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NEWS HIGHLIGHTS

Media Articles Related to Avandia (Rosiglitazone)

Avandia Raises Heart Failure Risk More Than Actos
Source: MedicineNet Diabetic Home Care and Monitoring Specialty [2009.08.19]
Title: Avandia Raises Heart Failure Risk More Than Actos
Category: Health News
Created: 8/19/2009 8:10:00 AM
Last Editorial Review: 8/19/2009

Avandia Study Spurs New Heart Risk Debate
Source: MedicineNet rosiglitazone Specialty [2009.06.08]
Title: Avandia Study Spurs New Heart Risk Debate
Category: Health News
Created: 6/8/2009
Last Editorial Review: 6/8/2009

Halting Avandia Use Hikes Blood Sugar Levels
Source: MedicineNet pioglitazone Specialty [2009.04.17]
Title: Halting Avandia Use Hikes Blood Sugar Levels
Category: Health News
Created: 4/17/2009 2:00:00 AM
Last Editorial Review: 4/17/2009

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Published Studies Related to Avandia (Rosiglitazone)

A multicentre, randomized, double-blind placebo-controlled trial evaluating rosiglitazone for the prevention of atherosclerosis progression after coronary artery bypass graft surgery in patients with type 2 diabetes. Design and rationale of the VeIn-Coronary aTherOsclerosis and Rosiglitazone after bypass surgerY (VICTORY) trial. [2009.09]
BACKGROUND: The number of patients with coronary artery disease and type 2 diabetes will increase dramatically over the next decade. Diabetes has been related to accelerated atherosclerosis and many patients with diabetes will require coronary artery bypass graft (CABG) surgery utilizing saphenous vein grafts. After CABG, accelerated atherosclerosis in saphenous vein grafts leads to graft failure in approximately 50% of cases over a 10-year period. Rosiglitazone, a peroxisome proliferator-activated receptor-gamma agonist, has been shown to improve multiple metabolic parameters in patients with type 2 diabetes. However, its role in the prevention of atherosclerosis progression is uncertain... CONCLUSIONS: The VICTORY trial is the first cardiometabolic study to evaluate the antiatherosclerotic and metabolic effects of rosiglitazone in post-CABG patients with type 2 diabetes.

Twice-daily dosing of a repaglinide/metformin fixed-dose combination tablet provides glycaemic control comparable to rosiglitazone/metformin tablet. [2009.09]
AIM: To assess the use of a new repaglinide/metformin fixed-dose combination (FDC) tablet for the treatment of type 2 diabetes... CONCLUSIONS: The repaglinide/metformin FDC BID regimen showed efficacy that was non-inferior to that of the rosiglitazone/metformin FDC BID regimen currently in clinical use and a more rapid reduction of HbA1c values. Thus, repaglinide/metformin FDC BID is a clinically feasible alternative to rosiglitazone/metformin FDC BID.

A rosiglitazone-induced increase in adiponectin does not improve glucose metabolism in HIV-infected patients with overt lipoatrophy. [2009.08.18]
HIV-infected patients on antiretroviral therapy frequently develop changes in body fat distribution and disturbances in glucose metabolism, associated with reduced adiponectin levels. As adiponectin, principally the HMW (high-molecular-weight) form, has insulin sensitizing properties, we investigated the effects of an increase in adiponectin on glucose metabolism in HIV-lipodystrophy...

Effect of rosiglitazone on progression of atherosclerosis: insights using 3D carotid cardiovascular magnetic resonance. [2009.07.27]
CONCLUSION: Treatment with rosiglitazone over 1 year had no effect on progression of carotid atheroma in patients with type 2 diabetes mellitus compared to placebo.

Impact of rosiglitazone and glyburide on nitrosative stress and myocardial blood flow regulation in type 2 diabetes mellitus. [2009.07]
Cardiovascular disease, the leading cause of death in patients with type 2 diabetes mellitus (T2DM), is usually preceded by endothelial dysfunction and altered myocardial blood flow (MBF) regulation... Rosiglitazone, but not glyburide, ameliorated markers of nitrosative stress and inflammation in subjects with T2DM without impairing myocardial perfusion.

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Clinical Trials Related to Avandia (Rosiglitazone)

Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer [Active, not recruiting]
The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate specific antigen (PSA) levels.

Rosiglitazone (Avandia) vs Placebo for Androgen-Dependent Prostate Cancer [Completed]
The purpose of this study is to see what effects the drug Rosiglitazone has on you and your prostate cancer. In particular, the study is also looking at the impact of the drug on Prostate Specific Antigen (PSA). PSA is a marker in your blood that is used to follow the progress of your disease.

Rosiglitazone Versus Theophylline in Asthmatic Smokers [Completed]
Asthmatic smokers display a blunted response to both inhaled and oral corticosteroid treatments and are at increased risk for exacerbations and near fatal asthma. The prevalence of smoking in asthmatics runs between 20-30%. Therefore, new, more efficacious treatments are required.

Recent work has demonstrated a mechanism which may explain steroid resistance. A commonly used drug called theophylline can reverse this steroid resistance in laboratory studies. Another commonly used drug, rosiglitazone can reverse smoking induced lung inflammation in laboratory studies.

The investigators aim to study the effects of these drugs on smoking asthmatics' lung function and other parameters including quality of life and asthma control.

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes [Completed]
This study is designed to evaluate the safety of BRL49653C administrated for 52 weeks

AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes Not Controlled by Glyburide Alone [Completed]
This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As microvascular and macrovascular disease are significant contributors to diabetes morbidity and mortality and previous studies suggest that the thiazolidinedione compounds could have potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum parameters associated with endothelial dysfunction, vascular inflammation and impaired fibrinolysis were examined in this study. Improvement in these parameters suggests that rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to improve glycemic control.

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