WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA
● Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions]. After initiation of AVANDIA, 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 AVANDIA must be considered.
● AVANDIA is not recommended in patients with symptomatic heart failure. Initiation of AVANDIA in patients with established NYHA Class III or IV heart failure is contraindicated. [See Contraindications and Warnings and Precautions .]
● A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared AVANDIA to placebo, showed AVANDIA to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing AVANDIA to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive. [See Warnings and Precautions .]
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.
Media Articles Related to Avandia (Rosiglitazone)
FDA requires removal of certain restrictions on the diabetes drug Avandia
Source: Diabetes News From Medical News Today [2013.11.27]
The U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Today's actions are consistent with the recommendations of expert advisory committees.
Avandia Decision a Moot Point for Prescribers?
Source: MedPage Today Cardiovascular [2013.11.26]
(MedPage Today) -- It's unlikely that the FDA's decision to loosen some of the restrictions on the type 2 diabetes drug rosiglitazone (Avandia) will have any impact on prescribing in the U.S., according to several experts contacted by MedPage Today.
FDA to Lift Restrictions on Diabetes Drug Avandia
Source: MedicineNet Diabetes Mellitus Specialty [2013.11.26]
Title: FDA to Lift Restrictions on Diabetes Drug Avandia
Category: Health News
Created: 11/25/2013 5:36:00 PM
Last Editorial Review: 11/26/2013 12:00:00 AM
FDA Lifts Avandia Prescribing Restrictions
Source: theheart.org | Medscape Cardiology Headlines [2013.11.25]
After a 2-day advisory committee meeting last June, the FDA has decided that current data do not suggest that the drug poses an increased cardiovascular risk.
FDA Opens Door to Wider Avandia Prescribing
Source: MedPage Today Cardiovascular [2013.11.25]
(MedPage Today) -- The FDA has loosened restrictions on the diabetes drug rosiglitazone (Avandia) -- under fire since 2007 because of potential cardiovascular risks -- and will allow drugmaker GlaxoSmithKline to drop a postmarketing study of the drug.
Published Studies Related to Avandia (Rosiglitazone)
Rosiglitazone decreases plasma levels of osteoprotegerin in a randomized clinical trial with type 2 diabetes patients. [2011.12]
Cardiovascular disease is the leading cause of death in patients with type 2 diabetes mellitus (T2DM). We suggested that plasma osteoprotegerin (OPG), a strong, independent predictor of cardiovascular disease, could discriminate between anti-diabetic treatments depending on their benefits regarding cardiovascular disease...
Rosiglitazone decreases fasting plasma peptide YY(3-36) in type 2 diabetic women: a possible role in weight gain? [2011.11.19]
Rosiglitazone often results in weight gain. We hypothesized that rosiglitazone may modulate circulating levels of ghrelin and peptide YY(3-36) and this modulation may be related to weight-gaining effect of this agent... Rosiglitazone-induced decrease in fasting peptide YY(3-36) levels may in part contribute to orexigenic and weight-gaining effect of this thiazolidinedione derivative.
Rosiglitazone and pioglitazone for the treatment of Alzheimer's disease. [2011.11]
CONCLUSIONS: Results from clinical trials and current safety data suggest that rosiglitazone should not be used for the treatment of AD. Application of results from trials evaluating pioglitazone in the treatment of AD is limited because of major trial limitations; therefore, it should not be recommended at this time. Although these drugs are not commonly used in the treatment of AD, further pharmacoepidemiologic studies are warranted before their use can be recommended.
Effect of lifestyle intervention plus rosiglitazone or placebo therapy on left ventricular mass assessed with cardiovascular magnetic resonance in the metabolic syndrome. [2011.10.28]
ABSTRACT: BACKGROUND: To evaluate the effect of lifestyle intervention in conjunction with rosiglitazone or placebo therapy on left ventricular (LV) mass, using cardiovascular magnetic resonance (CMR) in the metabolic syndrome... CONCLUSIONS: Lifestyle intervention resulted in a reduction of LV mass-I in the metabolic syndrome, indicating reverse remodeling. However, rosiglitazone therapy may have inhibited this positive reverse remodeling. TRIAL REGISTRATION: Current Controlled Trials ISRCTN54951661.
A randomized controlled trial of the effect of rosiglitazone and clomiphene citrate versus clomiphene citrate alone in overweight/obese women with polycystic ovary syndrome. [2011.10.04]
Background: In women suffering from polycystic ovary syndrome, correction of hyperinsulinemia results in enhanced responsiveness to ovulation induction agents. The effect of rosiglitazone was investigated on ovulation induction in obese women with PCOS... Conclusions: Short term administration of rosiglitazone to overweight and obese PCOS women results in enhancement of CC induced ovulation as well as improvement of insulin sensitivity.
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 Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH) [Recruiting]
The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with
rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy
proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question:
are there differences in the efficacy (as measured by histopathology and insulin resistance)
of three different therapeutic modalities used to treat NASH?
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
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
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.
Effects of ROSIglitazone on Inflammatory Markers and Adipokines in Diabetic Patients Using an Angiotensin Receptor Blocker (TELmisartan) - The ROSITEL Study [Recruiting]
The purpose of the ROSITEL study is to assess the effects of rosiglitazone, as compared to
standard oral therapies for diabetes (metformin/sulfonylurea), on inflammatory markers and
adipokine levels in diabetic patients using an angiotensin receptor blocker (ARB).
We hypothesize that ARB-treated diabetic patients receiving rosiglitazone will experience
greater reductions in vascular inflammation and levels of leptin and resistin, associated
with increased adiponectin levels, compared to a metformin/sulfonylurea regimen, and that
these benefits will result in part, from greater improvements in insulin sensitivity in the
Reports of Suspected Avandia (Rosiglitazone) Side Effects
Myocardial Infarction (3651),
Cardiac Failure Congestive (2677),
Cerebrovascular Accident (1726),
Coronary Artery Disease (1445),
Cardiac Disorder (1039),
Cardiovascular Disorder (838),
Stent Placement (377),
Coronary Artery Bypass (370),
Transient Ischaemic Attack (358), more >>
Page last updated: 2013-11-27