Rosiglitazone maleate: CONGESTIVE HEART FAILURE
Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions]. After initiation of AVANDAMET®, 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 AVANDAMET must be considered.
AVANDAMET is not recommended in patients with symptomatic heart failure. Initiation of AVANDAMET in patients with established NYHA Class III or IV heart failure is contraindicated. [See Contraindications (4), Warnings and Precautions .]
Metformin hydrochloride: LACTIC ACIDOSIS
Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. [See Warnings and Precautions .]
Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. [See Warnings and Precautions .]
If acidosis is suspected, discontinue AVANDAMET and hospitalize the patient immediately [see Warnings and Precautions].
AVANDAMET contains 2 oral antidiabetic drugs: rosiglitazone maleate and metformin hydrochloride.
Rosiglitazone maleate is an oral antidiabetic agent, which acts primarily by increasing insulin sensitivity. Rosiglitazone improves glycemic control while reducing circulating insulin levels.
AVANDAMET 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, AVANDAMET should not be used in patients with type 1 diabetes.
Coadministration of AVANDAMET with insulin is not recommended [see Warnings and Precautions (5.2, 5.3)].
Published Studies Related to Avandamet (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 Avandamet (Rosiglitazone)
Drug-Drug Interaction Study Between Quinine Sulfate and Rosiglitazone [Completed]
Rosiglitazone is predominantly metabolized by cytochrome P450 (CYP) 2C8. Quinine sulfate is
an inhibitor of CYP 2C8. This study will evaluate the effect of multiple doses of quinine
sulfate at steady-state on the pharmacokinetics of single-dose rosiglitazone in healthy
Rosiglitazone And Fenofibrate Additive Effects on Lipids (RAFAEL) [Terminated]
The design of the study will be randomized, double blind trial, which will examine the
effects of Rosiglitazone on the fasting triglycerides (TG), high-density lipoprotein (HDL),
low-density lipoprotein (LDL), and plasma concentrations of apolipoproteins A-I, A-II, and
C-III as compared to Fenofibrate and placebo. This study will also assess the synergistic
effect of Rosiglitazone and Fenofibrate on the same parameters. Data from this study will
help clarify whether Rosiglitazone favorably impacts plasma lipid and lipoprotein
concentrations through improving insulin sensitivity and glycemic control, or by directly
influencing the synthesis of the apolipoproteins that are responsible for very-low-density
lipoprotein (VLDL) and HDL metabolism.
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
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 and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH [Terminated]
This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic
acid, antioxidant on patients with pathologically proved NASH (non-alcoholic
A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists [Completed]
This is a single-arm, multicenter, Phase Ib study designed to describe the effect of
GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives in patients with
advanced solid tumors who are refractory to treatment or for whom no standard therapy
Reports of Suspected Avandamet (Rosiglitazone) Side Effects
Myocardial Infarction (617),
Cardiac Failure Congestive (445),
Coronary Artery Disease (319),
Cerebrovascular Accident (312),
Cardiac Disorder (195),
Cardiovascular Disorder (157),
Chest Pain (100),
Transient Ischaemic Attack (79),
Atrial Fibrillation (73), more >>
Page last updated: 2011-12-09