Metformin and Rosiglitazone Brand Name– Avandamet
What is Metformin and Rosiglitazone
Metformin and rosiglitazone is a combination product containing 2 oral antidiabetic agents.
The product is used as an adjunct to diet and exercise to lower blood glucose levels in adults with type 2 diabetes mellitus (DM).
Metformin is a biguanide agent that improves insulin sensitivity. While metformin carries a low risk for lactic acidosis as outlined in the prescribing information and boxed warning of all metformin-containing products, care in prescribing and monitoring can reduce this risk.
Rosiglitazone is a member of the thiazolidinedione (TZD) class. The TZDs, including rosiglitazone, cause or exacerbate congestive heart failure (HF) in some patients and are contraindicated in those with established NYHA Class III or IV HF.
A meta-analysis of mostly short-term trials suggested an increased risk for myocardial infarction (MI) with rosiglitazone vs. placebo; however, data from long-term clinical trials of rosiglitazone vs. other antidiabetes agents, including a cardiovascular (CV) outcome trial (RECORD), observed no difference in overall mortality or major adverse CV events (MACE).
Some uncertainty over the CV safety of rosiglitazone nevertheless remains, and thus close monitoring is prudent, especially among patients with greater CV risk factors.
Metformin is first-line in the treatment of type 2 DM. In patients with established CV disease, HF, or chronic kidney disease (CKD), a sodium-glucose co-transporter 2 (SGLT2) inhibitor or glucagon-like peptide-1 receptor agonist (GLP-1 RA) with proven CV benefit and reduction of CKD progression is recommended for add-on therapy, independent of baseline A1C or individualized A1C target.
In patients without indicators of high-risk or established CV disease, HF, or CKD, rosiglitazone and other TZDs are a therapeutic option associated with glycemic durability; however, the benefits must be balanced with the risk of adverse effects such as heart failure, edema, reduced bone mineral density, and weight gain.
Concomitant use of insulin with rosiglitazone is not recommended due to an increased risk for edema and congestive heart failure. In patients who are starting on insulin therapy and are currently taking a product with rosiglitazone, discontinue rosiglitazone.
Although not FDA-approved, the use of TZDs or metformin may prevent future development of diabetes in 60% to 75% and 25% to 30% of subjects with prediabetes, respectively
Indications
- type 2 diabetes mellitus
For the treatment of type 2 diabetes mellitus not controlled by diet and exercise
Side Effects
- abdominal pain
- anaphylactoid reactions
- anemia
- angina
- anorexia
- arthralgia
- back pain
- blurred vision
- bone fractures
- cholestasis
- diarrhea
- dizziness
- dysgeusia
- dyspepsia
- dyspnea
- edema
- elevated hepatic enzymes
- fatigue
- flatulence
- flushing
- folate deficiency
- headache
- heart failure
- hepatic encephalopathy
- hepatic failure
- hepatic necrosis
- hepatitis
- hyperbilirubinemia
- hypercholesterolemia
- hypoglycemia
- infection
- jaundice
- lactic acidosis
- macular edema
- malaise
- megaloblastic anemia
- menstrual irregularity
- metabolic acidosis
- metallic taste
- myalgia
- myocardial infarction
- nausea
- osteopenia
- peripheral edema
- pharyngitis
- pleural effusion
- pruritus
- pulmonary edema
- rash
- rhabdomyolysis
- sinusitis
- Stevens-Johnson syndrome
- urticaria
- visual impairment
- vitamin B12 deficiency
- vomiting
- weight gain
Monitoring Parameters
- blood glucose
- CBC
- glycosylated hemoglobin A1c (HbA1c)
- LFTs
- serum creatinine/BUN
- weight
Contraindications
- acidemia
- acute heart failure
- acute myocardial infarction
- adrenal insufficiency
- alcoholism
- anemia
- angina
- bone fractures
- breast-feeding
- burns
- cardiac disease
- cardiogenic shock
- children
- contraception requirements
- dehydration
- diabetic ketoacidosis
- diarrhea
- edema
- ethanol ingestion
- ethanol intoxication
- fever
- gastroparesis
- geriatric
- GI obstruction
- heart failure
- hepatic disease
- hypercortisolism
- hyperglycemia
- hyperthyroidism
- hypoglycemia
- hypothyroidism
- hypovolemia
- hypoxemia
- ileus
- infection
- jaundice
- lactic acidosis
- malnutrition
- menstrual irregularity
- metabolic acidosis
- myocardial infarction
- osteoporosis
- peripheral edema
- pernicious anemia
- pituitary insufficiency
- polycystic ovary syndrome
- pregnancy
- pulmonary edema
- radiographic contrast administration
- renal disease
- renal failure
- renal impairment
- sepsis
- surgery
- trauma
- type 1 diabetes mellitus
- vomiting
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- Abacavir; Dolutegravir; Lamivudine
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