Metformin and Rosiglitazone

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

  1. abdominal pain
  2. anaphylactoid reactions
  3. anemia
  4. angina
  5. anorexia
  6. arthralgia
  7. back pain
  8. blurred vision
  9. bone fractures
  10. cholestasis
  11. diarrhea
  12. dizziness
  13. dysgeusia
  14. dyspepsia
  15. dyspnea
  16. edema
  17. elevated hepatic enzymes
  18. fatigue
  19. flatulence
  20. flushing
  21. folate deficiency
  22. headache
  23. heart failure
  24. hepatic encephalopathy
  25. hepatic failure
  26. hepatic necrosis
  27. hepatitis
  28. hyperbilirubinemia
  29. hypercholesterolemia
  30. hypoglycemia
  31. infection
  32. jaundice
  33. lactic acidosis
  34. macular edema
  35. malaise
  36. megaloblastic anemia
  37. menstrual irregularity
  38. metabolic acidosis
  39. metallic taste
  40. myalgia
  41. myocardial infarction
  42. nausea
  43. osteopenia
  44. peripheral edema
  45. pharyngitis
  46. pleural effusion
  47. pruritus
  48. pulmonary edema
  49. rash
  50. rhabdomyolysis
  51. sinusitis
  52. Stevens-Johnson syndrome
  53. urticaria
  54. visual impairment
  55. vitamin B12 deficiency
  56. vomiting
  57. 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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