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Pioglitazone

Class
Hypoglycemic agents
Subclass
PPARα agonists
Substance name
Pioglitazone hydrochloride
Brand names
Actos®
Common formulations
Tablet
Contained in
Alogliptin / pioglitazone (Oseni®)
Pioglitazone / glimepiride (Duetact®)
Dosage and administration
Adults patients
Treatment
Diabetes mellitus type 2
•
Start at: 15-30 mg PO daily
•
Maintenance: 15-45 mg PO daily
•
Maximum: 45 mg per day
Titrate in 15 mg increments based on glycemic response. Start with 15 mg daily in patients with congestive HF.
Lichen planus • Appendageal • Off-label
•
15 mg PO daily for 8 months
MASH • Off-label
•
30-45 mg PO daily
Secondary prevention
Secondary prevention of AIS • Off-label
•
Start at: 15 mg PO daily
•
Maintenance: 45 mg PO daily
Other off-label uses
•
Treatment of diabetic nephropathy in patients with diabetes mellitus type 2
•
Secondary prevention of CVD in patients with diabetes mellitus type 2
Indications for use
Labeled indications
Adults
•
Treatment of diabetes mellitus type 2
Off-label indications
Adults
•
Treatment of diabetic nephropathy in patients with diabetes mellitus type 2
•
Treatment of lichen planus (appendageal)
•
Treatment of MASH
•
Secondary prevention of AIS
•
Secondary prevention of CVD in patients with diabetes mellitus type 2
Safety risks
Boxed warnings
Exacerbation of HF
•
Do not use in patients with symptomatic HF or established NYHA class III-IV HF, as thiazolidinediones, including pioglitazone, can cause or exacerbate congestive HF. Monitor for HF after initiating treatment and dose uptitration in all patients.
Contraindications
Hypersensitivity to pioglitazone or its components
Active bladder cancer
Warnings and precautions
ALF
•
Maintain a high level of suspicion, as pioglitazone has been associated with an increased risk of fatal and non-fatal liver failure. Discontinue pioglitazone in case of abnormal liver tests.
Bladder cancer
•
Maintain a high level of suspicion, as pioglitazone has been associated with an increased risk of urinary bladder tumors.
Bone fracture
•
Maintain a high level of suspicion, as pioglitazone has been associated with an increased risk of fractures in females.
Decreased blood glucose
•
Use caution in patients taking insulin or insulin secretagogues, such as sulfonylureas. Consider reducing the dose of the concomitant medication.
Exacerbation of edema
•
Use caution in patients with edema.
Exacerbation of HF
•
Maintain a high level of suspicion, thiazolidinediones have been associated with an increased risk of dose-related fluid retention leading to or exacerbating congestive HF. Start at 15 mg daily in patients with congestive HF (NYHA class I-II).
Macular edema
•
Maintain a high level of suspicion, as pioglitazone has been associated with an increased risk of macular edema in patients with diabetes.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
Use with caution.
Unexplained abnormality in LFTs
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Consider safer alternatives. Evidence of fetal harm in animals. Insulin is the preferred first-line treatment for diabetes in pregnancy.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
↓ blood glucose, peripheral edema, upper respiratory tract infections
Common 1-10%
•
Anemia, bone fracture, heart failure, pharyngitis, back pain, chest pain, flatulence, headache, myalgia, weight gain, sinusitis, urinary tract infections
Uncommon < 1%
•
Bladder cancer, ↑ liver enzymes
Unknown frequency
•
Acute liver failure, ↑ serum TBIL, macular edema, blurred vision, dyspnea
Interactions
Drug(s)
Check Interactions
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