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ALIMENTARY TRACT AND METABOLISM › DRUGS USED IN DIABETES › BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS › Combinations of oral blood glucose lowering drugs
pioglitazone and dapagliflozin
A10BD33
Forms & Strengths
- Pioglitazone 15 mg / Dapagliflozin 10 mg oral tablet
- Pioglitazone 30 mg / Dapagliflozin 10 mg oral tablet
Adult Dosing
- One tablet daily taken in the morning with or without food
- Select dose based on prior individual component therapy and tolerability
- Maximum daily dose: Pioglitazone 45 mg / Dapagliflozin 10 mg
Pediatric Dosing
- Safety and efficacy not established in pediatric patients below 18 years of age
Indications
- Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Reduction of heart failure hospitalization risk in adults with type 2 diabetes and established cardiovascular disease or cardiovascular risk factors (via dapagliflozin component)
Mechanism of Action
- Pioglitazone: Thiazolidinedione (TZD) acting as a potent and selective agonist for peroxisome proliferator-activated receptor-gamma (PPAR-gamma), decreasing insulin resistance in periphery and liver
- Dapagliflozin: Sodium-glucose cotransporter 2 (SGLT2) inhibitor, reducing renal glucose reabsorption and increasing urinary glucose excretion
Contraindications
- History of a serious hypersensitivity reaction to pioglitazone or dapagliflozin
- Initiation in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis
- Active bladder cancer or history of bladder cancer
- Established New York Heart Association (NYHA) Class III or IV heart failure (pioglitazone component)
- Severe renal impairment (eGFR < 30 mL/min/1.73m2), end-stage renal disease, or patients on dialysis
Adverse Reactions
- Hypoglycemia (especially when used with insulin or secretagogues)
- Fluid retention, peripheral edema, and weight gain
- Heart failure exacerbation or new-onset heart failure
- Genital mycotic infections and urinary tract infections
- Volume depletion, hypotension, and dizziness
- Increased risk of bone fractures
- Rare cases of bladder cancer, diabetic ketoacidosis, and necrotizing fasciitis of the perineum (Fournier's gangrene)
Drug Interactions
- CYP2C8 inhibitors (e.g., gemfibrozil) may significantly increase pioglitazone exposure
- CYP2C8 inducers (e.g., rifampin) may decrease pioglitazone efficacy
- Insulin or insulin secretagogues (e.g., sulfonylureas) increase the risk of hypoglycemia
- Diuretics combined with dapagliflozin may potentiate the risk of volume depletion and hypotension
- Lithium exposure may be decreased due to increased renal elimination by SGLT2 inhibition
Curated Content: Needs Vetting Before Put to Clinical Use