Alogliptin Maximum Dose
The maximum recommended dose of alogliptin is 25 mg once daily for patients with normal kidney function (creatinine clearance ≥60 mL/min). 1
Dosing Based on Renal Function
Alogliptin dosing must be adjusted based on kidney function, as the drug is primarily eliminated renally (60.8-63.4% excreted unchanged in urine) 2:
- Normal renal function (CrCl ≥60 mL/min): 25 mg once daily 3, 1
- Moderate renal impairment (CrCl 30-60 mL/min): 12.5 mg once daily 3, 1
- Severe renal impairment (CrCl 15-30 mL/min): 6.25 mg once daily 3, 1
- End-stage renal disease (CrCl <15 mL/min or on hemodialysis): 6.25 mg once daily 3, 1
The medication can be administered without regard to the timing of dialysis 1.
Administration Details
- Alogliptin may be taken with or without food 1
- No dose titration is required or recommended above 25 mg daily 1, 2
- Assessment of renal function is recommended prior to initiation and periodically thereafter 1
Clinical Efficacy at Maximum Dose
At the 25 mg dose, alogliptin demonstrates:
- Significant reduction in 4-hour postprandial glucose: -32.5 mg/dL after breakfast (p=0.008), -15.8 mg/dL after lunch (p=0.030), and -21.9 mg/dL after dinner (p=0.017) compared to placebo 2
- Reduction in HbA1c: -0.22% from baseline (p=0.044) 2
- Peak DPP-4 inhibition: 94-99% with sustained inhibition of 82% at 24 hours after dosing 2
Important Safety Considerations
Cardiovascular safety: Alogliptin has been associated with increased risk of heart failure hospitalization in some studies, requiring caution in patients with cardiac disease 4. Consider the risks and benefits prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and renal impairment 1.
Pancreatitis risk: Acute pancreatitis has been reported in 0.2-0.4% of patients treated with alogliptin 1. Patients should be observed for signs and symptoms of pancreatitis, and the drug should be promptly discontinued if pancreatitis is suspected 1.
Hypoglycemia risk: When used as monotherapy, alogliptin has minimal hypoglycemia risk, but this increases approximately 50% when combined with sulfonylureas 4.
Common Pitfalls to Avoid
- Do not exceed 25 mg daily in patients with normal renal function - higher doses (100 mg, 400 mg) have been studied but offer no additional benefit and may increase adverse effects like headache and dizziness 2
- Always assess renal function before prescribing - failure to adjust the dose in renal impairment can lead to drug accumulation 1, 5
- Avoid in patients with established heart failure or high heart failure risk - saxagliptin and alogliptin have shown increased heart failure hospitalization rates 4