Dosing and Administration
Dapagliflozin is under investigation in several phase III trials. Ongoing and published phase III clinical trials have used the following dapagliflozin dosing schemes: 1, 2.5, 5, and 10 mg once/day. Dose-dependent decreases in adverse effects, FPG, and A1C are witnessed with higher dosing schemes, although clinical trials have focused on the 1–10 mg/day range based on near maximal blood glucose effects and acceptable tolerability. Dapagliflozin will likely be dosed once/day without regard to meals, given its relatively long half-life and insulin-independent mechanism of action. Future clinical trials will need to assess the use of dapagliflozin in geriatric and pediatric patients and in pregnant or nursing women. Dosage adjustments in renally impaired patients will likely be unnecessary, as renal excretion is not a major elimination pathway for dapagliflozin. Studies have not been published to categorize the impact of hepatic impairment on dapagliflozin pharmacokinetics.
Pharmacotherapy. 2012;32(1):80-94. © 2012 Pharmacotherapy Publications