QTMeds

Drug Database Monograph

FORXIGA 10 mg

✓ VERIFIED BY DOCTOR

Active Ingredient: DAPAGLIFLOZINE

QTc Interval Status:
neutre

Clinical Description (Database Summary)

Dapagliflozin is an SGLT2 inhibitor that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals. In an ICH E14 thorough QTc crossover study of 50 healthy men, single therapeutic (20 mg) and supratherapeutic (150 mg) doses yielded upper bounds of the one-sided 95% confidence intervals for placebo-corrected QTc changes strictly below 10 ms. QTc variations were independent of plasma concentrations, with no values exceeding 450 ms and no increases greater than 30 ms from baseline.

Scientific Sources / References

https://www.fda.gov/media/178811/download, https://doi.org/10.1007/s13300-011-0003-2

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