Retrospective cases showed that some patients treated with canagliflozin had severe diabetes ketoacidosis…
The Food Drug Administration (FDA) had previously reported that Invokana® (canagliflozin) had cases of diabetes ketoacidosis (DKA) in type 2 diabetes; however, a recent study done by Janssen Research & Development shows that patients who were taking canagliflozin had lower events of DKA than previously reported.
This study was performed in 17,596 patients to demonstrate the severity of diabetes ketoacidosis in type 2 diabetes mellitus patients using canagliflozin.
In this trial, there were 12 cases (0.07%) of serious adverse events of DKA and related events were reported. The authors found 4 cases (0.07%) with an incidence rate of 0.522 in patients who were treated with canagliflozin 100 mg, 6 cases (0.11%) with an incidence rate of 0.763 in patients who were treated with canagliflozin 300 mg and 2 cases (0.03%) with an incidence rate of 0.238 of those on comparator; each incidence rate was per one thousand patient-years. Most of those patients who were diagnosed had DKA precipitating factors, including some with type 1 diabetes/latent autoimmune, were on insulin, and blood glucose level were >300 mg/dL (16.7 mmol/L).
The authors concluded that, “DKA and related events occurred at a low frequency in the canagliflozin type 2 diabetes program, with an incidence consistent with limited existing observational data in the general population with type 2 diabetes.”
- Invokana is beneficial in the management of type 2 diabetes in patients with hypertension and obesity.
- Use with caution in elderly patients due to dropping in blood pressure.
- Monitor closely patients with kidney disease.
Erondu, Ngozi, Mehul Desai, Kirk Ways, and Gary Meininger. “Diabetic Ketoacidosis and Related Events in the Canagliflozin Type 2 Diabetes Clinical Program.” Diabetes Care (2015): Dc151251.