Ceritinib-associated hyperglycemia in the Japanese Adverse Drug Event Report Database

Haruka Fujita1, Takaaki Murakami1, Fumiaki Tomoike2

  • 1Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Insights

Ceritinib, an anaplastic lymphoma kinase inhibitor, may increase the risk of hyperglycemia in non-small cell lung cancer patients. This finding suggests careful monitoring for elevated blood sugar is crucial when using ceritinib.

Area of Science:

  • Oncology
  • Pharmacovigilance
  • Endocrinology

Background:

  • Anaplastic lymphoma kinase (ALK) rearrangements drive non-small cell lung cancer (NSCLC) pathogenesis.
  • Ceritinib is an effective ALK inhibitor, even for patients with resistance to other ALK inhibitors.
  • A potential link between ceritinib and hyperglycemia requires investigation.

Purpose of the Study:

  • To investigate the association between ceritinib use and hyperglycemia.
  • To compare the risk of hyperglycemia with ceritinib versus other ALK inhibitors (crizotinib, alectinib).

Main Methods:

  • Disproportionality analysis of the Japanese Adverse Drug Event Report database (April 2004 - November 2018).
  • Calculation of reporting odds ratios (ROR) for hyperglycemia associated with ceritinib, crizotinib, and alectinib.
  • Analysis of ROR for ceritinib, excluding cases using antidiabetes agents.

Main Results:

  • Ceritinib showed a significantly increased reporting odds ratio (ROR) for hyperglycemia (2.25; 95% CI 1.24-4.08).
  • Crizotinib had a significantly decreased ROR (0.07; 95% CI 0.01-0.40), and alectinib showed no significant association (0.94; 95% CI 0.30-2.94).
  • Even without concomitant antidiabetes agents, ceritinib's ROR for hyperglycemia remained elevated (2.54; 95% CI 1.27-5.12).

Conclusions:

  • Ceritinib use is associated with an increased risk of hyperglycemia.
  • Healthcare providers should carefully monitor blood glucose levels in patients treated with ceritinib.
  • This finding highlights an important safety consideration for ceritinib in NSCLC treatment.

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