Cerebrovascular Accident in a High-Risk Patient During the Early Initiation Phase With Canagliflozin.

Objective: To report a case of cerebrovascular accident (CVA) in a high-risk patient following initiation of canagliflozin, the first-in-class sodium-glucose-co-transporter 2 inhibitor approved by the Food and Drug Administration for type 2 diabetes mellitus.

Case Summary: We describe a 62-year-old woman, with multiple clinical risk factors for stroke, who began canagliflozin 300 mg daily in addition to basal insulin therapy for diabetes management. The patient developed expressive aphasia 15 days following initiation of canagliflozin. Neuroimaging revealed acute infarcts of the left basal ganglia and temporal and parietal lobes. The patient was diagnosed with a CVA. Canagliflozin therapy was discontinued, metformin therapy was reinitiated in addition to the patient's basal insulin, and the patient was treated with antiplatelet, statin, and speech therapies.

Discussion: Assessment of the cardiovascular (CV) safety of canagliflozin is currently being investigated. A numerical increase in CV events, including nonfatal stroke, has been noted in preliminary data from ongoing analyses of canagliflozin in patients with preexisting CV risk factors. Although significant clinical risk factors were present in the patient described, a workup for routine causality came back negative. According to the Naranjo probability score, initiation of canagliflozin had a possible to probable association with the patient's CVA.

Conclusions: This case suggests a potential association between the timing of canagliflozin initiation and development of stroke in patients with multiple clinical risk factors. We advise practitioners to use caution when initiating this new agent in patients at high risk for stroke while long-term CV safety surveillance is ongoing.