2023 Volume 12 Pages 23-29
Purpose: Dehydration is an important risk of SGLT2 inhibitors. Although dehydration may lead to thrombosis and embolism, especially cerebral infarction, this concern has not been clinically validated. As a result, cerebral infarction is considered a suspected risk of these inhibitors. To determine whether treatment with SGLT2 inhibitors lead to cardiovascular adverse events, spontaneous adverse event reports were retrieved from a database and assessed using two statistical approaches.
Methods: Two approaches were employed to evaluate the spontaneous reports from the Japanese Adverse Drug Event Report (JADER) database: (1) the traditional safety signal, proportional reporting ratios (PRRs), of cardiovascular adverse events related to treatment with SGLT2 inhibitors; and (2) the new safety signal, odds ratios (ORs), between dehydration (Preferred Term [PT]) and cardiovascular adverse events in SGLT2 inhibitor reports.
Results: A positive PRR (7.13) was found between cerebral infarction [PT] and treatment with SGLT2 inhibitors. However, cerebral infarction [PT] was not associated with dehydration [PT] (OR = 0.35) in the SGLT2 inhibitor reports. Such finding does not align with the concern that dehydration due to treatment with SGLT2 inhibitors may lead to cerebral infarction.
Conclusion: Cerebral infarction due to dehydration has been a concern for patients with diabetes treated with SGLT2 inhibitors. However, to contradict the concern, the relationship between SGLT2 inhibitors, dehydration, and cerebral infarction was not clear. It is believed that this study brings us closer to more informed drug selection assessing the risks and benefits of patient and that is, a personalized medicine approach.
