Table 1.
Cases of DKA and ketoacidosis in postmarketing reports by drug manufacturers of adverse events in patients treated with SGLT2 inhibitors
| Age (years) | Sex | BMI (kg/m2) | pH | BG (mg/dL) | Possible contributing factors |
|---|---|---|---|---|---|
| Ipragliflozin | |||||
| 30s | F | 28.4 | 7.121 | 185 | Cessation of insulin secretagogue, carbohydrate restriction |
| 70s | M | 21.9 | 7.120 | 619 | Cessation of insulin secretagogue |
| 20s | M | 31.2 | ND | ND | Starvation (for 3 days) |
| 40s | M | 38.5 | ND | 245 | NA |
| 30s | M | 31.8 | ND | ND | Strenuous exercise? |
| 70s | F | 17.4 | ND | 413 | NA |
| 20s | F | 36.7 | ND | 292 | NA |
| 80s | F | 16.7 | ND | 398 | NA |
| 20s | F | 29.4 | 7.268 | 175 | NA |
| 60s | F | 16.9 | ND | ND | Appetite loss due to a flulike condition |
| 60s | M | 35.3 | 7.348 | 157 | NA |
| 50s | F | 20.3 | ND | 140 | NA |
| 60s | M | NA | ND | ND | NA |
| Dapagliflozin | |||||
| 50s | F | ND | ND | ND | Cessation of insulin |
| 60s | M | ND | 7.1 | 198 | Cessation of insulin |
| 70s | F | ND | 7.2 | 450 | NA |
| 40s | M | ND | 7.312 | 188 | Pancreatic cancer |
| 40s | F | ND | ND | ND | NA |
| 30s | F | ND | ND | 90 | Appendicitis |
| Tofogliflozin | |||||
| 30s | M | ND | ND | ND | Sick days(not specified) |
| 40s | M | ND | ND | ND | Carbohydrate restriction |
| 80s | F | ND | ND | ND | NA |
| Luseogliflozin | |||||
| 50s | M | ND | ND | ND | Cerebral infarction |
| Canagliflozin | |||||
| 50s | M | ND | ND | ND | Heavy alcohol use |
| 50s | F | ND | ND | ND | Influenza |
| 40s | M | ND | ND | ND | Cessation of insulin due to appetite loss |
| 60s | F | ND | ND | ND | Cessation of insulin and insulin secretagogue |
| Empagliflozin | |||||
| 30s | M | ND | ND | 798 | NA |
DKA, diabetic ketoacidosis; SGLT2, sodium‐glucose cotransporter 2; BMI, body mass index; pH, arterial blood pH; BG, blood glucose; ND, not determined; NA, information not available. In most cases, it is not known whether blood glucose level was determined with whole blood or plasma. The information described is available on the following websites (in Japanese): ipragliflozin, http://med2.astellas.jp/med/jp/basic/details/SGL/shihanchosa/shchosa-sgl07.pdf; dapagliflozin, http://med2.astrazeneca.co.jp/product/fxg_report201506.pdf and https://www.ononavi1717.jp/contents/pdf/diabetes/forxiga/report12.pdf; tofogliflozin, http://e-mr.sanofi.co.jp/di/information/apw_interim.pdf?date=20150622094749 and http://www.kowa-souyaku.co.jp/file/1506se_dbt.pdf; luseogliflozin; http://medical.nikkeibp.co.jp/all/special2/lusefi/pdf/survey_lusg_01.pdf; canagliflozin, http://medical.mt-pharma.co.jp/intro/can/pdfs/sideeffect_150716.pdf; and empagliflozin, http://www.bij-kusuri.jp/information/jad_t_info_201507.pdf.