Comparisons of sodium-glucose cotransporter 2 inhibitors-induced adverse reactions between Japanese and non-Japanese patients: a pooled analysis of randomized controlled trials
Abstract
[INTRODUCTION] Sodium-glucose co-transporter 2 inhibitor (SGLT2-i) is the oral antidiabetic drug for type 2 diabetes (T2DM). To date, six SGLT2-i have been approved in Japan (canagliflozin, dapagliflozin, empagliflozin, ipragliflozin, luseogliflozin, tofogliflozin). In the EMPA-REG OUTCOME trial, empagliflozin which was added on the standard drug reduced the risk of cardiovascular events by 14% in patients with T2DM compared with the placebo group, and subgroup analysis reported that empagliflozin reduced the risk of cardiovascular events by 32% in Asian patients with T2DM compared with the placebo group. In this study, we aimed to compare the frequencies of adverse reactions in addition to the risk of cardiovascular events of SGLT2-i between the Japanese and the non-Japanese patient by using the pooled clinical trials data. [METHODS] We extracted the adverse reaction data from common technical documents published by Pharmaceuticals and Medical Devices Agency (PMDA). For placebo-controlled randomized trials in adult patients with T2DM, data for at least 12 weeks of treatment and once-daily of intervention had been assessed. We added up the event numbers of genital tract infections, hypertension, hypoglycemia, major adverse cardiovascular events (MACE: composite of heart failure, myocardial infarction, stroke, angina pectoris), skin disorders, and urinary tract infections, respectively, and then calculated each relative risk ratio. [RESULTS] There was a significantly higher…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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