Efficacy and Safety of Empagliflozin in Type 1 Diabetes Mellitus Patients: A Systematic Review
Abstract
Introduction Type 1 diabetes mellitus (T1DM) is primarily a childhood-onset hyperglycemic autoimmune condition resulting from the death of pancreatic beta cells. It’s triggered by genetic predisposition (human leukocyte antigen alleles such as DQ and DR) or viruses or environmental toxins, and other unknown factors (1,2). These patients are at risk of hyperglycemic complications such as diabetic retinopathy, diabetic nephropathy, diabetic neuropathy, diabetic ketoacidosis, and As the efficacy and safety of empagliflozin remain poorly studied in Type 1 diabetes mellitus (T1DM) patients, this narrative-systematic review aims to review it. The randomized controlled trials studying the above across different empagliflozin dosages and placebo got searched in PubMed, Embase, and Scopus databases. The database searches yielded 5 eligible trials reporting data of about 1,870 T1DM patients from 45 countries. The empagliflozin dosages tested in these trials were 2.5, 10, and 25 mg. The trials collectively showed a low or unclear risk of bias (Cochrane tool used). The existing double-blinded randomized controlled trials mainly suggest a dose-dependent decrease in glycated hemoglobin, body weight, and total weekly insulin requirement in empagliflozin-treated T1DM patients. Ketoacidosis, urinary tract infection, and study discontinuation due to side effects were rare adverse effects of empagliflozin. Genital infection predominantly occurred among recipients of 10 or 25 mg empagliflozin.
How strong is the evidence?
Evidence Hub reads this as a systematic review, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,870 participants or records.
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