REVIEW

Efficacy and Safety of Empagliflozin in Type 1 Diabetes Mellitus Patients: A Systematic Review
Empagliflozinin Tip 1 Diabetes Mellitus Hastalarında Etkililiği ve Güvenliliği: Sistematik Bir Derleme
Received Date : 18 Apr 2021
Accepted Date : 05 Oct 2021
Available Online : 21 Oct 2021
Doi: 10.25179/tjem.2021-83912 - Makale Dili: EN
Turk J Endocrinol Metab. 2021;25:426-438
Bu makale, CC BY-NC-SA altında lisanslanmış açık erişim bir makaledir.
ABSTRACT
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.
ÖZET
Tip 1 diabetes mellitus (T1DM) hastalarında, empagliflozinin etkililiği ve güvenliliği hâlen yeterince çalışılmamış olduğundan bu geleneksel-sistematik derlemede, bu konunun gözden geçirilmesi amaçlandı. Farklı empagliflozin dozajları ve plasebo alan hastalarda, yukarıdaki kriterleri analiz eden randomize kontrollü çalışmalar için PubMed, Embase ve Scopus veri tabanları tarandı. Tarama sonrası 45 ülkeden yaklaşık 1.870 T1DM hastasının verilerini rapor eden 5 uygun çalışma seçildi. Bu çalışmalarda test edilen empagliflozin dozajları 2,5, 10 ve 25 mg idi. Çalışmalardaki ön yargı riski, genel olarak düşük veya belirsizdi (Cochrane aracı kullanıldı). Mevcut çift-kör, randomize kontrollü çalışmalar, empagliflozin ile tedavi edilen T1DM hastalarında glikolize hemoglobin, vücut ağırlığı ve haftalık toplam insülin gereksiniminde doza bağlı bir azalma olduğunu ortaya koydu. Ketoasidoz, idrar yolu enfeksiyonu ve yan etkiler nedeniyle çalışmanın kesilmesi, empagliflozinin nadir görülen yan etkileriydi. Genital enfeksiyon ise ağırlıklı olarak 10 veya 25 mg empagliflozin alanlarda meydana geldi.
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