The effect of low and high dose empagliflozin on HbA1c and lipid profile in type 2 diabetes mellitus: A real-world data

OBJECTIVE: This study aims to evaluate the efficacy and safety of the addition of 10 or 25 mg of empagliflozin to patients with type 2 diabetes mellitus using a maximum tolerable dose of metformin and gliclazide.
METHODS: A total of 60 patients who had been receiving a maximum tolerable dose of metformin plus gliclazide. was divided into two groups in this study. In the first group (Group 1, n=32), 10 mg empagliflozin was added to the current treatment once a day, and in the second group (Group 2, n=28) 25 mg empagliflozin was added to the same treatment once a day. Biochemical results, weight and blood pressure changes of the patients in both groups were evaluated before and after 12 weeks of empagliflozin addition. Patients who developed urinary tract and genital infections after treatment were recorded.
RESULTS: There was a statistically significant decrease in HbA1c in both groups after empagliflozin treatment (Group 1, p<0.001 and Group2, p=0.001). When the lipid profile was evaluated, no significant difference was found between basal and post-treatment parameters (p>0.05). Patients in Group 1 and Group 2 lost 2.6±1.2 and 3.8±2.0 kg of body weight, respectively (p<0.0001 for each). There were also significant reductions in systolic and diastolic blood pressure for groups 1 and 2 (p<0.0001 for each). Although there was a numerical increase in the urinary tract and genital infections in both groups after empagliflozin treatment, there was no statistically significant difference compared to the pre-treatment period (p>0.05).
CONCLUSION: Two doses of empagliflozin added to the present treatments showed a dose-independent improvement in glycemic control and a neutral effect on lipid metabolism.

Tip 2 Diabetes mellitusta düþük ve yüksek doz empagliflozinin HbA1c ve lipid profili üzerine etkisi

Amaç: Bu çalýþmanýn amacý, maximum tolere edilebilir dozda metformin ve gliklazid kullanan Tip 2 diabetes mellitus hastalarýnda 10 veya 25 mg empagliflozin eklenmesinin etkinliðini ve güvenliðini deðerlendirmektir.
Gereç ve Yöntem: Maksimum tolere edilebilir dozda metformin ve gliklazid kullanan toplam 60 hasta iki gruba ayrýldý. Birinci grupta (grup-1), mevcut tedaviye günde bir kez 10 mg (n=32) empagliflozin ve ikinci grupta (grup-2) ise tedaviye günde bir kez 25 mg (n: 28) empagliflozin eklenmiþ hastalar deðerlendirildi. Her iki gruptaki hastalarýn empagliflozin eklenmesinden önceki ve 12 hafta sonrasýndaki biokimyasal sonuçlarý, kilo ve kan basýnç deðiþiklikleri deðerlendirildi. Ayrýca empagliflozin tedavilerinden sonra idrar yolu ve genital enfeksiyon geliþen hastalar kaydedildi.
Bulgular: Tedavi sonrasý, her iki grupta da HbA1c ile ilgili istatistiksel olarak anlamlý düþüþler vardý (grup-1, p<0,001 ve grup-2, p=0,001). Lipid profili deðerlendirildiðinde, bazal ve tedavi sonrasý parametreler arasýnda anlamlý fark olmadýðý tespit edildi (p>0,05). Group-1 ve group 2‘de vücut aðýrlýðýnda sýrasýyla-2.6±1.2 ve-3.8±2,0 kg kadar kayýp gözlendi (her biri için p<0,0001). Yine sistolik ve diastolik kan basýncýnda grup-1 ve 2 için anlamlý azalmalara rastlandý (her biri için p<0,0001). Her iki empagliflozin grubunda idrar yolu ve genital enfeksiyonlarda her ne kadar sayýsal olarak artma olsa da tedavi öncesi döneme göre istatistiksel olarak anlamlý bir fark yoktu (p>0,05).
Sonuç: Mevcut tedavilere eklenen iki empagliflozin dozu, glisemik kontrolde dozdan baðýmsýz bir iyileþme ve lipid metabolizmasýna ise nötr bir etki ortaya koydu. (NCI-2019-0211)