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探討 Dapagliflozin作為附加療法對併用Liraglutide及口服抗糖尿病藥物的2 型血糖控制不佳糖尿病人的臨床成效:33位個案析報告

Clinical effectiveness study of dapagliflozin as add-on for 33 inadequate glycemic control patients using Liraglutide and OADs

作者:Yuan-Ching Liu, Ching-Yi Lin, I-Ying Chiu, Neng-Chun Yu
摘要

Background—
Liraglutide and dapagliflozin have two different anti-diabetical action mechanisms. They have shown ability to improve the glycemic and body weight control. In this study, for those patients who used OADs and liraglutide but failed to meet the glycemic control criteria, dapa-gliflozin was added to evaluate the effectiveness of liraglutide on glycemic and body weight control.
Methods—
The design was a real-world, observational study. A retrospective case note audit of type 2 diabetes patients who were added dapagliflozin to their liraglutide regimens was performed in a diabetes clinic located at Yilan County, Taiwan. Datum of glycated hemoglobin (A1C), body weight (BW), and adverse events were collected to analyze the effectiveness of initiating dapagliflozin 10mg for 6 months.
Results—
33 patients were included in the final analysis. The average age at baseline was 53.4 ±11.1 and the mean DM duration was 12.7± 6.6 years. 60.6% of patients were male and the average A1C and body mass index (BMI) at baseline were 8.0 ±1.0% and 29.7±5.7 kg/m2, respectively. The mean duration of using liraglutide before initiating dapagliflozin 10mg was 100.2±30.0 weeks. 54.5% of patients used 1.2 mg daily lira-glutide and 45.5% of patients used 1.8 mg daily liraglutide at baseline. After adding dapagliflozin for 6 months, A1C has been reduced in 24 pa-tients (72.7%), and the overall A1C has been significantly reduced by 0.71± 0.95% (t = -4.33, p<0.001). A1C has been reduced by equal and more than 1% in 55.6% of 18 patients with 1.2 mg liraglutide and 26.7% of 15 patients with 1.8mg liraglutide. BW has been reduced in 29 patients (87.9%), and the overall BW has been significantly reduced by 2.13±2.24 kg (t = -5.46, p<0.001). Body weight has been reduced by equal and more than 3 kg in 38.9% of 18 patients with 1.2 mg liraglutide and 26.7% of 15 patients with 1.8 mg liraglutide. Before dapagliflozin being initiated, the incidence of hypoglycemia was 21.2%. After using dapagliflozin for 3 months, the incidence of hypoglycemia was 15.2% (5 out of 33 patients). However, one urogenital infection case has been self-reported.
Discussion—
This study showed that after taking 10 mg dapagliflozin plus liraglutide regimen for six months, overall reduction of A1C and BW was 0.7% and 2.1 kg, respectively. Similar studies have been conducteded by Vasilakou et al. (2013) and Fulcher et al. (2016). Based on the meta-analysis results, Vasilakou et al. concluded that when adding SGLT2 inhibitors with other non-GLP-1 receptor agonist agents, A1C and BW was reduced by 0.61% and 1.74 kg, respectively. On the other hand, Fulcher et al. concluded that various dosage of SGLT2 inhibitors adding to liraglutide regimen, A1C was reduced by 1.0 ~ 1.6% and BW was reduced by 2.7 ~ 3.5 kg. According to these results, adding SGLT2 into li-raglutide regimens had better A1C and BW control. When using different liraglutide baseline dosages, the difference of glycemic and body weight control was compared. Regarding to efficacy on glycemic control, for those patients taking 1.2 mg of liraglutide with poor A1C control, early addition of 10 mg dapagliflozin reduced more A1C. Meanwhile, regarding to the efficacy on BW control, patients with obesity taking 1.8 mg liraglutide had better BW control when adding 10 mg of dapagliflozin. With regard to adverse events, there was no increased incidence of hypoglycemia. However, a urogenital infection case had been reported. Vasilakou et al. concluded similar results as well.
Conclusions—
Dapagliflozin improved glycemic and weight control in patients who used OADs and liraglutide but failed to meet the glycemic control cri-teria. Reductions in A1C and body weight were not affected by the dose of liraglutide used at baseline. After using dapagliflozin for 3 months, the incidence of hypoglycemia was not increased but one urogenital infection case was self-reported.

Keywords: liraglutide, dapagliflozin, type 2 diabetes
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