Hussain Mazhar, Elahi Asim, Iqbal Javed, Bilal Ghafoor Muhammad, Rehman Habib, Akhtar Shoaib
Pharmacology, Sheikh Zayed Medical College and Hospital, Rahim Yar Khan, PAK.
Internal Medicine, Pikeville Medical Center, Pikeville, USA.
Cureus. 2021 Apr 3;13(4):e14268. doi: 10.7759/cureus.14268.
Background Type 2 diabetes is a chronic metabolic disorder that is escalating at an alarming rate worldwide. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are recent oral antihyperglycemic drugs (OADs) with a unique mechanism of action. Objectives This study aimed compared the efficacy and safety profiles of two SGLT-2 inhibitors, empagliflozin and dapagliflozin, in patients with type 2 diabetes as add-on therapy to traditional first-line OADs. Methods We conducted a randomized controlled trial comparing empagliflozin and dapagliflozin in patients with type 2 diabetes. Patients were included in the study if they had type 2 diabetes with inadequate glycemic control, defined as glycated hemoglobin (HbA1c) of 7.5% to 11.0%, treated with conventional first-line OADs. Study participants were randomly assigned into two groups. Group A patients received oral empagliflozin, 10 to 25 mg, and Group B patients received oral dapagliflozin, 5 to 10 mg, for 12 weeks. The primary endpoint was the efficacy profile for each SGLT-2 agent in terms of body weight changes, body mass index (BMI), fasting blood glucose (FBG), and HbA1c. The secondary endpoint was to determine the safety and tolerability profiles of each SGLT-2 agent. Results After 12 weeks of treatment, the mean body weight was reduced significantly in both groups from baseline (empagliflozin: -3.2 kg ± 5.5 kg, p = 0.003; dapagliflozin -2.1 kg ± 4.6 kg, p = 0.008). However, the mean body weight reduction between groups was not statistically significant (p = 0.078). BMI was significantly reduced in both groups (empagliflozin from 28.5 ± 4.9 kg/m to 25.8 ± 5.2 kg/m, p = 0.002; dapagliflozin from 29 ± 5.2 kg/m to 27.7 ± 4.8 kg/m, p = 0.003). However, the patients who received empagliflozin experienced a significantly greater reduction in BMI than patients who received dapagliflozin (p = 0.007). The mean FBG was also reduced in both study groups (empagliflozin: -88.5 mg/dL ± 39.7 mg/dl, p = 0.003; dapagliflozin: -59.8 mg/dL ± 48.5 mg/dL; p = 0.007). However, the patients who received empagliflozin experienced a significantly greater reduction in mean FBG than patients who received dapagliflozin (p = 0.001). HbA1c was also significantly reduced in both groups (empagliflozin: -2.1% ± 1.1%, p = 0.002; dapagliflozin: -1.4% ± 0.9%; p = 0.004). However, patients who received empagliflozin experienced a significantly greater reduction in HbA1c than patients who received dapagliflozin (p = 0.001). The tolerability profiles of both SGLT-2 agents were quite good, and no major adverse effects were reported in the study groups. Urinary infection occurred more often in patients who received dapagliflozin (9.3%) than in patients who received empagliflozin (4.5%; p = 0.002). Patients in the dapagliflozin group also had a higher incidence of genital infections (7.3%) than those in the empagliflozin group (3.8%; p = 0.001). Conclusion Both empagliflozin and dapagliflozin demonstrated excellent efficacy and safety profiles in our study. These agents should be considered as add-on therapy in patients with type 2 diabetes taking conventional first-line OADs.
背景 2 型糖尿病是一种慢性代谢紊乱疾病，在全球范围内正以惊人的速度上升。钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂是最近出现的口服降糖药（OADs），其作用机制独特。目的 本研究旨在比较两种 SGLT-2 抑制剂恩格列净和达格列净作为传统一线 OADs 附加治疗药物在 2 型糖尿病患者中的疗效和安全性。方法 我们进行了一项随机对照试验，比较恩格列净和达格列净在 2 型糖尿病患者中的疗效。如果患者患有 2 型糖尿病且血糖控制不佳，糖化血红蛋白（HbA1c）为 7.5%至 11.0%，并接受传统一线 OADs 治疗，则纳入本研究。研究参与者被随机分为两组。A 组患者口服恩格列净，剂量为 10 至 25 毫克，B 组患者口服达格列净，剂量为 5 至 10 毫克，治疗 12 周。主要终点是每种 SGLT-2 药物在体重变化、体重指数（BMI）、空腹血糖（FBG）和 HbA1c 方面的疗效。次要终点是确定每种 SGLT-2 药物的安全性和耐受性。结果 治疗 12 周后，两组患者的平均体重均较基线显著降低（恩格列净：-3.2 千克±5.5 千克，p = 0.003；达格列净：-2.1 千克±4.6 千克，p = 0.008）。然而，两组之间的平均体重降低差异无统计学意义（p = 0.078）。两组患者的 BMI 均显著降低（恩格列净从 28.5±4.9 千克/米降至 25.8±5.2 千克/米，p = 0.002；达格列净从 29±5.2 千克/米降至 27.7±4.8 千克/米，p = 0.003）。然而，接受恩格列净治疗的患者 BMI 降低幅度显著大于接受达格列净治疗的患者（p = 0.007）。两个研究组的平均 FBG 也均降低（恩格列净：-88.5 毫克/分升±39.7 毫克/分升，p = 0.003；达格列净：-59.8 毫克/分升±48.5 毫克/分升；p = 0.007）。然而，接受恩格列净治疗的患者平均 FBG 降低幅度显著大于接受达格列净治疗的患者（p = 0.001）。两组患者的 HbA1c 也均显著降低（恩格列净：-2.1%±1.1%，p = 0.002；达格列净：-1.4%±0.9%；p = 0.004）。然而，接受恩格列净治疗的患者 HbA1c 降低幅度显著大于接受达格列净治疗的患者（p = 0.001）。两种 SGLT-2 药物的耐受性均良好，研究组未报告重大不良反应。接受达格列净治疗的患者发生尿路感染的频率（9.3%）高于接受恩格列净治疗的患者（4.5%；p = 0.002）。达格列净组患者发生生殖器感染的发生率（7.3%）也高于恩格列净组（3.8%；p = 0.001）。结论 在我们的研究中，恩格列净和达格列净均显示出优异的疗效和安全性。这些药物应被视为 2 型糖尿病患者在服用传统一线 OADs 时的附加治疗药物。
