Thewjitcharoen Yotsapon, Yenseung Nalin, Malidaeng Areeya, Nakasatien Soontaree, Chotwanvirat Phawinpon, Krittiyawong Sirinate, Wanothayaroj Ekgaluck, Himathongkam Thep
Diabetes and Thyroid Center, Theptarin Hospital, Bangkok, Thailand.
Diabetol Metab Syndr. 2017 Dec 1;9:96. doi: 10.1186/s13098-017-0297-y. eCollection 2017.
Diabetes is a progressive disease needing multiple drugs for achieving and maintaining good glycemic control. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) is a novel class of anti-diabetic agent which offers several beneficial effects. However, the long-term effectiveness in clinical practice and safety data of SGLT2 inhibitors is limited, especially in Asian patients. To better understand the effectiveness of SGLT2i in clinical practice, we conducted a retrospective evaluation of patients with diabetes on SGLT2i.
This retrospective observational study uses data of patients with diabetes who had been prescribed SGLT2i and continued to use at least 6 months at Theptarin Hospital, Bangkok. The characteristics of patients, changes in glycemic control and body weight at 3, 6, 12, 18, 24 months and the last follow-up were evaluated.
A total of 189 patients with diabetes (females 50.3%, mean age 59.9 ± 12.3 years, T2DM 97.3%, duration of diabetes 16.3 ± 9.2 years, baseline BMI 29.9 ± 6.1 kg/m, baseline HbA 8.8 ± 1.6%) were prescribed SGLT2i during the study period. At the time of first SGLT2i prescription, 80.4% used three or more other anti-diabetic agents concomitantly and 34.6% used insulin concomitantly. 151 patients who continue to use at least 6 months were included in analysis. At the last follow-up (median time 16 months), overall median HbA reduction and weight reduction were 1.0% and 1.5 kg, respectively. While glycemic control could maintain up to 18 months, weight loss gradually rebounded after the first 6 months and then backed to baseline body weight at 18 months (78.2 ± 18.0 kg vs. 78.0 ± 17.8, p value = 0.324). The incidence of adverse drug reactions of special interest (polyuria, volume depletion-related events, urinary tract infection, genital infection, and hypoglycemia) was 2.1, 1.6, 2.1, 2.6, and 7.9%, respectively.
This real-world study confirmed long-term durability of glycemic control with SGLT2i in not only monotherapy, but also add-on studies with other oral anti-diabetic drugs and/or insulin treatment. However, weight loss became evident early after 6 weeks then reached slightly rebounds after 24 weeks until the end of follow-up. Further studies should be done towards a better understanding of treatment with SGLT2i in routine clinical practice.
糖尿病是一种进展性疾病,需要多种药物来实现并维持良好的血糖控制。钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)是一类新型抗糖尿病药物,具有多种有益作用。然而,SGLT2抑制剂在临床实践中的长期有效性和安全性数据有限,尤其是在亚洲患者中。为了更好地了解SGLT2i在临床实践中的有效性,我们对使用SGLT2i的糖尿病患者进行了一项回顾性评估。
这项回顾性观察性研究使用了在曼谷Theptarin医院开具SGLT2i并持续使用至少6个月的糖尿病患者的数据。评估了患者的特征、在3、6、12、18、24个月及最后一次随访时血糖控制和体重的变化。
在研究期间,共有189例糖尿病患者(女性占50.3%,平均年龄59.9±12.3岁,2型糖尿病占97.3%,糖尿病病程16.3±9.2年,基线体重指数29.9±6.1kg/m,基线糖化血红蛋白8.8±1.6%)开具了SGLT2i。在首次开具SGLT2i时,80.4%的患者同时使用了三种或更多其他抗糖尿病药物,34.6%的患者同时使用了胰岛素。151例持续使用至少6个月的患者被纳入分析。在最后一次随访(中位时间16个月)时,总体糖化血红蛋白中位数降低和体重减轻分别为1.0%和1.5kg。虽然血糖控制可持续长达18个月,但体重减轻在最初6个月后逐渐反弹,然后在18个月时恢复到基线体重(78.2±18.0kg对78.0±17.8kg,p值=0.324)。特别关注的药物不良反应(多尿、容量耗竭相关事件、尿路感染、生殖器感染和低血糖)的发生率分别为2.1%、1.6%、2.1%、2.6%和7.9%。
这项真实世界研究证实了SGLT2i不仅在单药治疗中,而且在与其他口服抗糖尿病药物和/或胰岛素联合治疗中,血糖控制具有长期持久性。然而,体重减轻在6周后早期明显,然后在24周后略有反弹,直至随访结束。应进一步开展研究,以更好地了解SGLT2i在常规临床实践中的治疗情况。