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在至少4种口服抗糖尿病药物治疗仍未得到控制的亚洲印度裔2型糖尿病患者中,钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂作为第五种药物的疗效。

Efficacy of SGLT2 Inhibitors as the Fifth Drug in the Management of Type 2 Diabetes Mellitus in Asian Indians not Controlled with at least 4 Oral Antidiabetic Drugs.

作者信息

Panikar Vijay, Joshi Shashank R, Deogaonkar Narayan, Vadgama Jimit, Nasikkar Nikhil, Kamat Tejas, Sheikh Saalim, Jain Chandni C, Wagle Tejal

机构信息

Consultant, Department of Endocrinology, Lilavati Hospital and Research Centre, Mumbai, Maharashtra.

Owner, Deogaonkar Hospital, Nashik, Maharahstra.

出版信息

J Assoc Physicians India. 2018 Dec;66(12):46-49.

PMID:31315325
Abstract

AIM

To evaluate the efficacy of SGLT2 inhibitors as an add-on therapy along with stricter lifestyle modification in Asian Indian type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control despite receiving an optimum dose of at least 4 oral antidiabetic drugs (OADs).

METHODOLOGY

A retrospective analysis of data of 808 T2DM patients being treated with an SGLT2 inhibitor (Dapagliflozin, Empagliflozin or Canagliflozin) as an add-on drug in patients with inadequate glycemic control despite receiving optimum doses of at least any four OADs(metformin, sulphonylureas, pioglitazone, DPP4 Inhibitors, alpha-Glucosidase Inhibitors) and who preferred not to initiate insulin.

RESULTS

The average age of the patients included was 51.63 years (SD ± 9.88). 57.7% were males. Average weight was 81.95±16.08 kg. Mean duration of diabetes was 34.08±39.04 months. The mean baseline fasting plasma glucose was 198.21 ± 38.21 mg/dl and mean post prandial plasma glucose was 264.22 ± 45.22 mg/ dl. The baseline HbA1c was 8.92 ± 1.47 %. Total 87.4 % of the cases responded to addition of SGLT2 inhibitors during a mean follow-up period of 6 months. The fasting plasma glucose (FBS) was reduced by -63.65 ± 19.93 mg/dl to a mean FBS of 134.57 ± 33.65 mg/dl (P=0.001). The post prandial plasma glucose (PPBS) was reduced by -79.28 ± 23.57 mg/dl to a mean PPBS of 184.94 ± 38.34 mg/dl (P=0.001). The mean HbA1c reduced significantly by -1.63 ± 0.99 % (P= 0.001). The mean weight reduction at 6 months of therapy was -3.03± 01.84 kg that is 3.8 % decrease from baseline (p=0.001).The response in age group < 55 years was 90.9 %, whereas in ≥55 years, it was 82.2% (p=0.001). The males responded more (91.0%) compared to females (82.5%) (p=0.001). Those with BMI < 23.5 kg/ m2 had marginally higher but insignificant response of 93.0% as compared to 87.1% in patients with high a BMI (≥23.5 kg/m2) (p=0.253). Patients with < 5years duration of diabetes responded better (91.8%) as compared to patients with a ≥ 5 years of diabetes (85.4%).

CONCLUSION

SGLT2 inhibitors are effective in achieving desired glycemic goals even when used as a fifth add-on drug along with strict lifestyle modification in patients with inadequate glycemic control despite receiving an optimum dose of at least 4 oral antidiabetic drugs (OADs). SGLT2 inhibitors can be effectively used at any stage of diabetes.

摘要

目的

评估钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂作为附加疗法,联合更严格的生活方式改变,用于尽管接受了至少4种口服抗糖尿病药物(OAD)的最佳剂量但血糖控制仍不佳的亚洲印度2型糖尿病(T2DM)患者的疗效。

方法

对808例T2DM患者的数据进行回顾性分析,这些患者尽管接受了至少4种OAD(二甲双胍、磺脲类、吡格列酮、二肽基肽酶4抑制剂、α-葡萄糖苷酶抑制剂)的最佳剂量,但血糖控制仍不佳,且不愿起始胰岛素治疗,他们接受了SGLT2抑制剂(达格列净、恩格列净或卡格列净)作为附加药物治疗。

结果

纳入患者的平均年龄为51.63岁(标准差±9.88)。男性占57.7%。平均体重为81.95±16.08千克。糖尿病平均病程为34.08±39.04个月。平均基线空腹血糖为198.21±38.21毫克/分升,平均餐后血糖为264.22±45.22毫克/分升。基线糖化血红蛋白(HbA1c)为8.92±1.47%。在平均6个月的随访期内,总计87.4%的病例对添加SGLT2抑制剂有反应。空腹血糖(FBS)从-63.65±19.93毫克/分升降至平均FBS为134.57±33.65毫克/分升(P=0.001)。餐后血糖(PPBS)从-79.28±23.57毫克/分升降至平均PPBS为l84.94±38.34毫克/分升(P=0.001)。平均HbA1c显著降低-1.63±0.99%(P=0.001)。治疗6个月时平均体重减轻-3.03±1.84千克,即较基线下降3.8%(P=0.001)。年龄<55岁组的反应率为90.9%,而≥55岁组为82.2%(P=0.001)。男性的反应率(91.0%)高于女性(82.5%)(P=0.001)。体重指数(BMI)<23.5千克/平方米的患者反应率略高,为93.0%,但与高BMI(≥23.5千克/平方米)患者的87.1%相比无显著差异(P=0.253)。糖尿病病程<5年的患者反应较好(91.8%)高于病程≥5年的患者(85.4%)。

结论

即使作为第五种附加药物,联合严格的生活方式改变,SGLT2抑制剂对于尽管接受了至少4种口服抗糖尿病药物(OAD)的最佳剂量但血糖控制仍不佳的患者,在实现理想血糖目标方面是有效的。SGLT2抑制剂可在糖尿病的任何阶段有效使用。

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