简介2型糖尿病(T2DM),一种普遍的慢性代谢紊乱,需要多方面的治疗方法。新兴研究强调了钠-葡萄糖转运蛋白2(SGLT2)和二肽基肽酶4(DPP-4)抑制剂在T2DM中的心血管优势。本研究探讨了西格列汀和达格列净的固定剂量组合(FDC)的协同作用,为印度人口提供其安全性和有效性的见解。方法这个现实世界,回顾性,观察性研究涵盖了111个印度中心的328例病例,评估安全性,功效,在获得伦理批准后,西格列汀和达格列净FDC在T2DM患者中的临床应用。基线评估,第4周,第12周包括血红蛋白A1C(HbA1C),空腹血糖(FPG),餐后血糖(PPBG),低密度脂蛋白胆固醇(LDL-C),收缩压(SBP),舒张压(DBP),体重变化。统计分析是使用社会科学统计软件包(SPSS)29.0.1.0(171)版(IBMCorp.,Armonk,NY,美国),显著性水平p<0.05。结果研究参与者[平均年龄:51.14±5.55岁,77.74%(n=255)男性,22.26%(n=73)女性]表现出常见的危险因素,例如久坐的生活方式(n=167,50.91%)和吸烟(n=147,44.82%)。合并症包括高血压(n=235,71.65%)和血脂异常(n=139,42.38%)。二甲双胍(n=282,85.98%)和磺酰脲(n=134,40.85%)通常是口服抗糖尿病药(OAD)。FDC给药在第12周显著降低HbA1c1.05±0.83%(p<0.0001)。FPG和PPBG显着降低了22.98±22.23mg/dL(p<0.0001),4周时分别为165.50±37.02mg/dL和40.94±36.04mg/dL(p<0.0001)。到第12周,SBP显着降低(14.61±13.98mmHg降低,p值<0.0001),DBP(降低7.80±8.45mmHg,p值<0.0001),和LDL-C水平(降低18.14±23.95mg/dL,p值<0.0001)。在患有心血管疾病的患者中,12周后HbA1c水平降低1.02±0.63%,FPG降低54.52±32.67mg/dL,PPBG降低88.73±44.90mg/dL。治疗引起的不良事件包括头痛,排尿的变化,生殖器真菌感染,轻微的恶心和腹泻,瞬态,并且不需要停止治疗。结论FDC联合西格列汀和达格列净可显著改善T2DM患者的血糖控制和血脂水平。尤其是那些患有冠状动脉疾病的人。它在印度人口中表现出良好的安全性,这表明其作为一种有效和耐受性良好的治疗选择在已确定的心血管疾病患者的潜力。
Introduction Type 2 diabetes mellitus (T2DM), a prevalent chronic metabolic disorder, necessitates multifaceted treatment approaches. Emerging studies highlight the cardiovascular advantages of sodium-glucose transport protein 2 (SGLT2) and dipeptidyl peptidase 4 (DPP-4) inhibitors in T2DM. This investigation delves into the synergistic effects of the fixed-dose combination (FDC) of sitagliptin and dapagliflozin, offering insights into its safety and efficacy for the Indian population. Methods This real-world, retrospective, observational study spanned 328 cases across 111 Indian centres, evaluating the safety, efficacy, and clinical utilization of the sitagliptin and dapagliflozin FDC in T2DM patients after obtaining ethical approval. Assessments at baseline, week four, and week 12 encompassed hemoglobin A1C (HbA1C), fasting plasma glucose (FPG), postprandial blood glucose (PPBG), low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), and weight change. The statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 29.0.1.0(171) (IBM Corp., Armonk, NY, USA) with a significance level p<0.05. Results Study participants [mean age: 51.14±5.55 years, 77.74% (n=255) males, 22.26% (n=73) females] exhibited prevalent risk factors like sedentary lifestyle (n=167, 50.91%) and smoking (n=147, 44.82%). Comorbidities included hypertension (n=235, 71.65%) and dyslipidaemia (n=139, 42.38%). Metformin (n=282, 85.98%) and sulfonylurea (n=134, 40.85%) were commonly prescribed concomitant oral antidiabetic agents (OADs). FDC administration significantly reduced HbA1c by 1.05 ± 0.83% (p < 0.0001) at week 12. FPG and PPBG showed significant reductions of 22.98 ± 22.23 mg/dL (p < 0.0001), 165.50 ± 37.02 mg/dL and 40.94 ± 36.04 mg/dL (p < 0.0001) at four weeks respectively. By week 12, significant reductions were noted in SBP (14.61±13.98mmHg reduction, p-value <0.0001), DBP (7.80±8.45mmHg reduction, p-value <0.0001), and LDL-C levels (18.14±23.95 mg/dL reduction, p-value <0.0001). In patients with established cardiovascular disease, there was reduction in HbA1c levels by 1.02 ± 0.63% after 12 weeks, with FPG decreasing by 54.52 ± 32.67 mg/dL and PPBG decreasing by 88.73 ± 44.90 mg/dL. Treatment-emergent adverse events included headache, changes in micturition, genital mycotic infection, and nausea and diarrhoea which were mild, transient, and necessitated no treatment discontinuation. Conclusion The FDC of sitagliptin and dapagliflozin significantly improved glycaemic control and lipid profiles in T2DM patients, particularly those with coronary artery disease. It demonstrated a favourable safety profile in the Indian population, signifying its potential as an effective and well-tolerated therapeutic option in patients with established cardiovascular disease.