Sahay Rakesh Kumar, Mittal Vinod, Gopal G Raja, Kota Sunil, Goyal Ghanshyam, Abhyankar Mahesh, Revenkar Santosh
Department of Endocrinology, Osmania Medical College, Hyderabad, IND.
Centre for Diabetes & Metabolic Diseases, Delhi Heart & Lung Institute, New Delhi, IND.
Cureus. 2020 Sep 28;12(9):e10700. doi: 10.7759/cureus.10700.
Objective To evaluate the usage of various strengths of glimepiride and metformin fixed-dose combinations in the management of type 2 diabetes mellitus (T2DM) patients with comorbidities and complications. Methods A retrospective, non-randomized, non-comparative, multi-centric real-world study included T2DM patients (age > 18 years) taking glimepiride and metformin fixed-dose combinations. Age, duration of diabetes, diabetes complications, comorbidities (hypertension and dyslipidemia), dosage frequency, and concomitant medications were analyzed from medical charts. Results A total of 4858 T2DM patients were included, with a mean age of 52.67 years and males being predominant in the study population (60.85%). The laboratory investigations showed a mean glycated hemoglobin (HbA1c) of 7.5, low-density lipoprotein (LDL) cholesterol of 104.81 ± 38.19 mg/dL, and serum creatinine of 0.88 ± 0.26 mg/dL. Around 2055 (42.30%) T2DM patients were hypertensive, and telmisartan alone and a telmisartan-based combination were the drugs of choice for hypertension management. Similarly, 1073 (22.08%) T2DM patients were having dyslipidemia and were primarily managed with rosuvastatin and its combination in 664 (62%) patients. Macrovascular complications were observed in 339 (6.97%) T2DM patients, among which coronary artery disease (CAD) had maximum prevalence, affecting 273 (5.61%) T2DM patients. Microvascular complications were 1010 (20.79%) T2DM patients, among which neuropathy had affected a maximum of 686 (14.12%) followed by retinopathy (2.34%) and nephropathy (1.81%). Among the available 11 strengths, the glimepiride 2 mg and metformin 500 mg combination were most widely prescribed in 1297 (26.69%), followed by glimepiride 1 mg and metformin 500 mg in 1193 (24.57%) patients, and the preferred dosage pattern was twice a daily in 2665 (54.85%) T2DM patients. An age-wise prescription analysis showed that glimepiride and metformin combinations were the preferred choice for the management of diabetes across all the age groups. Conclusion The real-world evidence in the Indian clinical setting indicates that glimepiride and metformin fixed-dose combinations are widely used in the management in T2DM patients with comorbidities like hypertension, dyslipidemia, and diabetes complications. Glimepiride and metformin fixed-dose combinations are suitable for early as well as long-standing diabetes.
目的 评估不同强度的格列美脲和二甲双胍固定剂量复方制剂在合并症和并发症的2型糖尿病(T2DM)患者管理中的应用情况。方法 一项回顾性、非随机、非对照、多中心的真实世界研究纳入了服用格列美脲和二甲双胍固定剂量复方制剂的T2DM患者(年龄>18岁)。从病历中分析患者的年龄、糖尿病病程、糖尿病并发症、合并症(高血压和血脂异常)、给药频率及合并用药情况。结果 共纳入4858例T2DM患者,平均年龄52.67岁,研究人群中男性占主导(60.85%)。实验室检查显示糖化血红蛋白(HbA1c)均值为7.5,低密度脂蛋白(LDL)胆固醇为104.81±38.19mg/dL,血清肌酐为0.88±0.26mg/dL。约2055例(42.30%)T2DM患者患有高血压,单用替米沙坦及以替米沙坦为基础的复方制剂是高血压管理的首选药物。同样,1073例(22.08%)T2DM患者患有血脂异常,其中664例(62%)患者主要使用瑞舒伐他汀及其复方制剂进行治疗。339例(6.97%)T2DM患者出现大血管并发症,其中冠状动脉疾病(CAD)患病率最高,影响273例(5.61%)T2DM患者。微血管并发症患者有1010例(20.79%),其中神经病变影响最多,达686例(14.12%),其次是视网膜病变(2.34%)和肾病(1.81%)。在现有的11种强度中,格列美脲2mg和二甲双胍500mg复方制剂的处方量最大,为1297例(26.69%),其次是格列美脲1mg和二甲双胍500mg,为1193例(24.57%)患者,2665例(54.85%)T2DM患者的首选给药方案为每日两次。按年龄进行的处方分析显示,格列美脲和二甲双胍复方制剂是所有年龄组糖尿病管理的首选。结论 印度临床环境中的真实世界证据表明,格列美脲和二甲双胍固定剂量复方制剂广泛用于合并高血压、血脂异常和糖尿病并发症等合并症的T2DM患者的管理。格列美脲和二甲双胍固定剂量复方制剂适用于早期及长期糖尿病患者。