Sethi Bipin, Sahay Rakesh, Tiwaskar Mangesh, Negalur Vijay, Dhediya Rajnish, Gaurav Kumar, Rathod Rahul, Kotak Bhavesh, Dhanaki Gauri, Shah Snehal
Department of Endocrinology, Care Hospitals, Hyderabad, Telangana, India.
Department of Endocrinology, Osmania Medical College, Hyderabad, Telangana, India.
Drugs Real World Outcomes. 2024 Mar;11(1):81-90. doi: 10.1007/s40801-023-00398-8. Epub 2023 Oct 28.
Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce.
An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed.
A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin (D) + metformin (M) + at least one other OAD [D + M + OAD, n = 2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin + metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.6 ± 1.41%; p < 0.05 for HbA1c subgroup ≥ 8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4 ± 3.31 kg; p < 0.05 for HbA1c subgroup ≥ 7.5%; - 1.5 ± 3.22 kg; p < 0.05 for HbA1c subgroup ≥ 8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥ 7.5% (-1.0 ± 8.38 kg/m). However, the change in BMI in the HbA1c subgroup ≥ 8% was noted to be -1.4 ± 10.4 kg/m, which was not statistically significant (p = 0.08). In the overall study population, significant change in the SBP (-4.5 ± 14.9 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -4.5 ± 15.1 mmHg; p < 0.0001 for HbA1c subgroup ≥ 8%) was observed at visit 2 compared with visit 1. On identical lines, significant change in DBP (-1.5 ± 8.94 mmHg; p < 0.05 for HbA1c subgroup ≥ 7.5%; -1.4 ± 8.91 mmHg; p < 0.05 for HbA1c subgroup ≥ 8%) was noted.
Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario.
在印度，评估达格列净作为其他口服抗糖尿病药物（OAD）的附加药物对2型糖尿病（DM）患者有效性的真实世界研究很少。
开展了一项基于电子病历（EMR）的回顾性多中心研究，以评估达格列净作为附加疗法对使用二甲双胍且血糖控制不佳的成年患者（无论是否联用其他OAD）的有效性。分析了基线特征（访视1：使用二甲双胍或二甲双胍加OAD治疗至少30天）以及在加用/换用达格列净后60至140天之间的治疗相关结局（访视2：随访）[糖化血红蛋白（HbA1c）、体重指数（BMI）、收缩压（SBP）和舒张压（DBP）]。
从478个中心共筛选出3616例患者。大多数患者接受了达格列净（D）+二甲双胍（M）+至少一种其他OAD [D + M + OAD，n = 2907（80.4%），408例报告了HbA1c随访结果]，而709例患者（19.6%，138例报告了HbA1c随访结果）接受了达格列净+二甲双胍（D + M）。与访视1相比，在访视2时，达格列净作为附加疗法导致HbA1c有显著变化（-1.1±1.44%；HbA1c亚组≥7.5%时，p < 0.05；-1.6±1.41%；HbA1c亚组≥8%时，p < 0.05）。在访视2时观察到体重有显著变化（-1.4±3.31 kg；HbA1c亚组≥7.5%时，p < 0.05；-1.5±3.22 kg；HbA1c亚组≥8%时，p < 0.05）。同样，HbA1c亚组≥7.5%时，BMI有显著变化（-1.0±8.38 kg/m²）。然而，HbA1c亚组≥8%时，BMI变化为-1.4±10.4 kg/m²，无统计学意义（p = 0.08）。在总体研究人群中，与访视1相比，访视2时观察到SBP有显著变化（-4.5±14.9 mmHg；HbA1c亚组≥7.5%时，p < 0.05；-4.5±15.1 mmHg；HbA1c亚组≥8%时，p < 0.0001）。同样，DBP也有显著变化（-1.5±8.94 mmHg；HbA1c亚组≥7.5%时，p < 0.05；-1.4±8.91 mmHg；HbA1c亚组≥8%时，p < 0.05）。
在真实世界中，无论是否联用其他OAD，达格列净与二甲双胍联用时，在血糖参数、BMI和血压方面均有显著改善。
