Introduction and Objective: Tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated superior glycemic and weight-loss efficacy in randomized trials. However, real-world evidence in South Asian populations remains limited. This study was done to evaluate the early real-world effectiveness and safety of tirzepatide in Indian adults with type 2 diabetes mellitus (T2DM).Methods: This retrospective, multicenter observational study included adults with T2DM initiated on tirzepatide across seven diabetes care centers in North India. Patients with complete baseline and 3-month follow-up data were analyzed. The primary outcome was change in glycated hemoglobin (HbA1c). Secondary outcomes included changes in body weight, body mass index (BMI), blood pressure, lipid profile, liver enzymes, Fibrosis-4 (FIB-4) index, renal parameters, and adverse events.Results: Seventy-one patients (mean age 47.3±10.2 years; 54.9% women; mean diabetes duration 8.4±5.6 years) completed 3 months of follow-up. Mean HbA1c decreased from 8.7±1.4% to 6.9±1.0% (−1.8±1.2%; p<0.001), with 59.2% achieving HbA1c <7%. Mean body weight declined by 4.7±3.2 kg (−5.7%; p<0.001), and BMI decreased by 1.7±1.2 kg/m². Significant improvements were observed in systolic blood pressure (−5.6 mmHg), triglycerides (−46.4 mg/dL), LDL-cholesterol (−12.2 mg/dL), and HDL-cholesterol (+2.6 mg/dL) (all p<0.01). Liver enzymes improved with a reduction in FIB-4 index (−0.16±0.42; p=0.004). Renal function remained stable. Gastrointestinal adverse events were common (59.2%) but predominantly mild to moderate. No severe hypoglycemia or serious adverse events occurred.Conclusion: In routine clinical practice, tirzepatide demonstrated robust early improvements in glycemic control, weight, and cardiometabolic risk factors in Indian adults with T2DM, with a safety profile consistent with clinical trials. Cost-related discontinuation remains a key real-world challenge.
D. Kumar: None. K. Chandra: Speaker’s Bureau; Current; Eli Lilly and Company, Novo Nordisk, Sanofi, Boehringer Ingelheim International GmbH, Abbott, Cipla Inc. Advisory Panel; Current; Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., USV Private Limited. R. Awasthi: Speaker’s Bureau; Current; Eli Lilly and Company, Boehringer Ingelheim International GmbH, Sanofi, Novo Nordisk, Bayer AG, Cipla Inc., Sun Pharmaceutical Industries Ltd., Servier Laboratories, USV Private Limited. M. Gupta: None. A.R. Pande: Speaker’s Bureau; Current; Eli Lilly and Company, Novo Nordisk, Bayer AG. Advisory Panel; Current; Lupin Pharmaceuticals, Inc. Speaker’s Bureau; Current; Sanofi, Serdia Pharmaceuticals (India) Pvt. Ltd. Advisory Panel; Current; Sun Pharmaceutical Industries Ltd. Speaker’s Bureau; Current; USV Private Limited, Cipla Inc., Boehringer Ingelheim International GmbH. N.R. Gupta: Speaker’s Bureau; Current; Novo Nordisk. Advisory Panel; Current; Lupin Pharmaceuticals, Inc. Speaker’s Bureau; Current; Eli Lilly and Company, USV Private Limited. Advisory Panel; Current; Sun Pharmaceutical Industries Ltd. Speaker’s Bureau; Current; Cipla Inc. V. Agarwal: Speaker’s Bureau; Current; Novo Nordisk, Cipla Inc. Advisory Panel; Current; Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., USV Private Limited. Speaker’s Bureau; Current; Boehringer Ingelheim International GmbH. Advisory Panel; Current; Eris Lifesciences Ltd. Speaker’s Bureau; Current; Bayer AG. Advisory Panel; Current; Glenmark Pharmaceuticals. H. Lachhwani: None. S. Awasthi: None. T. Gupta: None.
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