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Year : 2022  |  Volume : 13  |  Issue : 3  |  Page : 242-248

Real-world evidence of generic dapagliflozin: Relevance and results from Indian multicenter retrospective study

1 Department of Endocrinology, CARE Hospital, Hyderabad, Telangana, India
2 Department of Endocrinology, Bharti Hospital, Karnal, Haryana, India
3 Department of Endocrinology, AMRI Hospital, West Bengal, Kolkata, India
4 Department of Endocrinology and Metabolism, Indira Gandhi Institute of Medical Sciences (IGIMS), Patna, Bihar, India
5 Department of Medicine, Institute of Medical Sciences, Banaras Hindu University (BHU), Varanasi, Uttar Pradesh, India
6 Manasvi Diabetes Clinic, Lucknow, Uttar Pradesh, India
7 Department of Endocrinology, BGS Gleneagles Global Hospital, Bangalore, Karnataka, India
8 Department of Endocrinology, Budhwar Super Speciality Clinic, Amritsar, Punjab, India
9 Dr. Savita Jain’s Clinic, Ludhiana, Punjab, India
10 Dr. Harish Mohan Rastogi Clinic, Meerut, Uttar Pradesh, India
11 Department of Endocrinology, Kingsway Hospitals, Nagpur, Maharashtra, India
12 Department of Endocrinology, Apollo Hospital, Chennai, Tamil Nadu, India
13 Endodiab Clinic, Kozhikode, Kerala, India
14 Scientific Services, USV Pvt Ltd, Mumbai, Maharashtra, India

Correspondence Address:
Mr. Prashant Sarda
Arvind Vithal Gandhi Chowk, BSD Marg, Station Road, Govandi East, Mumbai, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jod.jod_133_21

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Objective: The objective was to evaluate the clinical experience and treatment patterns of generic dapagliflozin usage in different patient profiles in Indian settings. Materials and Methods: A retrospective, multicentric, real-world study included patients with type 2 diabetes mellitus (T2DM) (aged >18 years), inadequately controlled by existing antidiabetic therapy and receiving generic dapagliflozin as an add-on to existing oral antidiabetic drug(s) with or without insulin or switch therapy. Baseline characteristics and treatment-related outcomes were retrieved from the medical records and analyzed. Results: A total of 1935 patients were included, of which 1279 (66.1%) were males. The mean age was 57.4 years, and around half of the patients (51.4%) were aged from 45 to 60 years. Hypertension (55.9%) and dyslipidemia (19.8%) were the common comorbidities. The majority (n = 1122; 60%) of patients received dapagliflozin in combination with one or two antihyperglycemic drugs. More than half of the patients received metformin (56.8%) or sulfonylurea (52.3%) in combination with dapagliflozin. A dose of 10 mg (93.4%) was the most commonly used dose of dapagliflozin. The mean levels of glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose were significantly reduced to 1.1% (1.0–1.1), 30.5 mg/dL (29.2–31.9), and 57.5 mg/dL (55.1–59.9), respectively, after the initiation of dapagliflozin. A total of 1935 patients experienced weight changes during the treatment, of which 90.5% of patients showed weight loss. Hypoglycemic events were reported in 12.5% of patients. Physician global evaluation of efficacy and tolerability showed a majority of patients on a good-to-excellent scale (97.3% and 97.1%). Conclusion: Generic dapagliflozin showed a significant improvement in glycemic parameters and reduced body weight with low hypoglycemic events. The administration of dapagliflozin provided a good-to-excellent efficacy and tolerability profile in patients with T2DM. To the best of our knowledge, this is the first study confirming the efficacy, safety, and usefulness of generic dapagliflozin in patients with T2DM.

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