A Retrospective Analysis of Fixed Combination of Empagliflozin and Linagliptin in Addition to the Existing Treatment for its Clinical Effectiveness in Adults with Type 2 Diabetes: A Real-World Clinical Experience
Abstract
BACKGROUND: The efficacy and safety of empagliflozin and linagliptin (Empa/Lina), is demonstrated in adults with T2DM in the various trials. The study was planned to investigate the clinical effectiveness and safety of Empa/Lina in a more representative population of the Indian outpatient setting.
METHODS: The study was conducted in poorly controlled T2DM patients being treated with Empa/Lina once daily (25/5mg) as an add on in a tertiary care institute in Jammu, India. Various efficacy and safety parameters were assessed prior to the initiation of Empa/Lina and thereafter at periodic intervals until week 12. Appropriate statistical tests were applied.
RESULTS: In a total of 347 eligible patients, the mean age (SD) was 57.84 ±7.3 years, Males were 49%, average body weight was 79.81±9.72 kg. The median duration of diabetes was 6.42±2.05 years. Empa/Lina as an add on therapy to other glucose-lowering treatment was associated with a significant lowering in HbA1c (-1.1 ±0.64 mg/dl), FPG level -47.11(±20.42) mg/dl, PPG level (-71.32± 26.56), body weight -2.64 (±1.97) kg and blood pressure parameters (systolic BP -7.68 ±5.2 and Diastolic BP -3.16±1.7) from baseline at 12 weeks. A total of 47.55 percent of patients responded to Empa/Lina (25/5mg) added in conjunction with other antidiabetes agents. There was no significant difference in glycemic parameters of various subgroups assessed based on concurrent antidiabetes drugs. However, a significant reduction in body weight of…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 347 participants or records.
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