J Assoc Physicians India. 2021 Jul;69(7):11-12.
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 subjects on insulin therapy was noticed. There was an improvement in eGFR level which was maintained across the study period. Genital mycotic infection was reported in 8.6% of patients. Empa/Lina (25/5 mg) as an add-on therapy was well tolerated with less hypoglycemic events.
DISCUSSION AND CONCLUSION: Thus, the combination of empagliflozin and linagliptin (25/5 mg) significantly improved the glycemic and non-glycemic measures in combination with one or more commonly prescribed antidiabetic drugs in inadequately controlled diabetes patients and is well tolerated.
PMID:34431269
