T2DM: safety and efficacy of fixed-dose combination of empagliflozin and linagliptin

  • Katsiki N & al.
  • Diabetes Obes Metab
  • 5 Feb 2020

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • In patients with type 2 diabetes mellitus (T2DM), empagliflozin (10 or 25 mg) + linagliptin 5mg demonstrated superior efficacy and similar safety in achieving euglycemia compared with empagliflozin (10 or 25 mg) or linagliptin 5mg monotherapies.

Why this matters

  • Fixed-dose empagliflozin plus linagliptin may simplify the drug dosing regimen, reduce pill burden and enhance treatment adherence; hence, it may be an important therapeutic option in patients with T2DM during routine clinical practice.

Study design

  • 6 randomised controlled trials (RCTs) including 2857 patients with T2DM met eligibility criteria.
  • Funding: None.

Key results

  • After 24 weeks, empagliflozin 10 mg plus linagliptin 5 mg vs either drug alone had significant reductions in:
    • haemoglobin A1c level (HbA1c; weighted mean difference [WMD], −0.72%, 95% CI, −1.04 to −0.40%; I2=90.0%);
    • weight (WMD, −2.08 [95% CI, −2.62 to −1.53] kg; I2=55.7%); and
    • fasting plasma glucose (FPG; WMD, −1.60 [95% CI, −2.21 to −1.00] mmol/L; I2=88.1%); P<.001 for all.>
  • Similar results were observed with empagliflozin 25 mg plus linagliptin 5 mg compared with linagliptin 5 mg or empagliflozin (10 or 25 mg) monotherapy.
  • Patients who received empagliflozin (10 or 25 mg) plus linagliptin 5mg were at 3-fold higher likelihood of achieving HbA1c
  • No significant difference was observed in adverse events between combination and monotherapy.

Limitations

  • Heterogeneity among studies.