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

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 <7% compared with either monotherapy
• No significant difference was observed in adverse events between combination and monotherapy.

Limitations

• Heterogeneity among studies.