How does dapagliflozin perform in the real world?

  • McGurnaghan SJ & al.
  • Diabetologia
  • 10 Jan 2019

  • curated by Miriam Tucker
  • Clinical Essentials
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Takeaway

  • Real-world data suggest dapagliflozin (Farxiga) reduces HbA1c, systolic BP (SBP), and BMI as effectively as in clinical trials, for up to 2 years.   

Why this matters

  • Real-world evidence can help corroborate clinical trial findings in more heterogeneous and less-supervised patient populations.

Study design

  • Data from national Scottish diabetes databases for 2004 to mid-2016 for 8566 dapagliflozin users.
  • Funding: Astra Zeneca.

Key results

  • At 3 months, mean change in HbA1c was −10.41 mmol/mol (−0.95%). 
  • Largest change at 12 months:
    • −12.99 mmol/mol (−1.19%), and
    • persisting above −10 mmol/mol throughout 30-month follow-up.
  • Proportions with HbA1c ≤58 mmol/mol (7.5%) increased from: 
    • 5.4% at baseline to
    • 26.0% at 6 months.
  • Proportions with ≤53 mmol/mol (7.0%) increased from:
    • 2.3% at baseline to 
    • 13.1% at 6 months.  
  • At 3 months, decreases seen in:
    • SBP: −4.32 mmHg;
    • BMI: −0.74 kg/m2; and 
    • Body weight: −2.10 kg.
    • Decreases persisted thereafter.
  • Accounting for expected upward change in HbA1c without the drug at that time point, change in HbA1c was:
    • −15.14 mmol/mol (95% CI, −15.87 to −14.4); or
    • −1.39% (95% CI, −1.45 to −1.32).
  • 111 cases of cardiovascular disease, 13 diabetic ketoacidosis, 28 lower-limb amputation.

Limitations

  • No unbiased control comparisons.
  • Cannot account for regression to the mean.
  • All-Scottish population.

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