- 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.
- Data from national Scottish diabetes databases for 2004 to mid-2016 for 8566 dapagliflozin users.
- Funding: Astra Zeneca.
- 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.
- No unbiased control comparisons.
- Cannot account for regression to the mean.
- All-Scottish population.