Key result
Real-world dapagliflozin linked to a ~1.4% HbA1c reduction alongside lower SBP and body weight.
Why the study?
Whether the effects of dapagliflozin on HbA1c, other variables, and safety outcomes in clinical trials are obtained in real-world practice needed to be established.
Does dapagliflozin improve HbA1c, BMI, body weight, SBP, and eGFR in patients with type 2 diabetes mellitus in real-world practice?
Observational (n=238,876)
Yes
Does dapagliflozin improve HbA1c, BMI, body weight, SBP, and eGFR in patients with type 2 diabetes mellitus in real-world practice?
Mean Difference: -15.14 (95% CI -15.87–-14.41)
Real-world use of dapagliflozin in type 2 diabetes is associated with significant reductions in HbA1c, SBP, body weight, and BMI, consistent with clinical trial data.
Supports cardiometabolic benefits with dapagliflozin in routine T2DM care; extends RCT findings to real-world settings but leaves causal effects open.
Dapagliflozin, a sodium–glucose cotransporter 2 (SGLT2) inhibitor, is indicated for improving glycaemic control in type 2 diabetes mellitus. Whether its effects on HbA 1c and other variables, including safety outcomes, in clinical trials are obtained in real-world practice needs to be established. We used data from the comprehensive national diabetes register, the Scottish Care Information-Diabetes (SCI-Diabetes) collaboration database, available from 2004 to mid-2016. Data within this database were linked to mortality data from the General Registrar, available from the Information Services Division (ISD) of the National Health Service in Scotland. We calculated crude within-person differences between pre- and post-drug-initiation values of HbA 1c , BMI, body weight, systolic blood pressure (SBP) and eGFR. We used mixed-effects regression models to adjust for within-person time trajectories in these measures. For completeness, we evaluated safety outcomes, cardiovascular disease events, lower-limb amputation and diabetic ketoacidosis, focusing on cumulative exposure effects, using Cox proportional hazard models, though power to detect such effects was limited. Among 8566 people exposed to dapagliflozin over a median of 210 days the crude within-person change in HbA 1c was −10.41 mmol/mol (−0.95%) after 3 months’ exposure. The crude change after 12 months was −12.99 mmol/mol (−1.19%) but considering the expected rise over time in HbA 1c gave a dapagliflozin-exposure-effect estimate of −15.14 mmol/mol (95% CI −15.87, −14.41) (−1.39% [95% CI −1.45, −1.32]) at 12 months that was maintained thereafter. A drop in SBP of −4.32 mmHg (95% CI −4.84, −3.79) on exposure within the first 3 months was also maintained thereafter. Reductions in BMI and body weight stabilised by 6 months at −0.82 kg/m 2 (95% CI −0.87, −0.77) and −2.20 kg (95% CI −2.34, −2.06) and were maintained thereafter. eGFR declined initially by −1.81 ml min −1 [1.73 m] −2 (95% CI −2.10, −1.52) at 3 months but varied thereafter. There were no significant effects of cumulative drug exposure on safety outcomes. Dapagliflozin exposure was associated with reductions in HbA 1c , SBP, body weight and BMI that were at least as large as in clinical trials. Dapagliflozin also prevented the expected rise in HbA 1c and SBP over the period of study.
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McGurnaghan et al. (2019) conducted an observational in Type 2 diabetes mellitus (n=238,876). Dapagliflozin vs. Expected within-person trajectory (pre-drug initiation values) was evaluated on Within-person change in HbA1c at 12 months (dapagliflozin-exposure-effect estimate) (MD -15.14 mmol/mol, 95% CI -15.87, -14.41). Dapagliflozin exposure in real-world practice reduced HbA1c by an estimated 15.14 mmol/mol (1.39%) at 12 months compared to expected trajectories, while also lowering systolic blood pressure and body weight.
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