FORXIGA® (dapagliflozin)

FORXIGA® (dapagliflozin) is a highly selective SGLT2 inhibitor for type 2 diabetes mellitus, with 4-year safety and efficacy data, that removes glucose and its associated calories via the kidney.1

FORXIGA® (dapagliflozin) Real-World Evidence

Success associated with treating type 2 diabetes with FORXIGA® (dapagliflozin) in the UK

Drawn from the Clinical Practice Research Database (CPRD), our retrospective analysis draws on patient records from 693 UK surgeries.15,16

Clinical Practice Research Datalink (CPRD): what is it? 
 
The CPRD is a governmental, not-for-profit research service, jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA).27 Over the course of 30 years, anonymised primary care records from CPRD have made possible over 1,700 research publications: these have led to improvements in drug safety, best practice, and clinical guidelines.

Examples include confirming safety of MMR vaccine, informing NICE cancer guidance, and influencing the management of hypertension in diabetics.

CPRD is now also using primary care data in clinical trials, including Real-World diabetes studies, comparing new therapies to routine standard of care.

A single-arm, retrospective, observational study drawing on CPRD database, containing records from more than 12 million patients across the primary care practices in the UK.15

Data covers the period of November 2012 to December 2015.15

The study aimed to characterise patients prescribed FORXIGA® (dapagliflozin) in UK primary care, and to assess the changes in HbA1c, weight* and systolic blood pressure** after FORXIGA® initiation for the overall cohort and for the co-prescription subgroups (dual, triple, add-on to insulin).15

Of the overall cohort, 7012 patients were prescribed FORXIGA® (dapagliflozin) and 4121 patients were on-label and had 3 months’ follow-up. ITT therapy sub-groups were based on prescribing in first 3 months from initiation of FORXIGA® (dapagliflozin).15

 

Study Analysis 115



Study Analysis 215

Database

CPRD

CPRD
Number of primary care practices included
684
684
Time period within which FORXIGA® first prescribed
Nov 2012-Sept 2014
Nov 2012-Dec 2015
Number of FORXIGA® patients
1732 fulfilled inclusion criteria
4121 on-label with follow-up
Duration of follow-up
Up to 12 months
Up to 2 years
Endpoints presented
HbA1c lowering
Weight loss*
HbA1c lowering
Weight loss*                       
Reduction in blood pressure**

*FORXIGA® (dapagliflozin) is not licensed for weight loss. Weight change was a secondary endpoint in clinical trials.1

**FORXIGA® (dapagliflozin) is not licensed for the management of high blood pressure.1

Adverse events were not analysed.15
Results from real-world observational studies may not necessarily relate to the effect of the intervention/ treatment alone and should be interpreted in the context of randomised clinical trials.

Average reductions in HbA1c in patients initiated on FORXIGA® (dapagliflozin) with metformin, with results evident from 3 months15

HbA1c change from baseline in the dual therapy arm15

HbA1c change from baseline with FORXIGA® in the dual therapy arm
HbA1c change from baseline with FORXIGA® in the dual therapy arm

Adapted from Wilding J et al. 2017: Appendix A

Results from real-world observational studies may not necessarily relate to the effect of the intervention/ treatment alone. Results should be interpreted in the context of randomised clinical trials findings. In the Phase 3 RTCs HbA1c reductions from baseline with Forxiga® ranged from -0.45% to 1.39%.1

Measurements are not necessarily repeated. A patient may have had a single measure in any one of the time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for a whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.15
CI, confidence interval.