FORXIGA® (dapagliflozin)

FORXIGA® 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® is the only SGLT2 inhibitor with UK-specific real world evidence from the CPRD database3

Patients in the UK initiated on FORXIGA® with metformin:

  • Experienced an average reduction in HbA1c of more than 1.1 % when treated for 6 months or longer with FORXIGA®3
  • Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised controlled trial findings.

What is CPRD?

  • CPRD stands for Clinical Practice Research Datalink29
  • 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)29
A database of 12,000,000 patient records
A database of 12,000,000 patient records

FORXIGA®’s Real World Evidence Study Details

FORXIGA®’s Real World Evidence Study Details
FORXIGA®’s Real World Evidence Study Details

*FORXIGA® is not indicated for weight loss.1
**FORXIGA® is not indicated for the management of high blood pressure.1
Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised controlled trial findings.

Study overview3

Forxiga study overview
Forxiga study overview

Adverse events were not analysed.3,32 
*FORXIGA® is not indicated for weight loss.1
FORXIGA® is not indicated for the management of high blood pressure.1

Results from real world evidence studies should be interpreted in the context of randomised controlled trial findings.

ITT=intention to treat.

Study inclusion criteria and definition of treatment groups3

Study inclusion criteria and definition of treatment groups
Study inclusion criteria and definition of treatment groups

 

*Creatinine clearance < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2.3
**Insulin ≤3 months prior to FORXIGA® initiation and ≤3 months post FORXIGA® initiation.3

Results

Across all diabetes treatment combinations, UK patients experienced an average reduction in HbA1c of more than 1% when treated with FORXIGA® for at least 3 months3

All treatment combinations
All treatment combinations

HbA1c reductions from baseline with Forxiga range from -0.45% to – 1.39% in the SmPC

Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

Patients initiated on FORXIGA® with metformin experienced an average reduction in HbA1c of more than 1.1% when treated for 6 months or longer with FORXIGA®3

Forxiga Dual treatment
Forxiga Dual treatment

HbA1c reductions from baseline with Forxiga range from -0.45% to – 1.39% in the SmPC

Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

HbA1c change post initiation of FORXIGA® in triple therapy group3

Forxiga triple treatment
Forxiga triple treatment

HbA1c reductions from baseline with Forxiga range from -0.45% to – 1.39% in the SmPC

Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

Patients initiated on FORXIGA® with insulin and potentially other OADs, experienced an average reduction in HbA1c of more than 1% when treated for 3 months or longer with FORXIGA®3

Forxiga add on to insulin
Forxiga add on to insulin

HbA1c reductions from baseline with Forxiga range from -0.45% to – 1.39% in the SmPC

Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

OAD=oral antidiabetic agent.

Across all diabetes treatment combinations, UK patients who received FORXIGA® lost, on average, more than 4.5kg after 1 year3

Forxiga weight all treatment
Forxiga weight all treatment

Weight reductions from baseline with Forxiga range from -1.67kg to -3.22kg in the SmPC

*FORXIGA® is not indicated for weight loss.3

Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

Forxiga dual weight
Forxiga dual weight

Weight reductions from baseline with Forxiga range from -1.67kg to -3.22kg in the SmPC

*FORXIGA® is not indicated for weight loss.3
Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

Forxiga weight triple
Forxiga weight triple

Weight reductions from baseline with Forxiga range from -1.67kg to -3.22kg in the SmPC

*FORXIGA® is not indicated for weight loss.3
Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

Forxiga add on to insulin
Forxiga add on to insulin

Weight reductions from baseline with Forxiga range from -1.67kg to -3.22kg in the SmPC

*FORXIGA® is not indicated for weight loss.3
Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

Patients in the UK initiated on FORXIGA® showed a strong trend towards a reduction in their systolic blood pressure3

In a prespecified pooled analysis of 13 placebo controlled trials, treatment with Forxiga 10mg resulted in a systolic blood pressure change from baseline of - 3.7mmHg

**FORXIGA® is not indicated for blood pressure reduction. Caution should be exercised in patients for whom a drop in blood pressure induced by FORXIGA® could pose a risk.1

Measurements are not necessarily repeated. A patient may have had a single measure in any one of the 5 time periods, or multiple measures. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. Results should be interpreted in the context of randomised clinical trial findings.

* FORXIGA® is not indicated for weight loss.1
**FORXIGA® is not indicated for blood pressure reduction.1

Across all diabetes treatment combinations, 70% of UK patients receiving FORXIGA® for at least 6 months experienced both a reduction in HbA1c and weight loss3*

Changes in weight (kg) and HbA1c at 180-365 days
Changes in weight (kg) and HbA1c at 180-365 days

* FORXIGA® is not indicated for weight loss.1
All ‘on-label’ patients with measures.3

Results from real-world evidence studies may not necessarily relate to the effect of the intervention/treatment alone. N numbers in the chart above reflect the specific number of patients for whom a reading was taken at the time-points specified, and not the total number of patients who entered the study.3