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) proven clinical trial data

Significant results demonstrated across 7 randomised controlled trials3,6-10 up to 4 years in duration11

FORXIGA® (dapagliflozin) offers the secondary benefit of systolic blood pressure reduction, with significant changes at 12 weeks vs placebo12†‡

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

Change from baseline in systolic blood pressure at 12 weeks, vs placebo12

Change from baseline in systolic blood pressure at 12 weeks (FORXIGA® vs placebo)
Change from baseline in systolic blood pressure at 12 weeks (FORXIGA® vs placebo)

Adapted from Weber MA et al. 2016

Caution should be exercised in patients for whom a FORXIGA® (dapagliflozin)-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension, or elderly patients.1FORXIGA® (dapagliflozin) is not recommended in patients receiving loop diuretics as it may add to the diuretic effect and may increase the risk of dehydration and hypotension.1

ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; AHT, antihypertensive therapy; CI, confidence interval.

In a prespecified pooled analysis of 12 placebo-controlled studies, treatment with FORXIGA® (dapagliflozin) 10 mg resulted in a systolic blood pressure change from baseline of  -4.4 mmHg and diastolic blood pressure of -2.1 mmHg versus -0.9 mmHg and -0.5 mmHg diastolic blood pressure for the placebo group at Week 24.24

Data are longitudinal repeated measures analysis excluding data after rescue. At 12 weeks, n corresponds to the number of randomised subjects with non-missing baseline and Week 12 values. Significant p-value: Co-primary endpoints tested at alpha = 0.05.12

 

A multi-centre, randomised, double-blind, placebo-controlled Phase III clinical trial within 311 centres in 16 countries. Eligible patients were those with type 2 diabetes, inadequate glycaemic control (HbA1c 7·0%–10·5%; 53–91 mmol/mol), and inadequately controlled hypertension (systolic 140–165 mm Hg and diastolic 85–105 mm Hg). The study aimed to analyse the efficacy and safety of FORXIGA® (dapagliflozin) 10 mg for reduction of systolic blood pressure (BP) and HbA1c in 449 adult patients with type 2 diabetes (T2D) and inadequate glycaemic and BP control.

Patients were randomly assigned (1:1) to receive FORXIGA® (dapagliflozin) 10 mg once daily or matched placebo. Randomisation was stratified by type of additional antihypertensive medication use and insulin use. Randomisation was done by interactive voice response system. Patients with T2D and elevated BP (seated systolic 140 < 165 mm Hg + seated diastolic blood 85 < 105 mm Hg) were randomised to placebo (n=244) or FORXIGA® (dapagliflozin) 10 mg (n=225) for 12 weeks in addition to their multidrug regimen. The trial consisted of a qualification period (14 days or less after enrolment), a lead-in period (4 weeks), a double-blind treatment period (12 weeks), and a follow-up period (1 week).

The co-primary endpoints were changes from baseline to week 12 in seated systolic blood pressure and HbA1c. Secondary endpoints included change from baseline to week 12 in 24-hour ambulatory BP, seated diastolic BP, and serum uric acid.

Safety evaluations over the study period included adverse events, laboratory variables, and vital signs.