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What is Jardiance® ?

Jardiance® (empagliflozin) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise1

  • as monotherapy when metformin is considered inappropriate due to intolerance
  • in addition to other medicinal products for the treatment of diabetes

Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.

Jardiance® is a reversible, highly potent and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2). Jardiance® improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption.1

Efficacy

HbA1c reduction

Adding Jardiance® to metformin provides significant HbA1c reduction.2,3

percentage
mmol/mol

Study design:

In a 24-week, double-blind, placebo-controlled study of 637 patients with type 2 diabetes, the efficacy and safety of Jardiance® 10 mg (n=217) and Jardiance® 25 mg (n=213) as add-on therapy to metformin ≥1500 mg were evaluated vs. placebo added to metformin (n=207). The primary endpoint was HbA1c change from baseline (baseline ≥7% to ≤10%); weight change was a secondary endpoint.2

In a subgroup analysis at 24 weeks of patients with baseline ≥8.5%, adjusted mean changes in HbA1c were -0.5% for placebo (n=50), -1.2% for JARDIANCE® 10 mg (n=57), and -1.5% for JARDIANCE® 25 mg (n=48). Difference from placebo (adjusted mean) was -0.73% for JARDIANCE® 10 mg and -1.0% for JARDIANCE® 25 mg.3

Cardiovascular outcomes

The EMPA-REG OUTCOME study was the first cardiovascular safety trial in oral antidiabetic drugs to show beneficial cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease.

The EMPA-REG OUTCOME trial evaluated the effects of Jardiance® on cardiovascular morbidity in 7,028 people with type 2 diabetes who were at high risk for cardiovascular disease and taking standard treatments for diabetes.4

EMPA REG OUTCOME Study Design

Length 1:38

EMPA REG OUTCOME Results

Length 3:00

ARR: Absolute risk reduction

RRR: Relative risk reduction

HR: hazard ratio

Weight loss

In patients with type 2 diabetes Jardiance® is associated with weight loss.1,2,5,6

Jardiance® is not indicated for weight loss.

Dual therapy: study design

Study design:

In a 24-week, double-blind, placebo-controlled study of 637 patients with type 2 diabetes, the efficacy and safety of Jardiance® 10 mg (n=217) and Jardiance® 25 mg (n=213) as add on therapy to metformin ≥1500 mg were evaluated vs. placebo added to metformin (n=207). The primary endpoint was HbA1c change from baseline (baseline ≥7% to ≤10%); weight change was a secondary endpoint.2

Triple therapy: study design

Study design:

In a 24-week, double-blind, placebo-controlled study of 666 patients with type 2 diabetes, the efficacy and safety of Jardiance® 10 mg (n=225) and Jardiance® 25 mg (n=216) as add-on therapy to metformin ≥1500 mg plus a sulphonylurea were evaluated vs. placebo added to metformin plus a sulphonylurea (n=225). The primary endpoint was HbA1c change from baseline (baseline ≥7% to ≤10%, respectively); weight change was a secondary endpoint.5

Add on to insulin therapy: study design

Study design:

In a 78-week double-blind, placebo-controlled study of 494 patients with type 2 diabetes, the safety and efficacy of Jardiance® 10 mg (n=169), and Jardiance® 25 mg (n=155), versus placebo (n=170), as add-on to basal insulin, was assessed. Patients included were those who were inadequately controlled on stable basal glargine or detemir insulin (≥20 units/day) or NPH insulin (≥14 units/day), with or without metformin and/or SU and who had a BMI ≤45 kg/m2.

Basal insulin dose remained fixed for 18 weeks. For the remaining 60 weeks, insulin dose could be adjusted at the discretion of the investigator. Primary endpoint was change from baseline in HbA1c (baseline >7% to ≤10%) at 18 weeks; weight change was a secondary endpoint.

The primary efficacy analysis was performed on completers in the full analysis set; FAS-18 completers: FAS patients who did not discontinue the trial before week 18, had a treatment duration of ≥119 days and had an on-treatment HbA1c value available in that visit window (n=125 for placebo, n=132 for empagliflozin 10 mg and n=117 for empagliflozin 25mg).6

Mechanism of action

Jardiance® (empagliflozin) is a reversible, highly potent and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2).

SGLT2 is highly expressed in the kidney. It is the predominant transporter of glucose, and it is responsible for the re-absorption of glucose from the glomerular filtrate back into the circulation. In patients with type 2 diabetes and hyperglycaemia, a greater amount of glucose is filtered than re-absorbed.

Dosing

Recommended Starting Dose

The recommended starting Jardiance® dosage is 10 mg once daily for monotherapy and add-on combination therapy with other medicinal products for the treatment of diabetes1. In patients who tolerate Jardiance® 10 mg once daily and need additional glycaemic control, the dose can be increased to 25 mg daily.

Jardiance® can be taken with or without food at any time of the day 1

Jardiance® should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or CrCl <60 ml/min. In patients tolerating empagliflozin whose eGFR is persistently below 60 ml/min/1.73 m2 or CrCl <60 ml/min, the dose of empagliflozin should be adjusted to or maintained at 10 mg once daily. Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min. Empagliflozin should not be used in patients with ESRD or in patients on dialysis as it is not expected to be effective in these patients.

Monitoring of Renal Function

Due to the mechanism of action, the glycaemic efficacy of empagliflozin is dependent on renal function. Therefore assessment of renal function is recommended as follows:

  • Prior to empagliflozin initiation and periodically during treatment, i.e. at least yearly
  • Prior to initiation of any concomitant medicinal product that may have a negative impact on renal function

Safety information

IMPORTANT SAFETY INFORMATION

Adverse events and product complaints should be reported. Reporting forms and information can be found at UK: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events and product complaints should also be reported to Boehringer Ingelheim: please call Boehringer Ingelheim on 01344 742579

The safety and tolerability of Jardiance® has been evaluated in 15,582 patients with type 2 diabetes within the clinical trial programme, of which 10,004 received Jardiance®.1

Very common adverse events (AEs) include hypoglycaemia (when used with an SU or insulin)1

Common adverse events include genital infections (GTI), urinary tract infections (UTI), pruritus, rash, thirst, and increased urination and serum lipids1

Uncommon AEs included dysuria, volume depletion, elevations in haematocrit and blood creatinine, a decrease in glomerular filtration rate, and urticaria.

In patients treated with SGLT2 inhibitors rare cases of diabetic ketoacidosis (DKA) have been reported and cases of Fournier’s gangrene have been reported (incidence unknown). Patients should be advised on the symptoms and need to seek medical attention. Please refer to the Jardiance® SmPC for further information1*

Angioedema has been reported with unknown frequency.1

*Rare cases of DKA have been reported in clinical trials and postmarketing in patients treated with SGLT2 inhibitors, including empagliflozin1

References

1.    Jardiance® (empagliflozin) Summary of Product Characteristics.
2.    Häring HU, Merker L, Seewaldt-Becker E, et al. Diabetes Care 2014;37:1650‐1659.
3.    Data on file. Boehringer Ingelheim.
4.    Zinman B, Wanner C, Lachin JM, et al. N Engl J Med. 2015;373:2117-2128. (& Supplementary Appendix).
5.    Häring HU, Merker L, Seewaldt-Becker E, et al. Diabetes Care 2013;36:3396‐3404.
6.    Rosenstock J, Jelaska A, Zeller C, et al. Diabetes Obes Metab 2015;17:936–948.

PC-GB-100639 November 2019