JARDIANCE® (Empagliflozin)

The content on this website is in relation to adult patients

 

EMPA-REG OUTCOME® Trial

JARDIANCE® (empagliflozin) was studied in a dedicated cardiovascular (CV) outcome trial published in The New England Journal of Medicine1

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The EMPA-REG OUTCOME® trial was a randomised, double-blind, placebo-controlled trial (N=7020). Patients with type 2 diabetes and cardiovascular disease were randomised to receive JARDIANCE 10mg (N=2345) or JARDIANCE 25mg (N=2342) or placebo (N=2333) once daily, on top of standard of care.1*

* Adults with type 2 diabetes, BMI ≤45 kg/m2, HbA1c 7-9%/7-10%, cardiovascular disease (which was defined as any one of the following: prior myocardial infarction, coronary artery disease, stroke, unstable angina, occlusive peripheral arterial disease).

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Reduced HbA1c infographic JARDIANCE® (empagliflozin)

‡ Antihypertensives included beta blockers, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers.

Patients’ CV risk factors and glucose levels were actively managed with standard of care in both the placebo and JARDIANCE® treatment arms.1,2 Standard of care included cardiovascular medications and glucose-lowering agents given at the discretion of a physician.1,2

The efficacy for preventing cardiovascular mortality has not been conclusively established in patients using JARDIANCE concomitantly with DPP-4 inhibitors or in black patients because the representation of these groups in the EMPA-REG OUTCOME® study was limited.3

EMPA-REG OUTCOME® Population4

The EMPA-REG OUTCOME® trial studied over 7,000 patients with T2D and CVD.1 One third of trial participants had no history of CVD events, defined as MI or stroke at baseline.1

EMPA-REG OUTCOME® Population
 
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Abbreviations

BMI: body mass index; CAD: coronary artery disease; CV: cardiovascular; HbA1c: haemoglobin A1c; MI: myocardial infarction; PAD: peripheral arterial disease.

References
  1. Zinman B, et al. N Engl J Med. 2015;373:2117–2128.
  2. Fitchett D, et al. Reduction in hospitalisation for heart failure with empagliflozin is consistent across categories of baseline HbA1c and change in HbA1c: results from the EMPA-REG OUTCOME® trial. Poster no. 301 presented at: European Society of Cardiology Heart Failure 2017 and 4th World Congress on Acute Heart Failure; April 29–May 2, 2017; Paris, France.
  3. JARDIANCE® (empagliflozin) Summary of Product Characteristics (SmPC). Available at: http://www.medicines.org.uk/emc/medicine/28973.
  4. Fitchett D et al. Circulation 2019; 139(11):1384–1395.

PC-GB-108853 V2

February 2024

Reporting adverse events

Adverse events should be reported. Reporting form and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).

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