JARDIANCE powerfully reduced the risk of CV death on top of standard of care
FOR ADULTS WITH ESTABLISHED CV DISEASE * AND TYPE 2 DIABETES
JARDIANCE powerfully reduced the risk of CV death on top of standard of care
A consistent finding for the two JARDIANCE dosing strengths , 10 mg and 25 mg
20
15
10
PATIENTS WITH A CV EVENT (%)
38 %
RRR IN CV DEATH
HR = 0.62 ( 95 % Cl : 0.49-0.77 )
REDUCED RISK OF CV DEATH
Placebo + standard of care ( N = 2333 )
JARDIANCE †
+ standard of care ( N = 4687 )
5
TIME ( MONTHS ) 0
0 6 12 18 24 30 36 42 48
EARLY AND SUSTAINED REDUCTIONS IN CV DEATH 1
Absolute rates for CV death : 5.9 % placebo VS 3.7 % JARDIANCE
ABSOLUTE RISK
2.2 % REDUCTION
JARDIANCE DEMONSTRATED A 14 % RRR FOR THE PRIMARY COMPOSITE ENDPOINT ( HR = 0.86 [ 95 % CI : 0.74-0.99 ]; p = 0.04 )
• The absolute risk reduction for the composite endpoint was 1.6 %
• There was no change in risk of nonfatal MI ( HR = 0.87 [ 95 % CI : 0.70-1.09 ]) or nonfatal stroke ( HR = 1.24 [ 95 % CI : 0.92-1.67 ]); the 14 % RRR in CV events was due to a reduction in the risk of CV death ( HR = 0.62 [ 95 % CI : 0.49-0.77 ])
IMPORTANT SAFETY INFORMATION ( continued ) WARNINGS AND PRECAUTIONS ( continued )
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues Insulin and insulin secretagogues are known to cause hypoglycemia . The use of JARDIANCE with these agents can increase the risk of hypoglycemia . A lower dose of insulin or the insulin secretagogue may be required when used in combination with JARDIANCE .
Genital Mycotic Infections JARDIANCE increases the risk for genital mycotic infections , especially in patients with prior infections . Monitor and treat as appropriate .
Study Design : A randomized , double-blind , parallel – group trial comparing the risk of experiencing a major adverse cardiovascular event between JARDIANCE and placebo when these were added to and used concomitantly with standard of care treatments for type 2 diabetes and cardiovascular disease . A total of 7020 patients were treated ( JARDIANCE 10 mg [ N = 2345 ]; JARDIANCE 25 mg [ N = 2342 ]; placebo [ N = 2333 ]) and followed for a median of 3.1 years . All patients had established atherosclerotic cardiovascular disease at baseline , including one or more of the following : a documented history of coronary artery disease , stroke , or peripheral artery disease . The primary outcome was reduction in risk of cardiovascular events , defined by the composite of cardiovascular death , nonfatal myocardial infarction , and nonfatal stroke .
* Patients with coronary artery disease , peripheral artery disease , or a history of myocardial infarction or stroke .
†
Pooled data from JARDIANCE 10 mg and JARDIANCE 25 mg ; similar magnitude of reduction was shown with both doses . CI = confidence interval ; HR = hazard ratio ; MI = myocardial infarction ; RRR = relative risk reduction .
Increased Low-Density Lipoprotein Cholesterol ( LDL-C ) Monitor and treat as appropriate .
ADVERSE REACTIONS The most common adverse reactions (> 5 %) associated with placebo and JARDIANCE 10 mg and 25 mg were urinary tract infections and female genital mycotic infections .
DRUG INTERACTIONS Diuretics may enhance the potential for volume depletion when administered with JARDIANCE .
USE IN SPECIAL POPULATIONS Pregnancy JARDIANCE is not recommended during the second and third trimesters of pregnancy based on animal data showing adverse renal effects .
Lactation JARDIANCE is not recommended while breastfeeding because of the potential for serious adverse reactions in breastfed infants .
Geriatric Use JARDIANCE is expected to have diminished efficacy in elderly patients with renal impairment . Urinary tract infections and volume depletion-related adverse reactions increased in patients ≥75 years treated with JARDIANCE .
JAR PROF ISI 12.3.16
Please see Important Safety Information and Brief Summary of Prescribing Information on adjacent pages .
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