JARDIANCE demonstrated a lifesaving CV benefit on top of standard of care
Add JARDIANCE to reduce their risk of CV death
FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES
JARDIANCE demonstrated a lifesaving CV benefit on top of standard of care
38 %
RRR IN CV DEATH vs placebo on top of standard of care
2.2 % absolute risk reduction HR = 0.62 ( 95 % CI : 0.49-0.77 )
46
NUMBER NEEDED TO TREAT to prevent one CV death
Median 3.1 years
CONVENIENT ORAL DOSING taken once daily in the morning
Add JARDIANCE to reduce their risk of CV death
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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 , peripheral artery disease , myocardial infarction , or stroke . The primary outcome was reduction in risk of cardiovascular events , defined by the composite of cardiovascular death , nonfatal myocardial infarction , and nonfatal stroke .
IMPORTANT SAFETY INFORMATION 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 .
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 .
USE IN SPECIAL POPULATIONS ( continued ) 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 additional Important Safety Information and Brief Summary of Prescribing Information on adjacent pages .
References : 1 . National Institute of Diabetes and Digestive and Kidney Diseases , US Department of Health and Human Services . Bethesda , MD : National Institutes of Health ; 2008 . 2 . Zinman B , Wanner C , Lachin JM , et al ; EMPA-REG OUTCOME Investigators . N Engl J Med . 2015 ; 373 ( 22 ): 2117-2128 .
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