For adults with established CV disease * and type 2 diabetes
CV DEATH HAS A NEW OPPONENT
JARDIANCE POWERFULLY REDUCED THE RISK OF CV DEATH
38 %
RRR IN CV DEATH
HR = 0.62 ( 95 % Cl : 0.49-0.77 )
2.2 %
ABSOLUTE RISK REDUCTION Absolute rates for CV death : 5.9 % placebo VS 3.7 % JARDIANCE
JARDIANCE DEMONSTRATED A 14 % RRR FOR THE PRIMARY COMPOSITE ENDPOINT ( HR = 0.86 [ 95 % Cl : 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 ])
Please see Study Design on following page .
IMPORTANT SAFETY INFORMATION ( continued )
WARNINGS AND PRECAUTIONS ( continued ) Acute Kidney Injury and Impairment in Renal Function JARDIANCE causes intravascular volume contraction and can cause renal impairment . Acute kidney injury requiring hospitalization and dialysis have been identified in patients taking SGLT2 inhibitors , including JARDIANCE ; some reports involved patients younger than 65 years of age . Before initiating JARDIANCE , consider factors that may predispose patients to acute kidney injury including hypovolemia , chronic renal insufficiency , congestive heart failure and concomitant medications ( diuretics , ACE inhibitors , ARBs , NSAIDs ). Consider temporary discontinuation in settings of reduced oral intake or fluid losses . Monitor patients for signs and symptoms of acute kidney injury . If acute kidney injury occurs , discontinue JARDIANCE promptly and institute treatment .
* Patients with coronary artery disease , peripheral artery disease , or a history of myocardial infarction or stroke .
CI = confidence interval ; HR = hazard ratio ; MI = myocardial infarction ; RRR = relative risk reduction .
WARNINGS AND PRECAUTIONS ( continued ) Acute Kidney Injury and Impairment in Renal Function ( continued ) JARDIANCE increases serum creatinine and decreases eGFR . Patients with hypovolemia may be more susceptible to these changes . Renal function should be evaluated prior to initiating JARDIANCE and periodically thereafter . More frequent monitoring is recommended in patients with eGFR < 60 mL / min / 1.73 m 2 . JARDIANCE should be discontinued in patients with a persistent eGFR < 45 mL / min / 1.73 m 2 .
Urosepsis and Pyelonephritis Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors , including JARDIANCE . Treatment with SGLT2 inhibitors increases the risk for urinary tract infections . Evaluate for signs and symptoms of urinary tract infections and treat promptly .
Please * Patients see with additional coronary artery Important disease , Safety peripheral Information artery disease and , or a history of Brief myocardial Summary infarction of Prescribing or stroke . Information on adjacent pages .
CI = confidence interval ; HR = hazard ratio ; RRR = relative risk reduction .
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