Physicians Office Resource Volume 11 Issue 01 - Page 67

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. 61