Escalating risk demands decisive early treatment

PC-QA-100380-Metabolism-SYNJARDY- POWER UP FROM THE START

PC-QA-100380-Metabolism-SYNJARDY - Guidelines

Footnotes

*In this 24-week, phase III, randomized, double-blind, parallel-group, a total of 1,364 drug-naïve adults with type 2 diabetes (baseline HbA1c 7.5–12%, mean 8.6–8.9%) were randomized to receive empagliflozin (5–12.5 mg twice daily or 10–25 mg once daily) plus metformin (500–1,000 mg twice daily), empagliflozin monotherapy, or metformin monotherapy. The primary endpoint was change from baseline in HbA1c at week 24. Initial combination therapy produced significantly greater reductions in HbA1c (−1.9% to −2.1%) compared with empagliflozin monotherapy (−1.4%) or metformin monotherapy (−1.2% to −1.8%), with additional benefits in body weight (−2.8 to −3.8 kg vs −0.5 to −1.3 kg for metformin).⁸
†Change in systolic blood pressure from baseline at 24 weeks: -4.5 mmHg for Empagliflozin 10 mg (n=217), -5.2 mmHg for Empagliflozin 25 mg (n=213), and -0.4 mmHg for placebo (n=207).¹⁵
‡In a subgroup analysis at 24 weeks, of patients with baseline BMI ≥35, adjusted mean changes in weight were -0.34 kg for placebo (n=29), -2.63 kg for Empagliflozin 10 mg (n=33), and -3.35 kg for Empagliflozin 25 mg (n=41). Difference from placebo (adjusted mean) was -2.28 for Empagliflozin 10 mg and -3.01 for Empagliflozin 25 mg. In a double-blind extension trial, adjusted mean changes in weight for patients with baseline BMI ≥ 35 at Week 76 were 0.23 kg for placebo (n=29), -3.74 kg for Empagliflozin 10 mg (n=33), and -4.77 kg for Empagliflozin 25 mg (n=41). Difference from placebo (adjusted mean) was -3.96 kg for Empagliflozin 10 mg and -4.99 for Empagliflozin 25 mg.⁹
§SYNJARDY® is not indicated for weight loss or BP reduction.
||In this 24-week, phase III, randomized, double-blind, placebo-controlled, parallel-group trial, a total of 637 adults with type 2 diabetes inadequately controlled on metformin (≥1500 mg/day) were randomized to empagliflozin 10 mg (n=217), empagliflozin 25 mg (n=213), or placebo (n=207). The primary endpoint was change in HbA1c from baseline at week 24. Key secondary endpoints included changes in body weight, mean daily glucose, and blood pressure. Empagliflozin significantly reduced systolic blood pressure by 5.2 mmHg versus placebo, in addition to improvements in glycemic control and body weight.⁹

Abbreviations

BMI=body mass index; BP=blood pressure; CV=cardiovascular; CKD=chronic kidney disease; Empa=empagliflozin; EMPA-REG=empagliflozin cardiovascular outcome event trial in type 2 diabetes mellitus patients; HbA1c=hemoglobin A1c; HR=hazard ratio; MET=metabolic equivalent of task; mmHg=millimetres of mercury; T2D=type 2 diabetes.

Reference

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SYNJARDY® Local SMPC.
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JARDIANCE® Local SMPC.

Document Number: PC-QA-100380
Expiry Date: 08/03/2028