Extension of Expected Lifetime When Treated with Empagliflozin in Patients with Type 2 Diabetes and Cardiovascular Disease

Introduction

The gold standard in assessing treatment efficacy in the short term is clinical trials, but evaluating long-term efficacy usually requires additional indicators. In the EMPA-REG OUTCOME study, the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin, added to standard therapy, reduced the risk of cardiovascular (CV) death by 38% and overall mortality by 32% during a 3-year follow-up of patients with T2DM and known CV disease.

Analysis of Therapy Impact on Lifetime

In the EMPA-REG OUTCOME study, patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. A total of 7,020 participants (average age 63 ± 9 years) were included in the study. The aim of the new data analysis from this study was to determine the long-term impact of empagliflozin treatment on the remaining expected lifetime of patients with T2DM at each year of life. In the combined empagliflozin treatment group and the placebo group, according to the EMPA-REG OUTCOME study results, the remaining expected lifetime of patients was estimated for each age year as the area under the survival curve up to 90 years. The treatment impact was estimated for patients aged 45 to 80 years.

Results

Expected average survival was significantly longer in patients treated with empagliflozin compared to those who received placebo, across all age categories. At the age of 45, empagliflozin treatment extended the patient's expected lifetime by 4.5 years, at the age of 50 by 3.1 years, at the age of 60 by 2.5 years, at the age of 70 by 2 years, and at the age of 80 by 1 year. While the absolute increase in expected survival time for patients treated with empagliflozin decreased with age, the relative increase remained constant regardless of age, at 12–15%.

Conclusion

Using data from the EMPA-REG OUTCOME study and advanced statistical-mathematical methods, it was shown that treatment with empagliflozin can extend the survival of patients with T2DM and known CV disease by 1–5 years (depending on age), even with imperfect adherence to therapy (including treatment discontinuation in the EMPA-REG OUTCOME study).

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Source:

Claggett B., Lachin J. M., Hantel S. et al. Long-term benefit of empagliflozin on life expectancy in patients with type 2 diabetes mellitus and established cardiovascular disease. Circulation 2018; 138 (15): 1599−1601, doi: 10.1161/CIRCULATIONAHA.118.033810.