Clinical Trial Demonstrates Positive Top-Line Results in Reducing the Risk for Cardiovascular Death or Hospitalisation due to Heart Failure
Boehringer Ingelheim - one of the world’s leading pharmaceutical companies has announced positive top-line results from the EMPEROR-Reduced Phase III trial in adults with chronic heart failure with reduced ejection fraction. The trial met its primary endpoint, demonstrating superiority empagliflozin (10mg) versus placebo on top of standard of care, in reducing the risk for cardiovascular death or hospitalisation due to heart failure.
Many Middle Eastern countries have observed increases in the prevalence of risk factors for heart failure, which is seen to develop in their populations at least 10 years earlier than in Western counterpart populations[1]. The risk factors include diabetes mellitus, obesity, and hypertension[2]. Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively and pumps out less blood to the body compared to a normally functioning heart[3]. Symptoms associated with heart failure include breathlessness and fatigue, which can severely impact upon quality of life[4]. There remains a high unmet need in the treatment of heart failure, as approximately 50 percent of all those diagnosed with the condition die within five years[5].
The EMPEROR-Reduced clinical trials form part of the EMPOWER clinical programme, one of the broadest, most comprehensive trials of any SGLT2 inhibitor, exploring the impact of treatments across cardio-renal-metabolic conditions. Building on findings from EMPA-REG OUTCOME®, these positive results demonstrate that empagliflozin has the potential to fill unmet therapeutic needs for people with this highly prevalent condition.
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the European Society of Cardiology (ESC) congress 2020, which is being held 29 August. A second trial, EMPEROR-Preserved, the results of which are expected in 2021, will explore the effect of empagliflozin on cardiovascular death and hospitalisation for heart failure in adults with heart failure with preserved ejection fraction[6] - an area of high unmet need as there are currently no treatment options available for people with this form of heart failure[7].
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Notes to the editor:
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References
[1] Al-Shamiri, Mostafa Q. “Heart failure in the Middle East.” Current cardiology reviews vol. 9,2 (2013): 174-8. doi:10.2174/1573403x11309020009
[2] Al-Shamiri, Mostafa Q. “Heart failure in the Middle East.” Current cardiology reviews vol. 9,2 (2013): 174-8. doi:10.2174/1573403x11309020009
[3] American Heart Association. Ejection Fraction Heart Failure Measurement. Available at: https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement. Accessed July 2020.
[4] American Heart Association. Warning Signs of Heart Failure. Available at: https://www.heart.org/en/health-topics/heart-failure/warning-signs-of-heart-failure. Accessed July 2020.
[5] Ponikowski P, Anker SD, AlHabib KF. Heart Failure: preventing disease and death worldwide. ESC Heart Fail. 2014;1(1):4–25
[6] ClinicalTrials.gov. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). Available at: https://clinicaltrials.gov/ct2/show/NCT03057951. Accessed July 2020.
[7] Harper A, Patel H, Lyon A. Heart failure with preserved ejection fraction. Clin Med (Lond). 2018;18(Suppl 2): s24–s29.