View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
September 8, 2021updated 11 Jul 2022 2:52pm

First successful trial in heart failure with preserved ejection fraction

According to the trial results, Jardiance reduces the risk of death or hospitalisation due to heart failure for diabetic and non-diabetic patients with HFpEF.

By GlobalData Healthcare

Full results of EMPEROR-Preserved, the first and only successful clinical trial in heart failure with preserved ejection fraction (HFpEF), were presented at the European Society of Cardiology (ESC) Congress and published in the New England Journal of Medicine on August 27. The trial results confirm that Eli Lilly and Boehringer Ingelheim’s sodium-glucose cotransporter 2 (SGLT-2) inhibitor Jardiance (empagliflozin) reduced the risk of a composite of cardiovascular death or hospitalisation for heart failure in both diabetic and non-diabetic patients with HFpEF compared to placebo. The results of this landmark trial are likely to prompt a change in clinical practice for HFpEF, a condition that is notoriously challenging to treat, with Jardiance becoming established as the preferred therapeutic option.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

The double-blind, Phase III trial enrolled 5,988 symptomatic HFpEF patients (left ventricular ejection fraction over 40%), both with and without type 2 diabetes (T2D), across 23 countries. Participants were randomised in a 1:1 ratio to receive either 10mg Jardiance or placebo once daily, in addition to standard of care therapies. Over a median follow-up of 26.2 months, 13.8% of Jardiance-treated patients and 17.1% of placebo-treated patients experienced a primary outcome event, equating to a hazard ratio of 0.79 (P<0.001). This effect was observed across subgroups, including patients with and without T2D, as well as patients with a left ventricular ejection fraction of less than 50%, 50% to less than 60% or 60% or more. The observed safety profile was generally consistent with the known safety profile of Jardiance.

Historically, no drug has demonstrated a clear clinical benefit in an HFpEF trial. The limited therapeutic options available to these patients represent a strong unmet need within heart failure, according to key opinion leaders (KOLs) interviewed by GlobalData. Recent high-profile trial failures in HFpEF include the PARAGON-HF trial for Novartis’ Entresto (sacubitril/valsartan), which narrowly missed statistical significance for its composite primary endpoint of reducing cardiovascular death and total heart failure hospitalisations. Despite this, Entresto was approved for the treatment of HFpEF in February 2021 in the US, indicating the low bar for new drug approvals in this field.

Due to the superior results obtained from EMPEROR-Preserved, Jardiance, which is already marketed for the treatment of heart failure with reduced ejection fraction (HFrEF) and T2D, is almost certain to achieve a label expansion for HFpEF. Boehringer Ingelheim and Eli Lilly will be keen to expedite this, with the companies planning regulatory submissions for this year. While Jardiance has a clear competitive advantage over Entresto in the HFpEF space, Boehringer Ingelheim and Eli Lilly will have to address the potential threat posed by AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin). DELIVER, a Phase III trial investigating Farxiga in HFpEF is currently ongoing and is expected to complete in Q1 2022. Boehringer Ingelheim and Eli Lilly still have a window of opportunity to market Jardiance as the only therapeutic clinically proven to improve cardiovascular disease outcomes for all heart failure patients regardless of ejection fraction status.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

Related Report
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena