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November 21, 2019
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VICTORIA: Vericiguat meets primary efficacy endpoint for treatment of worsening chronic HF

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Merck announced that a soluble guanylate cyclase stimulator for the treatment of patients with worsening chronic HF with reduced ejection fraction met its primary efficacy endpoint in the phase 3 VICTORIA trial.

Vericiguat (Merck/Bayer) was able to reduce the risk for the composite endpoint of CV death or HF hospitalization compared with placebo when administered with available HF therapies, according to a press release from the companies.

“Heart failure affects more than 60 million patients worldwide,” Joerg Moeller, MD, member of the executive committee of the pharmaceutical division and head of research and development for Bayer, said in the release. “Despite advances in therapies and prevention efforts, the cardiovascular event rates remain high. There is a high unmet need for new treatment options to reduce the risk of death and hospitalizations.”

The VICTORIA trial is a randomized, placebo-controlled, phase 3 trial with 5,050 patients with worsening chronic HFrEF after a decompensation event from more than 600 centers in 42 countries. Patients were assigned vericiguat or placebo in addition to available HF therapies. In addition to the primary efficacy endpoint, secondary endpoints included time to first occurrence of HF hospitalization, time to occurrence of CV death, time to the composite of HF hospitalization or all-cause mortality, time to total HF hospitalizations including first and recurrent events, and time to all-cause mortality, according to the release.

“VICTORIA is the first large contemporary outcomes study to focus exclusively on a population with worsening chronic heart failure who have a high risk for cardiovascular mortality and repeated heart failure hospitalizations,” Roy Baynes, MD, senior vice president and head of global clinical development and chief medical officer of Merck Research Laboratories, said in the release.

Results of the trial will be presented at a meeting in 2020, according to the release.

Disclosures: Moeller is an employee of Bayer. Baynes is an employee of Merck.