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  5. Drug Trials Snapshot: VERQUVO
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Drug Trials Snapshot: VERQUVO

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the VERQUVO Prescribing Information for complete information.

VERQUVO (vericiguat)
(ver-KYU-voh)
Merck Sharp & Dohme Corp.
Approval date: January 19, 2021

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

VERQUVO is a drug used to reduce the risk of dying and hospitalization in patients with chronic (long-lasting) heart failure.

Heart failure is a condition when the heart is not pumping as well as it should be.

How is this drug used?

VERQUVO is a tablet that is taken by mouth once a day.

VERQUVO is used in patients who are having symptoms of chronic heart failure and who have had a recent hospitalization or the need to receive intravenous medicines.

What are the benefits of this drug?

VERQUVO reduces the risk of dying and hospitalization in patients with chronic heart failure.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: VERQUVO worked similarly in men and women.
  • Race: VERQUVO worked similarly in Whites, Black or African Americans and Asians.
  • Age: VERQUVO worked similarly in patients across tested age groups.

What are the possible side effects?

VERQUVO causes a harm to unborn baby and should not be given to pregnant women. Common side effects of VERQUVO are low blood pressure and low red cell count (anemia).

Were there any differences in side effects among sex, race and age?

  • Sex: The risk of side effects was similar in men and women.
  • Race: The risk of side effects was similar in Whites, Black or African Americans, and Asians.
  • Age: The risk of side effects was similar in patients younger and older than 65 years of age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved VERQUVO based on evidence from a clinical trial (NCT02861534) which consisted of 5,050 patients 23 to 98 years old with worsening heart failure. The trial was conducted at 694 sites in 42 countries in Europe, Asia, North and South America.

Figure 1 summarizes how many men and women were in the clinical trial.

Figure 1. Demographics by Sex (Efficacy Population)

Verquvo Pie chart summarizing how many men and women were in the clinical trials.

Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trial.

Figure 2. Demographics by Race (Efficacy Population)

Verquvo Pie chart summarizing how many patients of different races were in the clinical trial. In total, 3,239 patients were White (64%), 1,132 patients were Asian (22%), 249 patients were Black or African American (5%), and 430 patients were Other (9%).

*includes Multiple, American Indian or Alaska Native, Native Hawaiian or Pacific Islander and Not Reported

Adapted from FDA Review

Figure 3 summarizes how many patients by age in the clinical trial.

Figure 3. Demographics by Age (Efficacy Population)

Pie chart summarizing how many individuals of certain age groups were in the clinical trial. In total, 1,873 patients were less than 65 years old (37%), 1,609 patients were between 65-74 years old (32%), and 1,568 patients were 75 years and older (31%).

Adapted from FDA Review

Figure 4 summarizes how many patients by ethnicity in the clinical trial.

Figure 4. Demographics by Ethnicity (Efficacy Population)

Verquvo Pie chart summarizing how many individuals of certain ethnicity groups were in the clinical trial. In total, 813 patients were Hispanic or Latino (16%), and 4,109 patients were not Hispanic or Latino (73%), and 128 patients were not reported (3%).

Adapted from FDA Review

How were the trials designed?

The trial enrolled patients with symptoms of worsening heart failure. Patients were randomly assigned to receive VERQUVO or a placebo pill once a day. Neither the patients nor the health care professionals knew if the patients were given VERQUVO or placebo pill until after the trial was complete.

The trial measured the timing of two possible events:

  • death of a patient that was considered to be related to diseases of blood vessels and heart, or
  • the first time a patient needed to be hospitalized for worsening heart failure.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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