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  5. Drug Trials Snapshot: ENTRESTO
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Drug Trials Snapshot: ENTRESTO

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.enter content

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 ENTRESTO Prescribing Information for complete information.

ENTRESTO (sacubitril/valsartan)
(en-TRESS-toh)
Novartis Pharmaceuticals Corporation
Approval date: July 7, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ENTRESTO is a drug to be taken in conjunction with other heart failure therapies for the long-term treatment of chronic heart failure. This is a condition in which the heart is weak and cannot pump enough blood to meet the body’s needs.

ENTRESTO should not be taken with any drug that belongs to certain classes of medication called ACE inhibitors and angiotensin receptor blockers. This is because ENTRESTO itself contains an angiotensin receptor blocker.

How is this drug used?

ENTRESTO is a tablet that is taken by mouth two times daily.

What are the benefits of this drug?

ENTRESTO reduced the risk of death related to the heart and blood vessels as well as hospitalization related to heart failure.

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

Subgroup analyses were conducted for sex, race, and age.

  • Sex: ENTRESTO worked similarly in men and women.
  • Race: ENTRESTO worked similarly in all races studied.
  • Age: ENTRESTO worked similarly in all age groups studied.

What are the possible side effects?

The most common side effects were low blood pressure, high blood potassium levels, cough, dizziness, and poor function of the kidneys.

ENTRESTO can harm or cause death to an unborn baby and should not be taken by pregnant women.

ENTRESTO may cause an allergic reaction called angioedema. This usually appears as swelling of the face, lips, tongue, and throat. The reaction may lead to trouble breathing and death.

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

Subgroup analyses were conducted for sex, race, and age.

  • Sex:  The risk of side effects appeared to be similar in men and women.
  • Race:  There was an increased risk of an allergic reaction called angioedema in black patients.
  • Age: The risk of low blood pressure was higher in patients 65 years and older.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved ENTRESTO based on evidence from a clinical trial that enrolled 8442 patients with chronic heart failure. The trial was conducted in the United States, Canada, Western and Central Europe, Latin America and Asia. The same trial was used to assess the benefits and the side effects of the drug.

The figure below summarizes how many men and women were enrolled in the clinical trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were enrolled in the clinical trials used to evaluate efficacy of the drug ENTRESTO.  In total, 6595 men (78%) and 1847 women (22%) participated in the clinical trials used to evaluate efficacy of the drug ENTRESTO.

Source: Company Clinical Trial Data

The figure and table below summarize how many patients by race were enrolled in the clinical trial.

Figure 2. Baseline Demographics by Race

chart summarizing the percentage of patients by race enrolled in the ENTRESTO clinical trial. In total, 5579 White (66%), 1510 Asian (18%), 753 identified as Other (9%), 428 Black or African American (5%), and 172 American Indian or Alaska Native (2%).

*Other: all other races combined
Source: Company Clinical Trial Data

Table 1. Baseline Demographics by Race

 Race  Number of Patients  Percentage of Patients
 White  5579  66
 Asian  1510  18
 Other  753  9
 Black or African American  428  5
 American Indian or Alaska Native  172  2

Source: Company Clinical Trial Data

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the ENTRESTO clinical trial. In total, 4299 were between 18 and 64 years (51%), 2574 were between 65 and 74 years (30%), and 1569 were 75 years of age or older (19%).

Source: Company Clinical Trial Data

How were the trials designed?

There was one trial that evaluated the benefits and side effects of ENTRESTO. In the trial, patients with heart failure were randomly assigned to receive either ENTRESTO or an approved drug called enalapril. Neither the patients nor the health care providers knew which treatment was being given until after the trial was complete. Patients in the trial were taking other drugs for heart failure.

The trial compared patients taking ENTRESTO to patients taking enalapril by measuring the numbers of patients who died from any cause related to the heart or blood vessels or were hospitalized for 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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