BEVYXXA is a drug known as a “blood thinner” that helps prevent venous thromboembolism (VTE) in hospitalized adult patients who at risk for developing VTE.
VTE is a condition characterized by the formation of a blood clot in a deep vein (deep vein thrombosis or DVT) which may be complicated by breaking off of the clot which can then travel to the lung and cause serious and sometimes fatal pulmonary embolism (PE).
Drug Trial Snapshots: Bevyxxa
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 BEVYXXA Prescribing Information for complete information.
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 BEVYXXA Prescribing Information for complete information.
BEVYXXA (betrixaban)
(be vix’ ah)
Portola Pharmaceuticals, Inc.
Approval date: June 23, 2017
(be vix’ ah)
Portola Pharmaceuticals, Inc.
Approval date: June 23, 2017
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
BEVYXXA is a drug known as a “blood thinner” that helps prevent venous thromboembolism (VTE) in hospitalized adult patients who at risk for developing VTE.
VTE is a condition characterized by the formation of a blood clot in a deep vein (deep vein thrombosis or DVT) which may be complicated by breaking off of the clot which can then travel to the lung and cause serious and sometimes fatal pulmonary embolism (PE).
How is this drug used?
BAXDELA is a capsule. Two capsules are taken together on the first day of treatment followed by one capsule a day for 35 to 42 days.
What are the benefits of this drug?
The trial showed that patients who received BEVYXXA had fewer VTE events in comparison to patients who received another drug approved for VTE prevention called enoxaparin.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: BEVYXXA worked similarly in men and women.
- Race: Most of the patients were White. Differences in how will the drug worked among races could not be determined because of the small number of patients in other races.
- Age: BEVYXXA worked similarly in patients above and below age 65.
What are the possible side effects?
The most common side effect of BEVYXXA is bleeding, which can be serious. This is because BEVYXXA is a medicine that works by interfering with the process of blood clotting in the body, making bleeding more likely.
People who take a blood thinner medicine like BEVYXXA, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis).
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of bleeding was greater in women.
- Race: Most of the patients were White. Differences in the occurrence of bleeding among races could not be determined because of the small number of patients in other races.
- Age: The occurrence of bleeding was similar in patients above and below age 65.
WHO WAS IN THE STUDIES?
Who participated in the clinical trials?
The FDA approved BEVYXXA based on evidence from one clinical trial that enrolled 7513 hospitalized patients who were at risk of developing VTE. The trial was conducted in Europe, Latin America, Asia, Australia, South Africa, Canada and United States.
Figure 1 summarizes how many men and women were enrolled in the clinical trial.
Figure 1. Baseline Demographics by Sex
Clinical trial data
Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trial.
Figure 2. Baseline Demographics by Race
Clinical trial data
Table 1. Baseline Demographics by Race
| Race | Number of Patients | Percentage |
|---|---|---|
| White | 7021 | 93 |
| Black or African American | 147 | 2 |
| Asian | 16 | less than 1 |
| Multiple | 52 | 1 |
| Other | 126 | 2 |
| Unknown* | 151 | 2 |
* Data collection prohibited by local regulatory authority
Clinical trial data
Figure 3 summarizes the percentage of patients by age enrolled in the clinical trial.
Figure 3. Baseline Demographics by Age
Clinical trial data
How were the trials designed?
There was one trial that established the benefit and side effects of BEVYXXA. Trial enrolled patients who were hospitalized for an acute illness and were at risk for developing VTE.
Patients were randomly chosen to receive one of two therapies: one group received once a day placebo injection (for 6 to 14 days) and BEVYXXA tablet (for 35 to 42 days) and, the second group received once a day enoxaparin injection (for 6 to 14 days) and placebo tablets for 35 to 42 days. This way, neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.
The benefit of BEVYXXA was measured by the proportion of patients who developed some form of VTE between day 32 and 47 and compared it to enoxaparin.
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.
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.
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