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  5. Drug Trials Snapshots: VISTOGARD
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Drug Trials Snapshots: VISTOGARD

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 VISTOGARD Prescribing Information for complete information.

VISTOGARD (uridine triacetate)
VIS-toe-gard
Wellstat Therapeutics
Approval date: December 11, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

VISTOGARD is a drug used for the emergency treatment of adults and children who received an overdose of the cancer drugs fluorouracil or capecitabine, or for patients who developed certain severe or life-threatening side effects within four days of receiving these cancer drugs.

How is this drug used?

VISTOGARD consists of orange-flavored granules. Each dose of VISTOGARD needs to be mixed with soft food before it is taken by mouth every 6 hours for a total of 20 doses.

What are the benefits of this drug?

In two trials (Trial 1 and Trial 2), 96% of patients taking VISTOGARD were alive at 30 days or were able to resume their cancer treatment prior to 30 days.

What are the benefits of this drug (results of trials used to assess efficacy)?

The table below summarizes efficacy results for the clinical trials.

Table 2. Efficacy Results in Trials 1 and 2

  Overdose Patients Early-Onset Patients Overall
Total enrolled 117 18 135
Survival* 114 (97%) 16 (89%) 130 (96%)
Death 3 (3%) 2 (11%) 5 (4%)

*Survival includes patients who survived at 30 days or patients who resumed chemotherapy prior to 30 days.
VISTOGARD Prescribing Information

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: VISTOGARD worked similarly in men and women.
  • Race: The majority of patients in the clinical trial were white. Differences in response to VISTOGARD among races could not be determined.
  • Age: The majority of patients in the clinical trial were below 65 years of age. Differences in response to VISTOGARD between patients below and above 65 years of age could not be determined.

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

The table below summarizes efficacy results by sex.

Table 3. Subgroup Analysis of Survival –Combined Trials 1 and 2

  Overall
N=135
n (%)
Survival* 130 (96%)
Sex
Male (n=76) 74 (97%)
Female (n=59) 56 (95%)

*Survival includes patients who survived at 30 days or patients who resumed chemotherapy prior to 30 days.
Clinical trial data

What are the possible side effects?

The most common side effects are vomiting, nausea, and diarrhea.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse reactions in the clinical trials.

Table 4. Adverse Reactions in > 2% of Patients Receiving VISTOGARD in Trials 1 and 2

Adverse reaction All Treated Subjects (N=135)
n (%)
Vomiting 13 (10%)
Nausea 7 (5%)
Diarrhea 4 (3%)

VISTOGARD Prescribing Information

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

The total number of patients who had side effects was low and differences by age, sex, and race could not be determined.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

Due to overall low frequency of side effects in the trials, differences by age, sex, race could not be assessed.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved VISTOGARD based on evidence from two clinical trials including a total of 135 patients who either received an overdose of the cancer treatment fluorouracil or capecitabine, or who developed certain severe or life-threatening toxicities within four days of receiving these cancer treatments. The trials were conducted in the United States, Canada, Denmark, France, Germany, Spain, Greece, Paraguay, Singapore, and Australia.

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

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were enrolled in the clinical trial of the drug VISTOGARD.  In total, 76 men (56%) and 59 women (44%) participated in the clinical trial used to evaluate the drug VISTOGARD.).

Clinical trial data

Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trials.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the VISTOGARD clinical trial. In total, 97 Whites (74%), 12 Blacks (9%), 5 Asian (4%), and 21 Others (15%) participated in the clinical trial.

Clinical trial data

Table 1. Demographics of Trials by Race

Race Number of Patients Percentage of Patients
White 97 71.9%
Black or African American 12 8.9%
Asian 5 3.7%
Other/Unknown 21 15.6%

Clinical trial data

Figure 3 summarizes the percentage of patients by age in the clinical trials.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups  participated in the VISTOGARD  clinical trial. In total, 6 participants were below 18 years (4%), 86 participants were between 18 and 64 years (64%) and 43 participants were 65 and older (32 %).

Clinical trial data

Who participated in the trials?

The table below summarizes demographics of patients in the clinical trials.

Table 5. Baseline Demographics of Patients in the Clinical Trials

Demographic Parameters N=135 ((1(100%)
Sex, n (%)
Male 76 (56.3)
Female 59 (43.7)
Age
Mean (SD) 57.6 (15.46)
Median (Range) 59
Min, Max 1.83
Age Group, n (%)
≤18 years 6 (4.4%)
≥18 -64 years 86 (63.7%)
≥65 years 43 (31.9%)
Race, n (%)
White 97 (71.9)
Black or African American 12 (8.9%)
Asian 5 (3.7%)
Other/Unknown 21 (15.5%)

Clinical Trial Data

How were the trials designed?

The benefits and side effects of VISTOGARD were evaluated in two clinical trials. All patients received VISTOGARD. The benefit of VISTOGARD was evaluated by measuring how many patients were alive at 30 days or how many patients were able to restart the cancer treatment before 30 days.

How were the trials designed?

The safety and efficacy of VISTOGARD were established in 135 patients who were treated in two single-arm multicenter open-label trials. The patients in both trials had either received an overdose of fluorouracil or capecitabine, or presented with severe or life-threatening toxicities within 96 hours following the end of fluorouracil or capecitabine administration.

The primary efficacy outcome was survival at 30 days or until the resumption of chemotherapy if prior to 30 days.

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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