If you're wondering whether GATTEX is right for you, the best thing to do is to talk with your doctor. No two patients with Short Bowel Syndrome (SBS) are alike, so it's important to understand the potential benefits and risks for your specific health situation and to remember that individual results may vary.
It's also a good idea to do as much research as possible. Take a look at the study results to see how patients with SBS who needed additional nutrition or fluids from intravenous (IV) feeding, also known as parenteral support (PS), responded to treatment.
GATTEX was studied in adult patients with Short Bowel Syndrome (SBS) who needed parenteral support (PS) at least 3 times every week for at least 12 months.
The first study lasted for 6 months. When it ended, almost all of the patients decided to continue in an extended 2-year study. They were joined by twelve more patients with SBS who also needed IV feeding or fluids. Here are the details:
A total of 43 patients received GATTEX and 43 patients received placebo, but the patients were not told which one they were taking.
Patients did not know if they were receiving once-daily GATTEX (0.05mg/kg) or placebo, which is a treatment with no actual medication.
The goal of the study was to see if significantly more patients on GATTEX achieved a reduction in weekly PS volume of at least 20% compared to patients taking placebo at weeks 20 and 24.
76 out of the 78 patients who completed the first study decided to continue to participate in this study. They were joined by an additional 12 patients, for a total of 88 patients.
Everyone who participated in this study knew they were taking GATTEX.
The goal of this study was to evaluate the efficacy and safety of GATTEX over 2 years.
30 patients completed a total of 2.5 years of GATTEX treatment. (They took GATTEX in study 1 and GATTEX in study 2.)
29 patients completed 2 years of GATTEX treatment. (They took placebo in study 1, then GATTEX in study 2.)
After 6 months, 63% of patients treated with GATTEX vs 30% of patients treated with placebo reduced their weekly PS by at least 20% compared to when they first started the study.
Clinical response was defined as reducing weekly PS by at least 20% compared to when they started the study.
93% of the patients who received GATTEX in both the first and second study, for a total of 30 months, had a 20% or greater reduction in weekly PS.
This group also had an average reduction in PS volume of 7.55 liters per week.
7 out of the 8 patients who didn’t respond to GATTEX in the first study did achieve a clinical response to GATTEX at 30 months.
aOf the 39 patients who were given placebo in the first study and continued on to the second study, 29 went on to complete the second study and received treatment with GATTEX. That means they received GATTEX for 24 months.
bOf the 37 patients who received GATTEX in the first study and continued on to the second study, 30 went on to complete the second study, for a total of 30 months of treatment with GATTEX.
After the study began, 4 patients receiving GATTEX and 4 patients receiving placebo stopped receiving treatment. This left 78 patients to evaluate.
Patients who received GATTEX in the first and second study received treatment for a total of 30 months.
GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become cancer. If you get cancer of the bowel (intestines), liver, gallbladder or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX.
Please see additional Important Safety Information below.
At week 24, the average weekly reduction in parenteral support was 4.4 L for GATTEX-treated patients (from pretreatment baseline of 12.9 L) vs 2.3 L for placebo-treated patients (from pretreatment baseline of 13.2 L)
A progressive decrease in average parenteral support volume was seen in patients who received GATTEX during both the 6-month study and the 24-month extended study.
GATTEX decreased infusion volume for patients by an average of 7.55 L per week from where they started, after 30 months.
33% (10 out of 30) patients who completed 30 months of GATTEX were able to stop taking parenteral support entirely. No patients were completely free of the need for parenteral support in the 6-month trial (study 1).
Of course, no two patients are alike so it’s important to remember that individual results may vary.
Important Safety Information: GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the colon (large intestine), blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload.
Click here for additional Important Safety Information.