How XERMELO was studied
In the TELESTAR study, XERMELO + SSA was compared with somatostatin analog (SSA) injections alone in 90 people (45 per test group) with carcinoid syndrome diarrhea (CSD). Participants were having between 4 to 12 bowel movements (BMs) per day and were already on a steady SSA dose for at least 3 months. All participants were followed for 12 weeks and recorded diarrhea frequency in a daily diary.
XERMELO pills + SSA injections provide long-term relief for CSD
TELESTAR, the clinical study that led to the FDA approval of XERMELO, showed meaningful reductions in CSD symptoms.
XERMELO was studied in multiple long-term safety studies. The average treatment was 92 weeks.
XERMELO + SSA reduced average daily BM frequency 2X more than SSA injections alone (-1.4 vs -0.6, respectively).
Give XERMELO 12 weeks to work
In the TELESTAR study, almost 9 out of 10 people with CSD (89%) taking XERMELO pills plus SSA injections had a reduction in diarrhea frequency at 12 weeks. In the same study, only 69% of patients on SSA injections alone reduced their BM frequency.
Most patients see improvement in 12 weeks and some patients may start to see results within 1 to 3 weeks.
XERMELO reduced serotonin levels
When serotonin breaks down in your body, it becomes 5-hydroxyindoleacetic acid (5-HIAA). People with CSD often have high levels of 5-HIAA.
In the TELESTAR study, about 57% of patients who were enrolled had elevated 5-HIAA levels at baseline, while 27% had normal levels and ~15% had unknown levels at baseline.
At the end of the TELESTAR study, patients’ 5-HIAA levels were measured. In the group treated with XERMELO + SSA injections, 5-HIAA levels were reduced by 40.1 mg. In patients treated with SSA alone, 5‑HIAA levels showed an increase of 11.5 mg.
Your healthcare provider may measure your 5-HIAA levels to see how much serotonin is in your body.
XERMELO was shown to be effective in patients regardless of their baseline 5-HIAA levels.
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