What is the safety profile of Simtriyo in pediatric patients?
Simtriyo demonstrated a consistent safety and tolerability profile in pediatric clinical trials (aged 6 through 17).1-3
In pooled, 6-week, placebo-controlled studies, the most common adverse events occurring in ≥5% of children aged 6-12 treated with Simtriyo and greater than placebo rate were decreased appetite and rash. In this study, 6% of Simtriyo-treated patients discontinued treatment because of an adverse event compared to 1% of placebo-treated patients.1
In adolescents aged 13 through 17, the most common adverse events occurring in ≥5% of Simtriyo patients and greater than placebo rate were decreased appetite, nausea, rash, headache, and abdominal pain.1-3 In this study, 8% of Simtriyo-treated patients discontinued treatment because of an adverse event compared to 0% of placebo-treated patients.1
Incidence of rash most commonly occurred within the first 14 days of treatment, and rashes were typically mild and resolved within 2 weeks. There were no serious cases of rash and no severe cutaneous adverse reactions across clinical studies and populations.4
Have studies assessed the effect of Simtriyo on cardiovascular health in pediatric patients?
Simtriyo has class-related warnings for cardiovascular effects. In clinical trials, cardiovascular AEs were not among the most commonly reported AEs in pediatric patients, and there was no clinically meaningful effect on the QT interval.1
Have studies assessed the effect of Simtriyo on sleep or appetite in pediatric patients?
In clinical studies, there was a low incidence of insomnia. In the adolescent study, insomnia occurred in 3% of Simtriyo-treated patients vs 1% for placebo. Insomnia was not among the most commonly reported adverse events in the children’s study.1-3
In the adolescent study, decreased appetite occurred in 15% of Simtriyo-treated patients vs 2% for placebo.1 In the children’s study, decreased appetite occurred in 8% of Simtriyo-treated patients vs 3% for placebo.1
Has the safety of Simtriyo been studied over the long term in pediatric patients?
In a 52-week open-label extension study, Simtriyo demonstrated a safety and tolerability profile consistent with short-term studies in pediatric patients (aged 6 through 17), with no new safety findings and a low overall incidence of serious adverse events.4
In this study, the most common adverse events were decreased appetite, headache, upper respiratory tract infection, nausea, and decreased weight.4