When initiating CAPLYTA in adults with schizophrenia, clinicians should also consider the safety profile of the treatment, including how that profile will impact patients. When we think about weight, for instance, the impact on patients goes beyond just the number and includes how it makes them feel.

So how do patients tend to think about the impact on their weight? They will often contextualize this by saying “my pants don't fit me anymore.” While clinicians are concerned with metabolic abnormalities—for which there can be long-term consequences in patients with schizophrenia—patients are concerned about their weight; however, we know these are interrelated issues that are important to address.

In the 4- to 6-week, short-term, placebo-controlled trials with CAPLYTA, mean changes in weight from baseline to the end of the study were similar in patients treated with CAPLYTA and placebo.

Furthermore, patients receiving CAPLYTA experienced weight loss over the long term. In a 1-year, open-label safety study, patients treated with CAPLYTA showed mean decreases in body weight of 4 lb at day 175, and 7 lb at day 350. At 1 year, 24% of patients had a clinically significant weight decrease, defined as a ≥7% decrease in body weight, and 8% of patients experienced a clinically significant weight increase, defined as a ≥7% increase in body weight.

CAPLYTA also had a favorable impact on metabolic and endocrine parameters with short-term use, including mean changes in fasting glucose, total cholesterol, and triglycerides that were similar between CAPLYTA and placebo. Not to mention, patients on CAPLYTA also had a mean change in prolactin levels of -1.3 ng/mL compared with -0.2 ng/mL for patients on placebo. Additionally, in a 1-year open-label safety study, CAPLYTA had a favorable metabolic and endocrine profile with long-term use.

Something that's also relevant to look at is the shift in metabolic parameters. When looking at the proportion of patients who had shifts from baseline in key metabolic parameters at Day 300, we can see that the majority of patients started normal and stayed normal. This means that most patients had no shift, either high or low, in their glucose, insulin, hemoglobin A1C, or cholesterol.

Metabolic changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain, have been reported with antipsychotic drugs. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. There have been reports of hyperglycemia in patients treated with CAPLYTA. Assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.