For bipolar I and II depression in adultsChanges in weight and metabolic impact
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| Safety data from 6-week pivotal trials and a 6-month, open-label safety trial1-3* | |||||
|---|---|---|---|---|---|
| POOLED Monotherapy: 6 weeks | Adjunctive (with lithium or valproate): 6 weeks | OPEN-LABEL SAFETY TRIAL, MONOTHERAPY: 6 months† | |||
| CAPLYTA (N=372) | Placebo (N=374) | CAPLYTA (N=177) | Placebo (N=175) | CAPLYTA (N=127) | |
| Weight change (lbs) | +0.1 | +0.4 | 0.0 | +0.5 | 0.0 |
| Metabolic profile (mean change from baseline, mg/dL) | |||||
| Total cholesterol | -0.6 | -1.1 | -6.5 | -0.7 | -2.5 |
| LDL cholesterol | -0.7 | -0.6 | -5.9 | -0.6 | -5.8 |
| HDL cholesterol | +0.4 | 0.0 | -0.6 | -0.2 | +1.4 |
| Triglycerides | -1.4 | -4.0 | -1.6 | -1.2 | +2.3 |
| Glucose | +0.1 | 0.0 | +1.2 | +0.8 | +2.4 |
| Insulin (mIU/L) | -0.8 | +0.6 | +3.5 | +0.4 | +0.1 |
| Hemoglobin A1c (%) | 0.0‡ | 0.0‡ | -0.1 | -0.1 | 0.0 |
| Prolactin (ug/L) | -0.2 | +1.1 | +0.6 | +1.8 | +1.3 |
| Safety data from 6-week pivotal trials and a 6-month, open-label safety trial1-3* | |||||
|---|---|---|---|---|---|
| POOLED Monotherapy: 6 weeks | Adjunctive (with lithium or valproate): 6 weeks | OPEN-LABEL SAFETY TRIAL, MONOTHERAPY: 6 months† | |||
| CAPLYTA (N=372) | Placebo (N=374) | CAPLYTA (N=177) | Placebo (N=175) | CAPLYTA (N=127) | |
| Weight change (lbs) | +0.1 | +0.4 | 0.0 | +0.5 | 0.0 |
| Metabolic profile (mean change from baseline, mg/dL) | |||||
| Total cholesterol | -0.6 | -1.1 | -6.5 | -0.7 | -2.5 |
| LDL cholesterol | -0.7 | -0.6 | -5.9 | -0.6 | -5.8 |
| HDL cholesterol | +0.4 | 0.0 | -0.6 | -0.2 | +1.4 |
| Triglycerides | -1.4 | -4.0 | -1.6 | -1.2 | +2.3 |
| Glucose | +0.1 | 0.0 | +1.2 | +0.8 | +2.4 |
| Insulin (mIU/L) | -0.8 | +0.6 | +3.5 | +0.4 | +0.1 |
| Hemoglobin A1c (%) | 0.0‡ | 0.0‡ | -0.1 | -0.1 | 0.0 |
| Prolactin (ug/L) | -0.2 | +1.1 | +0.6 | +1.8 | +1.3 |
In 6-week trials, changes in weight and metabolic parameters, including prolactin levels, were similar to placebo1
In 6-week trials, 99% of participants receiving CAPLYTA did not experience clinically significant weight gain3,4§
Mean weight change was 0 lbs at 6 months2†
†Limitation: This open-label safety extension trial was designed primarily to assess long-term safety and tolerability.2
*Number of patients with available data varies for each measurement; based on assessments of patients with a baseline and a last, non-missing value.
‡Endpoint for hemoglobin A1c was Day 57.1
§Defined as ≥7% increase from baseline to 6 weeks.3,4
HDL=high-density lipoprotein; LDL=low-density lipoprotein.
WARNINGS & PRECAUTIONS: Antipsychotic drugs have been reported to cause:
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Please see additional Important Safety Information, including Boxed WARNINGS, below.
