Does Vraylar (cariprazine) cause weight gain?

From the Guidelines

Vraylar (cariprazine) is associated with a lower risk of weight gain compared to many other antipsychotic medications, with some studies suggesting it may have a weight-neutral profile similar to lurasidone and ziprasidone 1. When considering the potential for weight gain with Vraylar, it's essential to look at the broader context of antipsychotic medications.

• Many antipsychotics, such as olanzapine, clozapine, quetiapine, and risperidone, are consistently associated with significant weight gain 1.
• In contrast, medications like lurasidone, ziprasidone, and aripiprazole tend to have a lower risk of weight gain, with some studies indicating they may be weight-neutral 1.
• Vraylar, with its unique mechanism of action affecting dopamine and serotonin receptors, may share a similar weight profile with these latter medications, although direct evidence from the provided study is limited. The potential for weight gain with any medication should be considered in the context of the individual patient's health status, lifestyle, and other medications they may be taking.
• Regular monitoring of weight, especially during the initial treatment period, is crucial for patients taking Vraylar or any other antipsychotic medication.
• Lifestyle modifications, including a balanced diet and regular physical activity, can help mitigate any potential weight changes associated with Vraylar or other antipsychotics 1.

From the FDA Drug Label

Weight Gain Weight gain has been observed with use of atypical antipsychotics, including VRAYLAR Monitor weight at baseline and frequently thereafter. Table 4. Change in Body Weight (kg) in 6-Week Schizophrenia Trials VRAYLAR* Placebo(N=573)1. 5 - 3 mg/day(N=512)4.5 - 6mg/day(N=570)9 - 12⸰ mg/day(N=203) Mean Change at Endpoint+0.3+0. 8+1+1 Proportion of Patients with Weight Increase (≥7%)5%8%8%17% In long-term, uncontrolled trials with VRAYLAR in schizophrenia, the mean changes from baseline in weight at 12,24, and 48 weeks were 1.2 kg, 1.7 kg, and 2.5 kg, respectively.

Weight gain is a potential side effect of Vraylar (cariprazine). The proportion of patients with weight increase (≥7%) ranged from 1% to 17% in various trials. Mean changes in body weight were also observed, with increases of up to 2.5 kg in long-term trials. Monitoring of weight is recommended at baseline and frequently thereafter 2.

From the Research

Weight Gain Associated with Vraylar (Cariprazine)

• Vraylar (cariprazine) has been studied for its effects on weight gain in several studies 3, 4.
• A retrospective study of electronic health records found that the average predicted weight change for patients during the cariprazine overall follow-up period was +2.4 kg, with predicted weight changes of +0.8 kg, +1.1 kg, and +1.4 kg at months 3,6, and 12, respectively 3.
• Another real-world analysis found that cariprazine was associated with an estimated weight gain of +0.91 kg/year, and had minimal impact on BMI and blood pressure when evaluated up to 12 months 4.
• In contrast to other atypical antipsychotics, cariprazine has been found to have a relatively neutral weight and metabolic profile 3, 5.
• However, it is worth noting that antipsychotic-induced weight gain is a common side effect, and significant weight gain can increase the relative risk for diabetes mellitus and hypertriglyceridemia 6.

Metabolic Effects of Cariprazine

• Cariprazine has been found to have minimal impact on metabolic parameters, including hemoglobin A1c, low-density lipoprotein, high-density lipoprotein, and triglycerides 3.
• A study found that average predicted HbA1c levels increased during baseline and decreased during cariprazine treatment, while average predicted triglyceride levels increased during baseline and decreased during cariprazine treatment 3.
• Another study found that cariprazine was associated with a decrease in systolic blood pressure and a minimal impact on diastolic blood pressure 4.

Comparison to Other Atypical Antipsychotics

• Cariprazine has been found to have a more favorable weight and metabolic profile compared to other atypical antipsychotics 3, 5.
• A study found that cariprazine was significantly more efficacious than risperidone in improving PANSS Factor Score for Negative Symptoms in patients with predominantly negative symptoms of schizophrenia 5.
• However, more research is needed to fully understand the metabolic effects of cariprazine and its comparison to other atypical antipsychotics 6.