Metabolic, Endocrine Profiles Examined in Long-term Schizophrenia Therapy
Outpatients with schizophrenia were examined in this 52-week open-label extension trial.
Patients with schizophrenia undergoing long-term injectable aripiprazole lauroxil (AL) therapy experienced modest changes in weight, fasting glucose, and glycated hemoglobin levels consistent with previous research, according to data presented at the American Psychiatric Association (APA) 2017 Annual Meeting, taking place May 20-24, 2017, in San Diego, California.
Henry Nasrallah, MD, chair of the Department of Psychiatry and Behavioral Neuroscience at the Saint Louis University School of Medicine Missouri, and colleagues conducted a 52-week, open-label extension study to examine the long-term metabolic and endocrine effects of intramuscular aripiprazole lauroxil (Aristada®, Alkermes, Inc.) injection to treat schizophrenia.
Nearly 500 patients (n=478) were enrolled in the study, receiving AL monotherapy via injection every 4 weeks; 368 patients received an injection of 882 mg, and 110 patients received injections of 441 mg. Thirty-eight percent of patients had previously received 3 AL injections.
Data on metabolic parameters, including weight, fasting blood sugar and lipids, and serum prolactin were collected at baseline and 1 year.
At the 1-year follow-up, 68% of patients remained in the study. Mean changes in glucose, glycated hemoglobin, total cholesterol, and triglycerides were recorded (+1.1±27.5 mg/dL, +0.07%±0.6%, −3.3±35.8 mg/dL, and −5.3±101.9 mg/dL, respectively). Changes in prolactin were recorded at −8.7±14.7 ng/dL for men and −14.9±43.4 ng/dL for women. Overall mean weight change among study participants was +0.8±5.9 kg; 18% of patients gained 7% body weight, and 12% lost 7% body weight.
"This presentation extends a recently published report on the short-term metabolic and endocrine effects of AL over a period of 12 weeks. The present study increased the follow-up period and was careful to use the first exposure to AL as the baseline," Dr Nasrallah and colleagues concluded. "Overall, the metabolic, weight and endocrine effects reported here are consistent with other long-term effects of oral aripiprazole treatment."Disclosures: This study was funded by Alkermes, Inc.
Nasrallah HA, Aquila R, Stanford A, et al. Metabolic and endocrine profiles during one-year treatment of outpatients with schizophrenia with aripiprazole lauroxil. Presented at: American Psychiatric Association (APA) 2017 Annual Meeting; May 20-24, 2017; San Diego, CA. Abstract 9.