BERLIN – The prevalence of metabolic syndrome remained stable in outpatients with schizophrenia during 12 months of double-blind treatment with lurasidone, while the rate climbed significantly in those randomized to risperidone in a multicenter head-to head comparative study.
The study included 611 outpatients with clinically stable schizophrenia who were randomized double-blind 2:1 to 12 months of flexibly dosed oral lurasidone (Latuda) at 37-111 mg/day or to oral risperidone (Risperdal) at 2-6 mg/day.
The prevalence of metabolic syndrome at enrollment as defined by International Diabetes Federation criteria was 32.5% in the lurasidone group and virtually identical at 32.7% in the risperidone group. After 1 year of double-blind treatment, 37% of those with baseline metabolic syndrome in the lurasidone group no longer met criteria for the metabolic derangement, compared with a 28% metabolic syndrome reversal rate in the risperidone group, Dr. John W. Newcomer reported at the annual congress of the European College of Neuropsychopharmacology.
Among subjects without metabolic syndrome at baseline, the incidence of new-onset metabolic syndrome during 12 months of therapy was 16% with lurasidone, compared with 27% in those on risperidone. Thus, the 1-year on-treatment risk of developing metabolic syndrome was reduced by 48% in patients treated with lurasidone – as compared to risperidone-treated patients – observed Dr. Newcomer, a psychiatrist who serves as executive vice dean and professor of clinical biomedical science at the Florida Atlantic University College of Medicine in Boca Raton.
Patients on risperidone gained a mean of 2.6 kg over the course of the year, and those on lurasidone lost 0.9 kg. Mean waist circumference grew by 2.6 cm in the risperidone group, compared with a 0.4-cm decrease in the lurasidone group. Blood pressure remained unchanged over time in both treatment arms.
At the end of 12 months of double-blind therapy, 223 study participants continued on for a 6-month open-label extension phase on flexibly dosed lurasidone. Among patients who had been on 12 months of double-blind risperidone, the prevalence of metabolic syndrome went from 42.9% at the outset of the double-blind phase to 48.4% 12 months later, thereafter dropping to 38.5% after 6 months of open-label lurasidone. During their 6 months on lurasidone, the patients formerly on risperidone lost a mean of 2.9 kg in body weight and 1.6 cm in waist circumference.
Meanwhile, among patients on lurasidone for the entire 18 months, the prevalence of metabolic syndrome decreased from 33.3% at enrollment to 26.6% after 18 months of continuous treatment. This benefit was driven by a mean 1.7-kg weight loss and a 1.5-cm reduction in waist circumference.
This head-to-head comparative study was sponsored by Sunovion Pharmaceuticals and Takeda Pharmaceuticals. Dr. Newcomer reported having served as an independent scientific member on data safety monitoring boards for studies sponsored by a handful of other companies while having no financial relationship with the cosponsors of the current study.