Sunovion Pharmaceuticals has revealed new data and analyses showing that treatment with their LATUDA (lurasidone) antipsychotic agent was associated with a significantly lower risk of metabolic syndrome compared with treatment with risperidone for schizophrenia in adults.
The European Commission granted marketing authorisation for LATUDA in the treatment of adults with schizophrenia on 21 March 2014. LATUDA will be available in the UK in August 2014 following presentations at this week's 2014 Summer Meeting of the British Association for Psychopharmacology (BAP) in Cambridge (20-23 July).
Schizophrenia affects more than 630,000 people in the UK and is associated with shortened life expectancy of 15-22.5 years, in part be due to the undesirable effects of antipsychotics such as weight gain, increased blood pressure and increased blood sugar.
In a 12-month, multiregional, double-blind study, outpatients with clinically stable schizophrenia were randomized to flexibly dosed, once-daily LATUDA (37-111 mg/day) or risperidone (2-6 mg/day). Patients who completed this study were then eligible to participate in a 6-month, open-label extension study of flexibly dosed LATUDA (37-111 mg/day).
Results from the post-hoc analysis found that after 12 months of treatment:
- The prevalence of metabolic syndrome remained stable in the LATUDA treatment group (31.5%; 47/149)
- Prevalence increased in the risperidone treatment group (44.1%; 41/93) (p<0.05).
- Patients without metabolic syndrome at double-blind baseline experienced a greater incidence of metabolic syndrome in the risperidone treatment group compared to the LATUDA treatment group (27.1% for risperidone vs. 16.3% for LATUDA).
- Patients with metabolic syndrome at double-blind baseline experienced a greater decrease in the prevalence of metabolic syndrome in the LATUDA treatment group compared to the risperidone treatment group (36.7% for LATUDA vs. 28.1% for risperidone).
Some antipsychotic treatments compound CV risk
Professor David Taylor, Director of Pharmacy and Pathology, South London and Maudsley NHS Foundation Trust said: "We are encouraged to see the results of this study showing lurasidone was associated with a significantly lower risk of metabolic syndrome compared with risperidone.
"Patients with schizophrenia are already at an increased risk for developing metabolic syndrome, which is associated with greater cardiovascular disease morbidity and mortality as well as other physical health problems. It is well documented that some antipsychotic treatments have been shown to further compound that risk."
In the 6-month open label extension study patients who took LATUDA in both the double-blind and open-label extension phases (n=109), prevalence of metabolic syndrome at open-label extension baseline and at month 6 was 33.0% and 26.6%, respectively.
In patients who switched to LATUDA after 12 months of treatment with risperidone (n=65), prevalence of metabolic syndrome at open-label extension baseline and after switching to LATUDA for 6 months was 48.4% and 38.5%, respectively.