Late-breaking news: Lurasidone HCl associated with low rates of weight gain, metabolic changes in patients with schizophrenia

May 18, 2011

Adult patients with schizophrenia treated with lurasidone HCl tablets (Latuda, Sunovion Pharmaceuticals) had minimal weight gain and metabolic changes, according to the results from a new pooled data analysis of short- and long-term studies, which were presented at the Annual Meeting of the American Psychiatric Association in Honolulu, Hawaii.

Adult patients with schizophrenia treated with lurasidone HCl tablets (Latuda, Sunovion Pharmaceuticals) had minimal weight gain and metabolic changes, according to the results from a new pooled data analysis of short- and long-term studies, which were presented at the Annual Meeting of the American Psychiatric Association in Honolulu, Hawaii.

“The study is pertinent as the effects of antipsychotics on weight gain and metabolic parameters in patients with schizophrenia is a common area of concern for both patients and clinicians-and a driver of cost for managed care plans,” Antony Loebel, MD, executive vice president, clinical research and medical affairs at Sunovion Pharmaceuticals, told Formulary.

“The comprehensive database analysis we conducted highlights Latuda's potential for low rates of weight gain and associated metabolic disturbances in both short and longer-term use. We will continue to evaluate the effect of Latuda in these areas in our ongoing clinical trials and based on our post-marketing safety surveillance activities,” Dr Loebel said.

The short-term data were pooled from 7 double-blind, placebo-controlled, 6-week studies in patients with schizophrenia. In this analysis, patients treated with lurasidone (once-daily doses of 20 mg to 160 mg) experienced, on an overall basis, low rates of weight gain and metabolic changes. The results for the pooled analysis of short-term study data were as follows:

* Weight*: +0.43 kg for lurasidone (n=1486); -0.02 for placebo (n=696)
* Clinically significant weight gain (≥7%): 4.8% for lurasidone (n=1486); 3.3% for placebo (n=696)
* Total cholesterol**: -5.0 mg/dL for lurasidone (n=1419); -5.0 for placebo (n=660)
* Triglycerides**: -4.0 mg/dL for lurasidone (n=1419); -6.0 for placebo (n=660)
* Glucose**: 0.0 mg/dL for lurasidone (n=1453); 0.0 mg/dL for placebo (n=680)

*As measured by mean LOCF end point change
** As measured by median LOCF end point change

“The potential effect of antipsychotic use on metabolic parameters in patients with schizophrenia is an area of concern for clinicians and the research community,” said Antony Loebel, MD, executive vice president, clinical research and medical affairs at Sunovion.

“We are encouraged by the results of this comprehensive database analysis and will continue researching the effect of Latuda on weight and metabolic disturbance in short- and longer-term treatment.”

Longer-term (ranging from 6 to 22 months) open-label treatment data were also included in this pooled analysis. The pooled analysis showed that change from baseline at month 12 on weight and various metabolic parameters for lurasidone-treated patients versus placebo were:

* Weight: -0.73 kg (mean) (n=377)
* Body mass index (BMI): -0.25 kg/m2 (mean) (n=377)
* Total cholesterol: -2.0 mg/dL (median) (n=307)
* Triglycerides: -5.0 mg/dL (median) (n=307)
* Glucose: +1.0 mg/dL (median) (n=307)

Lurasidone is an atypical antipsychotic that was FDA approved in October 2010 for the treatment of schizophrenia. The 160 mg/day dose has not been reviewed or approved by FDA.