Key result
Short-term and long-term treatment with lurasidone was associated with a relatively low risk for the development of metabolic syndrome in patients with bipolar I depression, with rates similar to placebo.
Why the study?
The elevated prevalence of metabolic syndrome in patients with depression is associated with increased mortality, prompting evaluation of the effect of lurasidone treatment on metabolic syndrome risk in bipolar depression.
Does lurasidone increase the risk of new-onset metabolic syndrome in adults with bipolar I depression?
Does lurasidone increase the risk of new-onset metabolic syndrome in adults with bipolar I depression?
Short- and long-term treatment with lurasidone in patients with bipolar depression is not associated with a clinically meaningful increased risk of developing metabolic syndrome compared to placebo.
Lurasidone shows no increased new-onset MetS risk versus placebo in short-term bipolar I depression; confirms metabolic safety in RCTs.
OBJECTIVE: The elevated prevalence of metabolic syndrome (MetS) in patients with depression has been associated with increased mortality. This post hoc analysis assessed the effect of treatment with lurasidone on risk of MetS in patients with bipolar depression. METHODS: Data used in the current analyses consisted of 3 double-blind (DB), placebo-controlled, 6-week studies in adults with bipolar I depression (N = 1192), consisting of 1 monotherapy, and 2 adjunctive trials (lithium or valproate). Also analyzed was a 6-month open-label (OL) extension study (monotherapy, N = 316; adjunctive therapy, N = 497); and a 5-month, OL, stabilization phase followed by randomization to a 28-week DB, placebo-controlled, adjunctive therapy study with lurasidone (N = 490). MetS was defined based on NCEP ATP III criteria (2005 revision). RESULTS: The proportion of patients with new-onset MetS was similar for lurasidone vs placebo in the short-term studies (monotherapy, 13.9% vs 15.3%; adjunctive therapy, 13.6% vs 11.0%); and remained stable during both the 6-month extension phase study (monotherapy, 15.2%; adjunctive therapy, 16.9%), and the 5-month stabilization study (adjunctive therapy, 12.2%). After 28 weeks of DB treatment (following 5-month treatment in the stabilization study), new onset MetS was observed at endpoint (OC) in 26.2% of the lurasidone group, and 30.8% of the placebo group. CONCLUSIONS: This post hoc analysis found that both short and long-term treatment with lurasidone was associated with a relatively low risk for the development of MetS in patients with bipolar I disorder. These findings are consistent with similar analyses in patients with schizophrenia.
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Tocco et al. (2023) studied Bipolar I depression (n=1,192). Lurasidone vs. Placebo was evaluated on New-onset metabolic syndrome at 6 weeks (monotherapy). Short-term and long-term treatment with lurasidone was associated with a relatively low risk for the development of metabolic syndrome in patients with bipolar I depression, with rates similar to placebo.
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