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March 24, 2023CNS Spectrums5 citationsOpen Access

Lurasidone and risk of metabolic syndrome: results from short and long-term studies in patients with bipolar depression

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Why the study?

Does lurasidone increase the risk of new-onset metabolic syndrome in adults with bipolar I depression?

Population

Adults with bipolar I depression without acute or unstable medical conditions, N=1192 in short-term studies.

Comparison

Lurasidone as monotherapy or adjunctive therapy… vs Matching placebo as monotherapy or adjunctive…

Design

Other, randomized, double-blind, placebo-controlled

Follow-up

6 weeks to 28 weeks

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.

Authors

MTMichael ToccoJNJohn W. NewcomerYMYongcai Mao

Discussion

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Overview

Lurasidone shows no increased new-onset MetS risk versus placebo in short-term bipolar I depression; confirms metabolic safety in RCTs.

Structured PICO

Does lurasidone increase the risk of new-onset metabolic syndrome in adults with bipolar I depression?

P
Population
1,192 adults aged 18-75 with bipolar I depression were evaluated for metabolic syndrome over 6 weeks of short-term treatment and up to 28 weeks of long-term treatment.
I
Intervention
Lurasidone (20-120 mg/day) as monotherapy or adjunctive therapy (with lithium or valproate) for 6 weeks to 28 weeks.
C
Comparator
Matching placebo as monotherapy or adjunctive therapy (with lithium or valproate).
O
Outcome
New-onset metabolic syndrome (MetS) based on NCEP ATP III criteria (2005 revision).safety

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.

Main Result

Absolute Event Rate: 13.9% vs 15.3%

Limitations

  • Post hoc analysis design.
  • Study entry criteria excluded patients with clinically significant baseline abnormalities in fasting glucose, triglycerides, cholesterol, and blood pressure, which may reduce generalizability.
  • Metabolic syndrome criteria required specific abnormal lab values, meaning medication treatment for hypertension, hypertriglyceridemia, or diabetes was insufficient to qualify without an abnormal lab value.
  • Post hoc analysis
  • Excluded patients with more severe acute or unstable components of MetS such as diabetes and hypertension
  • Medication treatment for hypertension, hypertriglyceridemia, or diabetes was insufficient to qualify as a criterion without an abnormal lab value

Cite This Study

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.

synapsesocial.com/papers/6a818ffa3385b84e88b6bda8https://doi.org/10.1017/s1092852923001190
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