Bipolar Depression: Treatment with LATUDA Monotherapy

INDICATIONS AND USAGE LATUDA is indicated treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. The efficacy of LATUDA was established in a 6-week monotherapy study and a 6-week adjunctive therapy study with lithium or valproate in adult patients with bipolar depression. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established. IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. LATUDA is not approved for use in patients under the aqe of 18 years. Patients with bipolar disorder are more likely to initially present with depressive symptoms than with mania, (1) and over the long-term course of the disease, they spend approximately twice as much time with depressive symptoms as with mania, hypomania, rapid cycling, or mixed features. (2) In addition, bipolar disorder is associated with elevated risk of several comorbid medical conditions, including high rates of endocrine/ metabolic disorders (eg, metabolic syndrome and diabetes, as in the case of Dave [inset]), vascular disease (eg, hypertension), obesity, and dyslipidemia. (3,4) A meta-analysis of more than 7000 patients found that 37.3% of patients with bipolar disorder have comorbid metabolic syndrome. In the study, the odds ratio for metabolic syndrome for patients with bipolar disorder compared with the general population was 1.98. (5) Individuals with bipolar disorder are at increased risk of cardiovascular mortality compared with the general population, and cardiovascular disease is a greater cause of excess mortality than suicide in this patient population. (4) As mentioned previously, many patients with bipolar disorder present with depressive symptoms that, even if treated, may recur. In the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study, 22.4% of patients who attained recovery from bipolar depression experienced a recurrence of depressive symptoms during 1 year of follow-up, compared with 6.4% of patients who had recurrent mania, hypomania, or mixed features. (6) LATUDA: A Treatment Option for Bipolar Depression The efficacy of LATUDA was established in a 6-week monotherapy study and a 6-week adjunctive therapy study with lithium or valproate in adult patients with bipolar depression. The effectiveness of LATUDA has not been established for longer-term use (more than 6 weeks) or for the treatment of mania associated with bipolar disorder. (7) The results of a phase 3, randomized, multicenter, double-blind, placebo-controlled clinical trial that examined the efficacy and safety of LATUDA monotherapy for patients with bipolar depression were published in the February 2014 issue of The American Journal of Psychiatry, (8) Adult patients (N=505) with major depressive episodes associated with bipolar disorder, with or without rapid cycling and without psychotic features, were evaluated for eligibility. …