Long-term Treatment of Bipolar Disorder with Carbamazepine Extended-Release Capsules in Adults, Adolescents, and Children

Lawrence D Ginsberg
US Psychiatry, 2010;3:6-10
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Abstract

Bipolar disorder is a complex mental illness that usually requires long-term treatment, thus there is a need for a well-tolerated, efficacious maintenance therapy that can be used across a broad range of ages. A successful therapy should also increase patient adherence. Carbamazepine extended-release capsules have been shown to be safe and efficacious in patients with bipolar disorder. Importantly, this formulation was specifically developed to increase adherence. In this retrospective 25-month study, carbamazepine extended-release capsules were found to be efficacious for patients 4 to 69 years of age with a diagnosis of bipolar disorder I, II, or not otherwise specified (NOS). Side effects were generally mild to moderate and similar to those seen in other studies of carbamazepine in this patient population.

Acknowledgments: This study was supported by an educational grant from Validus Pharmaceuticals, Parsippany, NJ. The author would like to acknowledge Yuxin Zhang, PhD, of XTiers Consulting, Inc., Potomac, Maryland, for his statistical expertise. Editorial support was provided by Medical Communications Depot, Inc., West Chester, PA.
Keywords
Bipolar disorders, carbamazepine, anticonvulsants, long-term treatment
Disclosure Lawrence D Ginsberg, MD, consults for over 20 pharmaceutical companies, including Validus Pharmaceuticals, LLC, the manufacturers of Equetro® (carbamazepine) Extended-Release Capsules.
Received: March 09, 2010 Accepted March 29, 2010
Correspondence: Lawrence D Ginsberg, MD, Red Oak Psychiatry Associates, PA, Suite #109, 17115 Red Oak Dr, Houston, TX 77090. E: larrydg@earthlink.net

Bipolar disorder is a serious, lifelong illness that affects approximately 5.7 million American adults, or approximately 2.6% of the US population 18 years of age and over in a given year.1 The median age of onset is 25 years.2 It is a complex illness characterized by mania, depression, or mixed episodes, and rapid cycling.3 Diagnosis and treatment are often complicated by the presence of a variety of comorbid mental and medical disorders.4

The choice of treatment for bipolar disorder is dependent on a variety of factors, including presentation (mania or depression), the phase of the illness (acute or maintenance), specific features, history of response, treatment compliance, and the presence of comorbid conditions.5 Long-term pharmacotherapy is necessary for most patients; however, even with continuous maintenance therapy relapse is frequent (37% of patients relapse within one year and 73% relapse within five years).6

The US Food and Drug Administration has approved several agents for the treatment of bipolar disorder. These include mood stabilizers (e.g. lithium, valproate, lamotrigine,7 and carbamazepine extended-release capsules [CBZ-ERC]8) and the antipsychotics olanzapine,9 aripiprazole,10 ziprasidone,11 risperidone,12 asenapine,13 and both the immediate14 and extended formulations of quetiapine.15 All of these agents possess certain benefits and drawbacks in terms of safety, tolerability, and efficacy. Lithium is associated with efficacy in bipolar I, although it appears to be less successful in treating mixed mania and concurrent substance abuse, and is prone to causing weight gain.16–19 Valproate has also proved to be effective in treating acute mania and appears to be efficacious in rapid cycling;20 its disadvantages include a propensity for weight gain and hair loss, a sedating profile, and an association with polycystic ovarian syndrome.21–23 Olanzapine has been shown to be effective in treating mania; however, it is associated with a high propensity for weight gain as well as strong associations with dyslipidemia, diabetes, and potentially life-threatening diabetic ketoacidosis.20,24–27

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