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European mania in bipolar longitudinal evaluation of medication (EMBLEM) study: Pan-European baseline results of a two year European, observational health outcomes study in bipolar disorder
© The Author(s) 2006
Published: 28 February 2006
Although several studies have examined the treatment of mania in routine clinical settings in individual countries, there has yet to be an observational study of actual care to evaluate the short and long-term management of patients with mania across Europe in terms of clinical, functional and economic outcomes.
EMBLEM (European Mania in Bipolar Evaluation of Medication) is a 2-year prospective observational study on the outcomes of pharmacological treatment for acute mania in the context of bipolar disorder. It has been successfully implemented in 14 European countries since its start in December 2002. Enrollment into the study ended on June 30, 2004. Follow-up observations will continue until July 2006.
The current objective is to describe the baseline treatment patterns of 3536 patients enrolled into EMBLEM during an acute manic episode.
Materials and methods
EMBLEM is a 2-year prospective, Pan-European observational study on the outcomes of pharmacological treatment for mania in the context of bipolar disorder. Adult patients are enrolled if they: present within the standard course of care as in- or outpatient; have, at the discretion of the treating psychiatrist, initiated or changed oral medication (antipsychotic, lithium or anticonvulsant) for treatment of acute mania; are not participating in an interventional study.
Investigators were asked, but not required, to include 50% of patients into the study who were initiated or changed to olanzapine and 50% of patients initiated or changed to non-olanzapine treatment. 530 psychiatrists enrolled 3681 patients in 14 European countries using the same study methods including assessment of mood with CGI-BP mania and CGI-BP depression rating scales as well as the Life Chart Method.
Baseline analysis has been completed with the last patient having been enrolled in June 2004. We will present baseline data of 3536 patients including suicide history, treatment patterns prior to and after start of new medication as well as the reason for start of new oral medication.
With 3684 patients having been enrolled, EMBLEM is the biggest naturalistic study on longitudinal outcomes associated with pharmacological treatment of acute mania.
1/4 of the patients had at least once attempted suicide.
1/4 of the patients were not taking any anti-manic medication when entering into the study.
Lack of effectiveness is the most common reason for switching oral medication.
Atypicals represented the 69% of the medication (antipsychotics, lithium or anticonvulsants) as monotherapy following the start of new oral medication.
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