Patterns of drug treatment for manic episode in the clinical practice. Outcomes of the Spanish sample in the EMBLEM Study.

INTRODUCTION: Although treatment for mania has been studied extensively in randomized clinical trials, there are few data that address how these patients are truly managed in clinical, functional, and economic terms in the psychiatric practice in Spain.
OBJECTIVE: To determine prescribing patterns in Spain on the basis of the Spanish sample of bipolar patients in manic or mixed phase included as part of the pan-European EMBLEM Study.
METHOD: The EMBLEM Study recruited 3,681 patients, 312 of whom (8.47%) were included in Spain. Patients had to be adults with a diagnosis of bipolar disorder who were initiating treatment for a manic phase. They underwent evaluation using the Spanish versions of scales that measure severity of mania (the Young Mania Rating Scale, CGI-BP and the Hamilton Scale) and functional level (LCM, SLICE of LIFE). Information was collected regarding drug and treatment adherence variables.
RESULTS: Prior to being admitted into the study, 42% of the patients were receiving polytherapy, 35% were on monotherapy, and 23% were not taking any medication whatsoever. Forty percent of the patients presented partial or total non-compliance with the treatment prescribed. During the first stage of the study, in the case of single-drug treatment, acute management for mania consisted of mean daily doses of 25 mg of olanzapine, 6.6 mg of risperidone, 9.5 mg of haloperidol, 165 mg of lamotrigine, 938.5 mg of valproate, and 909 mg of lithium, whereas when combined therapy was used, the following doses were used: olanzapine, 22.1 mg; risperidone, 7.3 mg; haloperidol, 12.3 mg; lamotrigine, 1,75.1 mg; valproate, 1,038.4 mg, and lithium, 1012.6 mg. Of those patients who were on monotherapy at the beginning of the study 51% were treated with a single drug, whereas 48% were receiving polytherapy. Among the participants who were receiving combined treatment when they began the study, almost all of them, 94%, were prescribed combined treatment. In the case of the hospitalized patients who made up 88% of the sample, the vast majority, 92%, had improved by the time the study was completed. Mean time to release from hospital was 24 days. DISCUSSION: In Spain, treatment for mania is essentially based on combined treatments, hospitalization, and antimania drugs that are prescribed at somewhat higher doses than those recommended in the corresponding prescribing information documents, which indicates that the clinical reality of this entity is far more complex than clinical trials conducted in experimental conditions suggest.