The management of bipolar mania: a national survey of baseline data from the EMBLEM study in Italy.
BACKGROUND
Although a number of studies have assessed the management of mania in routine clinical practice, no studies have so far evaluated the short- and long-term management and outcome of patients affected by bipolar mania in different European countries. The objective of the study is to present, in the context of a large multicenter survey (EMBLEM study), an overview of the baseline data on the acute management of a representative sample of manic bipolar patients treated in the Italian psychiatric hospital and community settings. EMBLEM is a 2-year observational longitudinal study that evaluates across 14 European countries the patterns of the drug prescribed in patients with bipolar mania, their socio-demographic and clinical features and the outcomes of the treatment.


METHODS
The study consists of a 12-week acute phase and a < or = 24-month maintenance phase. Bipolar patients were included into the study as in- or out-patients, if they initiated or changed, according to the decision of their psychiatrist, oral antipsychotics, anticonvulsants and/or lithium for the treatment of an episode of mania. Data concerning socio-demographic characteristics, psychiatric and medical history, severity of mania, prescribed medications, functional status and quality of life were collected at baseline and during the follow-up period.


RESULTS
In Italy, 563 patients were recruited in 56 sites: 376 were outpatients and 187 inpatients. The mean age was 45.8 years. The mean CGI-BP was 4.4 (+/- 0.9) for overall score and mania, 1.9 (+/- 1.2) for depression and 2.6 (+/- 1.6) for hallucinations/delusions. The YMRS showed that 14.4% had a total score < 12, 25.1% > or = 12 and < 20, and 60.5% > or = 20. At entry, 75 patients (13.7%) were treatment-naïve, 186 (34.1%) were receiving a monotherapy (of which haloperidol [24.2%], valproate [16.7%] and lithium [14.5%] were the most frequently prescribed) while 285 (52.2%) a combined therapy (of which 8.0% were represented by haloperidol/lithium combinations). After a switch to an oral medication, 137 patients (24.8%) were prescribed a monotherapy while the rest (415, 75.2%) received a combination of drugs.


CONCLUSIONS
Data collected at baseline in the Italian cohort of the EMBLEM study represent a relevant source of information to start addressing the short and long-term therapeutic strategies for improving the clinical as well as the socio-economic outcomes of patients affected by bipolar mania. Although it's not an epidemiological investigation and has some limitations, the results show several interesting findings as a relatively late age of onset of bipolar disorder, a low rate of past suicide attempts, a low lifetime rate of alcohol abuse and drug addiction.
Bellantuono
Cesario
C
Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, University of Verona, Italy. Cesario.bellantuono@univr.it
Barraco
Alessandra
A
Rossi
Andrea
A
Goetz
Iris
I
D000208:Acute Disease; D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D005260:Female; D006306:Health Surveys; D006764:Hospitals, Community; D006801:Humans; D007558:Italy; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012923:Social Class; D013406:Suicide, Attempted
D000927:Anticonvulsants; D014150:Antipsychotic Agents