Olanzapine monotherapy and olanzapine combination therapy in the treatment of mania: 12-week results from the European Mania in Bipolar Longitudinal Evaluation of Medication (EMBLEM) observational study.
BACKGROUND
To evaluate the 12-week outcomes (effectiveness, tolerability, and patterns of medication use) of olanzapine (either in antimanic monotherapy or in combination with other antipsychotics, anticonvulsants, and/or lithium) in patients with bipolar mania or mixed mania.


METHODS
EMBLEM (European Mania in Bipolar Longitudinal Evaluation of Medication) is a 24-month prospective observational study of in- and outpatients with acute mania/mixed mania conducted in 14 European countries. Primary outcome measures included Clinical Global Impressions-Bipolar Disorder scale (overall, mania, and depression); 5-item Hamilton Depression Rating Scale; and Young Mania Rating Scale. Tolerability measures included a questionnaire to assess patients' symptomatic complaints.


RESULTS
Overall, 2004 patients received olanzapine (olanzapine monotherapy, n=673; olanzapine combination, n=1331). Concomitant therapy with antidepressants and/or anxiolytics was possible in both groups. The countries significantly differed in the use of olanzapine monotherapy versus olanzapine combination (p<.0001). Baseline-to-endpoint changes on the CGI-BP subscales, YMRS, and HAMD-5 were significant within both treatment groups (p<.0001). Olanzapine monotherapy was generally better tolerated than olanzapine combination, particularly with regard to sedation (12% vs 17%; p<.001), tremor (2% vs 5%; p<.001), and akathisia (3% vs 6%; p<.001).


CONCLUSIONS
The acute-phase EMBLEM results suggest that in naturalistic settings, olanzapine (both as monotherapy and combination) may be effective in treating patients with bipolar mania. The use of olanzapine monotherapy or combination varies significantly across countries, but combination is generally the rule, rather than the exception.
Vieta
Eduard
E
Bipolar Disorders Program, Hospital Clinic, University of Barcelona IDIBAPS, Barcelona, Spain. evieta@clinic.ub.es
Panicali
Francesco
F
Goetz
Iris
I
Reed
Catherine
C
Comes
Merce
M
Tohen
Mauricio
M
D000208:Acute Disease; D000328:Adult; D000553:Ambulatory Care; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000009:adverse effects; D018692:Antimanic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy*; D003431:Cross-Cultural Comparison; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016651:Lithium Carbonate / Q000008:administration & dosage* / Q000009:adverse effects; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D010343:Patient Admission; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D000927:Anticonvulsants; D018692:Antimanic Agents; D014150:Antipsychotic Agents; D001569:Benzodiazepines; D016651:Lithium Carbonate; D000077152:Olanzapine