Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study.
OBJECTIVE
The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments.


METHODS
EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective, observational study of health outcomes associated with the treatment of mania. Severity of mania and depression were assessed at baseline and 6 weeks using the YMRS and the 5-item version of the HAMD, respectively.


RESULTS
621 patients were analysed (n=107 valproate, n=514 olanzapine). Both groups improved from baseline to 6 weeks in mean YMRS and HAMD-5 total scores, with greater mean improvements in the olanzapine compared with the valproate group. Olanzapine was associated with more weight gain and less gastrointestinal difficulties than valproate.


CONCLUSIONS
The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania.
Novick
D
D
Eli Lilly and Company, Lilly Research Centre, Erl Wood Manor, Windlesham, Surrey, UK. Novick_diego@lilly.com
Gonzalez-Pinto
A
A
Haro
J M
JM
Bertsch
J
J
Reed
C
C
Perrin
E
E
Tohen
M
M
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use; D018692:Antimanic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D000077152:Olanzapine; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D015430:Weight Gain / Q000187:drug effects
D000928:Antidepressive Agents; D018692:Antimanic Agents; D001569:Benzodiazepines; D014635:Valproic Acid; D000077152:Olanzapine