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Olanzapine/Fluoxetine Combination for Treatment-Resistant and Psychotic Depression Raises No New Safety Issues: Presented at ECNP

By Bruce Sylvester
Special to DG News

BARCELONA, SPAIN -- October 9, 2002 -- The use of olanzapine/fluoxetine combination therapy with treatment-resistant and psychotic depression patients entails no new safety issues other than those commonly associated with olanzapine and fluoxetine monotherapy.

The finding was reported here October 7 at the 15th Congress of the European College of Neuropsychopharmachology (ECNP).

"We saw no significant differences in categorical changes in laboratory analytes, vital signs, electrocardiograms or extrapyramidal symptoms. There don't appear to be a new safety issues in the combination therapy as distinct from the monotherapies," reported lead researcher Sanjay Dube, MD, senior clinical investigator at Lilly Laboratories in Indianapolis, Indiana, United States.

The investigators conducted a meta-analysis of safety data of five eight-week double-blind studies involving 762 subjects diagnosed with treatment-resistant depression (three studies with 614 subjects) or psychotic depression (two studies with 148 subjects).

Each of the two treatment groups in each study had received olanzapine/fluoxetine combination (OFC) therapy -- olanzapine at 5-20 mg/day and fluoxetine at 20-80 mg/day (447 subjects) -- or olanzapine monotherapy (OLZ) at 5-20 mg/day (315 subjects).

Of the adverse events seen at a level of at least 10 percent among the OFC group, there were no statistically significant differences from the OLZ group. A statistically significant but small proportion of OFC subjects (3 percent) showed low supine diastolic blood pressure compared with OLZ subjects (0.7 percent, p=0.032). There were no statistically significant differences between OFC and OLZ subjects with regard to categorical changes in laboratory analytes, electrocardiograms, heart rate and extrapyramidal symptoms.

"No significant adverse effects were seen when giving OFC compared with olanzapine monotherapy," the research team reported. "And the OFC safety profile was consistent with those expected for component monotherapies. These results support the acute safety and tolerability of OFC."

The research was funded by Lilly Laboratories.

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