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Vortioxetine in depression: No hint of added benefit

Inadequate limitation of the study pool for the indirect comparison with citalopram

Date:
August 11, 2015
Source:
Institute for Quality and Efficiency in Health Care
Summary:
A review of the drug Vortioxetine has concluded that there is no suitable data for acute treatment or for relapse prevention. The evidence was only partly considered for the indirect comparison with citalopram.
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Vortioxetine (trade name: Brintellix) has been approved since December 2013 for the treatment of depression in adults, but did not become actually available before May 2015. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether this drug offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the dossier because it contained no data evaluable for the assessment.

SSRI is drug component of comparator therapy

The Federal Joint Committee (G-BA) distinguished between three patient groups depending on the severity of the disease and specified a different appropriate comparator therapy for each of them: no drug treatment for mild episodes of depression, an antidepressant from the group of selective serotonin reuptake inhibitors (SSRIs) for moderate episodes and a combination of an SSRI and an offer of psychotherapy for severe episodes. In addition, differentiation between acute treatment and relapse prevention can be inferred from the Summary of Product Characteristics.

Only acute treatment investigated

However, the manufacturer only investigated acute treatment in its dossier. It presented no studies for the subgroup of mild episodes. It compared moderate and severe episodes, for which the G-BA had specified an SSRI and an SSRI plus offer of psychotherapy as appropriate comparator therapy, with the drug citalopram without considering psychotherapy.

Only small part of the studies included in meta-analysis

Due to a lack of studies of direct comparisons, the company conducted an adjusted indirect comparison with studies that tested either vortioxetine or citalopram against placebo. It identified 14 studies with vortioxetine and 10 with citalopram, but included only 3 and 4 of these studies in the meta-analysis. This important limitation was not convincingly justified and inadequate. This resulted in an incomplete consideration of the evidence, which is why no added benefit can be derived from the results.


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Cite This Page:

Institute for Quality and Efficiency in Health Care. "Vortioxetine in depression: No hint of added benefit: Inadequate limitation of the study pool for the indirect comparison with citalopram." ScienceDaily. ScienceDaily, 11 August 2015. <www.sciencedaily.com/releases/2015/08/150811113155.htm>.
Institute for Quality and Efficiency in Health Care. (2015, August 11). Vortioxetine in depression: No hint of added benefit: Inadequate limitation of the study pool for the indirect comparison with citalopram. ScienceDaily. Retrieved May 28, 2017 from www.sciencedaily.com/releases/2015/08/150811113155.htm
Institute for Quality and Efficiency in Health Care. "Vortioxetine in depression: No hint of added benefit: Inadequate limitation of the study pool for the indirect comparison with citalopram." ScienceDaily. www.sciencedaily.com/releases/2015/08/150811113155.htm (accessed May 28, 2017).

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