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Item-based analysis of the effects of duloxetine in depression: a patient-level post hoc study.

Artikel i vetenskaplig tidskrift
Författare Alexander Lisinski
Fredrik Hieronymus
Jakob Näslund
Staffan Nilsson
Elias Eriksson
Publicerad i Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology
Volym 45
Sidor 553–560
ISSN 1740-634X
Publiceringsår 2020
Publicerad vid Institutionen för matematiska vetenskaper
Institutionen för biomedicin
Institutionen för neurovetenskap och fysiologi, sektionen för farmakologi
Sidor 553–560
Språk en
Länkar dx.doi.org/10.1038/s41386-019-0523-...
Ämnesord Duloxetine in depression
Ämneskategorier Farmakologi och toxikologi, Neurovetenskaper


Oft-cited trial-level meta-analyses casting doubt on the usefulness of antidepressants have been based on re-analyses of to what extent the active drug has outperformed placebo in reducing the sum score of the Hamilton Depression Rating Scale (HDRS-17-sum) in clinical trials. Recent studies, however, suggest patient-level analyses of individual HDRS items to be more informative when assessing the efficacy of an antidepressant. To shed further light on both symptom-reducing and symptom-aggravating effects of a serotonin and noradrenaline reuptake inhibitor, duloxetine, when used for major depression in adults, we hence applied this approach to re-analyse data from 13 placebo-controlled trials. In addition, using patient-level data from 28 placebo-controlled trials of selective serotonin reuptake inhibitors (SSRIs), the response profile of duloxetine was compared to that of these drugs. Duloxetine induced a robust reduction in depressed mood that was not dependent on baseline severity and not caused by side-effects breaking the blind. A beneficial effect on depressed mood was at hand already after one week; when outcome was assessed using HDRS-17-sum as effect parameter, this early response was however masked by a concomitant deterioration with respect to adverse event-related items. No support for a suicide-provoking effect of duloxetine was obtained. The response profile of duloxetine was strikingly similar to that of the SSRIs. We conclude that the use of HDRS-17-sum as effect parameter underestimates the true efficacy and masks an early effect of duloxetine on core symptoms of depression. No support for major differences between duloxetine and SSRIs in clinical profile were obtained.

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