Efficacy, predictors of therapy response, and safety of sertraline in routine clinical practice: Prospective, open-label, non-interventional postmarketing surveillance study in 1878 patients

Bernd Löwe, Irini Schenkel, Matthew Bair, Claus Göbel

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Background: It is well established that subjects participating in controlled clinical trials may not be representative of patients seen in actual practice. Given that efficacy and safety of sertraline have been investigated almost exclusively in controlled clinical trials, the aim of this study was to investigate efficacy, safety, and predictors of treatment response to sertraline in routine clinical practice. Methods: A total of 1878 depressed outpatients (69.5% female; mean age, 50.3 years) participated in this prospective, open-label, non-interventional, postmarketing surveillance study of sertraline. The primary study outcome was change in depression severity as assessed independently with the Patient Health Questionnaire (PHQ-9) depression scale and Clinical Global Impression (CGI) scales after 12 weeks of treatment. Stepwise logistic regression analyses were used to identify independent predictors of treatment response. Results: Using standard criteria to define clinical improvement, responder rates were 87.7% (PHQ-9) and 87.2% (CGI), respectively. Remission, i.e. a PHQ-9 score of 5 or below, occurred in 56.9% of patients. Independent baseline predictors of CGI treatment response were: non-chronic course of depression (OR = 2.8, p < 0.001), non-psychiatric treatment setting (OR = 2.5, p < 0.001), absence of comorbid physical disease (OR = 1.9, p < 0.001), depression-related work disability (OR = 1.9, p < 0.001), and no previous antidepressant medication (OR = 1.5, p = 0.03). Adverse events were reported by 4.8% of patients. Limitations: Lack of a control group limits the conclusions that can be drawn from this study. Conclusions: For treatment of depressive disorders in routine outpatient settings, sertraline is safe and efficacious. Patients without prior episodes of depression, without medical comorbidity, and those with higher levels of depression-related functional limitations are most likely to respond to sertraline treatment.

Original languageEnglish
Pages (from-to)271-279
Number of pages9
JournalJournal of Affective Disorders
Volume87
Issue number2-3
DOIs
StatePublished - Aug 2005

Fingerprint

Sertraline
Safety
Depression
Controlled Clinical Trials
Therapeutics
Outpatients
Patient Advocacy
Depressive Disorder
Antidepressive Agents
Comorbidity
Logistic Models
Regression Analysis
Outcome Assessment (Health Care)
Control Groups
Health

Keywords

  • Adverse effects
  • Depressive disorder
  • Postmarketing product surveillance
  • Sertraline
  • Treatment
  • Treatment outcome

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Behavioral Neuroscience
  • Biological Psychiatry
  • Neurology
  • Psychology(all)

Cite this

@article{de19159fd7ac4c848cf29a26a43a4ee1,
title = "Efficacy, predictors of therapy response, and safety of sertraline in routine clinical practice: Prospective, open-label, non-interventional postmarketing surveillance study in 1878 patients",
abstract = "Background: It is well established that subjects participating in controlled clinical trials may not be representative of patients seen in actual practice. Given that efficacy and safety of sertraline have been investigated almost exclusively in controlled clinical trials, the aim of this study was to investigate efficacy, safety, and predictors of treatment response to sertraline in routine clinical practice. Methods: A total of 1878 depressed outpatients (69.5{\%} female; mean age, 50.3 years) participated in this prospective, open-label, non-interventional, postmarketing surveillance study of sertraline. The primary study outcome was change in depression severity as assessed independently with the Patient Health Questionnaire (PHQ-9) depression scale and Clinical Global Impression (CGI) scales after 12 weeks of treatment. Stepwise logistic regression analyses were used to identify independent predictors of treatment response. Results: Using standard criteria to define clinical improvement, responder rates were 87.7{\%} (PHQ-9) and 87.2{\%} (CGI), respectively. Remission, i.e. a PHQ-9 score of 5 or below, occurred in 56.9{\%} of patients. Independent baseline predictors of CGI treatment response were: non-chronic course of depression (OR = 2.8, p < 0.001), non-psychiatric treatment setting (OR = 2.5, p < 0.001), absence of comorbid physical disease (OR = 1.9, p < 0.001), depression-related work disability (OR = 1.9, p < 0.001), and no previous antidepressant medication (OR = 1.5, p = 0.03). Adverse events were reported by 4.8{\%} of patients. Limitations: Lack of a control group limits the conclusions that can be drawn from this study. Conclusions: For treatment of depressive disorders in routine outpatient settings, sertraline is safe and efficacious. Patients without prior episodes of depression, without medical comorbidity, and those with higher levels of depression-related functional limitations are most likely to respond to sertraline treatment.",
keywords = "Adverse effects, Depressive disorder, Postmarketing product surveillance, Sertraline, Treatment, Treatment outcome",
author = "Bernd L{\"o}we and Irini Schenkel and Matthew Bair and Claus G{\"o}bel",
year = "2005",
month = "8",
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language = "English",
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pages = "271--279",
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T1 - Efficacy, predictors of therapy response, and safety of sertraline in routine clinical practice

T2 - Prospective, open-label, non-interventional postmarketing surveillance study in 1878 patients

AU - Löwe, Bernd

AU - Schenkel, Irini

AU - Bair, Matthew

AU - Göbel, Claus

PY - 2005/8

Y1 - 2005/8

N2 - Background: It is well established that subjects participating in controlled clinical trials may not be representative of patients seen in actual practice. Given that efficacy and safety of sertraline have been investigated almost exclusively in controlled clinical trials, the aim of this study was to investigate efficacy, safety, and predictors of treatment response to sertraline in routine clinical practice. Methods: A total of 1878 depressed outpatients (69.5% female; mean age, 50.3 years) participated in this prospective, open-label, non-interventional, postmarketing surveillance study of sertraline. The primary study outcome was change in depression severity as assessed independently with the Patient Health Questionnaire (PHQ-9) depression scale and Clinical Global Impression (CGI) scales after 12 weeks of treatment. Stepwise logistic regression analyses were used to identify independent predictors of treatment response. Results: Using standard criteria to define clinical improvement, responder rates were 87.7% (PHQ-9) and 87.2% (CGI), respectively. Remission, i.e. a PHQ-9 score of 5 or below, occurred in 56.9% of patients. Independent baseline predictors of CGI treatment response were: non-chronic course of depression (OR = 2.8, p < 0.001), non-psychiatric treatment setting (OR = 2.5, p < 0.001), absence of comorbid physical disease (OR = 1.9, p < 0.001), depression-related work disability (OR = 1.9, p < 0.001), and no previous antidepressant medication (OR = 1.5, p = 0.03). Adverse events were reported by 4.8% of patients. Limitations: Lack of a control group limits the conclusions that can be drawn from this study. Conclusions: For treatment of depressive disorders in routine outpatient settings, sertraline is safe and efficacious. Patients without prior episodes of depression, without medical comorbidity, and those with higher levels of depression-related functional limitations are most likely to respond to sertraline treatment.

AB - Background: It is well established that subjects participating in controlled clinical trials may not be representative of patients seen in actual practice. Given that efficacy and safety of sertraline have been investigated almost exclusively in controlled clinical trials, the aim of this study was to investigate efficacy, safety, and predictors of treatment response to sertraline in routine clinical practice. Methods: A total of 1878 depressed outpatients (69.5% female; mean age, 50.3 years) participated in this prospective, open-label, non-interventional, postmarketing surveillance study of sertraline. The primary study outcome was change in depression severity as assessed independently with the Patient Health Questionnaire (PHQ-9) depression scale and Clinical Global Impression (CGI) scales after 12 weeks of treatment. Stepwise logistic regression analyses were used to identify independent predictors of treatment response. Results: Using standard criteria to define clinical improvement, responder rates were 87.7% (PHQ-9) and 87.2% (CGI), respectively. Remission, i.e. a PHQ-9 score of 5 or below, occurred in 56.9% of patients. Independent baseline predictors of CGI treatment response were: non-chronic course of depression (OR = 2.8, p < 0.001), non-psychiatric treatment setting (OR = 2.5, p < 0.001), absence of comorbid physical disease (OR = 1.9, p < 0.001), depression-related work disability (OR = 1.9, p < 0.001), and no previous antidepressant medication (OR = 1.5, p = 0.03). Adverse events were reported by 4.8% of patients. Limitations: Lack of a control group limits the conclusions that can be drawn from this study. Conclusions: For treatment of depressive disorders in routine outpatient settings, sertraline is safe and efficacious. Patients without prior episodes of depression, without medical comorbidity, and those with higher levels of depression-related functional limitations are most likely to respond to sertraline treatment.

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KW - Depressive disorder

KW - Postmarketing product surveillance

KW - Sertraline

KW - Treatment

KW - Treatment outcome

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