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Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study
BACKGROUND: Late-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age ≥ 65 years; n = 101) who part...
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2004
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC544561/ https://www.ncbi.nlm.nih.gov/pubmed/15585058 http://dx.doi.org/10.1186/1471-2318-4-11 |
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author | Wohlreich, Madelaine M Mallinckrodt, Craig H Watkin, John G Hay, Donald P |
author_facet | Wohlreich, Madelaine M Mallinckrodt, Craig H Watkin, John G Hay, Donald P |
author_sort | Wohlreich, Madelaine M |
collection | PubMed |
description | BACKGROUND: Late-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age ≥ 65 years; n = 101) who participated in a large, multinational, open-label study. METHODS: Patients meeting DSM-IV criteria for MDD received duloxetine 80 mg/d (40 mg twice daily (BID)) to 120 mg/d (60 mg BID) for up to 52 weeks. Efficacy measures included the Clinical Global Impression of Severity (CGI-S) scale, the 17-item Hamilton Rating Scale for Depression (HAMD(17)), the Beck Depression Inventory-II (BDI-II), the Patient Global Impression of Improvement (PGI-I) scale, and the Sheehan Disability Scale (SDS). Safety and tolerability were evaluated using discontinuation rates, spontaneously reported adverse events, and changes in vital signs, ECG, and laboratory analytes. RESULTS: Mean changes in HAMD(17 )total score at Weeks 6, 28, and 52 were -13.0, -17.4 and -17.5 (all p-values <.001). Significant improvement (p < .001) in both clinician- (CGI-S) and patient-rated (PGI-I) measures of improvement were observed at Week 1 and sustained throughout the study. Observed case response rates at Weeks 6, 28, and 52 were 62.9%, 84.9%, and 89.4%, respectively, while the corresponding rates of remission were 41.4%, 69.8%, and 72.3%. Adverse events led to discontinuation in 27 (26.7%) patients. Treatment-emergent adverse events reported by >10% of patients included dizziness, nausea, constipation, somnolence, insomnia, dry mouth, and diarrhea. Most events occurred early in the study. Mean changes at endpoint in blood pressure and body weight were less than 2.0 mm Hg, and -0.1 kg, respectively. CONCLUSIONS: In this open-label study, duloxetine was effective, safe, and well tolerated in the long-term treatment of MDD in patients aged 65 and older. |
format | Text |
id | pubmed-544561 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2004 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-5445612005-01-16 Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study Wohlreich, Madelaine M Mallinckrodt, Craig H Watkin, John G Hay, Donald P BMC Geriatr Research Article BACKGROUND: Late-life depression is a common, chronic and recurring disorder for which guidelines recommend long-term therapy. The safety and efficacy of duloxetine for the treatment of major depressive disorder (MDD) were evaluated using data from elderly patients (age ≥ 65 years; n = 101) who participated in a large, multinational, open-label study. METHODS: Patients meeting DSM-IV criteria for MDD received duloxetine 80 mg/d (40 mg twice daily (BID)) to 120 mg/d (60 mg BID) for up to 52 weeks. Efficacy measures included the Clinical Global Impression of Severity (CGI-S) scale, the 17-item Hamilton Rating Scale for Depression (HAMD(17)), the Beck Depression Inventory-II (BDI-II), the Patient Global Impression of Improvement (PGI-I) scale, and the Sheehan Disability Scale (SDS). Safety and tolerability were evaluated using discontinuation rates, spontaneously reported adverse events, and changes in vital signs, ECG, and laboratory analytes. RESULTS: Mean changes in HAMD(17 )total score at Weeks 6, 28, and 52 were -13.0, -17.4 and -17.5 (all p-values <.001). Significant improvement (p < .001) in both clinician- (CGI-S) and patient-rated (PGI-I) measures of improvement were observed at Week 1 and sustained throughout the study. Observed case response rates at Weeks 6, 28, and 52 were 62.9%, 84.9%, and 89.4%, respectively, while the corresponding rates of remission were 41.4%, 69.8%, and 72.3%. Adverse events led to discontinuation in 27 (26.7%) patients. Treatment-emergent adverse events reported by >10% of patients included dizziness, nausea, constipation, somnolence, insomnia, dry mouth, and diarrhea. Most events occurred early in the study. Mean changes at endpoint in blood pressure and body weight were less than 2.0 mm Hg, and -0.1 kg, respectively. CONCLUSIONS: In this open-label study, duloxetine was effective, safe, and well tolerated in the long-term treatment of MDD in patients aged 65 and older. BioMed Central 2004-12-07 /pmc/articles/PMC544561/ /pubmed/15585058 http://dx.doi.org/10.1186/1471-2318-4-11 Text en Copyright © 2004 Wohlreich et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Wohlreich, Madelaine M Mallinckrodt, Craig H Watkin, John G Hay, Donald P Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study |
title | Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study |
title_full | Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study |
title_fullStr | Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study |
title_full_unstemmed | Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study |
title_short | Duloxetine for the long-term treatment of Major Depressive Disorder in patients aged 65 and older: an open-label study |
title_sort | duloxetine for the long-term treatment of major depressive disorder in patients aged 65 and older: an open-label study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC544561/ https://www.ncbi.nlm.nih.gov/pubmed/15585058 http://dx.doi.org/10.1186/1471-2318-4-11 |
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