International clinical psychopharmacology
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Int Clin Psychopharmacol · Jan 2017
Meta AnalysisEarly improvement with pregabalin predicts endpoint response in patients with generalized anxiety disorder: an integrated and predictive data analysis.
Generalized anxiety disorder (GAD), a common mental disorder, has several treatment options including pregabalin. Not all patients respond to treatment; quickly determining which patients will respond is an important treatment goal. Patient-level data were pooled from nine phase II and III randomized, double-blind, short-term, placebo-controlled trials of pregabalin for the treatment of GAD. ⋯ Response to pregabalin in the first 1-2 weeks (≥20 or ≥30% improvement in HAM-A total, psychic or somatic score) was predictive of an endpoint greater than or equal to 50% improvement in the HAM-A total score. Pregabalin is an effective treatment option for patients with GAD. Patients with early response to pregabalin are more likely to respond significantly at endpoint.
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Int Clin Psychopharmacol · Jan 2013
Meta AnalysisSafety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies.
The objective of this study was to examine the safety and tolerability of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, in a large cohort of elderly patients with major depressive disorder. Data were pooled from 8-week and 12-week, double-blind, randomized, placebo-controlled trials of duloxetine 60 mg/day (duloxetine=456; placebo=225). Discontinuation rates because of adverse events, treatment-emergent adverse events, abnormal changes in vital signs and weight, and changes in laboratory analytes were compared between treatments using a Cochran-Mantel-Haenszel test. ⋯ The mean changes in platelet count, alkaline phosphatase, potassium, random glucose, uric acid, and cholesterol were significantly different between duloxetine and placebo (P<0.05), but none of these differences were considered clinically relevant. The incidence of abnormal low sodium levels was not significantly different between treatments. These safety results may better inform clinicians providing individualized care to elderly patients with major depressive disorder.
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Int Clin Psychopharmacol · Jan 2013
Meta AnalysisAntidepressant efficacy of agomelatine versus SSRI/SNRI: results from a pooled analysis of head-to-head studies without a placebo control.
Pooled analysis of individual patient data was used to compare the antidepressant efficacy of agomelatine with that of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). We sought head-to-head, double-blind, randomized studies without a placebo arm using antidepressant doses in the licensed range and primary evaluation on the Hamilton scale (HAM-D(17)). Six studies were identified versus venlafaxine, sertraline, fluoxetine, paroxetine or escitalopram. ⋯ Similar results were found in patients with severe depression. Agomelatine was associated with better tolerability than SSRI/SNRI. Agomelatine has favourable efficacy and tolerability versus a range of SSRIs and SNRIs - including agents considered to have superior efficacy - and may deserve benefit-risk analysis as a first-line treatment of major depressive disorder.
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Int Clin Psychopharmacol · Jul 2010
Meta AnalysisEscitalopram versus serotonin noradrenaline reuptake inhibitors as second step treatment for patients with major depressive disorder: a pooled analysis.
The objective of this study was to evaluate the efficacy and tolerability of escitalopram versus serotonin and noradrenaline reuptake inhibitors (SNRIs) as second step treatment (defined operationally as poor response or intolerability to an antidepressant) for major depressive disorder (MDD). Results from all eligible head-to-head clinical trials of MDD (which excluded patients who earlier failed two or more antidepressants) sponsored by Lundbeck or Forest comparing escitalopram and SNRIs (venlafaxine and duloxetine) were pooled. A second step treatment subgroup was identified, defined as patients treated earlier with any antidepressant in the 6-month period before baseline. ⋯ Escitalopram showed a better tolerability profile with lower all-cause withdrawals from study (9 vs. 23%, P<0.04) and lower withdrawals because of adverse events (2 vs. 17%, P<0.003). In conclusion, escitalopram is associated with a better efficacy and tolerability profile than SNRIs (duloxetine and venlafaxine) when used as a second step treatment in patients with MDD. These results should be confirmed in prospective randomized clinical trials.
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Int Clin Psychopharmacol · Nov 2008
Meta AnalysisClinical impact of duloxetine treatment on sleep in patients with major depressive disorder.
The objective of this study was to conduct a meta-analysis of the clinical impact of duloxetine treatment on sleep in adults with major depressive disorder. Data were pooled from 11 placebo-controlled, double-blind studies of duloxetine treatment (8-9 weeks acute therapy, modal dose 60 mg/day). Sleep outcome was assessed by the Hamilton Depression Rating Scale-17 (HAMD(17)) sleep items (onset latency, middle awakening, and early awakening) and their sum (insomnia subscale) and by occurrence of sleep-related treatment-emergent adverse events (TEAEs). ⋯ Sleep-related TEAEs that occurred more frequently for patients treated with duloxetine, compared with placebo, were insomnia (8.9 vs. 5.9%, P< or =0.001), middle insomnia (1.4 vs. 0.3%, P=0.001), and hypersomnia (1.0 vs. 0.3%, P< or =0.01). Patients with sleep-related TEAEs demonstrated similar mean improvement in Maier subscale score as patients without sleep-related TEAEs (P=0.223). Compared with placebo, duloxetine treatment was associated with a positive, but negligible, benefit on clinical ratings of insomnia and with more frequent sleep-related TEAEs that did not negatively impact overall efficacy for major depressive disorder.