Comparing venlafaxine extended release and fluoxetine for preventing the recurrence of major depression: Results from the PREVENT study
School of Medicine,University of Pennsylvania School of Medicine, Philadelphia, PA 19104-3309, United States. Journal of Psychiatric Research
(Impact Factor: 3.96).
03/2011; 45(3):412-20. DOI: 10.1016/j.jpsychires.2010.07.009
This secondary analysis from the Prevention of Recurrent Episodes of Depression with Venlafaxine Extended Release (ER) for Two Years (PREVENT) study compared the efficacy of venlafaxine ER and fluoxetine for the prevention of recurrence in patients with a history of recurrent major depressive disorder (MDD). Patients received double-blind treatment with venlafaxine ER (75-300 mg/d) or fluoxetine (20-60 mg/d) for 10 weeks (acute phase). Responders (17-item Hamilton Rating Scale for Depression [HAM-D(17)] score ≤ 12 and ≥ 50% reduction from baseline) continued on the same treatment during the 6-month continuation phase. At the start of the first and second 12-month maintenance phases, venlafaxine ER responders were randomly assigned to receive venlafaxine ER or placebo, whereas patients receiving fluoxetine continued to receive fluoxetine throughout both maintenance phases. The primary outcome was time to recurrence (HAM-D(17) > 12, reduction in HAM-D(17) score ≤ 50% from acute baseline, and meeting DSM-IV criteria for a diagnosis of MDD), which was assessed using Kaplan-Meier estimates. Using the primary definition of recurrence, the estimated probability of not experiencing a recurrence was 71.9% for venlafaxine ER (n = 160) and 55.8% for fluoxetine (n = 99) across 24 months of maintenance treatment. For this primary analysis, the overall effect of venlafaxine ER treatment was not statistically significant (p = 0.399) compared with fluoxetine; however, a significant treatment-by-time interaction was observed (p = 0.034). No significant between-group differences were observed with any of the secondary efficacy variables. Venlafaxine ER and fluoxetine were similarly well tolerated across 2 years of maintenance-phase therapy.
Available from: Boadie Dunlop
- "The study was reviewed and approved by the ethics review body responsible for each site, and all participants provided written informed consent prior to any study procedures being performed. A schematic diagram of the PREVENT trial was previously published (Thase et al., 2011). In the PREVENT trial, patients were randomly assigned to 10-week double-blind acute treatment with either flexible-dose venlafaxine ER (75e300 mg/d) or fluoxetine (20e60 mg/d). "
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ABSTRACT: In contrast to "remission" from an episode of major depressive disorder (MDD), for which there is general agreement in the literature, the optimal definition of "recovery" from MDD is uncertain. Previous definitions of recovery have used inconsistent thresholds for symptom severity and duration of wellness. To address the effects of duration and degree of recovery from an episode of MDD on recurrence risk, and the impact of maintenance antidepressant treatment on recurrence, we analyzed 258 patients from a randomized, double-blind study of outpatients with recurrent MDD. All patients had responded to 8½ months of venlafaxine extended release and were subsequently randomized to receive venlafaxine ER or placebo during 2 consecutive 12-month maintenance phases. Four definitions of recovery were used to evaluate recovery rates and time to recurrence: (1) 17-item Hamilton Depression Rating Scale (HAM-D(17)) total score ≤3 with duration ≥120 days; (2) HAM-D(17) ≤3 with duration ≥56 days; (3) HAM-D(17) ≤7 with duration ≥120 days; and (4) HAM-D(17) ≤7 with duration ≥56 days. Recovery definitions using lower symptom severity and longer duration thresholds produced lower rates of recurrence. Patients on placebo were more likely to have a recurrence than patients on venlafaxine ER, with hazard ratio (HR) ranging from 2.5 among patients who recovered by the most relaxed criteria (definition 4), to 5.3 among patients who recovered by the most stringent criteria (definition 1). We conclude that protection against recurrence derives from the degree and duration of recovery, particularly for patients maintained on antidepressant medication.
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ABSTRACT: Second-generation antidepressants dominate the management of major depressive disorder (MDD), but evidence on the comparative benefits and harms of these agents is contradictory.
To compare the benefits and harms of second-generation antidepressants for treating MDD in adults.
English-language studies from PubMed, Embase, the Cochrane Library, PsycINFO, and International Pharmaceutical Abstracts from 1980 to August 2011 and reference lists of pertinent review articles and gray literature.
2 independent reviewers identified randomized trials of at least 6 weeks' duration to evaluate efficacy and observational studies with at least 1000 participants to assess harm.
Reviewers abstracted data about study design and conduct, participants, and interventions and outcomes and rated study quality. A senior reviewer checked and confirmed extracted data and quality ratings.
Meta-analyses and mixed-treatment comparisons of response to treatment and weighted mean differences were conducted on specific scales to rate depression. On the basis of 234 studies, no clinically relevant differences in efficacy or effectiveness were detected for the treatment of acute, continuation, and maintenance phases of MDD. No differences in efficacy were seen in patients with accompanying symptoms or in subgroups based on age, sex, ethnicity, or comorbid conditions. Individual drugs differed in onset of action, adverse events, and some measures of health-related quality of life.
Most trials were conducted in highly selected populations. Publication bias might affect the estimates of some comparisons. Mixed-treatment comparisons cannot conclusively exclude differences in efficacy. Evidence within subgroups was limited.
Current evidence does not warrant recommending a particular second-generation antidepressant on the basis of differences in efficacy. Differences in onset of action and adverse events may be considered when choosing a medication.
Agency for Healthcare Research and Quality.
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ABSTRACT: Objective: To provide general practitioners with a comparison of major depressive disorder treatments received in primary care and psychiatric clinic settings, a focus on treatment outcomes related to currently prescribed antidepressants, and a review of new and emerging therapeutic strategies.
Data Sources: English-language evidence-based guidelines and peer-reviewed literature published between January 1, 2005, and December 31, 2011, were identified using PubMed, MEDLINE, and EMBASE. All searches contained the terms major depressive disorder and unipolar depression, and excluded the terms bipolar disorder/manic depressive disorder. The following search terms were also included: naturalistic study, antidepressant, relapse, recurrence, residual symptoms, response, remission, sequential medication trials, and treatment-resistant depression.
Study Selection: Meta-analyses, systematic reviews, and practice guidelines were included. Bibliographies were used to identify additional articles of interest.
Data Extraction: Abstracts and articles were screened for relevance to primary care practice. Population-based studies and those involving patients treated in primary care were used whenever possible.
Data Synthesis: Achieving remission from a major depressive episode is important to improve functional outcomes and to reduce relapse and recurrence. Despite the availability of numerous antidepressants, as many as 50% of patients require treatment modifications beyond first-line therapy. Among remitters, 90% report residual symptoms that may interfere with function. Patients treated in primary care often have chronic depression (symptom duration ≥ 24 months at presentation) and medical comorbidities. These are clinical predictors of worse outcomes and require individualized attention when treatment is initiated. Antidepressants differ in efficacy, tolerability, and side effects—factors that may affect adherence to treatment.
Conclusions: Major depressive disorder is highly prevalent in primary care and is among the most common causes of loss of disability-adjusted life-years worldwide. There are few differences in clinical profiles between depressed patients in primary care and those in specialist clinics, although differences in symptoms and comorbid conditions among individual depressed patients present a challenge for the physician providing individualized treatment. The goal of treatment is remission with good functional and psychosocial outcomes. Physicians in primary care should have expertise in working with a number of current antidepressant approaches and an awareness of new and emerging treatments.
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