| 1. |
- Gartlehner, Gerald, et al.
(author)
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Comparative benefits and harms of second-generation antidepressants for treating major depressive disorder : an updated meta-analysis.
- 2011
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In: Annals of Internal Medicine. - : American College of Physicians. - 0003-4819 .- 1539-3704. ; 155:11, s. 772-785
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Journal article (peer-reviewed)abstract
- BACKGROUND: Second-generation antidepressants dominate the management of major depressive disorder (MDD), but evidence on the comparative benefits and harms of these agents is contradictory.PURPOSE: To compare the benefits and harms of second-generation antidepressants for treating MDD in adults.DATA SOURCES: 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.STUDY SELECTION: 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.DATA EXTRACTION: 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.DATA SYNTHESIS: 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.LIMITATIONS: 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.CONCLUSION: 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.PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
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| 2. |
- Gartlehner, Gerald, et al.
(author)
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Drug Class Review: Second-Generation Antidepressants: Final Update 5 Report [Internet].
- 2011
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Reports (peer-reviewed)abstract
- PURPOSE: We compared the effectiveness and harms of second-generation antidepressants in the treatment of major depressive disorder (MDD), dysthymia, subsyndromal depression, seasonal affective disorder, generalized anxiety disorder, obsessive compulsive disorder, panic disorder, post-traumatic stress disorder, social anxiety disorder, and premenstrual dysphoric disorder.DATA SOURCES: We searched PubMed, Embase, PsycINFO, the Cochrane Library, and the International Pharmaceutical Abstracts until September 2010. For additional data we also hand searched reference lists, US Food and Drug Administration medical and statistical reviews and dossiers submitted by pharmaceutical companies.REVIEW METHODS: Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to standard Drug Effectiveness Review Project review methods.RESULTS AND CONCLUSIONS: Overall, we found no substantial differences in comparative efficacy and effectiveness of second-generation antidepressants for the treatment of depressive or anxiety disorders. Differences exist in the incidence of specific adverse events and the onset of action. Except for MDD, the evidence is limited to few direct comparisons for most indications. No head-to-head evidence is available for MDD in pediatric populations, dysthymia, subsyndromal depression, seasonal affective disorder, and premenstrual dysphoric disorder.
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| 3. |
- Gartlehner, Gerald, et al.
(author)
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Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression : An Update of the 2007 Comparative Effectiveness Review [Internet]
- 2011
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Reports (other academic/artistic)abstract
- BACKGROUND: Depressive disorders such as major depressive disorder (MDD), dysthymia, and subsyndromal depression may be serious disabling illnesses. MDD affects more than 16 percent of adults at some point during their lifetimes. Second-generation antidepressants dominate the medical management of depressive disorders. These drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and other drugs with related mechanisms of action that selectively target neurotransmitters.OBJECTIVES: The objective of this report was to compare the benefits and harms of bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazodone, and venlafaxine for the treatment of depressive disorders, including variations of effects in patients with accompanying symptoms and patient subgroups.DATA SOURCES: We updated a comparative effectiveness review published in 2007 by the Agency for Healthcare Research and Quality searching PubMed, Embase, The Cochrane Library, and International Pharmaceutical Abstracts up to January 2011.REVIEW METHODS: Two people independently reviewed the literature, abstracted data, and rated the risk of bias. If data were sufficient, we conducted meta-analyses of head-to-head trials of the relative benefit of response to treatment. In addition, we conducted mixed treatment comparisons to derive indirect estimates of the comparative efficacy among all second-generation antidepressants.RESULTS: From a total of 3,722 citations, we identified 248 studies of good or fair quality. Overall, no substantial differences in efficacy could be detected among second-generation antidepressants for the treatment of acute-phase MDD. Statistically significant differences in response rates between some drugs are small and likely not clinically relevant. No differences in efficacy were apparent in patients with accompanying symptoms or in subgroups based on age, sex, ethnicity, or comorbidities, although evidence within these subpopulations was limited. Differences exist in the incidence of specific adverse events and the onset of action. Venlafaxine leads to higher rates of nausea and vomiting, sertraline to higher rates of diarrhea, and mirtazapine to higher rates of weight gain than comparator drugs. Bupropion causes lower rates of sexual dysfunction than other antidepressants. The evidence is insufficient to draw conclusions about the comparative efficacy and effectiveness for the treatment of dysthymia and subsyndromal depression.CONCLUSIONS: Our findings indicate that the existing evidence does not warrant the choice of one second-generation antidepressant over another based on greater efficacy and effectiveness. Differences with respect to onset of action and adverse events may be taken into consideration for the choice of a medication.
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| 4. |
- Hultcrantz, Monica, et al.
(author)
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The GRADE Working Group clarifies the construct of certainty of evidence
- 2017
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In: Journal of Clinical Epidemiology. - : Pergamon Press. - 0895-4356 .- 1878-5921. ; 87, s. 4-13
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Journal article (peer-reviewed)abstract
- Objective: To clarify the grading of recommendations assessment, development and evaluation (GRADE) definition of certainty of evidence and suggest possible approaches to rating certainty of the evidence for systematic reviews, health technology assessments, and guidelines. Study Design and Setting: This work was carried out by a project group within the GRADE Working Group, through brainstorming and iterative refinement of ideas, using input from workshops, presentations, and discussions at GRADE Working Group meetings to produce this document, which constitutes official GRADE guidance. Results: Certainty of evidence is best considered as the certainty that a true effect lies on one side of a specified threshold or within a chosen range. We define possible approaches for choosing threshold or range. For guidelines, what we call a fully contextualized approach requires simultaneously considering all critical outcomes and their relative value. Less-contextualized approaches, more appropriate for systematic reviews and health technology assessments, include using specified ranges of magnitude of effect, for example, ranges of what we might consider no effect, trivial, small, moderate, or large effects. Conclusion: It is desirable for systematic review authors, guideline panelists, and health technology assessors to specify the threshold or ranges they are using when rating the certainty in evidence. (C) 2017 The Authors. Published by Elsevier Inc.
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| 5. |
- Kien, Christina, et al.
(author)
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[Comparative effectiveness and safety of screening and counselling interventions conducted by non-physicians and physicians : A systematic review].
- 2015
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In: Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen. - : Elsevier BV. - 2212-0289 .- 1865-9217. ; 109:1, s. 18-27
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Journal article (peer-reviewed)abstract
- BACKGROUND: Current forecasts project a future shortage of physicians which might compromise the quality of health care if not addressed adequately by health policy decisions. One proposed measure is to shift selected tasks and responsibilities from physicians to other medical staff, a strategy that has proven successful in some areas (e. g., chronic disease management). To date, no studies have systematically and objectively assessed whether the application of a similar strategy to screening and counselling in preventive medicine compromises patients' health outcomes and experiences.METHODS: A systematic search was conducted in MEDLINE, the Cochrane Library, CINAHL, and EMBASE (January 2000 - June 2014). We dually reviewed articles and assessed the risk of bias.RESULTS: 3,315 citations were identified and five relevant articles located. Overall, the available evidence indicated that there were no substantial differences in benefits and harms of screening (colon cancer screening, sexual transmitted diseases, and mammography) and counselling (genetic breast cancer risk) between non-physicians and physicians. The quality of evidence, however, is very low for most comparisons. Reported statistically significant differences for some outcomes need to be viewed cautiously.CONCLUSION: Shifting tasks from physicians to other medical staff for screening and counselling could be a viable strategy to address the shortage of practicing physicians. Adequate training by a physician, however, is a prerequisite for the safe and beneficial screening and counselling conducted by non-physicians.
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| 6. |
- Nussbaumer, Barbara, et al.
(author)
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Comparative Efficacy and Risk of Harms of Immediate- versus Extended-Release Second-Generation Antidepressants: A Systematic Review with Network Meta-Analysis
- 2014
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In: CNS Drugs. - : Adis / Springer Verlag (Germany). - 1172-7047 .- 1179-1934. ; 28:8, s. 699-712
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Research review (peer-reviewed)abstract
- Major depressive disorder (MDD) has detrimental effects on an individuals personal life, leads to increased risk of comorbidities, and places an enormous economic burden on society. Several second-generation antidepressants are available as both immediate-release (IR) and extended-release formulations. The advantage of extended-release formulations may be the potentially improved adherence and a lower risk of adverse events. We conducted a systematic review to assess the comparative efficacy, risk of harms, and patients adherence of IR and extended-release antidepressants for the treatment of MDD. English-language abstracts were retrieved from PubMed, EMBASE, the Cochrane Library, PsycINFO, and International Pharmaceutical Abstracts from 1980 to October 2012, as well as from reference lists of pertinent review articles and grey literature searches. We included head-to-head randomized controlled trials (RCTs) of at least 6 weeks duration that compared an IR formulation with an extended-release formulation of the same antidepressant in adult patients with MDD. We also included placebo-controlled trials to conduct a network meta-analysis. To assess harms and adherence, in addition to RCTs, we searched for observational studies with a parts per thousand yen1,000 participants and a follow-up of a parts per thousand yen12 weeks. We dually reviewed abstracts and full texts and assessed quality ratings. Lacking head-to-head evidence for many comparisons of interest, we conducted network meta-analyses using Bayesian methods. Our outcome measure of choice was response on the Hamilton Depression Rating Scale. We located seven head-to-head trials and 94 placebo- and active-controlled trials for network meta-analysis. Overall, our analyses indicate that IR and extended-release formulations do not differ substantially with respect to efficacy and risk of harms. The evidence is mixed with respect to differences in adherence, indicating lower adherence for IR formulations. The lack of head-to-head comparisons for many drugs compromises our conclusions. Network meta-analyses have methodological limitations that need to be taken into consideration when interpreting findings. Available evidence currently shows no clear differences between the two formulations and therefore we cannot recommend a first choice. However, if adherence or compliance with one medication is an issue, then clinicians and patients should consider the alternative medication. If adherence or costs are a problem with one formulation, consideration of the other formulation to provide an adequate treatment trial is reasonable.
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| 7. |
- Reichenpfader, Ursula, et al.
(author)
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[Clinical outcomes, health-related quality of life, and cost-effectiveness of a 6-month community- based lifestyle program for adults at increased cardiovascular risk in lower Austria].
- 2012
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In: Wiener Medizinische Wochenschrift. - : Springer Science and Business Media LLC. - 0043-5341 .- 1563-258X. ; 162:15-16, s. 321-329
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Journal article (peer-reviewed)abstract
- AIM: To investigate lifestyle intervention effects and cost-effectiveness of a structured 6-month exercise and nutrition program for individuals at high risk for cardiovascular disease.METHODS: Uncontrolled before and after study with assessments at baseline and six months. Adults without existing cardiovascular disease (CVD) but at increased CVD risk were eligible. The analysis was done by intention-to-treat (last-observation-carried-forward). Incremental cost-effectiveness analysis was performed. Main outcome measures were changes in cardiovascular risk-factors (blood pressure, weight, body-mass index, serum lipids, blood glucose, smoking cessation, and exercise) and health-related quality of life.RESULTS: A total of 356 adults (70.5% female; mean age 48.9 years; mean body mass index 32.4; drop-out 10.4%) participated. At 6 months significant favorable effects were observed in several cardiovascular risk outcomes, exercise behaviour and health related quality of life. At an average incremental cost per life year saved for the ITT-population of 22.474 the program can be considered cost-effective.
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| 8. |
- Reichenpfader, Ursula, et al.
(author)
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Sexual Dysfunction associated with Second-Generation Antidepressants in Patients with Major Depressive Disorder: Results from a Systematic Review with Network Meta-Analysis
- 2014
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In: Drug Safety. - : Adis. - 0114-5916 .- 1179-1942. ; 37:1, s. 19-31
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Journal article (peer-reviewed)abstract
- Sexual dysfunction (SD) is prevalent in patients with major depressive disorder (MDD) and is also associated with second-generation antidepressants (SGADs) that are commonly used to treat the condition. Evidence indicates under-reporting of SD in efficacy studies. SD associated with antidepressant treatment is a serious side effect that may lead to early termination of treatment and worsening of quality of life. Our objective was to systematically assess the harms of SD associated with SGADs in adult patients with MDD by drug type. We retrieved English-language abstracts from PubMed, EMBASE, the Cochrane Library, PsycINFO, and International Pharmaceutical Abstracts from 1980 to October 2012 as well as from reference lists of pertinent review articles and grey literature searches. Two independent reviewers identified randomized controlled trials (RCTs) of at least 6 weeks duration and observational studies with at least 1,000 participants. Reviewers abstracted data on study design, conduct, participants, interventions, outcomes and method of SD ascertainment, and rated risk of bias. A senior reviewer checked and confirmed extracted data and risk-of-bias ratings. Random effects network meta-analysis using Bayesian methods for data from head-to-head trials and placebo-controlled comparisons; descriptive analyses calculating weighted mean rates from individual trials and observational studies. Data from 63 studies of low and moderate risk of bias (58 RCTs, five observational studies) with more than 26,000 patients treated with SGADs were included. Based on network meta-analyses of 66 pairwise comparisons from 37 RCTs, most comparisons showed a similar risk of SD among included SGADs. However, credible intervals were wide and included differences that would be considered clinically relevant. We observed three main patterns: bupropion had a statistically significantly lower risk of SD than some other SGADs, and both escitalopram and paroxetine showed a statistically significantly higher risk of SD than some other SGADs. We found reporting of harms related to SD inconsistent and insufficient in some trials. Most trials were conducted in highly selected populations. Search was restricted to English-language only. Because of the indirect nature of the comparisons, the often wide credible intervals, and the high variation in magnitude of outcome, we rated the overall strength of evidence with respect to our findings as low. The current degree of evidence does not allow a precise estimate of comparative risk of SD associated with a specific antidepressant. In the absence of such evidence, clinicians need to be aware of SD as a common adverse event and should discuss patients preferences before initiating antidepressant therapy.
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