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1.  Efficacy comparison of duloxetine and SSRIs at doses approved in Japan 
Background
Approved doses of antidepressants in Japan are usually lower than those in the USA and European Union, but to date meta-analyses comparing antidepressants have all used the higher doses approved in the USA and European Union and often have used indirect comparisons. The purpose of this study was to conduct an integrated database analysis of patient level data to compare the effects of duloxetine with those of selective serotonin reuptake inhibitors (SSRIs) at the doses approved in Japan.
Methods
Pooled data were analyzed from four randomized, double-blind, placebo-controlled studies that compared duloxetine at the dose range approved in Japan (40–60 mg/day) with other SSRIs (paroxetine 20 mg/day or escitalopram 10 mg/day) and placebo in patients with major depressive disorder. In total, 1,694 patients were included in the analysis (duloxetine, n=688; selective serotonin reuptake inhibitors, n=690; placebo, n=316). The primary outcome measure was the mean change from baseline at week 8 in 17-item Hamilton Rating Scale for Depression (HAMD17) total and subscale scores.
Results
Duloxetine and both selective serotonin reuptake inhibitors were superior to placebo in HAMD17 total score at week 8 in both the all-randomized group and the more severe subgroup (HAMD17 total scores ≥19). Duloxetine was superior to SSRIs in improving the HAMD17 Retardation subscale score (least squares mean difference [95% confidence interval]): all-randomized group, −0.33 [−0.60, −0.07], P=0.015; severe subgroup, −0.45 [−0.83, −0.07], P=0.020).
Conclusion
Within the dose range approved in Japan for patients with major depressive disorder, duloxetine and selective serotonin reuptake inhibitors demonstrated comparable overall efficacy, with a possible advantage for duloxetine in improving loss of energy and interest. To the best of our knowledge, this analysis is unique not only in evaluating dosages specific to Japan, but also in using individual patient data and the same endpoint across studies to allow for strictly direct head-to-head data comparisons as opposed to pooling direct and indirect comparisons.
doi:10.2147/NDT.S72642
PMCID: PMC4296960  PMID: 25624763
duloxetine; selective serotonin reuptake inhibitors; Japan; approved dosage; meta-analysis; major depressive disorder
2.  Skeletonized versus pedicled internal thoracic artery and risk of sternal wound infection after coronary bypass surgery: meta-analysis and meta-regression of 4817 patients 
It is suggested that the internal thoracic artery (ITA) harvesting technique influences the incidence of sternal wound infection (SWI) after coronary artery bypass graft (CABG). To determine if there is any real difference between skeletonized vs pedicled ITA, we performed a meta-analysis to determine if there is any real difference between these two established techniques in terms of SWI. We performed a systematic review using MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles to search for studies that compared the incidence of SWI after CABG between skeletonized vs pedicled ITA until June 2012. The principal summary measures were odds ratio (OR) with 95% confidence interval (CI) and P values (statistically significant when <0.05). The ORs were combined across studies using the weighted DerSimonian–Laird random effects model and weighted Mantel–Haenszel fixed effects. Meta-analysis, sensitivity analysis and meta-regression were completed using the software Comprehensive Meta-Analysis version 2 (Biostat, Inc., Englewood, NJ, USA). Twenty-two studies involving 4817 patients (2424 skeletonized; 2393 pedicled) met the eligibility criteria. There was no evidence for important heterogeneity of effects among the studies. The overall OR (95% CI) of SWI showed a statistically significant difference in favour of skeletonized ITA (fixed effect model: OR 0.443, 95% CI 0.323–0.608, P < 0.001; random effect model: OR 0.443, 95% CI 0.323–0.608, P < 0.001). In the sensitivity analysis, the difference in favour of skeletonized ITA was also observed in subgroups such as diabetic, bilateral ITA and diabetic with bilateral ITA; we also observed that there was a difference in the type of study, since non-randomized studies together demonstrated the benefit of skeletonized ITA in comparison with pedicled ITA, but the randomized studies together did not show this difference (although close to statistical significance and with the tendency to favour the skeletonized group). In meta-regression, we observed a statistically significant coefficient for SWI and proportion of diabetic patients (coefficient −0.02, 95% CI −0.03 to −0.01, P = 0.016). In conclusion, skeletonized ITA appears to reduce the incidence of postoperative SWI in comparison with pedicled ITA after CABG, with this effect being modulated by the presence of diabetes.
doi:10.1093/icvts/ivt012
PMCID: PMC3653453  PMID: 23446674
Meta-analysis; Coronary artery bypass; Mammary arteries; Surgical wound infection
4.  Preservation versus non-preservation of mitral valve apparatus during mitral valve replacement: a meta-analysis of 3835 patients 
Resection of the chordopapillary apparatus during mitral valve replacement has been associated with a negative impact on survival. Mitral valve replacement with the preservation of the mitral valve apparatus has been associated with better outcomes, but surgeons remain refractory to its use. To determine if there is any real difference in preservation vs non-preservation of mitral valve apparatus during mitral valve replacement in terms of outcomes, we performed a systematic review and meta-analysis using MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles to search for clinical studies that compared outcomes (30-day mortality, postoperative low cardiac output syndrome or 5-year mortality) between preservation vs non-preservation during mitral valve replacement from 1966 to 2011. The principal summary measures were odds ratios (ORs) with 95% confidence interval and P-values (that will be considered statistically significant when <0.05). The ORs were combined across studies using a weighted DerSimonian–Laird random-effects model. The meta-analysis was completed using the software Comprehensive Meta-Analysis version 2 (Biostat Inc., Englewood, NJ, USA). Twenty studies (3 randomized and 17 non-randomized) were identified and included a total of 3835 patients (1918 for mitral valve replacement preservation and 1917 for mitral valve replacement non-preservation). There was significant difference between mitral valve replacement preservation and mitral valve replacement non-preservation groups in the risk of 30-day mortality (OR 0.418, P <0.001), postoperative low cardiac output syndrome (OR 0.299, P <0.001) or 5-year mortality (OR 0.380, P <0.001). No publication bias or important heterogeneity of effects on any outcome was observed. In conclusion, we found evidence that argues in favour of the preservation of mitral valve apparatus during mitral valve replacement.
doi:10.1093/icvts/ivs379
PMCID: PMC3501301  PMID: 23027596
Meta-analysis; Heart valve prosthesis implantation; Chordae tendineae
5.  Prognostic factors of improvement in health-related quality of life in atomoxetine-treated children and adolescents with attention-deficit/hyperactivity disorder, based on a pooled analysis 
The objective of this study is to identify prognostic factors of treatment response to atomoxetine in improvement of health-related quality of life (HR-QoL), measured by the Child Health and Illness Profile-Child Edition Parent Report Form (CHIP-CE PRF) Achievement and Risk Avoidance domains, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Pooled data from 3 placebo-controlled trials and separate data from 3 open-label trials of atomoxetine in children and adolescents with ADHD were analyzed using logistic regression methods. Based on baseline impairment in the Achievement and/or Risk Avoidance domains (CHIP-CE PRF < 40 points), 2 subsamples of subjects were included. Treatment outcome was categorized as <5 points or ≥5 points increase in the CHIP-CE PRF Achievement and Risk Avoidance domains. Data of 190 and 183 subjects from the pooled sample, and 422 and 355 subjects from the open-label trials were included in the analysis of Achievement and Risk Avoidance domains. Baseline CHIP-CE subdomain scores proved to be the most robust prognostic factors for treatment outcome in both domains, based on data from the pooled sample of double-blind studies and from the individual open-label studies (odds ratios [OR] 0.74–1.56, p < 0.05; OR < 1, indicating a worse baseline score associated with worse odds of responding). Initial treatment response (≥25 % reduction in ADHD Rating Scale scores in the first 4–6 weeks) was another robust prognostic factor, based on data from the open-label studies (OR 2.99–6.19, p < 0.05). Baseline impairment in HR-QoL and initial treatment response can be early prognostic factors of atomoxetine treatment outcome in HR-QoL in children and adolescents with ADHD.
doi:10.1007/s12402-013-0119-5
PMCID: PMC3935101  PMID: 24142305
ADHD; Health-related quality of life; Atomoxetine; CHIP-CE; Response prediction
6.  Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine 
Background
Attention deficit/hyperactivity disorder (ADHD) often presents as an impairing lifelong condition in adults; yet it is currently underdiagnosed and undertreated in many European countries. This analysis examines the characteristics of adult patients with ADHD in a European (EUR) and non-European (NE) patient population.
Methods
Baseline data from the open-label treatment period of a randomized trial of atomoxetine in adult patients with ADHD (N=2017; EUR, n=1217; NE, n=800) were examined. All patients who were enrolled were included in the baseline analyses.
Results
The demographics for patients in the EUR and NE groups were comparable. Patients in the EUR group had a somewhat lower percentage of prior exposure to psychostimulants compared with the NE group (32.7% vs. 38.9%, p=.0049). Scores on the Conners’ Adult ADHD Rating Scale-Investigator Rated: Screening Version with adult ADHD prompts (18-item total, inattentive and hyperactive/impulsive subscales, and index) were comparable. The adult ADHD Quality of Life-Life Outlook and Life Productivity domain scores were significantly different between groups (p≤.0004). The EuroQol-5 Dimension United Kingdom and United States population-based index scores and Health State score were comparable between groups.
Conclusions
Adults with ADHD in Europe present similar demographics and baseline characteristics to those outside Europe and hence, study results outside Europe may be generalizable to patients in Europe.
Trial registration
Clinicaltrials.gov, NCT00700427
doi:10.1186/1753-2000-7-14
PMCID: PMC3658949  PMID: 23648011
Attention deficit/hyperactivity disorder; Adult; European; Atomoxetine
7.  Psychometric properties of the quality of life scale Child Health and Illness Profile-Child Edition in a combined analysis of five atomoxetine trials 
Our aim was to evaluate the psychometric properties of the generic quality of life (QoL) scale Child Health and Illness Profile-Child Edition (CHIP-CE) by means of a combined analysis of atomoxetine clinical trials in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Individual patient-level data from five clinical trials were included in the combined analysis. Psychometric properties of the CHIP-CE were explored in terms of internal consistency and structure. Patients (n = 794) aged between 6 and 15 years (mean 9.7) with mean baseline ADHD Rating Scale of 41.8 ± 8.04 were included. On average, 0.7 (SD 2.23) items were missing for the whole CHIP-CE. The internal consistency of the CHIP-CE assessed by Cronbach’s alpha was good for all sub-domains at baseline and at endpoint. Considerable ceiling effects were only observed for the “restricted activity” sub-domain. No considerable floor effects were seen. The factor analysis supported the 12-factor solution for the sub-domains, but not the 5-factor solution for the domains. Our analyses were based on a large sample of non-US patients which allowed the measurement of clear changes in QoL over time. The results support that the CHIP-CE scale is psychometrically robust over time in terms of internal consistency and structure.
doi:10.1007/s12402-011-0066-y
PMCID: PMC3220810  PMID: 21986814
Attention-deficit disorder with hyperactivity; Quality of life; Psychometrics; Factor analysis
8.  Validation of the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) in a naturalistic sample of 278 patients with acute psychosis and agitation in a psychiatric emergency room 
Background
Despite the wide use of the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) in a clinical setting to assess agitated patients, a validation study to evaluate its psychometric properties was missing.
Methods
Data from the observational NATURA study were used. This research describes trends in the use of treatments in patients with acute psychotic episodes and agitation seen in emergency departments. Exploratory principal component factor analysis was performed. Spearman's correlation and regression analyses (linear regression model) as well as equipercentile linking of Clinical Global Impression of Severity (CGI-S), Agitation and Calmness Evaluation Scale (ACES) and PANSS-EC items were conducted to examine the scale's diagnostic validity. Furthermore, reliability (Cronbach's alpha) and responsiveness were evaluated.
Results
Factor analysis resulted in one factor being retained according to eigenvalue ≥1. At admission, the PANSS-EC and CGI-S were found to be linearly related, with an average increase of 3.4 points (p < 0.001) on the PANSS-EC for each additional CGI-S point. The PANSS-EC and ACES were found to be linearly and inversely related, with an average decrease of 5.5 points (p < 0.001) on the PANSS-EC for each additional point. The equipercentile method shows the poor sensitivity of the ACES scale. Cronbach's alpha was 0.86 and effect size was 1.44.
Conclusions
The factorial analyses confirm the unifactorial structure of the PANSS-EC subscale. The PANSS-EC showed a strong linear correlation with rating scales such as CGI-S and ACES. PANSS-EC has also shown an excellent capacity to detect real changes in agitated patients.
doi:10.1186/1477-7525-9-18
PMCID: PMC3078838  PMID: 21447155
9.  Differences between children and adolescents in treatment response to atomoxetine and the correlation between health-related quality of life and Attention Deficit/Hyperactivity Disorder core symptoms: Meta-analysis of five atomoxetine trials 
Objectives
To explore the influence of age on treatment responses to atomoxetine and to assess the relationship between core symptoms of attention deficit/hyperactivity disorder (ADHD) and health-related quality of life (HR-QoL) outcomes.
Data Sources
Data from five similar clinical trials of atomoxetine in the treatment of children and adolescents with ADHD were included in this meta-analysis.
Study Selection
Atomoxetine studies that used the ADHD Rating Scale (ADHD-RS) and the Child Health and Illness Profile Child Edition (CHIP-CE) as outcome measures were selected.
Interventions
Treatment with atomoxetine.
Main Outcome Measures
Treatment group differences (atomoxetine vs placebo) in terms of total score, domains, and subdomains of the CHIP-CE were compared across age groups, and correlations between ADHD-RS scores and CHIP-CE scores were calculated by age.
Results
Data of 794 subjects (611 children, 183 adolescents) were pooled. At baseline, adolescents showed significantly (p < 0.05) greater impairment compared with children in the Family Involvement, Satisfaction with Self, and Academic Performance subdomains of the CHIP-CE. Treatment effect of atomoxetine was significant in both age groups for the Risk Avoidance domain and its subdomains. There was a significant age-treatment interaction with greater efficacy seen in adolescents in both the Risk Avoidance domain and the Threats to Achievement subdomain. Correlations between ADHD-RS and CHIP-CE scores were generally low at baseline and moderate in change from baseline and were overall similar in adolescents and children.
Conclusions
Atomoxetine was effective in improving some aspects of HR-QoL in both age groups. Correlations between core symptoms of ADHD and HR-QoL were low to moderate.
doi:10.1186/1753-2000-4-30
PMCID: PMC3012018  PMID: 21134277

Results 1-9 (9)