BackgroundRandomized controlled clinical trials have shown vortioxetine to be efficacious and well tolerated for the treatment of major depressive disorder (MDD). The Real-Life Effectiveness of Vortioxetine in Depression (RELIEVE) study was undertaken to demonstrate the effectiveness and safety of vortioxetine for the treatment of MDD in routine clinical practice.MethodsRELIEVE was a 24-week, observational, prospective cohort study in outpatients with MDD initiating treatment with vortioxetine at their physician's discretion in routine care settings in Canada, France, Italy, and the USA (NCT03555136). The primary study outcome was patient functioning assessed by the Sheehan Disability Scale (SDS). Secondary outcomes included depression severity [9-item Patient Health Questionnaire (PHQ-9)], cognitive symptoms [5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5)], and cognitive performance [Digit Symbol Substitution Test (DSST)]. Mixed models of repeated measures were used to assess change from baseline at week 24, adjusted for relevant confounders.ResultsA total of 737 patients were eligible for inclusion in the full analysis set. Most patients (73.7%) reported at least one comorbid medical condition, 56.0% had comorbid anxiety and 24.4% had comorbid generalized anxiety disorder. Improvement in least-squares (LS) mean SDS score from baseline to week 24 was 8.7 points. LS mean PHQ-9, PDQ-D-5 and DSST scores improved by 7.4, 4.6, and 6.2 points, respectively. Adverse events were observed in 21.2% of patients [most commonly, nausea (8.2% of patients)].ConclusionsThese results demonstrate the effectiveness and tolerability of vortioxetine for the treatment of MDD in a large and heterogeneous patient population representative of that encountered in routine clinical practice.
Background Emotional blunting—inability to feel positive or negative emotions, detachment, or reduced emotional responsiveness—is common in people with depression. However, there is a paucity of studies comprehensively investigating this symptom and its functional impact. This study investigated the experience of emotional blunting, and its impact on overall functioning and quality of life, in the acute and remission phases of depression from the perspective of patients and healthcare providers. This paper presents data on the clinical presentation of emotional blunting in depression from the patient perspective. Methods Cross-sectional, observational study conducted in Brazil, Canada, and Spain between April 15 and May 18, 2021. Data were collected via a self-completed online survey. Respondents were adults with depression (acute or remission phase), who were currently using a prescribed antidepressant, and who reported emotional blunting during the past 6 weeks. Emotional blunting was assessed using the Oxford Depression Questionnaire (ODQ; total score range 26–130, higher scores indicate greater emotional blunting). Results In all, 752 patients completed the survey (62% female; mean age, 45 years). Overall, 44% of patients rated their emotional blunting as extremely severe (acute phase [n = 300], 72%; remission phase [n = 452], 25%; difference, p < 0.01). In all, 56% of patients considered their emotional blunting to be caused by their depression (acute phase, 62%; remission phase, 52%). Mean ODQ total score was 94.8 for patients in the acute phase of depression and 85.7 for those in remission (difference, p < 0.01). Mean score for the ODQ ‘antidepressant as cause’ domain (maximum possible score, 30) was 18.0 in patients in the acute phase and 17.6 in those in remission. Overall, 45% of patients believed that their antidepressant medication was blunting their emotions and 39% were considering stopping or had already stopped their antidepressant because of perceived emotion-related side effects. Conclusions Almost three-quarters of patients in the acute phase of depression and one-quarter of those in remission reported severe emotional blunting. Approximately 56% of patients considered their emotional blunting to be caused by their depression, while 45% believed that their antidepressant medication was negatively affecting their emotions. Just over one-third of patients were considering stopping or had stopped their antidepressant as a result.
IntroductionAnaplastic lymphoma kinase (ALK) rearrangement gene testing is used increasingly to identify patients with advanced non-small-cell lung cancer (NSCLC) who are most likely to benefit from crizotinib. This study was to evaluate the cost-effectiveness of the ALK tests followed by crizotinib compared to the standard chemotherapy in advanced NSCLC from the Chinese healthcare system perspective.MethodsA 10-year Markov model was constructed to compare the costs and quality-adjusted life-years (QALYs) of crizotinib with standard chemotherapy, guided by the ALK rearrangement tests: next-generation sequencing (NGS) panel tests and multiplex polymerase chain reaction (PCR) testing. The health states included progression-free survival (PFS), progressed survival, and death. The costs examined included cost of drugs (pemetrexed, standard chemotherapy, salvage chemotherapy, and crizotinib), follow-up, palliative care, supportive care, severe adverse events, and ALK rearrangement testing.ResultsUnder Patient Assistance Program (PAP), the model demonstrated that the patients using NGS panel tests spent US $31,388 and gained 0.780 QALYs, whereas patients using multiplex PCR spent US $31,362 and gained 0.780 QALYs, respectively. The incremental cost-effectiveness ratios of crizotinib with PAP compared to the control strategy were projected at $14,384 (NGS) and $13,740 (multiplex PCR) per QALY gained, respectively. Sensitivity analyses showed the utility of PFS and the costs of crizotinib and pemetrexed were the most impactful factors on the model outcomes. The results were robust to changes in all parameters.ConclusionALK-rearrangement test positive followed by crizotinib may be cost-effective compared to standard chemotherapy from the Chinese healthcare system perspective when PAP was available.
Purpose: This post hoc analysis was undertaken to further explore the association of cognitive symptoms with health-related quality of life (HRQoL) and work productivity at the time of treatment initiation in Chinese patients with major depressive disorder (MDD) in the Prospective Research Observation to Assess Cognition in Treated patients with MDD (PROACT) study. Patients and Methods: This was an epidemiological, non-interventional, prospective cohort study in adult outpatients with moderate-to-severe MDD initiating antidepressant monotherapy (first or second line). Crude and adjusted analyses of covariance were performed to assess the association of perceived cognitive symptoms (20-item Perceived Deficits Questionnaire-Depression [PDQ-D] total score) or observed cognitive performance (Digit Symbol Substitution Test [DSST] score) with HRQoL (EuroQoL 5-Dimensions Questionnaire index) and work productivity (Work Productivity and Activity Impairment [WPAI] or Sheehan Disability Scale [SDS] absenteeism and presenteeism scores). Adjusted analyses included depression severity, age, sex, residential area (urban/rural), and educational level. Results: Of 1008 patients enrolled in the PROACT study, 986 were included in this analysis. Severity of perceived cognitive symptoms (ie, higher PDQ-D total score) was significantly associated with worse HRQoL (P<0.001) and higher levels of absenteeism (P=0.020 for the WPAI and P=0.002 for the SDS) and presenteeism (P<0.001 for both scales). The association of perceived cognitive symptoms with HRQoL and presenteeism was independent of depression severity. The association between observed cognitive performance (DSST score) and HRQoL was less robust. No association was seen between observed cognitive performance and levels of absenteeism or presenteeism assessed by either scale. Conclusion: Results of this real-world study illustrate the impact of cognitive symptoms on HRQoL and work productivity in Chinese patients with MDD, and highlight the importance of assessing and targeting cognitive symptoms in order to improve functional outcomes when treating patients with MDD.
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