Objective:To assess the efficacy of desvenlafaxine succinate (DVS) treatment in patients with major depressive disorder (MDD).Methods:Seven randomized, double-blind, placebo-controlled, short-term studies were pooled ...
Objective:To assess the efficacy of desvenlafaxine succinate (DVS) treatment in patients with major depressive disorder (MDD).Methods:Seven randomized, double-blind, placebo-controlled, short-term studies were pooled to evaluate the efficacy of DVS in MDD. Adult outpatients with DSM-IV MDD were enrolled in all studies. Eligible patients were randomly assigned to DVS (n=1186) at doses of 100–400 mg/d, or placebo (n=797) for 8 weeks. The 17-item Hamilton Depression Rating Scale (HAM-D17) was the primary efficacy variable. Other efficacy variables were the Clinical Global Impressions scale (CGI), HAM-D6, Montgomery Åsberg Depression Rating Scale (MADRS), Covi Anxiety scale, Sheehan Disability Scale (SDS), WHO-5 Well-Being Index, and the Visual Analog Scale–Pain Intensity (VAS-PI). A mixed-effect model for repeated measures (MMRM) analysis was used to analyze continuous variables. Logistic regression was used to analyze response and remission ***:An adjusted mean difference of –2.8 points on HAM-D17 total score at end point for DVS vs placebo (95% confidence limits: –2.2, –3.4; P<0.001) was demonstrated. Response and remission rates were significantly elevated for DVS-treated patients compared with placebo (P<0.001) across rating scales (HAM-D17, MADRS, and CGI). For other secondary measures at end point, including the CGI, HAM-D6, MADRS, Covi, SDS, WHO-5, and VAS-PI, significant differences from placebo were also observed. No additional benefit was observed for DVS doses above 100 mg/d in analyses of fixed-dose ***:DVS was efficacious in treating MDD based on standard depression rating scales and measures of anxiety, global severity/improvement, functioning, well being, and pain.
Introduction Despite the high response rates seen with Chimeric Antigen Receptor (CAR) T-cell therapy for relapsed/refractory Large B-cell lymphoma (R/R LBCL), post-therapy relapse remains a key challenge. To date, no...
Introduction Despite the high response rates seen with Chimeric Antigen Receptor (CAR) T-cell therapy for relapsed/refractory Large B-cell lymphoma (R/R LBCL), post-therapy relapse remains a key challenge. To date, no study has evaluated the comparative efficacy and safety of experimental CAR T-cell products versus currently approved CAR T-cell therapies. Objective To indirectly compare the efficacy and safety of novel, experimental CAR T-cell products against the first FDA-approved CAR T-cell construct, Axicabtagene ciloleucel (Yescarta). Methods In compliance with the PRISMA guidelines, we performed a systematic review, which identified 16 independent, early-phase clinical trials consisting of 193 LBCL patients with individual patient data (IPD). We categorized eight pooled populations based on the target antigens (CD19, CD20), co-stimulatory domains (CD28, 4-1BB), and CAR T-cells administered with or without concomitant autologous stem cell transplant (ASCT). The pooled populations were categorized as follows: (1) dual targeting strategies, such as tandem ***20, n = 28; (2) co-infusion of CD19 and CD20 CARs, n = 21; (3) third-generation CARs, n = 26; (4) CD19 CARs with modified constructs for reduced toxicity, including ***.86, n = 21; and (5) ***828Z, n = 14; (6) CD19. 4-1BB.S manufactured in China, n = 24; (7) concomitant ASCT and ***28, n = 45; and (8) CD20 CARs with a 4-1BB co-stimulatory domain, n = 14. A Matching Adjusted Indirect Comparison (MAIC) statistical technique was applied to account for heterogeneity in the study population across trials. Estimates for the experimental CAR T-cell trials were adjusted using patient-level data to match the ZUMA-1 (Yescarta, n = 108) study population based on mutually reported key baseline covariates, including age, disease stage, histology, refractoriness, number of prior lines of therapy, and extranodal disease. The study endpoints for this study included progression-free survival (PFS), cytokine r
BackgroundClostridioides difficileinfection (CDI) may be life-threatening, and individuals aged ≥ 65 years are at increased risk. CDI burden among Medicare fee-for-service enrollees and nursing home residents in the ...
Background
Clostridioides difficile
infection (CDI) may be life-threatening, and individuals aged ≥ 65 years are at increased risk. CDI burden among Medicare fee-for-service enrollees and nursing home residents in the United States have been characterized previously. The present study aimed to describe the incidence of CDI among Medicare Advantage Enrollees (MAEs), who account for 34% of all Medicare beneficiaries with enrollment increasing annually since 2004.
Methods
De-identified claims data for this retrospective cohort study were collected from the Optum® Clinformatics® Data Mart and included MAEs aged ≥ 65 years with continuous enrollment for ≥ 1 year before January 1, 2016, followed through death or disenrollment. CDI incidence was defined using the International Classification of Diseases 9th Revision diagnosis code of 008.45 or 10th Revision code of A04.7 (other than admitting diagnosis) or by treatment with nontopical metronidazole, oral vancomycin, or fidaxomicin within 14 days of CDI test. Incident CDI cases were identified from January 1 to December 31, 2016, and required that no CDI occurred within the previous 60 days in 2016. Incidence in 2016 was calculated as CDI cases and CDI patients per 100,000 person-years (PY) of observation time.
Results
Of 2,542,341 MAEs analyzed, 15,201 patients (0.6%) experienced a total of 18,842 incident CDI episodes. Overall, incidence rates were 762.8 CDI cases and 616.5 CDI patients per 100,000 PY. Incidence increased with age (539.6, 847.3, and 1259.6 cases per 100,000 PY in patients aged 65‒74 years, 75‒84 years, and ≥ 85 years, respectively). Most episodes (50.9%) were community acquired; the remaining 37.7% and 11.4% of episodes were hospital acquired and indeterminate, respectively. CDI patients were more likely than non-CDI patients to be older (mean age, 78.3 vs. 76.1 years,
P <
0.0001), be women (64.5% vs. 58.1%,
P <
0.0001), or have comorbidities (mean Charlson comorbidity index score, 4.5 vs. 1.8,
P
< 0.0001
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