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Article ; Online: Tirzepatide 10 and 15 mg vs semaglutide 2.0 mg: A long-term cost-effectiveness analysis in patients with type 2 diabetes in the United States.

Mody, Reema / Valentine, William J / Hoog, Meredith / Sharland, Helen / Belger, Mark

Journal of managed care & specialty pharmacy

2024 Volume 30, Issue 2, Page(s) 153–162

Abstract: Background: Tirzepatide is a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved for type 2 diabetes (T2D) treatment.: Objective: To compare the long-term cost-effectiveness of tirzepatide 10 mg ... ...

Abstract	Background: Tirzepatide is a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved for type 2 diabetes (T2D) treatment. Objective: To compare the long-term cost-effectiveness of tirzepatide 10 mg and 15 mg vs semaglutide 2.0 mg, an injectable glucagon-like peptide-1 receptor agonist, in patients with T2D from a US health care payer perspective. Methods: The PRIME T2D Model was used to project clinical and cost outcomes over a 50-year time horizon. Baseline cohort characteristics and treatment effects were sourced from a published adjusted indirect treatment comparison that used data from the SURPASS-2 and SUSTAIN FORTE trials. Patients were assumed to intensify to insulin therapy at a hemoglobin A1c of greater than 7.5%. Costs and health state utilities were derived from published sources. Future costs and clinical benefits were discounted at 3% annually. Results: Tirzepatide 10 mg and 15 mg were associated with improved quality-adjusted life-expectancy (10 mg: 0.085 quality-adjusted life-years [QALYs], 15 mg: 0.121 QALYs), higher direct costs (10 mg: USD 5,990, 15 mg: USD 6,617), and incremental cost-effectiveness ratios of USD 70,147 and 54,699 per QALY gained, respectively, vs semaglutide 2.0 mg. Both doses of tirzepatide remained cost-effective vs semaglutide 2.0 mg over a range of sensitivity analyses. Conclusions: Long-term projections using the PRIME T2D model and based on treatment effects from an adjusted indirect treatment comparison indicate that tirzepatide 10 mg and 15 mg are likely to be cost-effective vs semaglutide 2.0 mg for the treatment of T2D in the United States.
MeSH term(s)	Humans ; United States ; Diabetes Mellitus, Type 2/drug therapy ; Hypoglycemic Agents ; Cost-Effectiveness Analysis ; Glucagon-Like Peptide-1 Receptor Agonists ; Cost-Benefit Analysis ; Glucagon-Like Peptide-2 Receptor ; Glucagon-Like Peptides ; Gastric Inhibitory Polypeptide
Chemical Substances	Hypoglycemic Agents ; semaglutide (53AXN4NNHX) ; tirzepatide (OYN3CCI6QE) ; Glucagon-Like Peptide-1 Receptor Agonists ; Glucagon-Like Peptide-2 Receptor ; Glucagon-Like Peptides (62340-29-8) ; Gastric Inhibitory Polypeptide (59392-49-3)
Language	English
Publishing date	2024-01-31
Publishing country	United States
Document type	Journal Article
ISSN	2376-1032
ISSN (online)	2376-1032
DOI	10.18553/jmcp.2024.30.2.153
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Testing the "RCT augmentation" methodology: A trial simulation study to guide the broadening of trials eligibility criteria and inform on effectiveness.

Nordon, Clementine / Sanchez, Benoit / Zhang, Mei / Wang, Xiaowei / Hunt, Phillip / Belger, Mark / Karcher, Helene

Contemporary clinical trials communications

2023 Volume 33, Page(s) 101142

Abstract: Background: Exclusion criteria that are treatment effect modifiers (TEM) decrease RCTs results generalisability and the potentials of effectiveness estimation. In "augmented RCTs", a small proportion of otherwise-excluded patients are included to allow ... ...

Abstract	Background: Exclusion criteria that are treatment effect modifiers (TEM) decrease RCTs results generalisability and the potentials of effectiveness estimation. In "augmented RCTs", a small proportion of otherwise-excluded patients are included to allow for effectiveness estimation. In Hodgkin Lymphoma (HL) RCTs, older age and comorbidity are common exclusion criteria, while also TEM. We simulated HL RCTs augmented with age or comorbidity, and explored in each scenario the impact of augmentation on effectiveness estimation accuracy. Methods: Simulated data with a population of HL individuals initiating drug A or B was generated. There were drug-age and drug-comorbidity interactions in the simulated data, with a greater magnitude of the former compared to the latter. Multiple augmented RCTs were simulated by randomly selecting patients with increasing proportions of older, or comorbid patients. Treatment effect size was expressed using the between-group Restricted Mean Survival Time (RMST) difference at 3 years. For each augmentation proportion, a model estimating the "real-world" treatment effect (effectiveness) was fitted and the estimation error measured (Root Mean Square Error, RMSE). Results: In simulated RCTs including none (0%), or the real-world proportion (30%) of older patients, the interquartile range of RMST difference was 0.4-0.5 years and 0.2-0.3 years, respectively, and RMSE were 0.198 years (highest possible error) and 0.056 years (lowest), respectively. Augmenting RCTs with 5% older patients decreased estimation error substantially (RMSE = 0.076 years). Augmentation with comorbid patients proved less useful for effectiveness estimation. Conclusion: In augmented RCTs aiming to inform the effectiveness of drugs, augmentation should concern in priority those exclusion criteria of suspected important TEM magnitude, so as to minimie the proportion of augmentation necessary for good effectiveness estimations.
Language	English
Publishing date	2023-04-14
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2023.101142
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Article ; Online: Generalizability of clinical trial efficacy results to a real-world population: An example in migraine prevention.

Paget, Marie-Ange / Tockhorn-Heidenreich, Antje / Belger, Mark / Chartier, Florence / Lantéri-Minet, Michel

Journal of managed care & specialty pharmacy

2023 Volume 29, Issue 12, Page(s) 1321–1330

Abstract: Background: Health care decision makers are often concerned about the external validity of randomized controlled trials (RCTs), as their results may not apply to certain patients in the real world who intend to receive treatment.: Objective: To ... ...

Abstract	Background: Health care decision makers are often concerned about the external validity of randomized controlled trials (RCTs), as their results may not apply to certain patients in the real world who intend to receive treatment. Objective: To demonstrate a methodology for assessing the generalizability of clinical trial results to a real-world population, before sufficient and appropriate real-world effectiveness data are available, using individual patient-level data from an RCT and aggregated baseline data from a real-world French registry in migraine. Methods: The analyses were conducted in 2 steps. First, individual patient-level baseline data from the multinational CONQUER RCT were weighted to match aggregated real-world InovPain registry patient characteristic data. Matched patient characteristics were sex, age, migraine type and duration, number of monthly migraine headache days, and number of monthly headache days at baseline. Second, the weighted CONQUER patient data were used to reanalyze the primary endpoint of CONQUER (least squares mean change from baseline in the number of monthly migraine headache days during the 3-month double-blind treatment phase) using predefined methodology. Sensitivity analyses were conducted to assess the robustness of findings. Results: A total of 462 patients with migraine were randomized and treated with galcanezumab or placebo in CONQUER; aggregated InovPain data were available from 130 patients with migraine. We identified no important differences in baseline patient characteristics between the 2 prespecified populations, suggesting good external validity for CONQUER. Although this limited the extent of observed differences between the original and matched CONQUER populations, weighting of CONQUER data did help harmonize the 2 datasets and allow the results obtained in CONQUER to be generalized to patients more representative of the real-world French population with migraine. Results of weighted analyses suggested that galcanezumab would be superior to placebo for reducing monthly migraine headache days in a clinical trial in patients with episodic or chronic migraine who reflected the characteristics of patients eligible to receive the drug in France. Conclusions: Findings suggest that our methods may be helpful for assessing the generalizability of clinical trial results to a real-world population before the availability of substantial real-world clinical data.
MeSH term(s)	Humans ; Double-Blind Method ; Migraine Disorders/drug therapy ; Migraine Disorders/prevention & control ; Randomized Controlled Trials as Topic ; Registries ; Treatment Outcome ; Male ; Female
Language	English
Publishing date	2023-12-06
Publishing country	United States
Document type	Journal Article
ISSN	2376-1032
ISSN (online)	2376-1032
DOI	10.18553/jmcp.2023.29.12.1321
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Article ; Online: Long-term cost-effectiveness analysis of tirzepatide versus semaglutide 1.0 mg for the management of type 2 diabetes in the United States.

Valentine, William J / Hoog, Meredith / Mody, Reema / Belger, Mark / Pollock, Richard

Diabetes, obesity & metabolism

2023 Volume 25, Issue 5, Page(s) 1292–1300

Abstract: Aim: To evaluate the long-term cost-effectiveness of tirzepatide (5, 10 and 15 mg doses), a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, versus semaglutide 1.0 mg, an injectable glucagon- ... ...

Abstract	Aim: To evaluate the long-term cost-effectiveness of tirzepatide (5, 10 and 15 mg doses), a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, versus semaglutide 1.0 mg, an injectable glucagon-like peptide-1 receptor agonist, based on the results of the head-to-head SURPASS-2 trial, from a US healthcare payer perspective. Materials and methods: The PRIME Type 2 Diabetes Model was used to make projections of clinical and cost outcomes over a 50-year time horizon. Baseline cohort characteristics, treatment effects and adverse event rates were derived from the 40-week SURPASS-2 trial. Intensification to insulin therapy occurred when HbA1c reached 7.5%, in line with American Diabetes Association recommendations. Direct costs in 2021 US dollars (US$) and health state utilities were derived from published sources. Future costs and clinical benefits were discounted at 3% annually. Results: All three doses of tirzepatide were associated with lower diabetes-related complication rates, improved life expectancy, improved quality-adjusted life expectancy and higher direct costs versus semaglutide. This resulted in incremental cost-effectiveness ratios of US$ 75 803, 58 908 and 48 785 per quality-adjusted life year gained for tirzepatide 5, 10 and 15 mg, respectively, versus semaglutide. Tirzepatide remained cost-effective versus semaglutide over a range of sensitivity analyses. Conclusions: Long-term projections based on the SURPASS-2 trial results indicate that 5, 10 and 15 mg doses of tirzepatide are likely to be cost-effective versus semaglutide 1.0 mg for the treatment of type 2 diabetes in the United States.
MeSH term(s)	Humans ; United States/epidemiology ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Diabetes Mellitus, Type 2/complications ; Hypoglycemic Agents/adverse effects ; Cost-Effectiveness Analysis ; Cost-Benefit Analysis
Chemical Substances	Hypoglycemic Agents ; semaglutide (53AXN4NNHX) ; tirzepatide (OYN3CCI6QE)
Language	English
Publishing date	2023-02-20
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.14979
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Zs.A 5442: Show issues

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Article ; Online: Relative efficacy of lasmiditan versus rimegepant and ubrogepant as acute treatments for migraine: network meta-analysis findings.

Polavieja, Pepa / Belger, Mark / Venkata, Shiva Kumar / Wilhelm, Stefan / Johansson, Erin

The journal of headache and pain

2022 Volume 23, Issue 1, Page(s) 76

Abstract: Background: In the absence of head-to-head trials, comprehensive evidence comparing onset of efficacy of novel agents for acute treatment of migraine is lacking. This study aimed to explore the relative efficacy of lasmiditan (serotonin [5- ... ...

Abstract	Background: In the absence of head-to-head trials, comprehensive evidence comparing onset of efficacy of novel agents for acute treatment of migraine is lacking. This study aimed to explore the relative efficacy of lasmiditan (serotonin [5-hydroxytryptamine] 1F receptor agonist) versus rimegepant and ubrogepant (calcitonin gene-related peptide antagonists) for the acute oral treatment of migraine through network meta-analysis (NMA). Methods: Data included in the NMA were identified through a systematic literature search (conducted April 2018, updated May/December 2020) of phase II-IV, randomised controlled trials (RCTs) in adults with chronic/episodic migraine with/without aura. Treatments included: lasmiditan 50, 100, 200 mg; rimegepant 75 mg; ubrogepant 25, 50, 100 mg. Pairwise treatment comparisons from Bayesian fixed-effect/random-effects NMA, adjusted by baseline risk where appropriate, were conducted. Comparisons were reported as odds ratios with 95% credible intervals. Early-onset efficacy endpoints included: pain freedom at 2 hours and pain relief at 1 and 2 hours. Adverse drug reaction (ADR) profiles were summarised. Heterogeneity and inconsistency in the network were explored; sensitivity analyses investigated robustness of findings. Results: Across 12 RCTs included in the base case, females represented >80% of included patients (mean age 37.9-45.7 years). Odds of achieving both pain freedom and pain relief at 2 hours were higher with lasmiditan 100 and 200 mg versus rimegepant 75 mg and ubrogepant 25 and 50 mg. Results for pain relief at 1 hour were consistent with those at 2 hours, but fewer comparisons were available. There were no statistically significant differences between lasmiditan 50 mg and ubrogepant or rimegepant for any outcome. Sensitivity analyses were in the same direction as base case analyses. Most commonly reported ADRs (incidence ≥2%) were: dizziness, fatigue, paraesthesia, sedation, nausea/vomiting and muscle weakness with lasmiditan; nausea with rimegepant; and nausea, somnolence and dry mouth with ubrogepant. Conclusions: The efficacy findings of this indirect comparison indicate that lasmiditan 100 mg or 200 mg might be an appropriate acute treatment option for patients with migraine seeking a fast onset of action. Differently from rimegepant and ubrogepant, lasmiditan use is associated with mainly neurological events, which are mostly mild or moderate in severity and self-limiting. 350/350 words.
MeSH term(s)	Adult ; Benzamides/adverse effects ; Benzamides/therapeutic use ; Double-Blind Method ; Female ; Humans ; Middle Aged ; Migraine Disorders/drug therapy ; Network Meta-Analysis ; Piperidines/adverse effects ; Piperidines/therapeutic use ; Pyridines/adverse effects ; Pyridines/therapeutic use ; Pyrroles/adverse effects ; Pyrroles/therapeutic use ; Randomized Controlled Trials as Topic
Chemical Substances	Benzamides ; Piperidines ; Pyridines ; Pyrroles ; rimegepant sulfate (1383NM3Q0H) ; lasmiditan (760I9WM792) ; ubrogepant (AD0O8X2QJR)
Language	English
Publishing date	2022-07-06
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Systematic Review
ZDB-ID	2036768-5
ISSN	1129-2377 ; 1129-2369
ISSN (online)	1129-2377
ISSN	1129-2369
DOI	10.1186/s10194-022-01440-w
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Zs.A 5464: Show issues

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Article ; Online: Sintilimab plus chemotherapy for first-line treatment of advanced or metastatic nonsquamous non-small-cell lung cancer: network meta-analysis.

Molife, Cliff / Brnabic, Alan / Stefaniak, Victoria J / Belger, Mark A / Gruver, Kristi / Chen, Jing V / Souri, Saman / Blumenschein, George R

Immunotherapy

2023 Volume 15, Issue 4, Page(s) 293–309

Abstract: Aim: ...

Abstract	Aim:
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/pathology ; Lung Neoplasms/pathology ; Pemetrexed/therapeutic use ; Platinum/therapeutic use ; Bayes Theorem ; Ipilimumab/therapeutic use ; Network Meta-Analysis ; Nivolumab/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Chemical Substances	sintilimab (8FU7FQ8UPK) ; Pemetrexed (04Q9AIZ7NO) ; Platinum (49DFR088MY) ; Ipilimumab ; Nivolumab (31YO63LBSN)
Language	English
Publishing date	2023-02-07
Publishing country	England
Document type	Systematic Review ; Meta-Analysis ; Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	2495964-9
ISSN	1750-7448 ; 1750-743X
ISSN (online)	1750-7448
ISSN	1750-743X
DOI	10.2217/imt-2022-0252
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Article ; Online: Validating the Assumptions of Population Adjustment: Application of Multilevel Network Meta-regression to a Network of Treatments for Plaque Psoriasis.

Phillippo, David M / Dias, Sofia / Ades, A E / Belger, Mark / Brnabic, Alan / Saure, Daniel / Schymura, Yves / Welton, Nicky J

Medical decision making : an international journal of the Society for Medical Decision Making

2022 Volume 43, Issue 1, Page(s) 53–67

Abstract: Background: Network meta-analysis (NMA) and indirect comparisons combine aggregate data (AgD) from multiple studies on treatments of interest but may give biased estimates if study populations differ. Population adjustment methods such as multilevel ... ...

Abstract	Background: Network meta-analysis (NMA) and indirect comparisons combine aggregate data (AgD) from multiple studies on treatments of interest but may give biased estimates if study populations differ. Population adjustment methods such as multilevel network meta-regression (ML-NMR) aim to reduce bias by adjusting for differences in study populations using individual patient data (IPD) from 1 or more studies under the conditional constancy assumption. A shared effect modifier assumption may also be necessary for identifiability. This article aims to demonstrate how the assumptions made by ML-NMR can be assessed in practice to obtain reliable treatment effect estimates in a target population. Methods: We apply ML-NMR to a network of evidence on treatments for plaque psoriasis with a mix of IPD and AgD trials reporting ordered categorical outcomes. Relative treatment effects are estimated for each trial population and for 3 external target populations represented by a registry and 2 cohort studies. We examine residual heterogeneity and inconsistency and relax the shared effect modifier assumption for each covariate in turn. Results: Estimated population-average treatment effects were similar across study populations, as differences in the distributions of effect modifiers were small. Better fit was achieved with ML-NMR than with NMA, and uncertainty was reduced by explaining within- and between-study variation. We found little evidence that the conditional constancy or shared effect modifier assumptions were invalid. Conclusions: ML-NMR extends the NMA framework and addresses issues with previous population adjustment approaches. It coherently synthesizes evidence from IPD and AgD studies in networks of any size while avoiding aggregation bias and noncollapsibility bias, allows for key assumptions to be assessed or relaxed, and can produce estimates relevant to a target population for decision-making. Highlights: Multilevel network meta-regression (ML-NMR) extends the network meta-analysis framework to synthesize evidence from networks of studies providing individual patient data or aggregate data while adjusting for differences in effect modifiers between studies (population adjustment). We apply ML-NMR to a network of treatments for plaque psoriasis with ordered categorical outcomes.We demonstrate for the first time how ML-NMR allows key assumptions to be assessed. We check for violations of conditional constancy of relative effects (such as unobserved effect modifiers) through residual heterogeneity and inconsistency and the shared effect modifier assumption by relaxing this for each covariate in turn.Crucially for decision making, population-adjusted treatment effects can be produced in any relevant target population. We produce population-average estimates for 3 external target populations, represented by the PsoBest registry and the PROSPECT and Chiricozzi 2019 cohort studies.
Language	English
Publishing date	2022-08-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	604497-9
ISSN	1552-681X ; 0272-989X
ISSN (online)	1552-681X
ISSN	0272-989X
DOI	10.1177/0272989X221117162
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Zs.A 1665: Show issues

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Article ; Online: Demonstration of Clinical Meaningfulness of the Integrated Alzheimer's Disease Rating Scale (iADRS): Association Between Change in iADRS Scores and Patient and Caregiver Health Outcomes.

Wessels, Alette M / Belger, Mark / Johnston, Joseph A / Yu, Youying / Rentz, Dorene M / Dowsett, Sherie A / Chandler, Julie

Journal of Alzheimer's disease : JAD

2022 Volume 88, Issue 2, Page(s) 577–588

Abstract: Background: The integrated Alzheimer's Disease Rating Scale (iADRS) is a validated cognitive/functional composite that effectively captures cognitive and functional decline over a broad spectrum of disease. The clinical meaningfulness of change on iADRS ...

Abstract	Background: The integrated Alzheimer's Disease Rating Scale (iADRS) is a validated cognitive/functional composite that effectively captures cognitive and functional decline over a broad spectrum of disease. The clinical meaningfulness of change on iADRS can be supported by establishing an association with changes on important health outcome measures. Objective: To evaluate the relationship between change on the iADRS and changes in health outcomes in individuals with mild cognitive impairment (MCI) due to Alzheimer's disease (AD), or mild or moderate AD dementia using placebo data from four AD clinical trials and data from one AD observational study. Methods: Analysis of covariate (ANCOVA) models were used to estimate the relationship between 18-month change on the iADRS and changes on health outcome measures (related to cost, quality of life, and caregiver burden). The regression coefficients for the iADRS were used to compute impact of natural disease progression and disease-modifying treatment on health outcomes. Additional ANCOVAs were conducted to understand whether cognition and/or function was the underlying explanation of any association between iADRS and health outcome change. Results: Across datasets and disease stages, a worsening on the iADRS was significantly associated with increased societal costs, caregiver burden (time and distress) and worsening in measures of patient quality of life. Conclusion: Decline on the iADRS was associated with worsening in health outcome measures. These findings suggest that the iADRS can be used in clinical trials as a proxy measure of clinically meaningful outcomes of AD progression.
MeSH term(s)	Alzheimer Disease/drug therapy ; Caregivers/psychology ; Clinical Trials as Topic ; Cognitive Dysfunction/psychology ; Humans ; Observational Studies as Topic ; Outcome Assessment, Health Care ; Quality of Life
Language	English
Publishing date	2022-06-13
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1440127-7
ISSN	1875-8908 ; 1387-2877
ISSN (online)	1875-8908
ISSN	1387-2877
DOI	10.3233/JAD-220303
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Zs.A 6084: Show issues

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Article ; Online: Comparative Effectiveness of Dexamethasone in Hospitalized COVID-19 Patients in the United States.

Choong, Casey Kar-Chan / Belger, Mark / Koch, Alisa E / Meyers, Kristin J / Marconi, Vincent C / Abedtash, Hamed / Faries, Douglas / Krishnan, Venkatesh

Advances in therapy

2022 Volume 39, Issue 10, Page(s) 4723–4741

Abstract: Introduction: To compare the mortality of hospitalized patients with COVID-19 between those that required supplemental oxygen and received dexamethasone with a comparable set of patients who did not receive dexamethasone.: Methods: We utilized the ... ...

Abstract	Introduction: To compare the mortality of hospitalized patients with COVID-19 between those that required supplemental oxygen and received dexamethasone with a comparable set of patients who did not receive dexamethasone. Methods: We utilized the Premier Health Database to identify hospitalized adult patients with COVID-19 from July 1, 2020-January 31, 2021. Index date was when patients first initiated oxygen therapy. The primary endpoint was in-hospital mortality for patients receiving dexamethasone versus those not receiving dexamethasone 1-day pre- to 1-day post-index period. Secondary endpoints included 28-day mortality, time to in-hospital mortality, progression to invasive mechanical ventilation or death, time to discharge, and proportion discharged alive by day 28. Twenty-three models using weighting, matching, stratification, and regression were deployed through the concept of frequentist model average (FMA) to estimate the effect of dexamethasone on all-cause mortality up to the 28-day hospitalization period. Results: A total of 1,208,881 patients with COVID-19 were screened; as an inpatient 255,216 used oxygen, and 251,536 were included in the analysis. In the dexamethasone group, odds of in-hospital mortality were higher than those of the comparator (FMA: odds ratio [OR] 1.15, 95% CI 1.08, 1.22). Using a best fit model, OR for in-hospital mortality was non-significant for the dexamethasone group compared with the comparator (OR 1.02, 95% CI 0.92, 1.14). Dexamethasone treatment was associated with poorer outcomes versus the comparator group across the majority of secondary endpoints, except for number of days in hospital, which was lower in the dexamethasone group versus the comparator group (mean difference - 2.14, 95% CI - 2.43, - 1.47). Conclusions: Hospitalized adult patients with COVID-19 who required supplemental oxygen and received dexamethasone did not have a survival benefit versus similar patients not receiving dexamethasone. The dexamethasone group was not associated with favorable responses for outcomes such as progression to death or mechanical ventilation and time to in-hospital death.
MeSH term(s)	Adult ; Dexamethasone/therapeutic use ; Hospital Mortality ; Humans ; Inpatients ; Oxygen ; SARS-CoV-2 ; United States ; COVID-19 Drug Treatment
Chemical Substances	Dexamethasone (7S5I7G3JQL) ; Oxygen (S88TT14065)
Language	English
Publishing date	2022-08-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632651-1
ISSN	1865-8652 ; 0741-238X
ISSN (online)	1865-8652
ISSN	0741-238X
DOI	10.1007/s12325-022-02267-2
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Zs.A 2101: Show issues

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Article ; Online: Alternative Weighting Approaches for Anchored Matching-Adjusted Indirect Comparisons via a Common Comparator.

Petto, Helmut / Kadziola, Zbigniew / Brnabic, Alan / Saure, Daniel / Belger, Mark

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2018 Volume 22, Issue 1, Page(s) 85–91

Abstract: Background: Adjusted indirect comparisons (anchored via a common comparator) are an integral part of health technology assessment. These methods are challenged when differences between studies exist, including inclusion/exclusion criteria, outcome ... ...

Abstract	Background: Adjusted indirect comparisons (anchored via a common comparator) are an integral part of health technology assessment. These methods are challenged when differences between studies exist, including inclusion/exclusion criteria, outcome definitions, patient characteristics, as well as ensuring the choice of a common comparator. Objectives: Matching-adjusted indirect comparison (MAIC) can address these challenges, but the appropriate application of MAICs is uncertain. Examples include whether to match between individual-level data and aggregate-level data studies separately for treatment arms or to combine the arms, which matching algorithm should be used, and whether to include the control treatment outcome and/or covariates present in individual-level data. Results: Results from seven matching approaches applied to a continuous outcome in six simulated scenarios demonstrated that when no effect modifiers were present, the matching methods were equivalent to the unmatched Bucher approach. When effect modifiers were present, matching methods (regardless of approach) outperformed the Bucher method. Matching on arms separately produced more precise estimates compared with matching on total moments, and for certain scenarios, matching including the control treatment outcome did not produce the expected effect size. The entropy balancing approach was used to determine whether there were any notable advantages over the method proposed by Signorovitch et al. When unmeasured effect modifiers were present, no approach was able to estimate the true treatment effect. Conclusions: Compared with the Bucher approach (no matching), the MAICs examined demonstrated more accurate estimates, but further research is required to understand these methods across an array of situations.
MeSH term(s)	Algorithms ; Computer Simulation ; Cost-Benefit Analysis ; Endpoint Determination/economics ; Health Care Costs ; Humans ; Randomized Controlled Trials as Topic/economics ; Reproducibility of Results ; Technology Assessment, Biomedical/economics ; Technology Assessment, Biomedical/methods ; Treatment Outcome
Language	English
Publishing date	2018-08-23
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2018.06.018
Database	MEDical Literature Analysis and Retrieval System OnLINE

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