Comparative Study of Static, Dynamic, and Proprioceptive Neuromuscular Facilitation Stretching Techniques on Flexibility

1984 ◽  
Vol 58 (2) ◽  
pp. 615-618 ◽  
Author(s):  
Ranna C. Lucas ◽  
Robert Koslow
Keyword(s):  
Comparative Study ◽  
Factorial Design ◽  
College Women ◽  
Group Factor ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Proprioceptive Neuromuscular Facilitation ◽  
Flexibility Training ◽  
Gastrocnemius Muscles ◽  
Post Hoc

63 college women served as subjects in this 7-wk. study examining the effects of static, dynamic, and proprioceptive neuromuscular facilitating stretching techniques on the flexibility of the hamstring-gastrocnemius muscles. Subjects were assigned to one of the 3 treatment groups and received treatment 3 days a week. A pretest, a midtest (after 11 treatment days), and a posttest (after 21 treatment days) were administered. Analysis of group and test effects was accomplished by using a 3 × 3 factorial design with the group factor nested and the test factor crossed. Post hoc analysis indicated that all scores significantly improved from pretest to posttest. The findings indicated all 3 methods of flexibility training produced significant improvements when pretest and posttest mean scores were compared.

Skeletal Muscle Density Is Independently Prognostic of Outcomes in Newly Diagnosed Mantle Cell Lymphoma Patients: Post Hoc Analysis of LYM 3002

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 1477-1477
Author(s):  
Michael P. Chu ◽  
Andrew Belch ◽  
Lixia Pei ◽  
Xue (Loya) Yang ◽  
Tadeusz Robak ◽  
...  
Keyword(s):  
Research And Development ◽  
Cancer Cachexia ◽  
Cell Lymphoma ◽  
Ct Images ◽  
Post Treatment ◽  
Newly Diagnosed ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Mantle Cell ◽  
Post Hoc

Abstract Introduction Non-Hodgkin lymphoma impacts a patient's physiology beyond manifesting as lymphadenopathy, which was recognized in the original Ann Arbor staging such as B-symptoms. Likewise, cancer cachexia is prevalent across tumor types, but it is felt to be a late feature of advanced disease. We have previously demonstrated that cancer patients may have muscle changes well before cachexia's onset such as a reduced muscle radiation attenuation as seen on computed tomography (CT) imaging. This drop in skeletal muscle radiographic density (SMD) was shown to be prognostic and possibly predictive of rituximab-containing treatment response in retrospective studies of follicular and diffuse large B-cell lymphomas1. This post hoc analysis of LYM 3002 (NCT00722137), a phase III randomized trial of newly diagnosed mantle cell lymphoma (MCL) patients, sought to investigate SMD's impact in both MCL and validate it in prospectively collected data. Methods 487 newly diagnosed MCL patients were randomized 1:1 between R-CHOP or VR-CAP (vincristine or bortezomib at 1.3 mg/m2 d1, 4, 8, 11 q3wk) for a total of 6-8 cycles in LYM 30022. CT images at pre-treatment, 12-weeks post treatment, and 26-weeks post treatment were anonymized (for blinding) and reviewed to measure patient SMD at the L3 vertebral body level. Based on prior retrospective data, normal SMD was defined as ≥ 41 and 33 Hounsfield Units for non-overweight (BMI < 25 kg/m2) and overweight (BMI ≥ 25 kg/m2) patients, respectively. Patients with normal vs. low SMD were compared for differences in investigator-assessed progression free (PFS) and overall survival (OS). Cox proportional hazards multivariate analysis weighed SMD's significance against other known prognostic factors: gender, MIPIb score (accounting for Ki-67 score), and treatment received. Results Of 487 patients, 478 had CT images available for review and were split equally between either treatment arm. 42.5% (n=203) were found to have low SMD at baseline. At a median follow-up of 40 months, patients with low vs. normal baseline SMD had substantially poorer, investigator-assessed, median PFS (16.3 vs. 23.7 months, hazard ratio [HR] 1.52, p<0.001) in both treatment groups combined. Though not yet mature for comparison between treatment groups, OS was similarly impacted between SMD groups (HR 1.85, p<0.001) with 3-year OS rate was 61.6 vs. 76.8%, respectively. The presence of low vs. normal SMD at 12 or 26 weeks post treatment completion was still prognostic of PFS (n=371, HR 1.54, p=0.001 and n=317, HR 1.43, p=0.02, respectively) and OS (HR 1.89, p=0.004 and 1.85, p=0.02, respectively). In multivariate analysis taking into consideration gender, MIPIb score and treatment received, low baseline SMD retained its negative impact on OS (HR 1.86, p=0.005) and trended to significance on PFS (HR 1.27, p=0.12) owing partially to improved PFS seen in patients receiving VR-CAP. SMD status at 12 and 26 weeks post treatment displayed similar prognostic impact. Though low SMD patients receiving VR-CAP had improved median PFS compared to those receiving R-CHOP (22.4 vs. 14.4 months, HR 0.66, p=0.02), the presence of low vs. normal SMD still impacted outcomes of VR-CAP patients (22.4 vs. 36.2 months, HR 1.64, p=0.007). From baseline to 12 weeks post treatment in both arms, 27 patients with low SMD were able to regain muscle density to normal levels while 68 moved from normal to low SMD. A comparison of median PFS based on change in SMD over time showed a stepwise trend from those who remained with low SMD throughout, those who developed low SMD, those who became normal, and those who stayed with normal SMD throughout (23.7 vs. 25.4 vs. 29.4 vs. 37.5 months, respectively). Conclusions This post hoc analysis demonstrates and validates SMD's prognostic ability in MCL regardless of therapy similar to retrospective findings in follicular and diffuse large B-cell lymphoma. We also demonstrate that not only can SMD change post treatment, but this change may predict for better outcomes. By using routine CT images, SMD assessment can be a strong, inexpensive, and simple complement to MIPIb prognostication. Low SMD is hypothesized to represent a specific inflammatory cytokine milieu such as seen in cancer cachexia. Whether this same inflammatory phenomenon represents the SMD changes seen in lymphoma is currently being investigated. 1 PLOS One 2015;doi:10.1371/journal.pone.0127589 2 N Engl J Med 2015;372(10):944-53. Disclosures Belch: Janssen-Cilag: Consultancy. Pei:Janssen Research and Development: Employment; Johnson & Johnson: Other: Stock Ownership. Yang:Janssen Research and Development: Employment. Robak:Janssen: Consultancy, Research Funding; MorphoSys AG: Consultancy, Honoraria, Research Funding. Rooney:Janssen Research and Development: Employment; Johnson & Johnson: Other: Stock Ownership. Cakana:Janssen Research and Development: Employment. van de Velde:Millennium Pharmaceuticals, Inc.: Employment; Johnson & Johnson: Equity Ownership.

An exploratory study on interferon beta dose effect in reducing size of enhancing lesions in multiple sclerosis

2007 ◽  
Vol 13 (3) ◽  
pp. 343-347 ◽  
Author(s):  
S. Di Rezze ◽  
S. Gupta ◽  
V. Durastanti ◽  
E. Millefiorini ◽  
C. Pozzilli ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Magnetic Resonance Images ◽  
Dose Effect ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
The Mean ◽  
Post Hoc ◽  
Beta Dose ◽  
To Receive

Sixty-two patients with multiple sclerosis (MS) were imaged monthly over a six-month (ie, seven monthly magnetic resonance images [MRI]) natural history period (NHP). Thereafter, patients were randomized to receive 11 or 33 μg of subcutaneously injected interferon beta 1a (IFNp-1 a) with imaging monthly for nine months and at months 12, 18 and 24 of therapy phase (TP). In the present exploratory post hoc analysis, the authors evaluated IFNβ-1a dose effect on reducing the size of contrast-enhancing lesions (CELs). MRIs performed at months 0, 3 and 6 of NHP and at months 3, 6, 9, 18 and 24 of TP were analysed. While a significant reduction in mean number of CELs was observed in both treatment groups of patients, the mean total volume and size of CELs was reduced only in patients undergoing therapy with 33 μg of IFNβ-1a. The latter suggests a significant dose effect exerted by IFNβ-1a in the evolution of CELs' dimensions during therapy. Multiple Sclerosis 2007; 13: 343-347. http://msj.sagepub.com

SAT0139 AGE-BASED (<65 VS ≥65 YEARS) INCIDENCE OF INFECTIONS AND SERIOUS INFECTIONS IN TOFACITINIB-, ADALIMUMAB- AND PLACEBO-TREATED PATIENTS WITH RHEUMATOID ARTHRITIS: A POST HOC ANALYSIS OF PHASE 2, PHASE 3 AND PHASE 3B/4 TOFACITINIB STUDIES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1007-1008
Author(s):  
K. Winthrop ◽  
D. Gold ◽  
D. Henrohn ◽  
L. Wang ◽  
A. Shapiro ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factor ◽  
Active Treatment ◽  
Kinase Inhibitor ◽  
Janus Kinase ◽  
Research Support ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Link Type ◽  
Post Hoc

Background:Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). A recent ad hoc safety analysis (as of August 2019; may be subject to change) from an ongoing, open-label, randomised, post-authorisation safety study, Study A3921133 (NCT02092467), conducted in RA patients (pts) aged ≥50 years with ≥1 cardiovascular risk factor has shown that incidence rates (IRs) of serious infection events (SIEs) were higher with tofacitinib 10 mg BID vs tumour necrosis factor inhibitors (TNFi; adalimumab [ADA] and etanercept) and this difference was more pronounced in pts aged ≥65 years (Pfizer Inc; data on file).Objectives:To assess the IRs of overall infection events and SIEs in pts from Phase (P)2, P3 and P3b/4 tofacitinib RA trials which had a TNFi (ADA) active control or comparator arm.Methods:This is a post hoc analysis of Month 0–12 data pooled from P2 (A3921035;NCT00550446[first 12-week randomised parallel treatment period only]), P3 (ORAL Standard;NCT00853385) and P3b/4 (ORAL Strategy;NCT02187055) studies. Pts randomised to receive tofacitinib 5 mg BID, tofacitinib 10 mg BID, ADA 40 mg subcutaneously every other week and placebo (PBO) were included and assessed overall and by age (<65 or ≥65 years). SIEs were defined as infections requiring hospitalisation or parenteral antimicrobial therapy, or meeting other criteria for a serious adverse event. IRs (pts with events/100 pt-years of exposure [PY]) and 95% confidence intervals (CIs) were calculated for all infection events and SIEs; only the first infection events that occurred up to 28 days after the last dose or to the data cut-off date were considered.Results:Of 2180 pts included in the pooled studies (tofacitinib 5 mg BID: N=1064 [943.4 PY]; tofacitinib 10 mg BID: N=306 [236.6 PY]; ADA: N=643 [554.3 PY]; PBO: N=167 [108.1 PY]), 1841 (84.4%) were aged <65 years and 339 (15.6%) were aged ≥65 years. In general, the IRs for all infection events and SIEs were higher with tofacitinib 5 mg BID, tofacitinib 10 mg BID and ADA in pts aged ≥65 years compared with pts aged <65 years. Overall and when stratified by age, IRs for all infection events were similar across the active treatment groups (Figure 1); IRs with PBO were lower vs the active treatment groups overall and in pts aged <65 years, and numerically lower vs the active treatment groups in pts aged ≥65 years. IRs for SIEs were comparable across active treatment groups in pts aged <65 years, while among pts aged ≥65 years, IRs were numerically higher for tofacitinib 10 mg BID vs ADA, and appeared to be similar for tofacitinib 5 mg BID and ADA (Figure 2).Conclusion:In this analysis of data pooled from P2, P3 and P3b/4 tofacitinib RA studies which included a TNFi arm (ADA), the risk of SIEs or infections overall was similar for tofacitinib and ADA with the exception of a numerically higher rate of SIEs with tofacitinib 10 mg BID vs ADA in pts aged ≥65 years. In most countries, tofacitinib 10 mg BID is not an approved dose for the treatment of RA. This post hoc comparison is limited by variation in sample size and PY of exposure between treatment and age groups, and a small number of cases of SIEs in the ≥65-year age group resulting in wide 95% CIs; interpretation of results should be made with caution. The findings in the present analysis are consistent with increasing age being a known risk factor for infections.Acknowledgments:Study sponsored by Pfizer Inc. Medical writing support was provided by Christina Viegelmann of CMC Connect and funded by Pfizer Inc.Disclosure of Interests: :Kevin Winthrop Grant/research support from: Bristol-Myers Squibb, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Pfizer Inc, Roche, UCB, David Gold Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Dan Henrohn Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lisy Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Andrea Shapiro Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Harry Shi Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Gustavo Citera Grant/research support from: AbbVie, Amgen, Eli Lilly, Gema, Genzyme, Novartis and Pfizer Inc, Consultant of: AbbVie, Amgen, Eli Lilly, Gema, Genzyme, Novartis and Pfizer Inc, Hendrik Schulze-Koops Grant/research support from: Pfizer Inc

Making Meaning out of MANOVA: The Need for Multivariate Post Hoc Testing in Gifted Education Research

2019 ◽  
Vol 64 (1) ◽  
pp. 41-55 ◽  
Author(s):  
Kendal N. Smith ◽  
Kristen N. Lamb ◽  
Robin K. Henson
Keyword(s):  
Multivariate Analysis ◽  
Education Research ◽  
Discriminant Analysis ◽  
Factorial Design ◽  
Gifted Education ◽  
Group Differences ◽  
Data Set ◽  
Making Meaning ◽  
Post Hoc Analysis ◽  
Post Hoc

Multivariate analysis of variance (MANOVA) is a statistical method used to examine group differences on multiple outcomes. This article reports results of a review of MANOVA in gifted education journals between 2011 and 2017 ( N = 56). Findings suggest a number of conceptual and procedural misunderstandings about the nature of MANOVA and its application, including pervasive use of univariate post hoc tests to interpret MANOVA results. Accordingly, this article aims to make MANOVA more accessible to gifted education scholars by clarifying its purpose and introducing descriptive discriminant analysis as a more appropriate post hoc technique. A heuristic data set is used to demonstrate the procedures for running a descriptive discriminant analysis, both in place of a one-way MANOVA and as a post hoc analysis to a factorial design. SPSS and R syntax are provided.

Attitudes of Physical Educators Toward Teaching Handicapped Pupils

1984 ◽  
Vol 1 (4) ◽  
pp. 267-274 ◽  
Author(s):  
Terry L. Rizzo
Keyword(s):  
Factorial Design ◽  
Teacher Attitudes ◽  
Grade Level ◽  
Survey Instrument ◽  
Physical Educators ◽  
Post Hoc Analysis ◽  
Regular Class ◽  
Attitudes Toward Teaching ◽  
Post Hoc

This study assessed the attitudes of physical educators (n = 194) toward teaching handicapped pupils in the regular class. The survey instrument used was the Physical Educators Attitude Toward Teaching the Handicapped (PEATH), which assesses teacher attitudes according to the type of handicapping condition (learning and physical) and grade level (K-3, 4-6, 7-8). A 2 × 3 randomized block factorial design and the Tukey (HSD) post hoc analysis were applied to the data. Results indicated that physical educators held more favorable attitudes toward teaching pupils with learning handicaps than those with physical handicaps. Furthermore, as grade level advanced from primary (K-3) to intermediate (4-6) and upper (7-8) grades, teacher attitudes became progressively less favorable.

scholarly journals POS0086 ANALYSIS OF DISEASE ACTIVITY MEASURES IN THE CONTEXT OF A METHOTREXATE WITHDRAWAL STUDY AMONG PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH TOFACITINIB 11 MG ONCE DAILY + METHOTREXATE: POST HOC ANALYSIS OF DATA FROM ORAL SHIFT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 251.2-251
Author(s):  
R. Fleischmann ◽  
B. Haraoui ◽  
M. H. Buch ◽  
D. Gold ◽  
G. Sawyerr ◽  
...  
Keyword(s):  
Disease Activity ◽  
Research Support ◽  
Open Label ◽  
Double Blind ◽  
Once Daily ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Activity Measures ◽  
Post Hoc ◽  
Disease Activity Measures

Background:The Phase 3b/4 study ORAL Shift demonstrated sustained efficacy and safety of tofacitinib modified-release (MR) 11 mg once daily (QD) following methotrexate (MTX) withdrawal that was non-inferior to continued tofacitinib + MTX use (per DAS28-4[ESR]), in patients (pts) with rheumatoid arthritis (RA) who achieved CDAI-defined low disease activity (LDA) with tofacitinib + MTX at Week (W)24.1Objectives:To assess the performance of alternative disease activity measures at W24 (randomisation) and W48 (study endpoint) in ORAL Shift.Methods:ORAL Shift (NCT02831855) enrolled pts aged ≥18 years with moderate to severe RA and an inadequate response to MTX. Pts received open-label tofacitinib MR 11 mg QD + MTX for 24 weeks. Achievement of CDAI LDA (≤10) at W24 was set as the criteria for entry to the 24-week double-blind MTX withdrawal phase, with pts randomised 1:1 to receive tofacitinib MR 11 mg QD + placebo (PBO) (ie blinded MTX withdrawal) or continue tofacitinib + MTX. In this post hoc analysis, efficacy analyses were performed in 8 subgroups defined by achievement of various disease activity criteria at W24: DAS28-4(ESR) remission (<2.6) or LDA (≤3.2); DAS28-4(CRP) <2.6 or ≤3.2; RAPID3 remission (≤3) or LDA (≤6); CDAI remission (≤2.8); and SDAI remission (≤3.3). For each subgroup, the proportion of pts who achieved the corresponding disease activity criterion at W48 was calculated, with a 95% confidence interval (CI) estimated using the normal approximation to the binomial distribution. The change (Δ) from W24 to W48 in least squares (LS) mean DAS28-4(ESR) and DAS28-4(CRP) was also calculated in each subgroup, with a 95% CI for the difference between treatment groups estimated using a mixed model with repeated measures. Nominal p values were calculated and are presented with no formal statistical hypothesis testing formulated.Results:Overall, 694 pts entered the open-label phase of ORAL Shift, and 530 were randomised and received treatment in the double-blind phase; 264 and 266 pts received tofacitinib + PBO and tofacitinib + MTX, respectively (Figure 1a). Considering those pts who were randomised and treated, the proportion of pts achieving each disease activity criterion at W24 varied, but was similar between treatments within each subgroup (Figure 1a). Among pts who met each disease activity criterion at W24, generally the majority of pts in both treatment groups also met the same criterion at W48 (Figure 1b). Numerically more pts receiving tofacitinib + MTX vs tofacitinib + PBO continued to meet the corresponding criterion at W48. Regardless of the disease activity criterion met at W24, differences between treatment groups in LS mean ΔDAS28-4(ESR) (Figure 1c) and ΔDAS28-4(CRP) (data not shown) from W24 to W48 favoured tofacitinib + MTX vs tofacitinib + PBO.Conclusion:This post hoc analysis of data from pts randomised and treated in ORAL Shift demonstrated that, regardless of the disease activity state criterion met at W24, generally a majority of pts receiving tofacitinib maintained achievement of the corresponding disease activity criterion at W48, with or without continued MTX. Differences between treatment groups in LS mean ΔDAS28-4(ESR) from W24 to W48, as defined by achievement of LDA or remission with a variety of disease activity measures, were less than a change of 1.2, which is considered to be the threshold for a minimal clinically important improvement.2References:[1]Cohen et al. Lancet Rheumatol 2019; 1: E23-34.[2]Ward et al. Ann Rheum Dis 2015; 74: 1691-1696.Acknowledgements:Study sponsored by Pfizer Inc. Medical writing support was provided by Gemma Turner, CMC Connect, and funded by Pfizer Inc.Disclosure of Interests:Roy Fleischmann Speakers bureau: Pfizer Inc, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celltrion, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, Sanofi-Aventis, UCB, Grant/research support from: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celltrion, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, Samumed, Sanofi-Aventis, UCB, VORSO, Boulos Haraoui Speakers bureau: Amgen, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Eli Lilly, Merck, Pfizer Inc, UCB, Grant/research support from: AbbVie, Maya H Buch Speakers bureau: AbbVie, Consultant of: AbbVie, Eli Lilly, Gilead, MSD, Pfizer Inc, Roche, Sanofi, Grant/research support from: Pfizer Inc, Roche, UCB, David Gold Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Gosford Sawyerr Consultant of: Pfizer Inc, Employee of: Syneos Health Inc, Harry Shi Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Annette Diehl Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Kristen Lee Shareholder of: Pfizer Inc, Employee of: Pfizer Inc.

scholarly journals Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Analysis of Quality of Life during a Phase III Study

2021 ◽  
pp. 1-8
Author(s):  
Alexander V. Karaulov ◽  
Natalia Nenasheva ◽  
Yury Smolkin ◽  
Aleksandr Maslakov ◽  
Luiz Lucio
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Triamcinolone Acetonide ◽  
Allergic Conjunctivitis ◽  
Phase Iii ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Previous Diagnosis ◽  
Post Hoc

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease that affects ≤24% of people in Russia, significantly impairing quality of life (QoL). Intranasal corticosteroids, such as triamcinolone acetonide (TAA), are considered effective drugs for treatment. A post hoc analysis of data (phase III NASANIF trial) examined weekly QoL changes in patients receiving TAA for the treatment of perennial AR (PAR). <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel group, multicenter, prospective, noninferiority, phase III clinical trial. Patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) for 4 weeks. Here, a post hoc analysis measures QoL using a shortened Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ). Differences in miniRQLQ score were evaluated using a mixed linear model and descriptive statistics. A subgroup analysis was performed in patients with a previous diagnosis of allergic conjunctivitis. <b><i>Results:</i></b> Of 260 patients eligible for randomization, 128 each completed treatment with TAA or FP. Overall and individual domain scores progressively improved and were significantly different versus baseline at week 4 in both treatment groups: LS mean difference TAA: −30.92 (95% CI [−33.01 to −28.83]), <i>p</i> &#x3c; 0.001, and FP: −31.13 (−33.23 to −29.04), <i>p</i> &#x3c; 0.001. In both arms of the subgroup, there was a significant reduction in eye symptoms. There was no significant difference between the TAA and FP treatment groups in any analyses. <b><i>Conclusions:</i></b> TAA is effective in improving overall and individual domains of QoL in patients with PAR, over 4 weeks. Patients with a previous diagnosis of allergic conjunctivitis experienced significant improvements in QoL related to the resolution of these symptoms.

scholarly journals Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies

2021 ◽  
Author(s):  
Tobias Welte ◽  
Thomas WL Scheeren ◽  
J Scott Overcash ◽  
Mikael Saulay ◽  
Marc Engelhardt ◽  
...  
Keyword(s):  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Skin Structure ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Hospital Acquired ◽  
Phase Iii Studies

Aim: To evaluate the efficacy and safety of ceftobiprole in patients aged ≥65 years. Materials & methods: We conducted a post hoc analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Results: Findings for patients aged ≥65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged ≥75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16.3% [95% CI:1.8–30.8]). The safety profile was similar between treatment groups in all studies. Conclusion: This analysis further supports the efficacy and safety of ceftobiprole in older patients with acute bacterial skin and skin structure infections or pneumonia. Clinicaltrials.gov trial identifiers: NCT03137173 , NCT00326287 , NCT00210964 , NCT00229008

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