Effect of lorcaserin in different age groups: a post hoc analysis of patients from the BLOOM, BLOSSOM and BLOOM‐DM studies

Abstract After the age of fifty years the prevalence of osteoporosis and incidence of osteoporotic fractures rise substantially with age. It is ironic however that the pivotal trials for the common drugs used to treat osteoporosis mainly recruited participants under the age of 80 years leading some to question the use of these drugs in the older population. This talk explores the evidence accumulated for the treatment of osteoporosis in the frailer older population. The FOSIT trial showed a 47% reduction in non-vertebral fractures with alendronate in people up to 84 years, and a study in long term care in those up to 91 years showed a significant improvement in bone density at the spine and hip. A post hoc analysis of the risedronate HIP trial in people aged 70-100 years with established osteoporosis showed a 47% reduction in hip fractures. In the zoledronic acid Horizon studies fractures were significantly reduced in a population up to the age of 89 years and mortality was reduced by 28%, with half of the participants being older than 75 years. Interestingly a post hoc analysis showed that those participants who ended up having only a single infusion had a reduction of all clinical fractures at 3 years. The Freedom trial of denosumab was performed in a population aged up to 90 years with significant fracture reduction across all age groups. Studies with the anabolic agent teriparatide showed that vertebral and non-vertebral fracture reduction occurred in both the under and over 75 age groups. Trials with the recently developed agents abaloparatide and romosozumab have shown significant fracture reductions in populations up to ages of 86 and 90 years respectively. There is now enough evidence to suggest that the oldest old should be considered for osteoporosis treatment as well having a focus on falls reduction.

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Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials

Rheumatology ◽

10.1093/rheumatology/keaa424 ◽

2020 ◽

Cited By ~ 1

Author(s):

Alemnew F Dagnew ◽

Debora Rausch ◽

Caroline Hervé ◽

Toufik Zahaf ◽

Myron J Levin ◽

...

Keyword(s):

Adverse Events ◽

Age Groups ◽

Zoster Vaccine ◽

Post Dose ◽

Serious Adverse Events ◽

Post Hoc Analysis ◽

Immune Mediated ◽

Recombinant Zoster Vaccine ◽

Post Hoc ◽

Placebo Recipients

Abstract Objective In the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV’s efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies. Methods Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomized to receive two doses of RZV or placebo 2 months apart. In this subgroup analysis of participants with at least one pIMD at enrolment, the efficacy was calculated for two-dose recipients who did not develop confirmed HZ before 30 days post-dose 2. SAE occurrence was evaluated for all participants who received at least one dose. Results Of the 14 645 RZV and 14 660 placebo recipients from the ZOE-50/70 studies, 983 and 960, respectively, reported at least one pre-existing pIMD at enrolment and were included in these analyses. The most frequent pre-existing conditions were psoriasis, spondyloarthropathy and RA. Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70–79-year-old age group. SAEs and fatal SAEs were similar between RZV and placebo recipients. Conclusion In ZOE-50/70 participants with pre-existing pIMDs, RZV was highly efficacious against HZ and SAE incidence was similar between RZV and placebo recipients. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT01165177 (ZOE-50), NCT01165229 (ZOE-70).

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Effectiveness of Indapamide/amlodipine Single-pill Combination in Patients With Isolated Systolic Hypertension: Post-hoc Analysis of the ARBALET Study

10.21203/rs.3.rs-125731/v1 ◽

2021 ◽

Author(s):

Zh Kobalava ◽

Eteri Kolesnik ◽

E Shavarova ◽

L Goreva ◽

L Karapetyan

Keyword(s):

Clinical Practice ◽

Systolic Hypertension ◽

Age Groups ◽

Real Life ◽

Isolated Systolic Hypertension ◽

Open Label ◽

Post Hoc Analysis ◽

Single Pill ◽

Treatment Naïve ◽

Post Hoc

Abstract Background: Isolated systolic hypertension (ISH) is a major cause of morbidity and mortality. This study evaluated the effectiveness of treatment with an indapamide/amlodipine single-pill combination (SPC) in outpatients with uncontrolled ISH aged over 55 years in real-life clinical practice.Methods: This was a post-hoc analysis of the subgroup of patients with ISH from ARBALET, a 3-month, multicenter, observational, open-label study conducted in Russia among patients with grade I or II hypertension who were either uncontrolled on previous antihypertensive treatment or treatment-naïve. The effectiveness of indapamide/amlodipine SPC was assessed by the change in office systolic blood pressure (SBP) and the rate of target SBP (<140 mmHg) achievement at 2 weeks, 1 month and 3 months, in four age groups: 55-59 years, 60-69 years, 70-79 years, and 80 years or older.Results: The ARBALET study recruited 2217 patients, of whom 626 had ISH and were included in this post-hoc analysis (mean age 66.1±7.8 years; 165 men [26.36%] and 461 women [73.64%]). Target SBP <140 mmHg was achieved in 43%, 75% and 93% of patients at 2 weeks, 1 and 3 months, respectively. SBP decreased from baseline by 18.8±10.5 mmHg, 27.2±10.6 mmHg and 31.8±9.9 mmHg at 2 weeks, 1 month and 3 months, respectively. In the groups of patients aged 55-59, 60-69, 70-79, and ≥80 years, SBP reductions at 3 months compared with baseline were -30.3±9.4, -32.4±9.7, -32.5±10.7, and -28.9±9.6 mmHg, respectively. Conclusion: This post-hoc analysis of the observational ARBALET study showed that indapamide/amlodipine SPC was associated with significant reductions in BP and high rates of target BP achievement in a broad age range of patients with ISH treated in routine clinical practice.Trial registration number: ISRCTN40812831

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Similar Efficacy and Safety of Basaglar® and Lantus® in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study

Diabetes Therapy ◽

10.1007/s13300-018-0405-5 ◽

2018 ◽

Vol 9 (2) ◽

pp. 827-837 ◽

Cited By ~ 1

Author(s):

Robyn K. Pollom ◽

Timothy Costigan ◽

Lyndon B. Lacaya ◽

Liza L. Ilag ◽

Priscilla A. Hollander

Keyword(s):

Type 2 Diabetes ◽

Age Groups ◽

Similar Efficacy ◽

Efficacy And Safety ◽

Post Hoc Analysis ◽

Post Hoc

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Effects of Short-Term Practice With a Tonic Drone Accompaniment on Middle and High School Violin and Viola Intonation

String Research Journal ◽

10.1177/1948499219851407 ◽

2019 ◽

Vol 9 (1) ◽

pp. 51-61

Author(s):

John-Rine A. Zabanal

Keyword(s):

High School ◽

High School Students ◽

Age Groups ◽

Age Group ◽

Years Of Experience ◽

Short Term ◽

School Students ◽

Post Hoc Analysis ◽

Significant Difference ◽

Post Hoc

The purpose of this study was to investigate the effect of tonic drone accompaniment on the intonation of violinists and violists. Twenty-eight middle and high school students performed an ascending diatonic line and a descending dominant 7th arpeggio on the violin or viola in three trials: pretest, posttest accompanied with drone, and posttest unaccompanied. The students were grouped based on age and years of experience. A significant difference in cent deviation scores was found between age groups but not years of experience. Post hoc analysis revealed a significant difference between the middle-age group and the youngest group. No significant difference was found overall between pretest, drone accompanied posttest, and unaccompanied posttest conditions.

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PROSPER subgroup analysis by age and region: Overall survival and safety in men with nonmetastatic castration-resistant prostate cancer receiving androgen deprivation therapy plus enzalutamide.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.84 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 84-84

Author(s):

Ugo De Giorgi ◽

Maha H. A. Hussain ◽

Neal D. Shore ◽

Karim Fizazi ◽

Bertrand Tombal ◽

...

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Androgen Deprivation Therapy ◽

Age Groups ◽

Androgen Deprivation ◽

Castration Resistant Prostate Cancer ◽

Post Hoc Analysis ◽

Castration Resistant ◽

Geographic Regions ◽

Post Hoc

84 Background: Previous reports on the PROSPER trial have shown that enzalutamide (ENZA) plus androgen deprivation therapy (ADT) significantly improves metastasis-free survival and overall survival (OS) over placebo (PBO) in men with nonmetastatic castration-resistant prostate cancer (nmCRPC) and rapidly rising prostate-specific antigen (PSA) levels. (Hussain et al. N Engl J Med. 2018;378:2465-2474/Sternberg et al. N Engl J Med. 2020;382:2197-2206). To inform decision-making for specific patients, we report here a post hoc analysis of OS and safety in subgroups of PROSPER by age and region. Methods: PROSPER included men with nmCRPC and a PSA doubling time ≤ 10 months. Enrolled men continued ADT and were randomized 2:1 to ENZA 160 mg once daily vs PBO. We performed a multivariable analysis for OS, including age (≤ 70 yrs and > 70 yrs), geographic region, and other variables and further examined exposure-adjusted adverse events (AEs) by age and region. Results: Based on this post hoc analysis, OS benefit with ENZA treatment was similar across geographic regions (table) and for patients aged ≥ 70 yrs (hazard ratio [HR] 0.73; 95% CI 0.58-0.9) and those aged < 70 yrs (HR 0.72, 95% CI 0.5-1.04). In our multivariate analysis, 3 factors emerged as significantly impacting estimated OS: Eastern Cooperative Oncology Group (ECOG) performance status (1 vs 0; HR 1.7; 95% CI 1.4-2.1), log of PSA (HR 1.2; 95% CI 1.1-1.3), and use of subsequent therapy (yes vs no; HR 2.5; 95% CI 2.1-3.1). Overall safety was consistent between age groups and across geographic regions. The proportion of patients reporting any grade treatment-emergent AEs (TEAEs) related to ENZA use was similar between age groups but decreased with increasing age. Conclusions: In men with nmCRPC and rapidly rising PSA, ENZA plus ADT treatment reduced the risk of death, regardless of age or geographic location. Patients reported any grade TEAEs at a similar proportion in both arms. Variables impacting OS included ECOG status, log PSA, and subsequent therapy. Clinical trial information: NCT02003924. [Table: see text]

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A Lifespan View on Modulation of Peripersonal and Extrapersonal Reach Space via Tool Use

Brazilian Journal of Motor Behavior ◽

10.20338/bjmb.v8i1.69 ◽

2014 ◽

Vol 8 (1) ◽

Author(s):

Priscila Caçola

Keyword(s):

Older Adults ◽

Young Adults ◽

Tool Use ◽

Age Groups ◽

Action Representation ◽

Post Hoc Analysis ◽

Length Estimation ◽

Extrapersonal Space ◽

Post Hoc ◽

Reach Space

This study examined lifespan characteristics associated with tool use in the modulation of peripersonal and extrapersonal space. Three age groups: Children (7-12 years), Young Adults (19-23 years), and Older Adults (65-92 years) were presented with two experiments using an estimation of reach paradigm involving arm and tool conditions and a switch-block of the opposite condition. Experiment 1 tested Arm and Tool (20 cm length) estimation and switch-block conditions (from Arm to Tool and Tool to Arm) and found a significant effect for Age and Condition (ps <.05). Post-hoc analysis for Age indicated that children were significantly less accurate than young and older adults. Analysis for condition revealed significant differences for the Arm Switch-Block condition (Retraction) when compared to Tool and Arm estimations. Experiment 2 was similar to Experiment 1 with the exception of using a 40 cm length tool. Results were analogous to those found in Experiment 1. Considered together, these results hint that: (1) the ability to be as accurate when estimating reach with a tool and arm is present across the lifespan, (2) development and decline of action representation follow distinct paths, and (3) retraction of space seems to be more difficult than extension.

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The age-dependent immunogenicity after two doses of MVC-COV1901 vaccine.

10.1101/2021.12.12.21267573 ◽

2021 ◽

Author(s):

Chia En Lien ◽

Yi-Jiun Lin ◽

Yi-Ling Lin ◽

I-Chen Tai ◽

Charles Chen

Keyword(s):

Immune Responses ◽

Antibody Response ◽

Age Groups ◽

Phase 2 ◽

Protein Vaccine ◽

Live Virus ◽

Post Hoc Analysis ◽

Subunit Protein ◽

Age Dependent ◽

Post Hoc

A post-hoc analysis of the phase 2 data was performed for the SARS-COV-2 subunit protein vaccine MVC-COV1901. Anti-spike IgG, neutralization assays with live virus and pseudovirus were used to demonstrate age-dependent vaccine-induced antibody response to the vaccine. Results showed that an association exists between age and immune responses to the vaccine, providing further support for the need of booster shots, especially for the older age groups.

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