scholarly journals Serious adverse events of older adults in nursing home and community intervention trials

2018 ◽  
Vol 9 ◽  
pp. 77-80 ◽  
Author(s):  
Rupak Datta ◽  
Mark Trentalange ◽  
Peter H. Van Ness ◽  
Joanne M. McGloin ◽  
Jack M. Guralnik ◽  
...  
Keyword(s):  
Older Adults ◽  
Nursing Home ◽  
Adverse Events ◽  
Community Intervention ◽  
Serious Adverse Events ◽  
Intervention Trials

scholarly journals Potentially inappropriate medication use in older adults with mild-moderate Alzheimer’s disease: prevalence and associations with adverse events

2020 ◽  
Vol 49 (4) ◽  
pp. 580-587
Author(s):  
Claire Murphy ◽  
Adam H Dyer ◽  
Brian Lawlor ◽  
Sean P Kennelly ◽  
Keyword(s):  
Alzheimer’S Disease ◽  
Older Adults ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Inappropriate Medication ◽  
Potentially Inappropriate Medication ◽  
Randomised Control Trial ◽  
Vulnerable Group ◽  
Serious Adverse Events

Abstract Aim Potentially inappropriate medication (PIM) use is prevalent in older adults and is associated with adverse events, hospitalisation and mortality. We assessed the patterns and associations of PIM use in older adults with mild-to-moderate Alzheimer’s Disease (AD), who may represent a particularly vulnerable group. Design Analysis of data from NILVad, an 18-month Randomised Control Trial of Nilvadapine in mild-to-moderate AD. The v2 STOPP criteria were applied in duplicate to identify PIM use. Associations between PIM use and adverse events/unscheduled healthcare visits in addition to the associations between PIM use and AD progression were evaluated. Setting and Participants 448 older adults with mild-to-moderate AD from 23 centres in nine European countries. Results Of 448 participants (mean age: 72.56 ± 8.19 years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs. The most frequent PIMs were (i) long-term benzodiazepines (11.6% N = 52/448), (ii) selective serotonin reuptake inhibitors without appropriate indication (11.1% N = 50/448), and (iii) Proton-Pump Inhibitors (PPIs) without appropriate indication (10.7% N = 48/448). Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13–1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17–1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03–1.30, P = 0.016) and GP visits (IRR 1.22, 1.15–1.28, P < 0.001). PIM use was not associated with dementia progression. Conclusions and Implications PIM use is highly prevalent in mild-to-moderate AD and is associated with adverse events and unscheduled healthcare utilisation. Further attention to de-prescribing in this vulnerable group is warranted.

Pharmacological management of treatment-resistant schizophrenia: advanced use of clozapine

2018 ◽  
Author(s):  
Siobhan Gee ◽  
David Taylor
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Plasma Concentrations ◽  
Practical Experience ◽  
Treatment Resistant ◽  
Serious Adverse Events ◽  
Pharmacological Management ◽  
Off Label ◽  
Theoretical Support ◽  
The Uk

Clozapine is licensed in the UK for use in treatment-resistant schizophrenia, treatment-intolerant schizophrenia, or psychosis associated with Parkinson’s disease. As with many drugs, it is also used outside of these licensing parameters for other conditions or clinical situations—often referred to as ‘off-label’ prescribing. These off-label indications have varying degrees of theoretical support, peer-reviewed evidence, and practical experience associated with them. This chapter discusses the use of clozapine for children and adolescents, older adults, and in the treatment of aggression and mood disorders. The use of supramaximal doses of clozapine to achieve therapeutic plasma concentrations is also off-label, although adding interacting medication to reach the same result is not; these contrasting approaches are also debated. Finally, rechallenging with clozapine in patients who have previously had serious adverse events to the drug is also considered.

Phase 1 Safety and Immunogenicity Study of a Respiratory Syncytial Virus Vaccine With an Adenovirus 26 Vector Encoding Prefusion F (Ad26.RSV.preF) in Adults Aged ≥60 Years

2020 ◽  
Vol 222 (6) ◽  
pp. 979-988 ◽  
Author(s):  
Kristi Williams ◽  
Arangassery Rosemary Bastian ◽  
Robert Allen Feldman ◽  
Edmund Omoruyi ◽  
Els de Paepe ◽  
...  
Keyword(s):  
Older Adults ◽  
Respiratory Syncytial Virus ◽  
Adverse Events ◽  
Immune Responses ◽  
Phase 1 ◽  
Geometric Mean ◽  
High Dose ◽  
Serious Adverse Events ◽  
Syncytial Virus ◽  
Vector Particles

Abstract Background Despite the high disease burden of respiratory syncytial virus (RSV) in older adults, there is no approved vaccine. We evaluated the experimental RSV vaccine, Ad26.RSV.preF, a replication-incompetent adenovirus 26 vector encoding the F protein stabilized in prefusion conformation. Methods This phase 1 clinical trial was performed in healthy adults aged ≥60 years. Seventy-two participants received 1 or 2 intramuscular injections of low-dose (LD; 5 × 1010 vector particles) or high-dose (HD; 1 × 1011 vector particles) Ad26.RSV.preF vaccine or placebo, with approximately 12 months between doses and 2-year follow-up for safety and immunogenicity outcomes. Results Solicited adverse events were reported by 44% of vaccine recipients and were transient and mild or moderate in intensity. No serious adverse events were related to vaccination. After the first vaccination, geometric mean titers for RSV-A2 neutralization increased from baseline (432 for LD and 512 for HD vaccine) to day 29 (1031 for LD and 1617 for HD). Pre-F–specific antibody geometric mean titers and median frequencies of F-specific interferon γ–secreting T cells also increased substantially from baseline. These immune responses were still maintained above baseline levels 2 years after immunization and could be boosted with a second immunization at 1 year. Conclusions Ad26.RSV.preF (LD and HD) had an acceptable safety profile and elicited sustained humoral and cellular immune responses after a single immunization in older adults.

scholarly journals Semi-Recumbent Vibration Exercise in Older Adults: A Pilot Study of Methodology, Feasibility, and Safety

2019 ◽  
Vol 5 ◽  
pp. 233372141988155
Author(s):  
Murad H. Taani ◽  
Ellen Siglinsky ◽  
Jessie Libber ◽  
Diane Krueger ◽  
Neil Binkley ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Physical Function ◽  
Retention Rate ◽  
Functional Decline ◽  
Adherence Rate ◽  
Serious Adverse Events ◽  
Vibration Exercise ◽  
Type Of Exercise ◽  
And Control

Objectives: Older adults with impaired physical function are at risk for further functional decline in part due to limited ability to engage in regular exercise. Effective approaches to exercise in this vulnerable population are needed to improve functional capacity and optimize independence. Methods: Thirty-two residential care apartment complex (RCAC) residents, age ≥70, with low short physical performance battery (SPPB) scores were recruited and randomly assigned to a crossover-design study exploring feasibility and safety of semi-recumbent vibration exercise in older adults living in one RCAC. The primary outcomes were retention and adherence rates and adverse events. Results: The retention rate was 78%. Adherence rate was 79.7% and 78.6% during the vibration and control training sessions, respectively. Thirty-eight adverse events (AEs) occurred. Mild muscle soreness and knee pain were the only AEs related to vibration exercise. No serious adverse events (SAEs) were study-related. Participants were able to increase training intensity and load and rated the training enjoyable. Conclusion: Semi-recumbent vibration exercise was feasible, well tolerated, and safe in RCAC residents with reduced physical function. Future studies need to examine the effect of this type of exercise on physical function, mobility, falls, and quality of life.

scholarly journals 1122. Evaluation of Fecal Microbiota Transplant (FMT) in Elderly Patients With recurrent Clostridium difficile Infection (CDI)

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S336-S336 ◽  
Author(s):  
Ali Hassoun ◽  
Jonathan Edwards
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Success Rate ◽  
Fecal Microbiota ◽  
Age Group ◽  
Serious Adverse Events ◽  
Fecal Microbiota Transplant ◽  
Treatment Regimens ◽  
Recurrent Clostridium Difficile Infection ◽  
Deadly Disease

Abstract Background CDI is a bacterial infection that typically occurs after the use of broad-spectrum antibiotics. Older adults are particularly susceptible to this potentially deadly disease and at higher risk of recurrence. Methods The study was approved by the hospital’s IRB. Patients 65 years of age and older with refractory or recurrent CDI who received FMT administered via colonoscopy or oral capsules were included. Patients with severe-complicated infection were excluded and ineligible to receive FMT. Each patient was evaluated 8 weeks post-transplant to assess for sustained clinical response and adverse events. Data collection included patient demographics, number of recurrent CDI episodes, CDI severity, previous antibiotic treatment regimens, clinical cure, adverse events, and donor information. Results Thirty-five patients were enrolled (23 colonoscopy FMT vs. 13 oral capsule FMT). One patient received FMT via colonoscopy twice. Mean age was 77 years [65–93], female 60%, median recurrent episode was 3, and median CDI severity score was 2. Total success rate was 69.4% (25/36), 60.9% (14/23) via colonoscopy vs. 84.6% (11/13) via capsule. Total success rate for female 67% vs. 73% male and age group of 65–75 was 60% vs. 76% in age group 75+. For capsules only, cure rate was 80% in female vs. 100% in male and 75% in 65–75 age group vs. 89% in patients older than 75 while in colonoscopy only group, success rate was 55% in female vs. 67% in males and 46% in 65–75 age group vs. 67% in age group 75+. There did not seem to be a correlation between FMT donor and success rate. No serious adverse events were reported in the study population. Conclusion FMT may be considered a potentially useful therapy for the treatment of refractory or recurrent CDI cases in patients 65 years of age and older. Further studies are needed to confirm the above findings. Older adults are particularly susceptible to this potentially deadly disease Disclosures All authors: No reported disclosures.

Deficits in Selective Attention Alter Gait in Frail Older Adults

GeroPsych ◽  
2016 ◽  
Vol 29 (1) ◽  
pp. 29-36 ◽  
Author(s):  
Véronique Cornu ◽  
Jean-Paul Steinmetz ◽  
Carine Federspiel
Keyword(s):  
Older Adults ◽  
Nursing Home ◽  
Selective Attention ◽  
Dual Task ◽  
Nursing Home Residents ◽  
Gait Rehabilitation ◽  
Rehabilitation Programs ◽  
Gait Parameters ◽  
Growing Body ◽  
Task Conditions

Abstract. A growing body of research demonstrates an association between gait disorders, falls, and attentional capacities in older adults. The present work empirically analyzes differences in gait parameters in frail institutionalized older adults as a function of selective attention. Gait analysis under single- and dual-task conditions as well as selective attention measures were collected from a total of 33 nursing-home residents. We found that differences in selective attention performances were related to the investigated gait parameters. Poorer selective attention performances were associated with higher stride-to-stride variabilities and a slowing of gait speed under dual-task conditions. The present findings suggest a contribution of selective attention to a safe gait. Implications for gait rehabilitation programs are discussed.

Analysis of Self-Concept in Older Adults in Different Contexts

2004 ◽  
Vol 20 (4) ◽  
pp. 262-274 ◽  
Author(s):  
Manuel de Gracia Blanco ◽  
Josep Garre Olmo ◽  
María Marcó Arbonès ◽  
Pilar Monreal Bosch
Keyword(s):  
Older Adults ◽  
Nursing Home ◽  
Depressive Symptoms ◽  
External Validity ◽  
Aging Process ◽  
Well Being ◽  
Self Esteem ◽  
Self Concept ◽  
Self Perceptions ◽  
Discriminatory Capacity

Summary: Self-concept is a construct consisting of a group of specific self-perceptions that are hierarchically organized. Age-associated changes of self-concept are related to the individual's perception of the changes occurring throughout the aging process. The authors examined external validity and internal consistency of an instrument that has been developed to assess self-concept in older adults and examined self-concept's characteristics in two different contexts. Results confirm the multidimensionality of the scale and show a satisfactory external validity, indicating good discriminatory capacity. Findings support the hypothesis that older people who live in a nursing home have a poor self-esteem, self-concept, and psychological well-being and have a greater presence of depressive symptoms than people who live in their own home.

Statin-induced adverse effects – facts and genes

2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh
Keyword(s):  
Risk Factors ◽  
Single Nucleotide Polymorphisms ◽  
Adverse Effects ◽  
Adverse Events ◽  
Statin Therapy ◽  
Significant Proportion ◽  
Gene Mutations ◽  
Nucleotide Polymorphisms ◽  
Serious Adverse Events ◽  
Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

Phosphene perceptions and safety of chronic visual cortex stimulation in a blind subject

2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  
Keyword(s):  
Visual Cortex ◽  
Adverse Events ◽  
Clinical Intervention ◽  
Occipital Cortex ◽  
Neuronal Population ◽  
Serious Adverse Events ◽  
Stimulation Parameters ◽  
The Right ◽  
Visual Cortical ◽  
Stimulation Of

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.

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