Related Articles

Risk Factors for Adverse Drug Reactions in Older Subjects Hospitalized in a Dedicated Dementia Unit.

Am J Geriatr Psychiatry. 2017 Mar;25(3):290-296

Authors: Kanagaratnam L, Dramé M, Novella JL, Trenque T, Joachim C, Nazeyrollas P, Jolly D, Mahmoudi R

Abstract
OBJECTIVE: To identify risk factors for the occurrence of adverse drug reactions (ADRs) based on geriatric evaluation.
DESIGN: Longitudinal prospective study from May 2010 to November 2011.
SETTING: Dedicated acute geriatric care unit specializing in the management of patients with dementia syndrome (Alzheimer disease or related syndromes) at the University Hospital of Reims, France.
PARTICIPANTS: Older patients with dementia syndrome (Alzheimer disease or related syndromes).
MEASUREMENTS: Sociodemographic variables and comprehensive geriatric assessment were recorded. Occurrence of ADRs was noted. Risk factors for ADR were identified by multivariate logistic regression.
RESULTS: During the study period, 293 patients were included; average age was 82 ± 8 years; the majority were women (61.4%). Average Mini-Mental State Examination score was 13 ± 8; average activities of daily living (ADL) score was 3.6 ± 2.1. Independent risk factors for occurrence of at least one ADR were polypharmacy (≥5 drugs/day) (OR: 4.0, 95% CI: 1.1-14.1) and dependence on at least 1 ADL (OR: 2.6, 95% CI: 1.1-6.5).
CONCLUSIONS: Risk factors for ADRs were polypharmacy and dependence on at least one ADL. Our findings underline the importance of taking into consideration the characteristics of the patients when prescribing drugs in this specific population. Prescriptions should be re-evaluated at each follow-up.

PMID: 27742527 [PubMed - indexed for MEDLINE]

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Imatinib and polypharmacy in very old patients with chronic myeloid leukemia: effects on response rate, toxicity and outcome.

Oncotarget. 2016 Nov 29;7(48):80083-80090

Authors: Iurlo A, Nobili A, Latagliata R, Bucelli C, Castagnetti F, Breccia M, Abruzzese E, Cattaneo D, Fava C, Ferrero D, Gozzini A, Bonifacio M, Tiribelli M, Pregno P, Stagno F, Vigneri P, Annunziata M, Cavazzini F, Binotto G, Mansueto G, Russo S, Falzetti F, Montefusco E, Gugliotta G, Storti S, D'Addosio AM, Scaffidi L, Cortesi L, Cedrone M, Rossi AR, Avanzini P, Mauro E, Spadea A, Celesti F, Giglio G, Isidori A, Crugnola M, Calistri E, Sorà F, Rege-Cambrin G, Sica S, Luciano L, Galimberti S, Orlandi EM, Bocchia M, Tettamanti M, Alimena G, Saglio G, Rosti G, Mannucci PM, Cortelezzi A

Abstract
BACKGROUND: About 40% of all patients with chronic myeloid leukemia are currently old or very old. They are effectively treated with imatinib, even though underrepresented in clinical studies. Furthermore, as it happens in the general population, they often receive multiple drugs for associated chronic illnesses. Aim of this study was to assess whether or not in imatinib-treated patients aged >75 years the exposure to polypharmacy (5 drugs or more) had an impact on cytogenetic and molecular response rates, event-free and overall survival, as well as on hematological or extra-hematological toxicity.
METHODS: 296 patients at 35 Italian hematological institutions were evaluated.
RESULTS: Polypharmacy was reported in 107 patients (36.1%), and drugs more frequently used were antiplatelets, diuretics, proton pump inhibitors, ACE-inhibitors, beta-blockers, calcium channel blockers, angiotensin II receptors blockers, statins, oral hypoglycemic drugs and alpha blockers. Complete cytogenetic response was obtained in 174 patients (58.8%), 78 (26.4%) within 6 month, 63 (21.3%) between 7 and 12 months. Major molecular response was obtained in 153 patients (51.7%), 64 (21.6%) within the 12 month. One hundred and twenty-eight cases (43.2%) of hematological toxicity were recorded, together with 167 cases (56.4%) of extra-hematological toxicity. Comparing patients exposed to polypharmacy to those without, no difference was observed pertaining to the dosage of imatinib, cytogenetic and molecular responses and hematological and extra-hematological toxicity.
CONCLUSION: Notwithstanding the several interactions reported in the literature between imatinib and some of the medications considered herewith, this fact does not seem to have a clinical impact on response rate and outcome.

PMID: 27579540 [PubMed - indexed for MEDLINE]

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Asian perspectives on the recognition and management of levodopa 'wearing-off' in Parkinson's disease.

Expert Rev Neurother. 2015;15(11):1285-97

Authors: Bhidayasiri R, Hattori N, Jeon B, Chen RS, Lee MK, Bajwa JA, Mok VC, Zhang B, Syamsudin T, Tan LC, Jamora RD, Pisarnpong A, Poewe W

Abstract
Most Parkinson's disease patients will receive levodopa therapy, and of these, the majority will develop some levodopa-induced complications. For many patients, the first complication to develop is the decline in the duration of therapeutic benefit of each levodopa dose, a phenomenon commonly termed 'wearing-off'. There is already extensive literature documenting the epidemiology and management of wearing-off in Parkinson's disease patients of western descent. However, data derived from these studies might not always apply to patients of Asian descent due to genetic variations, differences in co-morbidities or non-availability of certain drugs. This review summarizes the current literature regarding the epidemiology of wearing-off in Asian (including Arab) patients and discusses the management issues in the context of drug availability in Asia.

PMID: 26390066 [PubMed - indexed for MEDLINE]

Notice NOT-AI-18-019 from the NIH Guide for Grants and Contracts

Funding Opportunity PA-18-670 from the NIH Guide for Grants and Contracts. The purpose of the Kirschstein-NRSA postdoctoral fellowship is to support research training of highly promising postdoctoral candidates who have the potential to become productive, independent investigators in scientific health-related research fields relevant to the missions of the participating NIH Institutes and Centers. Applications are expected to incorporate exceptional mentorship. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Notice NOT-AI-18-018 from the NIH Guide for Grants and Contracts

Notice NOT-NS-18-043 from the NIH Guide for Grants and Contracts

Notice NOT-NR-18-008 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-DK-18-004 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing original research addressing barriers that limit progress toward effective cell replacement therapies for type 1 diabetes (T1D). The purpose is to support research leading to the development and testing of novel and supportive technologies for the improvement of cell replacement interventions using novel biomaterials and devices for T1D treatment.

Funding Opportunity RFA-FD-18-005 from the NIH Guide for Grants and Contracts. The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Training Education and Development (OTED) is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement Grant. The goals of this Cooperative Agreement Grant are to continue the development of the Integrated Food Safety System (IFSS) National Curriculum Standard (NCS) for the laboratory competency and curriculum frameworks, further work on the development and validation of competency statements. As the NCS is completed at each level, then training content can be developed to meet the standard, post web courses and deliver classroom courses to IFSS laboratorians nationwide. Under FSMA Section 209, FDA is directed to improve the training of state, local, territorial and tribal food safety officials and set standards and administer training and education programs to ensure a competent work force doing comparable work.

Funding Opportunity PAR-18-665 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIHs SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.

Funding Opportunity PA-18-666 from the NIH Guide for Grants and Contracts. The purpose of this Kirschstein-NRSA predoctoral fellowship (F31) award is to enhance the diversity of the health-related research workforce by supporting the research training of predoctoral students from population groups that have been shown to be underrepresented in the biomedical, behavioral, or clinical research workforce, including underrepresented racial and ethnic groups and those with disabilities. Through this award program, promising predoctoral students will obtain individualized, mentored research training from outstanding faculty sponsors while conducting well-defined research projects in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The proposed mentored research training is expected to clearly enhance the individuals potential to develop into a productive, independent research scientist

Funding Opportunity RFA-DK-17-024 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing clinical studies of the use of current and emerging technologies for monitoring of blood glucose and insulin administration in older adults. (aged 65 years or older) Older adults may have increased vulnerability to hypoglycemia, cognitive impairment and/or multiple co-morbidities which may affect the risks and benefits of these technologies in this population. This research is intended to improve health, glucose control and quality of life of older patients with type 1 diabetes Only human studies will be considered responsive to this FOA; applications involving animal or invitro studies are not responsive to this FOA.

Funding Opportunity RFA-DK-17-023 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing clinical trials to test a highly reliable, wearable/implantable, portable, and easy to operate system linking continuous glucose monitoring and pancreatic hormone delivery in a closed loop system. This research is also intended to study behavioral and physiological aspects of relevance to the use and adoption of these systems. The main goal of this FOA is to improve glucose control and quality of life of patients with type 1 diabetes. Only human studies will be considered responsive to this FOA, applications involving animal or in vitro studies are not responsive to this FOA.

Funding Opportunity RFA-DK-17-025 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing original research addressing barriers that limit progress toward effective open- and closed-loop glucose control systems. Proposed research should tackle important obstacles at the level of sensing, hormone formulation and delivery, self-management decision support systems, and/or design of automated controllers/algorithms able to manage an integrated platform. This research may contribute to development of affordable and user friendly technologies to improve glucose control in patients with type 1 diabetes.

Notice NOT-FD-18-005 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-DA-19-003 from the NIH Guide for Grants and Contracts. This initiative will support projects that exploit Omics assays to address outstanding questions regarding molecular regulation of persistent HIV (e.g. latency or reservoirs) in the context of chronic substance use or substance use disorder (SUD).

Funding Opportunity RFA-DK-17-031 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing original research aimed at the characterization and discovery of neoantigens and neoepitopes in type 1 diabetes. These include the characterization of the humoral and cell mediated autoimmune responses elicited by these neoepitopes and neoantigens and their role in the etiology and pathophysiology of type 1 diabetes. These studies should be integrated with the present knowledge of established epitopes and antigens (e.g. autoantibodies for insulin, GAD65, IA-2, and ZnT8T).

Funding Opportunity RFA-DK-18-003 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing research on the use of current and emerging technologies for monitoring of blood glucose levels to capture the relationship between blood glucose excursions, perception of wellbeing, and cognitive status in people with type 1 diabetes (T1D). This information will inform the design of more effective interventions that may improve patient reported outcomes (PROs), including quality of life measures, and validate glycemic measures that may serve as outcomes in clinical trials to improve glucose management in T1D.

Funding Opportunity RFA-DK-17-021 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) requests applications to explore human pancreatic tissues for the discovery of early biomarkers of T1D pathogenesis, the description of specific signaling or processing pathways that may contribute to the asymptomatic phase of T1D, the development of clinical diagnostic tools for the detection and staging of early T1D in at-risk or recently-diagnosed individuals, and/or the identification of therapeutic targets for the development of preventative or early treatment strategies. Successful applicants will join the Consortium on Beta Cell Death and Survival (CBDS), whose mission is to better define and detect the mechanisms of beta cell stress and destruction central to the development of T1D in humans, with the long-term goal of detecting beta cell destruction and protecting the residual beta cell mass in T1D patients as early as possible in the disease process, and of preventing the progression to autoimmunity. The CBDS is part of a collaborative research framework, the Human Islet Research Network (HIRN, https://hirnetwork.org), whose overall mission is to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans. This FOA will only support studies with a primary focus on increasing our understanding of human disease biology (as opposed to rodent or other animal models). This FOA will not accept applications proposing a clinical trial.