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2019| October-December | Volume 4 | Issue 4
January 13, 2020
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Psoriatic arthritis: combinational therapy of biologics and methotrexate – What do we know?
Stephanie Dauth, Michaela Köhm, Frank Behrens
October-December 2019, 4(4):94-100
Psoriatic arthritis (PsA) is a systemic inflammatory disease characterized by musculoskeletal involvement mostly associated with skin psoriasis. PsA is associated with significant morbidity and disability, and thus constitutes a major socioeconomic burden. For therapeutic strategies, early diagnosis and sufficient treatment lead to the best outcome with prevention of structural damage and loss of function. The combination of biologics (e.g., tumor necrosis factor inhibitors) and methotrexate (MTX) shows a significantly stronger clinical effect in the treatment of rheumatoid arthritis compared to biologic monotherapy as demonstrated by randomized controlled clinical trials. However, the influence of concomitant MTX on biologic therapy for PsA has not yet been fully clarified due to the lack of data from controlled studies that directly compare both treatment strategies, biologic monotherapy and combination of biologic and MTX. Moreover, data from subgroup analyses, register studies and from non-interventional clinical trials show discrepant results. The Germany-wide MUST study is a placebo-controlled, multicenter, randomized study to investigate the influence of MTX on the efficacy, safety and adherence to biologic therapy with ustekinumab in patients with active PsA. The aim of the study is to evaluate whether MTX naive patients would achieve a greater disease improvement with the combination of MTX and biological therapy than with a biologic monotherapy and whether MTX patients who, in addition to MTX, start a biologic therapy would become worse if MTX is discontinued. Data from randomized and controlled clinical trials are important to better understand the role of MTX as a concomitant medication in patients with PsA. The MUST study offers the ideal opportunity to investigate this question in a controlled study and to find out whether the addition of MTX to ustekinumab therapy is beneficial for patients. The results of this and other studies could improve PsA treatment by potentially omitting additional, possibly ineffective, medication that might increase the risk of adverse reactions. This article gives an overview of the current knowledge and published data regarding the effect of MTX as additional therapy to biological treatments in PsA patients. Additionally, the article introduces current efforts to evaluate the role of MTX for PsA treatment, including the MUST study.
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Remote ischemic conditioning of the brain in dementia patients: protocol for a crossover non-pharmaceutical intervention study
October-December 2019, 4(4):89-93
Background and objectives:
Brain ischemia is one of the mechanisms causing dementia; this refers to vascular dementia, however its involvement in other forms of dementia cannot be excluded. We will study the potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury in people with mild cognitive impairment (percondition) and early and middle stage dementia (postcondition).
Subjects and methods:
This crossover study will be held with individuals suffering from peripheral arteriopathy that can cause intermittent claudication after structured exercise, thus inducing extensive transient leg’s ischemia. The level of cerebral function will be checked at baseline and after the intervention with cognitive tests, electroencephalography, magnetic resonance imaging, blood tests, immunological examinations, Event Related Potentials and level of proteins of cerebrospinal fluid (only at baseline). We will examine the possible slowing of progression or the improvement of the disease (dementia), we will suggest or exclude possible biomarkers that are transmitted to the process as well as the intracellular mode of action in the target organs, with a study comprising independent samples and comparison groups. Patient recruitment will begin in January 2020, the analysis of primary outcome measures will be completed in August 2021, and the study will finish in December 2021. The study was approved by the Ethical Committee of the “Greek Association of Alzheimer’s Disease and Related Disorders” (Alzheimer Hellas) (Pr Nr 250 / 2019 AI) on November 8, 2019.
Participants’ cognitive function will be assessed by cognitive scales (primary outcome measure), electroencephalography, magnetic resonance imaging, blood tests and immunological examinations, and cognitive induced potentials (secondary outcome measure) at the beginning and at the end of the study.
This is the first time in the literature that protection of the human brain from dementia of different stages by remote conditioning is investigated. Also innovating is the method that the remote organ ischemia is achieved. The above mentioned strategy of cerebral protection from the initiation or the development of dementia is safe and costless.
ClinicalTrials.gov NCT04168021 registered on November 18, 2019.
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Management of type 2 diabetes mellitus in the elderly population with cardiovascular diseases
Ravi Kant, Nathan A Gilreath, Vipin Verma
October-December 2019, 4(4):101-103
Addressing the glycemic control of the elderly patients with type 2 diabetes mellitus (T2DM) requires creating an individualized plan for each patient due to the heterogeneity among this population. The personalized plan should address topics such as comorbidities, polypharmacy, and cost of medications. One of the major comorbidities that necessitate consideration is cardiovascular disease (CVD), which makes it essential for clinicians to stay updated with literature on cardiovascular safety of diabetes medications. Metformin, along with dietary changes and adequate exercise, should be the first line treatment for patients with T2DM. Glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors should be considered for add-on therapy for elderly patients with CVD whom do not reach their hemoglobin A1c goal on metformin alone. All drugs in these two categories have been shown to be safe in patients with CVD and most of them have shown to reduce adverse cardiovascular events. Sulfonylureas should be used cautiously in elderly due to their high risk of hypoglycemia. Thiazolidinediones, saxagliptin and alogliptin should be avoided in patients with heart failure. With the high rate of major adverse cardiovascular events in elderly population, it is imperative to consider cardiovascular safety and efficacy of non-insulin diabetes medications in formulating management plan for elderly patients with concurrent T2DM and CVD.
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Cognitive rehabilitation in Alzheimer’s disease
Christos Voucharas, Christos G Tsagkaris, Dimitrios V Moysidis, Andreas S Papazoglou
October-December 2019, 4(4):104-107
Cognitive rehabilitation has been defined as a comprehensive program aiming to cognitive enhancement. It has been developed as a method of rehabilitation for people with cognitive impairment of various etiologies such as traumatic brain injury, cerebral vascular accident, cerebral palsy, Down syndrome, Alzheimer’s disease, attention deficit hyperactivity disorder, and developmental disorders. Cognitive rehabilitation is a non-interventional, non-pharmaceutical personalized treatment. Due to the low efficacy of pharmacological approaches to the day, cognitive rehabilitation is expected to play an important role in the treatment of Alzheimer’s disease. The aim of this review is to present cognitive rehabilitation as a mental enhancement strategy in Alzheimer’s disease and to state the worth of cognitive rehabilitation in patients with Alzheimer’s disease, the benefits and drawbacks, the cost and the overall implementation, as well as the optimal future approach of the strategy.
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