Iris Publishers- Open access Journal of Pediatrics & Neonatal Care | Use of the Pacifiers in Children with Disabilities

 

Authored by Sun Joung Leigh An*

Opinion

Pacifiers are commonly used with babies all around the world. Pacifiers are used primarily to stimulate sucking and to calm self. These pacifiers, “also known as soothers, dummies and artificial teats are as rooted in history as they are in controversy” [1]. Recommendations for and against its use are given to parents from various professionals including nurses, doctors, dentists and therapists grounded on the benefits or risks.

There are researches to show both potential benefits and risks for using pacifiers. Potential benefits of using pacifiers include self-comforting and calming [2], pain relief [3] and reduction in incidence of SIDS [4] and potential risks include fear of potential for malformation of teeth [5], negative impact on breastfeeding [6], cause otitis media [7] and negative impact on speech development [8]. However, “the body of research literature addressing the risks and benefits of pacifier usage is large and multidimensional and arrived at different conclusions, and made different, sometimes contradictory recommendations” [8] which have contributed to the already perplexing and controversial topic.

Due to decades of worldwide controversy, many parents continue to be in dilemma about whether to use or not use pacifiers with their infants and young children. Some parents even start following a recommendation from one professional and offer the pacifier to their infants then when they hear a different recommendation stop then go back and forth, reporting feeling confused and guilty.

Most studies to date have focused on the use of pacifiers, however, the purpose of this paper is to bring attention for the need to do research on the relationship between not using the pacifier and oral motor problems, especially for children with disabilities. This author has worked with children with disabilities for the last 30 years and observed that children who have a strong suckling reflex cannot suck on a pacifier and parents reported suckling as infants not liking the pacifier and as refusal. Many of the children whose parents reported as infants refusing to use the pacifiers were demonstrating a seeking sensory stimulation in their mouths by constantly chewing whatever was available to them including food, clothing items and writing utensils such as pencils and pens. These children also continued to exhibit suckling reflex as children when they were eating and poor oral motor control.

Researches to date have looked at the use of pacifiers and the effect in infants and however this author would like to suggest that researches be done to look at the long term effects of the use or nonuse of the pacifiers in relationship to oral motor control including feeding solids and speech in children with and without disabilities.

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Iris Publishers- Open access Journal of Modern Concepts in Material Science | The Airless Tire: Will this Revolutionary Concept be the Tire of the Future?

 

Authored by Ulf Sandberg*

Abstract

Conventional pneumatic (air-inflated) tires have dominated the tire market for over a century. However, several tire manufacturers have presented concepts or prototypes for airless tires which use rubber only in the treads, while the load-carrying structure is made of composite materials such as polyurethane, thermoplastics, fiberglass and epoxy laminates, but also eco-friendlier and bio-degradable materials have been proposed.

First, some early projects (1989-2008) are described in which a Swedish innovative airless tire concept was tested, resulting in so-called Composite Wheel prototypes. This reduced noise emission and rolling resistance substantially and had excellent wet skid resistance properties while also providing acceptable vehicle handling. However, in full-scale testing, it did not endure an extreme test on a “pot-hole” test track due to a design lapse.

Then, a number of concept or prototype airless tires suggested by tire manufacturers in the last 15 years are reviewed. In general, very sparse information have been provided, but they all promise (without scientific proof) significant improvements over pneumatic tires. Advantages are foreseen especially in terms of dramatic reduction in global use of raw materials, use of more eco-friendly materials and much less complicated production. Even 3D-printing can be used in some cases. One of the prototypes is currently tested for use on an electric vehicle in service, with a possible market introduction targeted in 2024.

It is concluded that airless tires have substantial potential for initiating a revolution in terms of use of raw materials of which many may be eco-friendly, in addition to significant advantages over pneumatic tires in the environmental footprint during operation. However, a wide use of airless tires will have dramatic consequences for the tire manufacturing plants, and significantly influence the vehicle industry, with a risk of recent investments not being fully paid-off. Therefore, a wide introduction of airless tires on the market might take a longer time than what is technically needed, regardless of all benefits.

The Pneumatic Tire, A Most Sophisticated Product

The pneumatic (or air-inflated) tire as a concept was invented in the 19th century and was conquering the market for tires in the first decades of the 20th century. Since then, this concept has completely dominated the tire market and is currently stronger than ever. The basic idea is to use compressed air contained in a toroid or torus as a cushion between the vehicle and the road pavement and to let the solid materials in the outer part of this toroid or torus transfer the forces in both transverse and longitudinal directions between the axle and the pavement. To this end a rubber tread is added around the torus. However, the most essential material in the tires is air which, in case of punctures, will make the tire non-useable. Trials have been made with inflation by other gases, primarily nitrogen, but air is used in almost all road vehicle tires.

The product we call tire and is used on all rolling vehicles, is thus pneumatic in its principle and relies on a proper inflation. From its invention until today, the main principle is the same, but today’s product has been improved continually and in several relatively small steps over the more than 100 years since it entered the market. It is now an incredibly sophisticated product; an average tire today contains well over 100 separate components of various materials. It is often claimed by experts that the tires are the most important and sophisticated part of a road vehicle. Rubber is the main raw material used in manufacturing tires, and both natural and synthetic rubber are used, where synthetic rubber constitutes 60-70% of the total rubber amount. Other materials include carbon black, various oils, sulfur, silica, textile and steel reinforcements, to name a few.

Manufacturing such a product is very complicated. This means that manufacturing plants and the materials chains get complicated too, which has led to very substantial investments by the manufacturers that must be paid off during decades of production. Thus, when the radial tire was invented by Michelin in the 1940’s, despite it soon was found to be technically much better than its predecessors (i.e., the diagonal or bias ply tires), it took until the 1960’s until the radial tire became dominant on the European market. However, in USA, the tire and vehicle manufacturers hesitated to accept the radial tires. It was not until about 20 years after Europe when radial tires started to dominate the market in USA. This was partly due to US cars with very soft suspension not being adapted to the new tires, partly due to the refusal to rebuild their tire plants, as radial tires required very costly retooling.

Other major concepts that have been tried including building air inflated tires with essentially only a plastic torus fitted with a rubber tread, or to replace the air with solid material, such as polyurethane. None of them have been developed further than into prototypes.

The Airless Tire - First Trials

In 1982, Goodyear was granted a patent for an Integral Wheel- Tire (IWT) for passenger cars, based on a single-sided wheel rim with an asymmetrical deformation behavior [1]. The IWT was made of composite materials, having a circumferential part covered with a rubber tread. An extensive report dealing with this IWT was presented in 1989 [2], indicating very good characteristics. Yet, nothing more happened, at least not publicly reported.

Without being aware of the Goodyear concept, another airless tire (with dimensions suited for cars) was designed by the Swedish inventor Mr. Hans-Erik Hansson [3]. The patent was granted in Sweden and applications were filed in the major industrial countries. This wheel, like the Goodyear IWT, was a non-pneumatic, highly flexible construction in composite materials giving unique characteristics. Relative to the Goodyear design it used a more sophisticated shape, potentially giving much more flexibility in the design.

This product was named the “Composite Wheel (CW)” due to its integration of rim with tire, using a composite material of glass-fiber/ polyester laminate. To avoid confusion, it should be noted that, in principle, a normal air-inflated tire is also made of composite materials, although many more and totally different ones. Figure 1 shows a cross-section through the first version of the Composite Wheel (Figure 1).

In a project run at Swedish National Road and Transport Research Institute (VTI), the tread and underlying “belt” of this CW design was perforated with holes that let air and water flow through the tread and structure. With this design a noise reduction of up to 10 dB (A-weighted) was measured compared to one of the most popular quality tires of the time (a Goodyear Eagle NCT70) [4]. A problem was that after some driving with normal loads at highway speeds some cracks appeared in the “belt” area. The design was apparently not durable enough, which had not been the purpose with this particular design. The purpose had been to study the potential for noise reduction of the concept and not to build a fully durable tire. Nevertheless, as intended, the noise reduction potential had been demonstrated. It should be noted that in today’s traffic, the noise emission of tires constitutes the major part of traffic noise, so a 10 dB reduction would mean a revolution to traffic noise mitigation.

The reasons for the noise reduction were identified to be essentially two-fold [5]:

For low frequencies, the torus of a normal air-inflated tire can be compared to a closed loudspeaker cabinet. The latter separates the sound waves from the rear of a loudspeaker and the sound waves from the front of the loudspeaker, in order to avoid that these waves will cancel each other (which happens if there is no loudspeaker cabinet or large baffle). In loudspeaker technology this is known as “the baffle effect”. In the CW design, the sound waves from the rubber tread and the sidewall are not separated from the waves of the rear side of the same; therefore, creating a case where these low-frequency waves are partly or fully cancelling each other.

For high frequencies, the so-called air pumping sound which is created by trapping the air in the interface between rubber tread (with its open or closed grooves) and pavement surface, results in high air pressure gradients, when air is “pumped” in and out of the interface. In the CW design, this mechanism is eliminated by holes constructed or drilled through the tread and belt where air in tread grooves or trapped in cavities in the pavement can easily escape from the traps. Further, the so-called “horn effect” (the shape of the front and rear of the tire circumference curved over the flat pavement surface technically resembles an acoustic horn which may amplify sound created in the throat of the horn) is eliminated as the tire tread is perforated.

In reality, the two noise-reducing mechanisms are partly overlapping between low and high frequencies and in combination they constitute an efficient “killer” of noise.

Later Trials with the Composite Wheel

Tires are required to meet several very important requirements, of which noise would be one, but other performances should not be impaired when noise is reduced. Consequently, later projects should aim at studying the CW concept from a holistic point of view, considering primarily safety, wear, durability, vehicle handling, energy consumption and CO2 emission (the latter two depending on rolling resistance). In a later international project [6], utilizing carbon- fiber and epoxy laminate as materials but retaining the basic principle shown in Figure 1, focus was on noise, rolling resistance, durability, and vehicle handling. With regard to safety, it was obvious that skid resistance or hydroplaning on wet roads would be improved by the CW design as long as the tread was “ventilated” by holes, so no measurements were needed to confirm it. In order to improve durability, some of the noise properties had to be sacrificed. Figures 2 and 3 show the prototype samples during the final testing session.

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Iris Publishers- Open access Journal of Cardiology Research & Reports | Research of Oxidative Stress and Serum Thiols as a Criterion for the Antioxidant Barrier in Patients with Heart Failure (NYHA FC III-IV)

 

Authored by Mariana Georgieva Yordanova*

Abstract

Aim: To evaluate the status of oxidative stress and antioxidant systems (thiol and biological plasma antioxidant potential) in patients with heart failure, combined with disorders of carbohydrate metabolism and renal failure, and to what extent their values depend on the duration and severity of the disease (by NYHA).

Materials and Methods: Forty subjects (age 66.4±6.8) admitted for exacerbated chronic heart failure (III and IV FC), and 12 of them were examined in the same age range without clinical and echocardiography for HF. The levels of total thiols (SHp), reactive oxygen metabolites (dROMs), plasma antioxidant potential (BAP), creatinine, calculated GFR, glucose and C-reactive protein are analysed. Measurement of SHp, dROMs and BAP assays was performed spectrophotometrically with kits of Diacron International-Italy with an Olympus AU400 biochemical analyser and Carpe diam analyser (Diacron).

Results: An increase in oxidative stress was observed in the patient group, which had a high negative correlation with the thiol groups and the plasma antioxidant potential (r=-0.7404; r=-0.7567). The decrease in glomerular filtration also corresponds to a high degree with the reduction of the organism’s antioxidant capacity and the increase of oxidative stress. We found a high degree of dependence on the severity of HF (according to the NYHA classification), with the studied levels of oxidative stress and the antioxidant barrier. A similar relationship is observed between disease duration and SHp, dROMs and BAP concentrations.

Conclusion: Oxidative stress plays an essential role in the pathogenesis and progression of CHF. The observed thiol levels have decreased statistically significant, such as the collapse of the antioxidant system is key in the disturbed homeostasis of organisms in ROS/RNS coping.

Keywords: Thiols; Oxidative stress; Antioxidant system; Heart failure; GFR, Inflammatory response.

Introduction

Heart failure is a severe chronic condition where, as a result of dysfunction, the heart is unable to expel sufficient blood to meet the body’s metabolic needs. The most common causes are coronary heart disease, myocardial infarction, congenital heart defects, damage to the heart valves, atrial fibrillation. Heart failure (HF) is the most common cause of hospitalisation in people over 65 and is associated with increased health costs. It is a global pandemic affecting at least 26 million people worldwide, with disease rates increasing as the population ages [1]. The death rate from this diagnosis in Bulgaria has doubled, with over 20,000 people dying annually. Oxidative stress is a key element in the pathophysiology of heart failure (HF) [2]. Several studies support the hypothesis of a link between oxidative status change and the development and progression of many diseases, such as neurodegenerative conditions, cardiovascular, inflammatory diseases, and cancer [2-5]. In the course of oxidation processes, reactive free radicals (ROS) are formed continuously, which are missing one electron. To achieve their stability as compounds, they obtain electrons from other organic molecules such as DNA, fats, proteins, and enzymes by oxidising them. Free radicals are extremely reactive, damaging cell membranes and DNA molecules [6] (Figure 1).

Physiologically free radicals are formed during normal metabolic processes in the cell. They play a role in the regulation of basic functions and act as signalling molecules in the transduction cascades or pathways for various growth factors, cytokines and hormones [6]. On the other hand, the so-called “oxidative explosion” is absolutely necessary for the initiation of immunological responses. It activates neutrophil cells and phagocytosis as the body’s primary immune response against foreign antigens. Oxidative stress is a term used to refer to an imbalance between the concentrations of reactive oxygen and nitrogen species (RNS) formed and the body’s antioxidant protection. The body counteracts oxidative stress with its plasma and intracellular antioxidants. An antioxidant is any substance or compound that can bind ROS and RNS or inhibit the oxidation process in the cell. The deficiency of natural antioxidants increases with advancing age and the worsening of chronic pathological processes.

Thiols are compounds with a free sulfhydryl (R-SH) group. Most often they are presented in the form of proteins containing one or more free cysteine groups, or low molecular weight compounds (e.g. glutathione GSH). They are localised in cells and extracellular fluids. They are endogenous organic compounds that support the maintenance of aerobic cells in a reducing state despite the oxidising environment. R-SH exists in vivo in three forms, which include free thiol (e.g., cysteine), identical thiols formed between two homodisulfides (e.g., GSSG glutathione disulfide) and heterodisulfides formed between different thiols (e.g. proteinbound thiols). Proteins with their sulfhydryl groups are the main component of the serum antioxidant effect. In the case of high oxidative stress, thiol levels are reduced to neutralise reactive oxygen species. In this case, the sulfhydryl groups of the thiols are oxidised to form disulfide (-S-S-) bonds. These connections can be transformed back to thiols, and thus the thiol/disulfide homeostasis is maintained [7]. Thiol is one of the most important antioxidant barriers in humans, and thiol / disulfide homeostasis is a new marker for oxidative stress [8]. In a recent study, SH protein groups were found to contribute 52.9% of measured total serum antioxidant capacity in healthy subjects [9]. Impaired balance oxidative stress, antioxidant defences and changes occurring in the redox thiol system are associated with ischemic heart disease, atherosclerosis, renal and hepatic failure, rheumatoid arthritis, dementia and Alzheimer’s disease. In addition to their role in protecting against free radicals, thiols share a significant role in detoxification, signal transduction, apoptosis, and various other molecular-level functions.

Frenay A-RS, et al. shows that high serum concentrations of R-SH are associated with a favourable cardiovascular risk profile and better survival for patients with the transplanted kidney [10]. Oxidative stress causes the development of myocardial and vascular dysfunction and is an important pathophysiological factor in HF. Quantitative studies of reactive oxygen metabolites (dROMs), biological antioxidant potential (BAP), and the main aminothiol compounds in plasma or serum stimulate scientific search with the potential for therapeutic modulation.

Materials and Methods

Forty patients (24 men and 16 women) that have a mean age of 66.38 years (range 54-78 years) admitted to the MMAVarna Cardiology Department for exacerbated CHF (NYHA IIIIV FC) were examined. Criteria for inclusion in the study are the presence of typical subjective and objective symptoms of heart failure and ultrasound-proven ventricular dysfunction (ejection fraction <35%). The control group consisted of 12 individuals with a mean age of 62.5 years (range 55-70 years) with no subjective and objective data on cardiovascular disease, no clinical and laboratory criteria for diabetes and impaired renal function. The study was approved by the Ethics Committee of MMA-Varna. Body mass index (BMI) was determined in both groups. A standard pre-analytical procedure is used to take venous blood. The blood serum was removed by centrifugation for 10 minutes at 3500 rpm. In serum, we determine the following indicators: creatinine, CRP, glucose, cholesterol, oxidative stress (dROMs), serum antioxidant capacity (BAP), and total serum thiol. GFR was calculated based on serum creatinine using the MDRD formula. Oxidative stress (dROMs) and serum antioxidant capacity (BAP) were determined spectrophotometrically with ready-made kits from Diacron International-Italy using a semi-automatic Carpe diam analyser (Diacron Labs Italy). The d-ROM test is based on the ability of a biological sample to oxidise aromatic amine (DPPD). Reactive oxygen metabolites (ROMs) (hydroperoxides, chloramines and their derivatives) react with appropriately buffered chromogen and develop a colour derivative that is photometric at 505 nm. The concentration of this class of ROMs directly correlates with the intensity of the colour and the increased levels of oxidative stress. The units that express dROMs are Carratelli units (1 CARR U=0.08 mg% hydrogen peroxide). The range in healthy individuals is 250- 300 UCARR.

The BAP test is spectrophotometric (λ=505 nm) for measuring the antioxidant capacity (AOC) of a sample placed in a solution of ferric chloride. It has the ability to reduce iron from ferric Fe3+ to Ferro Fe2+ ion. Reducing the intensity of the colour is a criterion for the concentration of antioxidants present in the plasma. For both tests, quality control is performed with two levels of control materials (Low and High).

The testing of plasma thiol groups (R-SH) (lipoic acid, glutathione, cysteine) is performed with a colourimetric SHp test (Diacron International-Italy) with an Olympus AI 400 biochemical analyser with our adapted program. The principle of the method is based on the interaction of thiols with 5, 5’-dithiobis- (2-nitrobenzoic acid) (DTNB), forming highly coloured anions with maximum absorption at 405 nm. Thiols are extremely unstable. Within the same day, samples were examined in fresh plasma (serum) without a trace of hemolysis. Pre-analytic requirements have been described and imposed because time and oxygen from the air enhances the reduction of glutathione by γ-glutamyl cysteine and the rapid conversion of reduced glutathione into oxidised form, which interferes with the result. Each series was controlled by two levels of controls - low and high. VK 2.8%; 5.2%, bis 2.8% respectively for low control and high. CRP and serum creatinine were determined using routine methods of an Olympus AU 640 biochemical analyser with Beckman Coulter reagents (USA).

Statistical Methods

Data analysis is performed with Graph Pad Prism v software. 6.0 using standard statistical methods (descriptive statistics, nonparametric T-test for mean comparison, ANOVA test for continuous variables with normal distribution between the groups of analysis, variance and Pearson correlation analysis). Biochemical parametric data were presented as mean and standard deviation (mean±SD) at a 95% confidence interval. Statistical significance was stated at p <0.05.

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Iris Publishers- Open access Journal of Cardiology Research & Reports | From Strict Glycemic Control to Improving Cardiovascular Outcomes: A Shift in the Management Strategies for Type 2 Diabetes

 

Authored by May Mak1*

Abstract

Newer classes of agents targeted to enhance glycemic control have been the focus of attention for their demonstrated reduction of cardiovascular (CV) events. In the latest 2020 American Diabetes Association (ADA) Standards of Medical Care in Diabetes, specific recommendations are made regarding improvement of CV outcomes in patients with diabetes. For those patients with type 2 diabetes (T2DM) who have established atherosclerotic cardiovascular disease (ASCVD) or indicators of high-risk for CVD, established kidney disease, or heart failure (HF), a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or glucagon-like peptide 1 receptor agonist (GLP-1 RA) with demonstrated CV benefits can be recommended as part of the regimen independent of glycosylated hemoglobin (HgbA1c) while considering patient-specific factors. In addition, for patients with T2DM who need to achieve better control than with existing oral medications, GLP-1 RAs are preferred to insulin, when feasible. Similar to the ADA recommendation, the 2020 Management Algorithm from American Association of Clinical Endocrinologists (AACE) & American College of Endocrinology (ACE) also suggests the addition of a GLP-1 RA or SGLT2i independent of glycemic control, if there is established ASCVD or high risk for CVD, chronic kidney disease (CKD), or reduced ejection heart failure.

This review aims to interpret the CV outcomes demonstrated for the SGLT2i and GLP-1 RA agents that currently have FDA approved indications for reduction of risk of major adverse cardiovascular events (MACE) in T2DM patients with established CVD or CV risks. The information in this article will suggest overlapping effects on the heart, kidney while achieving glycemic control.

Background

Recent report from the U.S. Food and Drug Administration (FDA) estimates that more than 30 million Americans have diabetes, and 90% to 95% of them have type 2 diabetes (T2DM). This group of population can suffer from short- and long-term complications, including microvascular damage to the nerves, kidneys, and eyes; as well as macrovascular consequences that may increase the risks of sleep apnea, heart and blood vessel diseases [1]. The high morbidity and mortality rate caused by cardiovascular (CV) diseases have long been recognized, and now improving CV outcomes is becoming a focus in managing diabetes along with glycemic control.

In 2008, the FDA issued a Guidance for Industry stating that all new T2DM drug development programs should rule out unacceptable cardiovascular risk by demonstrating an upper bound of the two-sided 95% confidence interval (CI) of the risk ratio < 1.8 pre-approval for a composite end point of major adverse cardiac events (MACE), consisting of at least cardiovascular death, nonfatal myocardial (MI) infarction, and stroke. If the upper CI lies between 1.3 to 1.8, then a post-marketing CV trial is usually required to demonstrate the CI to be < 1.3. However, in practice, each sponsor of recently approved drugs has followed this guidance, making post-marketing CV studies almost obligatory [2]. These FDA recommendations stemmed from previous concerns over high prevalence of cardiovascular disease (CVD) in diabetes, possibly contributed by conventional pharmacologic agents used to achieve glycemic control. Based on historical data, sulfonylureas are associated with a higher all-cause mortality, CV mortality, composite incidence of myocardial infarction, and stroke compared to other diabetes medications. As a result, the class of sulfonylurea medications carries a “black box” CV warning from the FDA regarding heightened risk for CV events. Earlier implications associating the thiazolidinediones with fluid retention, heart failure, and bladder cancer have also led to reduced use of these agents. Although the MI risks for rosiglitazone have been largely dispelled and pioglitazone showing net CV benefits, the concern of heart failure risk, in addition to weight gain and potential risks for bone fractures, continue to limit the wide use of these agents in recent years.

More recently, cardiovascular outcome trials (CVOTs) have shown cardiovascular safety with the class of dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), but they have not demonstrated net CV benefits. More recent data, however, suggested a higher risk of heart failure with the use of sitagliptin and alogliptin. As a result, FDA issued warnings of the potential of heart failure and its exacerbation while on these agents. Patients are urged to contact their physicians if they experience increasing shortness of breath, unusually fast increase in weight, swelling or fluid retention, and unusual tiredness [3]. Newer classes of agents targeted to enhance glycemic control have been the focus of attention for their demonstrated reduction of cardiovascular (CV) events. In the latest 2020 American Diabetes Association (ADA) Standards of Medical Care in Diabetes, specific recommendations are made regarding improvement of CV outcomes in patients with diabetes. Among these recommendations is a patient-centered approach with therapeutic considerations for CV comorbidities. For those patients with type 2 diabetes (T2DM) who have established atherosclerotic cardiovascular disease (ASCVD) or indicators of high-risk for CVD, established kidney disease, or heart failure (HF), a sodium-glucose cotransporter 2 inhibitor (SGLT2i) or glucagonlike peptide 1 receptor agonist (GLP-1 RA) with demonstrated CV benefits can be recommended as part of the regimen independent of glycosylated hemoglobin (HgbA1c) while considering patientspecific factors. In addition, for patients with T2DM who need to achieve better control than with existing oral medications, GLP-1 RAs are preferred to insulin, when feasible [4]. Similar to the ADA recommendation, the 2020 Management Algorithm from American Association of Clinical Endocrinologists (AACE) & American College of Endocrinology (ACE) also suggests the addition of a GLP-1 RA or SGLT2i independent of glycemic control, if there is established ASCVD or high risk for CVD, chronic kidney disease (CKD), or reduced ejection heart failure [5].

The following sections summarize the positive CV outcomes demonstrated for agents that currently have FDA approved indications for reduction of risk of major adverse cardiovascular events (MACE) in T2DM patients with established CVD or CV risks. Other agent-specific approved indications include reduction of risk of end stage renal disease (ESRD), doubling of serum creatinine, and hospitalization for heart failure (hHF) in those with T2DM and DM nephropathy with albuminuria > 300 mg/day.

Sodium-glucose Cotransporter 2 Inhibitors

Currently, three of the four SGLT2 inhibitors on the market have FDA approved labelling for CV benefits in addition to improving glycemic control as an adjunct therapy. Empagliflozin is indicated to reduce the risk of CV death in adults with T2DM and established CVD [6]. Dapagliflozin is indicated to reduce the risk of hHF in adults with T2DM and established CVD or multiple CV risk factors [7]. Canagliflozin is indicated to reduce the risk of MACE in adults with T2DM and established CVD as well as to reduce the risk of ESRD, doubling of serum creatinine, CV death, and hHF in adults with T2DM and diabetic nephropathy with albuminuria [8] (Table 1). The Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial highlights the effects of empagliflozin in CV morbidity and mortality when compared to placebo. This trial enrolled 7,020 participants for a median duration of 3.1 years. The primary hypothesis of the EMPA-REG OUTCOME trial was noninferiority for the primary outcome with empagliflozin. In adult patients with T2DM, eGFR of 30 mL/ min/1.73m2 or greater, and established CV disease, empagliflozin was shown to have superiority over placebo, resulting in a lower rate of primary composite CV outcomes (including CV death, nonfatal MI, or nonfatal stroke), when added to standard care. However, empagliflozin did not show a significant difference compared to placebo for individual outcomes of MI or stroke. For the secondary composite CV outcomes, including hospitalization for unstable angina, empagliflozin was shown to be non-inferior to placebo, with limited evidence in superiority. There was more genital infection reported in the empagliflozin group than placebo, but overall, there was no significant difference in the two study groups in adverse events. This study concluded that empagliflozin, as compared to placebo, had a lower rate of the primary composite CV outcome and of death from any cause when it was added to standard care in patients with T2DM at high risk for CV events [9].

The Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes (CANVAS) program integrated data from two sister trials -- CANVAS and CANVAS-R, evaluated the cardiovascular, renal, and safety outcomes of canagliflozin when compared to placebo. Similar to the EMPA-REG OUTCOME trial, the primary hypothesis of the CANVAS trial was also to determine the noninferiority for the primary outcome: composite of death from CV causes, nonfatal MI, or nonfatal stroke. Reported data was compiled from 9,734 participants who were followed for 188.2 weeks. In adult patients with T2DM, mean age of 63.3 years, eGFR greater than 30 mL/ min/1.73m2, and established CV disease or elevated risk of CVD, canagliflozin was shown to have a significantly lower rate of the primary composite outcome. There was no difference between the two groups in secondary endpoints, however, fewer patients had progression of albuminuria in the canagliflozin group than the placebo group. A significant finding from this study was the higher risk of amputation of toes or foot in the canagliflozin group than with the placebo group. The authors of the CANVAS program concluded that canagliflozin had a lower risk of CV events, but a greater risk of amputation than placebo in T2DM patients with an elevated risk of CV disease [10].

The Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (CREDENCE) trial evaluated the renal effects of canagliflozin in patients with T2DM and albuminuric CKD. Reported data was extracted from 4,401 participants who had a median follow-up of 2.62 years. Participants were adult patients with T2DM, mean age of 63 years, eGFR of ≥30 to <90 (mean of 56.2) mL/min/1.73m2, urinary albumin creatinine ratio (UACR) >300 to ≤5000 (mean of 927) mg/g, and established CVD or elevated risk of CVD. The primary composite outcome, which included ESRD, doubling of the serum creatinine level or renal/CV death, was significantly lower in the canagliflozin group than in the placebo group. From the individual outcomes under the primary composite result, canagliflozin was shown to have a significantly lower rate of doubling of serum creatinine level and ESRD than the placebo group. In addition, specific secondary outcomes such as CV death or hospitalization for heart failure (hHF), and renal composite outcome of ESRD, doubling of SCr, or renal death were also lower in the canagliflozin than the placebo group. Safety outcomes were similar between the two study groups. The authors concluded that there was a lower risk of kidney failure and CV events in patients who received canagliflozin compared to placebo in the study population. These results suggest that canagliflozin may be an effective treatment for renal and CV protection in patients with T2DM and CKD [11].

The Dapagliflozin and Cardiovascular Outcomes in Type 2 diabetes (DECLARE-TIMI 58) trial evaluated the safety and efficacy outcomes of dapagliflozin in patients with T2DM who had or were at risk for atherosclerotic CV disease. Reported data was gathered from 17,160 participants who were followed for a median of 4.2 years. The primary efficacy outcomes included MACE and a composite of CV death or hHF. In adult patients with T2DM, mean age of 63.9 years, established CVD (41%) or multiple risk factors (59%), and a mean eGFR of 85.4 mL/min/1.73m2, the dapagliflozin group did not have a lower rate of MACE, but had a lower rate of composite outcome for CV death or hHF. Dapagliflozin did not demonstrate any difference from placebo, in respect to secondary outcomes, which included a renal composite (either 40% or more decrease in eGFR to <60 ml/min/1.73m2, new ESRD, or death from renal or CV cause) and death from any cause. While diabetic ketoacidosis was more common in the dapagliflozin group, the rate of genital infection was significantly higher in patients who received dapagliflozin than those taking placebo. Based on these results, the authors concluded that treatment with dapagliflozin resulted in a lower rate of CV death or hHF, a finding that reflects a lower rate of hospitalization for heart failure [12].

Although CV benefits in patients with T2DM were demonstrated in these trials, there were also limitations. In the EMPA-REG OUTCOME trial, 99% of patients had established CVD, therefore making the benefit of empagliflozin in T2DM patients without a history of CVD uncertain. Due to the established CVD, patients in this trial were also well treated with use of renin-angiotensinaldosterone system inhibitors, statins, and acetylsalicylic acid. Therefore, the CV benefits from empagliflozin may be multidimensional, possibly including positive changes such as arterial stiffness, cardiorenal effects, blood pressure, glycemic control, etc. All the other trials (CANVAS, CREDENCE, DECLARETIMI 58) had more balanced number of patients with established CVD and high risk of CVD, which may reflect better applicability of canagliflozin and dapagliflozin to either primary or secondary CVD prevention. However, this may also be interpreted as having a “diluted” CV benefits from these agents [9].

A major limitation of the CANVAS program is the relatively small proportion of participants with established kidney disease. This might have limited its generalization to that particular population. Moreover, there was a greater use of other glucose-lowering agents in the placebo group, which may indicate an underestimation of any benefits and risks associated with canagliflozin [10]. While the CREDENCE trial dispelled the concern of paucity of ESRD events in the CANVAS program and included a population with high risk of CV events, it might have overestimated the effect sizes when the trial was stopped early at a planned interim analysis. The CREDENCE trial was also flawed by not having off-treatment eGFR levels measured in patients who had completed the trial, so the differences in eGFR compared to the placebo group might have been under-estimated. In addition, the study did not include patients who had very advanced kidney disease, non-albuminuric or micro-albuminuric disease, and kidney diseases not due to T2DM. Therefore, its findings cannot be generalized to those populations [11]. Compared to other trials, the DECLARE-TIMI 58 had a more restrictive exclusion criteria of creatinine clearance of < 60 mL/min, which might have limited the demonstration of mortality benefit in patients with poorer kidney function [12]. Finally, all four trials also had concentrated data from the white and male population, therefore it is unknown whether this study limits the external validity in patients who may benefit from a SGLT2-inhibitor, especially in different races or the female population.

Glucagon-like Peptide 1 Receptor Agonists

At this time, three of the five GLP1 receptor agonists on the market have FDA approved indications to reduce the risk of MACE in adults with T2DM and established CVD in addition to improve glycemic control as an adjunct therapy. In addition to the indication for MACE reduction, dulaglutide is also approved for the reduction of MACE T2DM patients with multiple CV risk factors [13-15] (Table 2). The Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (LEADER) trial studied the cardiovascular effects of liraglutide in 9,340 patients with T2DM, aged 50 years or more with at least one CV coexisting condition, or aged 60 years or more with at least one CV risk factors. After a median follow up of 3.8 years, liraglutide was shown to be non-inferior to placebo in the primary outcomes of CV composite, which included first occurrence of death from CV causes, nonfatal MI, or nonfatal stroke. Liraglutide was also shown to be non-inferior in the expanded composite outcome measure that included coronary revascularization, or hospitalization for unstable angina or heart failure. In the composite outcome of microvascular nephropathy, the liraglutide group had a lower rate of events than placebo. Significant adverse events in the liraglutide group included a higher rate of acute gallstone disease, as well as nausea, vomiting, and diarrhea. Based on these results, the authors concluded that the rate of the first occurrence of death from CV causes, nonfatal MI, or nonfatal stroke among patients with T2DM was lower with liraglutide than with placebo [16].

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Iris Publishers- Open access Journal of Complementary & Alternative Medicine | Perceptions of Drug Use in The Workplace

 

Authored by Debra Charles*

Abstract

Given the ongoing conversation regarding the national legalization of cannabis, it is important to understand perceptions of the use of cannabisrelated substances. In the current study, we collected data from 197 adults via an online survey to examine moral perceptions about drug use in general and in the workplace. Specifically, we asked subjects to report whether testing positive for a given substance was sufficient grounds for being fired when that substance was prescribed by a doctor or when taken independent of a physician. Our results indicate that adults view use of marijuana, specifically CBD, in a similar a manner as use of Tylenol or Motrin in the workplace. Indeed, an equal percentage of subjects— approximately 83%--reported that it was wrong to fire an employee for testing positive for Tylenol or for CBD. We discuss the implications of our findings.

Introduction

Recent work has started to examine perceptions and effects of substance use in the workplace [1-4]. A gap in this literature relates to the moral perceptions people hold regarding the use of various substances in the workplace. Whereas certain types of drugs might be regarded as acceptable (e.g., ibuprofen), others might not (e.g., opioids). Given the epidemic associated with opioid abuse, researchers have become interested in the extent to which other, substances (e.g., cannabinoids), might serve to replace more highly addictive narcotics [5]. Indeed, cannabis less harmful has a long history of being used medicinally [6]. But to the extent substances, like cannabinoid products, and their users are stigmatized, it might be more difficult to change medical norms. Here we examine perceptions of how morally wrong it is to use various substances in the workplace both under medical advisement and under conditions of self-medication. Specifically, we explore perceptions of how appropriate it would be to fire an employee based on either doctor-directed or self-directed substance use in the workplace.

Methods

Participants

197 participants (127 males; 70 females) completed an online survey on cannabis usage (age range: 20-68; M=33.48, SD=8.94). Participants identified as White (54.3%), African American (5.1%), Hispanic/Latino (6.1%), Asian (33.5%), and/or Native American, Alaskan Native (1.0%). Participants were paid $1.00 for completing a survey that took on average approximately 8 minutes to complete (range: 133s-4732s; M=471.39s; SD=419.75s). Local IRB approval was obtained.

Materials and Procedure

Participants were recruited using Amazon’s Mechanical Turk. After reading and agreeing to the consent form, participants responded to questions regarding their perceptions of use of various substances as medically prescribed or not. Upon completion, participants were supplied with a survey code to use for participation payment via Amazon’s Mechanical Turk.

Results

We report on usage statistics of various substances in our sample in Table 1. As can be seen, large proportions of subjects reported using each kind of substance. Next we evaluated subjects’ reports of how morally wrong it is to take each type of substance without a prescription. For each substance that was not medically prescribed, we asked subjects to respond whether taking the substance was morally wrong on the following scale: 1= “not morally wrong”; 2=“somewhat morally wrong”; or 3= “extremely morally wrong”. As shown in Table 1, subjects reported taking Tylenol and Motrin without a prescription as least morally, followed by taking cannabinoid products without a prescription. Taking morphine without a prescription was views as the most morally wrong of all the substances. Last, we asked subjects to image two scenarios. One in which a co-worker tested positive for a drug he was taking with a doctor’s prescription and was subsequently fired and another scenario in which a co-worker tested positive for a drug he was taking without a doctor’s prescription and was subsequently fired. The scenarios were as follows: Prescription: “An acquaintance, who works a 9-5 office job, recently underwent back surgery to help reduce chronic nerve pain. The surgery was a success, but left him in sporadic pain, which he was told would subside after a few months. To manage his pain, the doctor prescribed him medication, which he started to take. Upon returning to work, he was asked to take a routine drug test. Results from his urine sample revealed trace amounts of the drug his doctor prescribed, which ultimately lead his boss to fire him.”

No prescription: “Now, imagine your colleague had the same back surgery with the same post-surgery pain, but that his doctor had not prescribed any medication. His doctor thought it was better to “feel the body’s signals of pain”. However, your colleague found the pain unbearable and took some medication, which was discovered in his urine during his workplace drug test. He was then fired. ”We then asked if it was okay for the coworker to be fired if the substance was either Tylenol, Motrin, Codeine, Vicodin, Percocet, Morphine, street bought marijuana, over the counter CBD vapes or tinctures, physician recommended legal marijuana, physician recommended legal CBD/ THC tinctures, alcohol, or Xanax.

As reported in Table 1, we found that overall, it was more acceptable to fire an employee for using a substance without a medical prescription. Also, the substances viewed as justifying termination the most were Percocet, street bought marijuana, and alcohol.

Discussion

In this study, we examined perceptions of the morality of the use of various substances as well as whether different substances are differentially perceived to justify job termination. Despite the large proportion of subjects reporting the use of street bought marijuana, the perception appears to be that its use in the workplace justifies termination similar to other schedule 1 narcotics. If the medical establishment aims to supplement or replace opioid substances with plant based palliative medicines like cannabinoids, there is much work to be done in terms of public perception. The data here contribute to this area of growing research.

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Iris Publishers- Open access Journal of Complementary & Alternative Medicine | A Four-Year Prospective Study of Injuries in Elite Ontario Youth Soccer Players During Training and Match Play: A Follow-Up

 

Authored by Robert Gringmuth*

Abstract

Introduction: With over 200 million amateur athletes worldwide, with soccer as one of the most popular and internationally recognized sports today. By understanding how and why soccer injuries occur, we hope to reduce prevalent injuries amongst soccer athletes.

Methods: Via a prospective cohort, we tracked male and female soccer players between the ages of 13 to 17 eligible to train with the Ontario Soccer Association provincial program during the period of January 1st, 2013 and December 31st, 2016. Data collection occurred during all player exposures to potential injury. Exposures occurred at the Ontario Soccer Centre training grounds and various other venues on multiple playing surfaces throughout Ontario.

Results: 473 injuries were recorded. Muscle strain, pull or tightness was responsible for 35.7% of all injuries and ranked as the most prevalent injury.

Discussion: As anticipated, the most common injury reported in a four-year prospective study of injuries in elite Ontario youth provincial and national soccer players during training and match play was muscular strain, which warrants more suitable preventive programs aimed at strengthening and properly warming up the players’ muscles.

Keywords: Soccer; Injury; Athlete; Youth; Muscle strain; Epidemiology; Prevalence; Incidence

Introductio

It is estimated that there are some 200 million amateur soccer players and approximately 200,000 professional athletes worldwide, soccer is one of the most popular and internationally recognized sports played today. The 2014 Fédération Internationale de Football Association (FIFA) World Cup in Brazil was one of the most watched television events in history [1]. A total of 3.43 million people watched 64 games, meaning the average attendance per game was 53,592. This was the highest average since the 1994 World Cup in the United States. As of 2014 [2], there were approximately 270 million active player memberships to FIFA.

In considering the various aspects of the game, player safety is first and foremost considered the responsibility of the participants and organizers. With many sports being played, injuries are inevitable as the potential for injuries increases with intensity, frequency, and vigor of the training sessions. As reported by Schmikli SL, et al. [3] the incidence rate of outdoor soccer injuries, particularly for adult male soccer players, is among the highest of all sports including rugby, boxing, fencing, and cricket. Although there is some discrepancy in reports of the number of injuries per 1,000 playing hours, according to Goncalves CA, et al. [1] the incidence of soccer related injuries is estimated to be 10 to 15 injuries per 1,000 hours of practice. Dvorak J, et al. [4] found similar statistics, reporting 12 to 35 injuries per 1000 match hours, and 1.5 to 7.6 injuries per 1000 training hours. Injury avoidance is a crucial element for the youth soccer athlete at all competitive levels. This allows athletes to train and develop their skill sets at their maximal effort without avoidable layoffs. Time loss due to injury is critical for both a promising soccer athlete and their team due to injury limiting the possibility of the team reaching its highest performance potential. There is an estimated time loss due to injury of two weeks for a team made up of 25 players.

Injury has a negative economic impact on both the athlete and the team. There are long-term consequences associated with being injured as an athlete. FIFA estimates that the average treatment cost is $150-U.S. per injury, which leads to an estimated $30 billion U.S. a year for treatment of injuries in soccer around the world [2]. In addition, English Premier League clubs were estimated to be $19 to 26 million-U.S. out-of-pocket in lost wages due to injuries suffered by their players in the 2010/11 season after taking part in the World Cup [5].

It is evident that injury prevention plays a necessary role in reducing the costs incurred from soccer-related injuries along with minimizing a player’s time loss due to injury. Prevention is usually seen as the first step in maintaining optimal health. With injury prevention we must understand the types of injuries and their mechanisms that are common amongst soccer athletes. The consensus is that the majority of soccer injuries are related to the lower extremities, which is not surprising since soccer is a highintensity sport characterized by continuous changes of direction and high-load actions [6]. Nonetheless, in various soccer nations, such as the United Kingdom, the United States and Brazil, the epidemiology of injuries within the sport has shown a variation in injury patterns. For instance, the Carling et al. study suggested strains to the hamstring region are the most common type of injury at the professional levels in soccer [7]. Research studies suggest eccentric strength training can reduce the risk of hamstring injury in heterogeneous populations of soccer players [8]. In addition, plyometric training and agility drills, the main components of a preventive program developed by Heidt RS Jr, et al. [9] were effective in lowering the incidence of injuries in soccer. The Dick R, et al. [10] study concluded ankle ligament sprains, knee internal derangements and concussions are common injuries in women’s soccer. Ekstrand J, et al. [11] determined that almost one-third of all injuries in professional soccer are muscle injuries with the vast majority affecting the hamstring, adductors, quadriceps and calf muscles [11]. Therefore, it will be difficult to correlate the reported injury incidence, and thus formulate effective injury prevention strategies, for elite soccer athletes outside the geographic domain in which the study was conducted. To date, an epidemiological study has not been conducted regarding elite youth soccer athletes in Canada aside from our previous study.

According to Aaltonen S, et al. [12] decreased risk of sports injuries was associated with the use of insoles, external joint supports, and multi-intervention training programs. A paper by Emery CA & Meeuwisse WH [13] found that an implemented training program was effective in reducing the risk of all injuries as well as preventing injuries. The protective effect of the neuromuscular training program in reducing lower extremity injury is clinically relevant. Finally, Dvorak J & Junge A [4] showed that there is some evidence that multi-modal intervention programs result in a general reduction in injuries. They found that external ankle supports and proprioceptive/coordination training, especially in athletes with previous ankle sprains, could prevent ankle sprains. In addition, training of neuromuscular and proprioceptive performance as well as improvement of jumping and landing technique seems to decrease the incidence of anterior cruciate ligament injuries in female athletes [14].

Therefore, it will be difficult to correlate injury incidence and thus injury prevention for youth soccer athletes outside the geographic domain in which the study was conducted. To date such a study has not been conducted within the scope of elite youth soccer athletes in Canada. The variability of the conclusions of these studies likely reflects that there are many factors (i.e. location, weather, surface playing field, age, sex and performance level) that ultimately determine the variation on why and how soccer players are injured and in turn, the preventative strategies that can be utilized to help reduce both the occurrence and recurrence of such injuries.

By taking into consideration the model for epidemiological studies on professional soccer player injuries in Brazil [1], the purpose of this preliminary study is to provide an injury incidence report for youth soccer in both Ontario as well as nationally in Canada. As such, due to differences in climate, technical level and total hours of play and training we believe that occurrence of injury per 1,000 hours of play and training, will be less in Canada compared to other soccer nations. The second objective is to provide an injury incidence report for the most common injuries during training and match play among youth soccer players in Ontario. By understanding how and why soccer injuries occur we ultimately hope to reduce the most prevalent injuries amongst youth Canadian soccer athletes beginning with an incidence inventory as a necessary first step.

Research Design and Methods

In concordance with Goncalves CA, et al. [1] the research design selected for this study is a prospective cohort. Historically, epidemiological studies examining soccer injury incidence have been prospective in nature. Methodology utilizing retrospective study design had many biases, which reduced the validity of risk assessments. Prospective study design has been shown to be the most useful method for estimating the risk of injury or disease, the incidence rate and/or relative risk [7].

Through a prospective concurrent longitudinal study, we can determine and define the population at the beginning of the study and follow the subjects through time. Cases are enrolled from a well-defined population, current exposure status is determined as non-injured and the onset of injury is observed in subjects over time. Injury status can be compared to non-injured status relative to exposure time. The study begins at the exposure of the cohort to exposure. Exposure status has been predetermined as all strength and conditioning sessions, training sessions and games overseen by an athletic therapist. The characteristics of the group of people studied have been pre-determined as healthy eligible Ontario Soccer Association (OSA) provincial and National Training Centre Ontario (NTCO) players. Non-cases or uninjured eligible players are followed forward in time. Cases or injury status and recording of the aforementioned have also been pre -determined.

The population of this study included all soccer players, males and females, between the ages of 13 to 17 years, eligible to train with the Ontario Soccer Association provincial program during the period of January 1, 2013 to December 31, 2016. It also included all players eligible to play for the NTCO Under-17 women’s program during the aforementioned periods. The players were selected based on criteria determined by the Ontario Soccer Association coaches and are considered among the elite population of soccer players in the province and country. In total, the study worked with seven teams each 28 players per team through four calendar seasons which runs from mid-October until the end of April of the following year. The total exposure hours were calculated combining training, match and strength conditioning hours for one calendar year or the provincial program from mid-October until the end of April. The exposure hours were then extrapolated over four years due to the consistency in scheduling within the provincial program related to limitations in field time. A total of 32,270 hours of exposure were recorded over one calendar year and estimated as 129,080 hours over four years.

Collection of Data

The source of data collection is The Sports Injury & Rehabilitation Centre, Inc. (SIRC). All player injuries were tracked and recorded on site using the centre’s electronic medical recording database called Injury Tracker®. Data collection occurred during all player exposures to potential injury including strength and conditioning sessions, training sessions and matches. Exposures occurred at the Soccer Centre, Ontario training grounds and various other venues on various playing surfaces. An athletic therapist employed by SIRC oversaw all exposures. Injury reports were filled out by a healthcare provider at occurrence of injury and before a player is referred for follow up medical care. An injury report is required to be completed if any of the following criteria are met:

•Player is removed from field of play by a health care provider or player is unable to return to play.

•Player requires treatment to return to play.

•Player suffers a concussion.

•Player does not participate in practice due to injury/condition.

•Player intake at the clinic directly due to inability to play.

Injury reports are submitted at the end of the session by the healthcare provider to the clinic supervisor who ensures that designated clinic personnel enters them into the clinic database.

Ethics and Human Subjects Issues

Players’ names or personal medical information cannot be tracked or identified in any manner.

Results

A total of 473 injuries were recorded through 129,080 exposure actual hours experienced by seven teams over the span of four seasons. The cumulative injury incidence rate among all players through four seasons was 8.34 injuries per 1,000 hours of training, strength and conditioning, or match play. The highest injury incidence rate occurred during the 2013 to 2014 season valued at 11.62 injuries per number of hours trained and played. The seasonal injury incidence variation across four years is presented in Figure 1.

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