Degludec Versus Glargine in Type 2 Diabetes for CV risk

Tibin K. Titus, Mercer University College of Pharmacy

Type 2 diabetes affects millions of people worldwide. [1] Among the complications that arise from diabetes are cardiovascular (CV) complications such as stroke, coronary heart disease, and vascular disease. [1] Additionally, studies have shown that type 2 diabetics who require insulin have increased rates of cardiovascular events. [2,3]

Degludec is a new and ultra long acting basal insulin that came into the market in 2016. It is approved for glycemic control in type 2 diabetes. The Food and Drug Administration (FDA) requires all new diabetes drugs to have a CV risk study. [6] To fill the gap in knowledge for the CV safety of degludec, the following study was conducted. [7]

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Delayed Versus Immediate Umbilical Cord Clamping

Shanterra Grable, Mercer University College of Pharmacy

Delayed umbilical cord clamping is performed from 25 seconds to five minutes after birth. The practice is thought to allow more blood to transfer from the placenta to the newborn, possibly increasing the baby’s blood volume by 30%. The American Congress of Obstetricians and Gynecologists (ACOG) supports delayed cord clamping in preterm infants but not in full term infants due to insufficient evidence showing benefits. The current standard during delivery  is to clamp the umbilical cord 10 to 30 seconds immediately after birth.  [1]

One of the associated benefits of delayed clamping is decreased risk of iron deficiency anemia due to transfer of additional 40 to 50 mg/kg of iron from the placenta to the infant. [1] Prior randomized controlled trials found that delayed cord clamping in preterm infants less than 32 weeks gestational age had lower instances of mortality, necrotizing enterocolitis, and infection than infants with immediate cord clamping; however, these studies did not show if delayed cord clamping is the sole factor leading to mortality and neurodevelopmental benefits. Despite the potential benefits, delayed clamping is not a universal practice due to concerns of delayed resuscitation and hyperbilirubinemia.  The following study was performed to add knowledge regarding the effects of delayed clamping on death and major morbidity in preterm infants. [2]

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Surgery for Drug- Resistant Epilepsy in Children

Shanterra Grable, Mercer University College of Pharmacy

Epilepsy affects 65 million people worldwide. Of those, 3.4 million are in the United States. One third of the people with epilepsy are thought to be resistant to available treatments and live with uncontrolled seizures. [1]

If seizures persist after two trials of the appropriate medication at the proper dose, they are considered to be “drug resistant”. [2] Surgery is an option if patients do not respond to medication therapy alone. These surgeries have been performed for over a century, and their use has seen a significant increase in the 1980s and 1990s. However, evidence suggests that success cannot be guaranteed; therefore, risk versus benefits of these procedures should be carefully weighed. [3]

It has been suggested that the earlier surgery is performed, the better patient outcomes are.  Despite the evidence, the Epilepsy Foundation recommends to consider surgery as a last resort. [3] Previously, a retrospective analysis of 142 children showed that 79.3% were free from seizures post surgery with an average follow up of four years. This study was performed as a follow up on to the aforementioned trial in order to compare outcomes of surgery to medical therapy alone. [4]

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Effects of Oral Insulin on Prevention of Diabetes in Relatives of Patients with Type 1 Diabetes

Julia Lvovich, Mercer University College of Pharmacy

Type I diabetes, also known as juvenile diabetes, is a chronic disease where the insulin producing cells of the pancreas are destroyed. Currently, there is no cure for this autoimmune disease, but studies have been using immunologic markers to predict the disease onset and predisposition. The diabetes prevention trial-type 1(DPT-1) explored the possibility of preventing type I diabetes in first- and second-degree relatives by preforming two trials; one trial in which patients received parenteral insulin therapy, and in the other trial, patients received oral insulin therapy. [1,2] Both trials failed to show a significant reduction or delay in the development of type I diabetes; however, new developments have since been made in the field of autoantibody tests prompting TrialNet study. [1,2]

TrialNet study used microinsulin autoantibody assay, which requires much less blood than radioimmunoassay that was used in the DPT-1 trials. TrialNet chose a similar group of subjects to those who have shown a trend toward benefit in the oral subgroup in from the DPT-1 trial. [3] However, the difference is that it first identified subjects by positive microinsulin indicators rather than positive islet cell antibodies, which was the baseline eligibility in the DPT-1 trials. By doing so, TrialNet included a subgroup of patients that may have been excluded in the DPT-1 trials. [1-3]

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Naproxen Plus Muscle Relaxants vs. Naproxen Alone for Lower Back Pain

Shanterra Grable, Mercer University College of Pharmacy

In Americans under 45 years old, back pain is the leading cause of disability. It is estimated that anywhere from 60 to 80 % of the United States suffer from low back pain. This can affect flexibility, stability, and strength that can cause pain and discomfort, which can lead to chronic or temporary disability. [1]

While there is moderate evidence to show that a combination of  NSAIDS and muscle relaxants can be beneficial in treating acute back pain, it is not known which medications improve patient perceptions of pain. The mechanism in which muscle relaxants aid in relieving back pain is unknown but is thought to be related to their general analgesic effects in the central nervous system and not directly on skeletal muscles. The two muscle relaxants used in the following study, orphenadrine and methocarbamol, are prescribed in over 250,000 emergency room visits annually; however, there is little evidence to suggest that these two muscle relaxants are effective in treating low back pain.  [2]

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ACE Inhibitors and Statins in Adolescents with Type-1 Diabetes

Julia Lvovich, Mercer University College of Pharmacy

Type 1 diabetes most frequently occurs in children and adolescents, although this autoimmune disease can occur at any age. In type 1 diabetes, beta cells are destroyed by the body’s own immune system, causing a complete insulin dependence. Due to the early onset of disease and difficulty of glycemic control, type 1 diabetic patients are at an increased risk of long-term complications, such as diabetic kidney disease. [1]

During early stages of diabetic kidney disease, kidneys begin removing trace amounts of albumin from the blood and may lead to microalbuminuria. It is suggested that an increase in albumin excretion during adolescence predicts the development of microalbuminuria and diabetic kidney disease. [1] Currently, there is no established clinical criteria for early interventions based on microalbuminuria; however, it is suggested that management may prove beneficial for type 1 diabetics. In adult diabetic (type 1 and 2) patients, microalbuminuria is managed by angiotensin-converting enzyme (ACE) inhibitors; however, in adolescents there is a lack of evidence to support the use of preventative measures to reduce the incidence of and progression to diabetic kidney disease. [2,3]
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Fremanezumab for the Preventative Treatment of Chronic Migraine

Shawn Yee, Mercer University College of Pharmacy

Migraine headache is a neurological disorder that manifests as recurrent attacks of pulsating head pain, with or without visual disturbances. Migraines are moderate to severe in pain and can be debilitating, leading to a lower quality of life. [1] The current Neurology Guideline suggests divalproex sodium, sodium valproate, topiramate, metoprolol, propranolol, and timolol are effective for migraine prevention and can be used to reduce migraine frequency and severity. [2]

Chronic migraine is seen in about 2% of the general population, and in comparison with episodic migraine, it is associated with decreased quality of life and increased headache-related burden. Therefore, preventing the onset could reduce the burden of chronic migraine and is an ongoing area of research. [3]

Fremanezumab is a humanized IgG2a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP). In a phase II trial, the number of migraine and headache days were significantly lower with fremanezumab treatment, and no serious treatment-related adverse events occurred. [4] Below is a summary of phase III trial. [5]

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