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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Sotagliflozin Added to Insulin in Type 1 Diabetics

Shanterra Grable, Mercer University College of Pharmacy

Type 1 diabetes, previously considered juvenile diabetes, affects approximately 29 million adults worldwide. It develops when the pancreas stops producing insulin, eliminating the body’s ability to maintain glucose control. The autoimmune disease can have a rapid onset and must be managed with insulin administered via injection or by pump.  It is  approximated that less than one-third of people living with type 1 diabetes achieve the target A1c of less than 7%. [1]

Sotagliflozin is the newest agent in a class of antidiabetic agents known as sodium –glucose cotransporter 1 and 2 (SGLT2) inhibitors. Prior phase two studies on sotagliflozin have shown improved glycemic control, reduced body weight, and reduced glycemia in both type 1 and type 2 diabetics. None of the current medications on the market are approved for use in conjunction with insulin to lower glucose in type 1 diabetic patients. The inTandem3 phase three trial evaluated the effects of sotagliflozin when used in combination with insulin on glycemic control, instances of severe hypoglycemia, and diabetic ketoacidosis in adults with type 1 diabetes. [2]

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A Controlled Trial of Erenumab for Episodic Migraine

Shawn Yee, Mercer University College of Pharmacy

Migraine is a common neurological disorder that is ranked top 10 in terms of global disease burden. [1] The term migraine can be categorized into either episodic (< 15 migraine or headache days per month) or chronic (≥ 15 headache days per month, with ≥ eight days of migraine days). [2] Patients with debilitating or frequent migraines are eligible for preventative treatment; however, none of these options target the pathophysiologic pathways involved in migraines. [3]

Erenumab is a fully human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor, which is involved in migraine pathophysiology of the trigeminovascular system. [3] There are other monoclonal antibodies targeting CGRP, such as fremanezumb that have shown safety and efficacy in migraine prevention. Erenumab in particular, has also demonstrated efficacy in reducing the number of migraine days per month at doses ranging from 70 mg to 140 mg per month in a prior phase II trial. [3,4] Below is the summary of a phase III trial. [3]

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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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Effect of Bisphosphonate Initiation at Week 2 Versus Week 12 on Short-Term Functional Recovery after Femoral Neck Fracture: a Randomized Controlled Trial.

Shawn Yee, Mercer University College of Pharmacy

Hip fractures in the elderly population are associated with serious health consequences, which includes significant mortality, loss of mobility, and decreased independence. [1,2] Bisphosphonates are the most commonly used medications for osteoporosis treatment and prevention. [3,2] They work by inhibiting bone resorption and causing osteoclast apoptosis. [4,2] However, due to concerns with correcting low vitamin D and calcium levels as well as potentially negative effects on healing, the appropriateness of early treatment initiation of bisphosphonates is unclear. [5,2]

A recent meta-analysis (N= 10 trials, N= 2,888) that reviewed early versus late initiation of bisphosphonates after surgery for fractures found that fracture healing time was not delayed with early initiation of bisphosphonates. The included studies used alendronate, zoledronic acid, risedronate, and etidronate. [6] Below is a summary of a randomized controlled trial evaluating the effects of early versus late initiation of risedronate post-hemiarthroplasty. [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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