Efficacy and Safety of Alirocumab in Insulin-treated Diabetics with High Cardiovascular Risk

Kayla Peltier, Mercer University College of Pharmacy

In 2015, the Centers for Disease Control and Prevention (CDC) estimates that 23.0 million Americans were living with diabetes and 7.2 million of Americans had undiagnosed diabetes. [1]

Diabetes is a risk factor for atherosclerotic cardiovascular disease (ASCVD), and the National Lipid Association (NLA) guidelines classify patients with diabetes as high-to-very-high-risk for developing ASCVD. [2] Due to the concern, the most current lipid guidelines from the American College of Cardiology (AHA)/American Heart Association (AHA) and the American Diabetes Association (ADA) standards of care recommend that patients aged 40 to 75 years with diabetes be started on moderate-intensity statin therapy for primary prevention of ASCVD. [3,4] The NLA guidelines recommend that diabetic patients receive either moderate- or high-intensity statin therapy, regardless of patient age. [2]

Alirocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin kexin type 9 (PCSK9) and is indicated for the treatment of heterozygous familial hypercholesterolemia or clinical ASCVD in addition to lifestyle modifications and maximally tolerated statin therapy in adults who require additional LDL-C lowering. [5] Concerns have been raised about the safety and efficacy of PCSK9 inhibitors in addition to the use of insulin therapy in diabetic patients. Therefore, this study aimed to investigate the efficacy and safety of alirocumab in patients with diabetes mellitus. [6] Continue reading


Weight Loss, is it Worth the Cost?

Meron Mezgebe, Mercer University College of Pharmacy

The estimated global incidence of diabetes is predicted to increase to 439 million adults by 2030 partially due to increasing prevalence of obesity and sedentary lifestyle. Diabetes may lead to premature death and complications such as blindness, amputations, renal disease, and cardiovascular diseases. [1] In the U.S., Type 2 Diabetes (T2D) costs the economy over $245 billion yearly. [2] Gastric band (GB) surgery for obese people with T2D was previously found to be cost-effective and clinically effective compared with non-surgical interventions. [3]

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Cost-Benefit Analysis of Appointment-Based Medication Synchronization in the Community Pharmacy

Qaashif Panjwani, Mercer University College of Pharmacy

The U.S. healthcare system incurred a cost of approximately $2.7 trillion in 2010, which accounted for nearly 17.9% of the gross domestic product. Of the total healthcare expenditure, nearly 30% has been identified as wasteful expense such as hospitalization due to medication non-adherence. Non-adherence to medications is suggested to lead to billions of dollars in avoidable direct medical costs. [1]

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Novel glucose-sensing technology, tight blood-glucose control, and hypoglycemia

Ben Uphouse, Mercer University College of Pharmacy

According to the American Diabetes Association (ADA), tight blood glucose control is defined as maintaining a level as close to normal (nondiabetic) as possible.  Specifically, this means aiming for blood glucose (BG) levels between 70 – 130 mg/dL before meals, less than 180 mg/dL after a meal, and a glycated hemoglobin (A1C) of less than 7%. [1] Tight control is stated to be advantageous for diabetics because it delays onset of macrovascular and microvascular diabetic complications. [2] However, according to the American Diabetes Association (ADA), tight BG levels may be difficult to maintain due to two major problems: potential for hypoglycemia and weight gain. [3]

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Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes

Caitlin Higgins, Mercer University College of Pharmacy

Jardiance® (empagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).  According to the package insert, empagliflozin should not be initiated if glomerular filtration rate (GFR) is below 45 mL/min/1.73 meters squared (m2).  Empagliflozin is contraindicated in patients with severe renal impairment, end-stage renal disease, or those receiving dialysis. [1]

A review article discusses the role of SGLT2 inhibitors, in which the drug class mechanism of action was stated to improve glucose control by increasing urinary glucose excretion.  The SGLT2 inhibitors were suggested to be most effective under normal circumstances, in which the adult kidney filters about 180 grams of glucose per day; it is noted that effectiveness is decreased in the presence of renal dysfunction. [2]

According to Diabetes Care, it was suggested that if an A1C target is not achieved after approximately three months, a combination of metformin and one of the following six treatment options should be initiated: sulfonylurea, thiazolidinedione, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, or basal insulin. Patient preferences, as well as various patient, disease, and drug characteristics were suggested to guide drug choice. [3]

A review of the management of hyperglycemia in T2DM states that metformin is placed as a first line therapy and it can lower glycated hemoglobin (A1C) values by 1% to 1.5% and was suggested to cause weight loss. [4]

Currently, the SGLT2 inhibitors lower A1C by 0.5% to 1%, depending on the agent and the dosage used.  The drug class is associated with modest reductions in weight (-1.5 to -3.5 kg) and systolic blood pressure (-3 to -5 mmHg).  The SGLT2 inhibitors were suggested to be best suited for obese or hypertensive patients. [2]

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Association of Neighborhood Walkability in Overweight, Obesity, and Diabetes

Hilary T. Box, PharmD- Mercer University College of Pharmacy

The National Health and Nutrition Examination Survey estimated that 69% of US adults were overweight or obese in 2011-2012 resulting in an increase in diabetes prevalence from 15% in the late 1970’s.1-2 Diabetes prevalence has increased from less than 4% in 1990 to 8.3% in 2012.3-4 It is thought that neighborhoods have shifted towards sprawling, car-oriented communities that discourage walking with heavy reliance on motorized transportation. However, it has been shown that neighborhoods with high population density, well-connected streets, and high number of destinations within walking distance of residential areas have higher rates of walking and bicycling for transportation.5-6

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Genetic Evidence for Causal Relationships Between Maternal Obesity-Related Traits and Birth Weight

Hannah Webb, Mercer University College of Pharmacy

It is stated that on average, neonates born to overweight or obese women are larger than those neonates born to normal-weight women. Maternal overweight and obesity are considered to be risk factors for gestational diabetes. It is known that even in the absence of diabetes and when following the same controlled diet, obese women have an average reading of 7.2 mg/dL higher glucose levels than normal-weight women. [1]

Title: Genetic Evidence for Causal Relationships Between Maternal Obesity-Related Traits and Birth Weight
Design Meta analysis of 18 community based studies; N= 30,487
Objective To test for genetic evidence of casual association of maternal body mass index (BMI) and related traits with birth weight
Study Groups N/A
Methods Single-nucleotide polymorphism (SNP) genotype data were used from 30,487 women participating in 18 population or community-based studies
Duration N/A
Primary Outcome Measure Offspring birth weight from 18 studies
Baseline Characteristics Babies were born from the United Kingdom, Germany, the United States, Denmark, Canada, the Netherlands, Australia, Norway, and Finland.
Results Study Source Offspring birth weight (grams)
Fraser et al, 2013 3,481
Schlemm et al, 2010 3,472
Power and Elliott, 2006 3,325
Power and Elliott, 2006 3,379
Zhao H et al, 2009 3,440
Bisgaard, 2004 3,560
Nohr et al, 2009 3,643
Olsen et al, 2001 3,595
Knight et al 3,512
Lacroix et al, 2013 3,448
Jaddoe et al, 2012 3,528
Metzger et al, 2008 3,557
Mangus et al, 2006 3,526
Rantakallio, 1969 3.525
Boomsma et al, 2006 3,469
Medland et al, 2009 3,344
Nalatteru et al, 2013 3,365
Moayyeri et al, 2013 3,365
Adverse Events Common Adverse Events: N/A
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions Genetically elevated maternal BMI and blood glucose levels were potentially causally associated with higher offspring birth weight, whereas genetically elevated maternal SBP was potentially causally related to lower birth weight. If replicated, these findings may have implications for counseling and managing pregnancies to avoid adverse weight-related birth outcomes.

The causal relationship between birth weight and maternal obesity-related obesity remains uncertain. This meta-analysis was able to determine that genetically elevated maternal BMI and blood glucose levels were potentially causally associated with higher offspring birth weight. This leads to an increase in the risk of birth complications and opens the door to have implications for counseling and managing pregnancies to avoid adverse weight-related birth outcomes. Continue reading