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


Bivalirudin vs. Heparin for Improving Clinical Outcomes in PCI patients

Akpan Anani, Mercer College of Pharmacy

For patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS), anticoagulant therapy is necessitated by risk of thrombotic events. [1] Angiomax® (bivalirudin) is a direct thrombin inhibitor indicated for patients undergoing PCI and concurrently using a glycoprotein IIb/IIIa inhibitor (GPI). [2] Bivalirudin has been shown in some studies to cause less major bleeding than Hep-Lock® (heparin) in myocardial infarction (MI) patients needing anticoagulation [1,3]; however, limited research exists comparing bivalirudin to heparin for assessment of repeat MI or all-cause mortality risk.

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Rivaroxaban plus Aspirin for Stable Cardiovascular Disease?

Akpan Anani, Mercer University College of Pharmacy

Xarelto® (rivaroxaban) is an oral anticoagulant with indications for the treatment and prevention of thromboses, but not for the secondary prevention of cardiovascular events. [1] Conversely, aspirin has been shown to lower the risk of major adverse cardiovascular events and even cardiovascular death compared to placebo. [2] As a result, low dose aspirin (≤100 mg) is recommended for all tolerant patients in need of secondary prevention. [3] Due to bleeding risks, anticoagulants have not been recommended for these same patients. [4]

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Who is at Risk for Atherosclerotic Cardiovascular Disease

Meron Mezgebe, Mercer University College of Pharmacy

Elevated cholesterol increases the risk for developing atherosclerotic cardiovascular disease (ASCVD). [1] For the monitoring of cholesterol levels the American College of Cardiology and American Heart Association (ACC/AHA) recommend an initial lipid panel of patients 21 years or older, with no clinical ASCVD, and not currently on cholesterol-lowering drugs. The ACC/AHA statin benefit group assignment is made using patients’ age, comorbidities, 10-year ASCVD risk, and lipid panel. [2] A systematic review on lipid screening of younger adults (21-39 years) found no studies directly evaluating the effects of lipid screening versus no screening in younger adults. [3] The U.S. preventative services task force (USPSTF) recommends screening for lipid disorders in men 35 years or older and women 45 years or older, unless they have increased risk of coronary heart disease. [4] Continue reading

Is There a Link Between The Degree of Maternal Obesity and Congenital Malformations?

Derek Ebot-Akoachere, Mercer University College of Pharmacy


According to the United States Surgeon General, the Centers for Disease Control and Prevention, and the National Institutes of Health, obesity is a health issue of nationwide epidemic proportions, [1] Almost one-third of women of childbearing age are considered obese [2], and obesity is associated with many pregnancy complications including congenital malformations (CMF). [3] The relationship between obesity in pregnancy and CMF has been investigated, but there is little data associating increasing severity of obesity and CMF.

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Telemonitoring in Heart Failure Patients Treated by Cardiac Resynchronization Therapy with Defibrillator (CRT-D): the TELECART Study

Raiza Gandola, Mercer University College of Pharmacy

An analysis that evaluated 3,857,420 Medicare beneficiary patients over 65 years old who were hospitalized with heart failure found that little progress has been made in improving short-term mortality, with minimal improvements in long-term mortality in this patient population. [1]

Telemonitoring, as suggested in a review that analyzed its use in the management of chronic heart failure patients, is an effective tool in reducing the risk of all cause mortality and heart failure related hospitalizations. [2]

Telemonitoring involves remotely monitoring patients who are not at the same location as the health care provider, giving them the information necessary to manage patient’s conditions. As noted from patient feedback about the use of telemonitoring, its use has had a positive impact on their health giving them peace of mind that their condition is being closely followed. [3]

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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