Evan M. Sisson

Liraglutide: clinical pharmacology and considerations for therapy.

Liraglutide is a United States Food and Drug Administration (FDA)‐approved glucagon‐like peptide−1 (GLP‐1) analog that is 97% homologous to native human GLP‐1. The additional 16‐carbon fatty acid chain causes noncovalent binding to albumin, which slows absorption from the injection site and protects the molecule from degradation by the enzyme dipeptidyl peptidase‐4, allowing for protraction of action. Albumin binding and an elimination half‐life of 13 hours combine to allow for once‐daily dosing. Liraglutide 1.2 and 1.8 mg/day given as monotherapy for up to 52 weeks produced mean reductions in hemoglobin A1c (A1C) of 0.6–1.6%; combination therapy of liraglutide with oral antidiabetic agents demonstrated mean A1C reductions up to 1.5%. The satiety effect of GLP‐1 receptor agonists and documented weight loss as great as 3.38 kg in clinical trials may make liraglutide ideal for obese patients with type 2 diabetes mellitus. Like other incretin‐based agents, preliminary studies suggest liraglutide may also increase β‐cell mass and function. Hypoglycemia is rare with liraglutide and tends to occur when used in combination with sulfonylureas; liraglutide in combination with insulin is not yet FDA approved. The pharmacokinetic parameters of liraglutide are unaffected by age, sex, race, or ethnicity, and no special recommendations for altered dosing of liraglutide need apply to populations with hepatic or renal impairment. Results from clinical trials have not shown an increased risk of medullary thyroid cancer, pancreatitis, or poor cardiovascular outcomes with liraglutide treatment. Ongoing, long‐term monitoring studies continue to evaluate the safety of liraglutide treatment in these outcomes.

Lomitapide and mipomersen: novel lipid-lowering agents for the management of familial hypercholesterolemia.

Background:Familial hypercholesterolemia (FH) is an autosomal dominant disorder caused primarily by mutations in the low-density lipoprotein receptor gene. Familial hypercholesterolemia is characterized by exceedingly high levels of low-density lipoprotein cholesterol (LDL-C) and subsequent premature coronary heart disease. Homozygous FH (HoFH) is less prevalent, but more severe, than heterozygous FH. Current treatment options include dietary therapy, lipid-lowering agents (eg, statins), and/or LDL-C apheresis. Purpose:Despite the available treatment options, patients with FH rarely attain treatment goals. This review will focus on 2 novel agents, lomitapide and mipomersen, with recently approved US Food and Drug Administration (FDA) labeling for use in patients with HoFH. Conclusions:Lomitapide and mipomersen are 2 agents with novel mechanisms of action and the ability to significantly lower LDL-C, apolipoprotein B, and non–high-density lipoprotein cholesterol levels. A black box warning exists for lomitapide and mipomersen regarding the risk for transaminase elevations and hepatic steatosis. Furthermore, these agents are currently restricted for use only in patients with HoFH and have been required by the FDA to participate in a Risk Evaluation and Mitigation Strategy. Clinical Implications:These new agents offer additional treatment options for clinicians managing patients with HoFH, but it remains uncertain whether lomitapide and mipomersen will gain FDA approval for use in patients with heterozygous FH or in the general population. Cost and concern for the risk for hepatotoxicity will remain limiting factors to these agents being more widely used.

Pharmacist scope of practice, standards of practice, and standards of professional performance for diabetes educators

In 2005, the American Association of Diabetes Educators (AADE) published “The Scope of Practice, Standards of Practice, and Standards of Professional Performance for Diabetes Educators,” written by a multidisciplinary team. Nurses and dietitians developed and published complementary, discipline-specific documents. Similarly, this document addresses the specific role of the pharmacist in the delivery of diabetes education and is meant to complement the AADE “Scope of Practice, Standards of Practice, and Standards of Professional Performance for Diabetes Educators.” The purposes of this document are

Effectiveness of a Pharmacist-Physician Team-Based Collaboration to Improve Long-Term Blood Pressure Control at an Inner-City Safety-Net Clinic

To evaluate the effectiveness of a pharmacist‐physician collaborative practice model (PPCPM) to improve long‐term blood pressure (BP) control rates in a primarily African‐American underserved urban population.

Pharmacist-physician collaborative care model and time to goal blood pressure in the uninsured population

Pharmacist‐physician collaborative practice models (PPCPMs) improve blood pressure (BP) control, but their effect on time to goal BP is unknown. This retrospective cohort study evaluated the impact of a PPCPM on time to goal BP compared with usual care using data from existing medical records in uninsured patients with hypertension. The primary outcome was time from the initial visit to the first follow‐up visit with a BP <140/90 mm Hg. The study included 377 patients (259 = PPCPM; 118 = usual care). Median time to BP goal was 36 days vs 259 days in the PPCPM and usual care cohorts, respectively (P < .001). At 12 months, BP control was 81% and 44% in the PPCPM and usual care cohorts, respectively (P < .001) and therapeutic inertia was lower in the PPCPM cohort (27.6%) compared with usual care (43.7%) (P < .0001). Collaborative models involving pharmacists should be considered to improve BP control in high‐risk populations.

A Prescription for Prescribing: Ensuring Continued Pharmacist Preparedness:

The scope of practice for pharmacists in the United States increasingly includes elements of prescribing under collaborative practice agreements and statewide protocols. However, as a result of continued health care access concerns, we believe that pharmacists will be called on to serve as independent prescribers in the future. For this anticipated practice expansion to become a successful reality, the assurance of pharmacist preparedness and continuous professional development through profession-wide standards will be imperative.

An Overview of Concentrated Insulin Products.

IN BRIEF This article provides a summary of the use of available concentrated insulins in the outpatient treatment of patients with diabetes. Concentrated insulins work through the same mechanisms as other insulin products. They vary from each other in concentrations and pharmacokinetic/pharmacodynamics profiles but are each similar to their U-100 concentration counterparts. Patient education is important to minimize errors and the risk of hypoglycemia when using these insulin formulations.

The 2017 American College of Cardiology/American Heart Association hypertension guideline and opportunities for community pharmacists

OBJECTIVES To initiate a call to action for community pharmacists to maximize the opportunities to improve the management of hypertension (HTN) in light of the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) HTN guideline. SUMMARY In November 2017, the ACC and the AHA, along with 9 other professional organizations, released a comprehensive guideline on the prevention, detection, evaluation, and management of high blood pressure (BP). Major changes included the reclassification of BP and redefinition of HTN to 130/80 mm Hg or above, significantly increasing the number of individuals with HTN. The 2017 ACC/AHA HTN guideline also emphasized out-of-office BP readings and recommended team-based care models that include pharmacists and other health professionals as one strategy to improve BP control rates and provide appropriate follow-up and monitoring. Community pharmacists are highly accessible health professionals that now have an even greater opportunity to improve the monitoring and management of patients with HTN. Monitoring of BP in pharmacies could be greatly improved if BP kiosks were replaced by automated BP monitors operated by appropriately trained personnel that would initiate a face-to-face consultation with a community pharmacist. Physicians and other prescribers should also refer patients directly to their community pharmacists to receive assistance in selecting a home BP monitor. Given recent expansion of collaborative practice legislation and prescriptive authority, health information exchanges, and reimbursement models, community pharmacists have a renewed opportunity to collaborate with medical practices and health systems to improve BP control. In addition, greater collaboration among pharmacists practicing in primary care and community pharmacy could improve care coordination. CONCLUSION Community pharmacists have a significant opportunity to collaborate with patients, physicians, and the health care community at large to improve the monitoring and management of HTN and ensure that the 2017 ACC/AHA HTN guideline is successfully implemented.

Recent Developments in the Role of Coenzyme Q10 for Coronary Heart Disease: a Systematic Review

Purpose of ReviewThis review examines recent randomized clinical trials evaluating the role of coenzyme Q10 (CoQ10) in the management of coronary heart disease.Recent FindingsCoQ10 is one of the most commonly used dietary supplements in the USA. Due to its antioxidant and anti-inflammatory effects, CoQ10 has been studied extensively for possible use in managing coronary heart disease. One of the most common applications of CoQ10 is to mitigate statin-associated muscle symptoms (SAMS) based on the theory that SAMS are caused by statin depletion of CoQ10 in the muscle. Although previous studies of CoQ10 for SAMS have produced mixed results, CoQ10 appears to be safe. Because CoQ10 is a cofactor in the generation of adenosine triphosphate, supplementation has also recently been studied in patients with heart failure, which is inherently an energy deprived state. The Q-SYMBIO trial found that CoQ10 supplementation in patients with heart failure not only improved functional capacity, but also significantly reduced cardiovascular events and mortality. Despite these positive findings, a larger prospective trial is warranted to support routine use of CoQ10. Less impressive are the effects of CoQ10 on specific cardiovascular risk factors such as blood pressure, dyslipidemia, and glycemic control.SummaryCurrent evidence does not support routine use of CoQ10 in patients with coronary heart disease. Additional studies are warranted to fully determine the benefit of CoQ10 in patients with heart failure before including it in guideline-directed medical therapy.

COMPARISON OF A PHARMACIST-PHYSICIAN COLLABORATIVE CARE MODEL TO STANDARD CARE ON THE TIME TO REACH GOAL BLOOD PRESSURE FOR PATIENTS PRESENTING WITH URGENT HYPERTENSION

Background: Delayed intensification of blood pressure (BP) management is associated with an increased risk of cardiovascular disease. Pharmacist-physician collaborative care models (PPCMs) improve BP control rates and reduce mean BP, but it is unknown if PPCMs affect time to BP goal when compared to