Romosozumab: A Novel Agent in the Treatment for Postmenopausal Osteoporosis.

Objective: To review the safety and efficacy of romosozumab (Evenity) in the treatment of osteoporosis in women. Data Sources: An English-language search of PubMed and Medline (1966 to August 2020) was conducted using the keywords romosozumab, sclerostin inhibitor, AMG785, and osteoporosis. Manufacturer prescribing information, abstracts, fda.gov, and ClinicalTrials.gov data were incorporated for additional materials. In addition, a review of bibliographies of retrieved articles was performed to identify additional references. Study Selection/Data Extraction: Articles selected included those that described clinical studies of pharmacokinetics, efficacy, or safety of romosozumab. Data Synthesis: Romosozumab is a human monoclonal antibody that inhibits the action of sclerostin and is the first agent in its class to reach Phase III trials. Significant increases in bone mineral density and decreases in vertebral and hip fractures are demonstrated in Phase III trials. Favorable results led to its marketing approval in several countries. Major adverse cardiac events were observed in one clinical trial. Other adverse effects include arthralgia, headache, and injection site reactions. Place in Therapy: Romosozumab is the first agent to inhibit bone resorption and stimulate bone formation. Romosozumab should be reserved for postmenopausal women at highest risk for fracture and should be followed by an anti-resportive agent to maintain or further increase bone mineral density. This injectable agent should not be considered for women with a history of or at high risk of cardiovascular disease.

Girls scouting out pharmacy: A story about youth empowerment.

INTRODUCTION: The American Association of Colleges of Pharmacy's vision statement is part of a national strategic endeavor to elevate pharmacy's professional profile. Community populations lack awareness of the unique roles and responsibilities of pharmacists. To positively influence the pipeline of future pharmacists, it is necessary to promote pharmacy as a career path. Proactively targeting younger age groups to engage in science, technology, engineering, mathematics, and health (STEM+H) educational activities will increase knowledge and understanding of the profession of pharmacy. Educational engagement is most successful when a positive relationship is established with a community alliance. PERSPECTIVE: Doctor of pharmacy students established a community partnership to create the inaugural "Girl Scouting Out Pharmacy" event. Over forty pharmacy students and faculty created and led an interactive event to advocate for the betterment of our profession while simultaneously educating on various pharmacy topics. Four unique, hands-on sessions incorporated pharmacy activities for girl scouts and their parents. These activities engaged youth to imagine their future while promoting an appreciation of pharmacy careers. IMPLICATIONS: Creating unique events to promote STEM+H education grants early opportunities to explore pharmacy-related concepts. The combination of healthcare professional students and community outreach produces the greatest potential to spark interest. Pharmacists have a duty to inspire young individuals, ensuring the next generation meets the needs of the nation's workforce. It is the responsibility of today's pharmacists to foster intellectual curiosity and instill a progressive drive in the following generation, lest we fall behind the curve on an ever-evolving healthcare culture.

Professionalism development through the curriculum: Developing a new system for identifying and tracking professional behavior lapses.

INTRODUCTION: Pharmacy education has evolved from focusing on knowledge alone to highlighting personal and professional growth. Providing a standardized process for tracking, mentoring, and guiding students in professionalism and other soft skills may help achieve compliance with the current Center for the Advancement of Pharmacy Education Educational Outcomes and Accreditation Council for Pharmacy Education Standards 2016. COMMENTARY: Becoming a pharmacist requires more than demonstrating proficiency in tasks and responsibilities associated with pharmacy practice. Exhibiting strong professional behavior and soft skills are important for the clinical practice environment. These behaviors are more difficult to measure due to the broad definition of professionalism. In the academic setting, it is important to identify students struggling in this area. IMPLICATIONS: Promotion of professional behavior and soft skills development is a responsibility of higher education; however, it is difficult to assess. Development and implementation of an effective tracking and monitoring system for professionalism lapses will aid in identifying students struggling with professional behavior and offer mentoring opportunities for student personal growth and professional development.

Ambulatory care elective: Introduction to core practice concepts.

BACKGROUND AND PURPOSE: Introduction to various pharmacy practice environments is effectively accomplished through concentrated elective courses. The ambulatory care elective utilized innovative active learning strategies to enhance chronic disease management, foster empathy, and introduce strategic planning in an ambulatory care center. EDUCATIONAL ACTIVITY AND SETTING: A new two-credit hour ambulatory elective course was offered to third-year pharmacy students in a four-year doctor of pharmacy program. This 30-hour, 2-week long course, ran simultaneously between three campuses, and included six modules. The course employed lectures, active learning activities, shadowing, role playing, and a simulation. FINDINGS: Course evaluations and student reflections indicate high satisfaction with the course and reveal value in the simulation. SUMMARY: Active learning sessions in this third-year pharmacy elective allowed application of lecture materials to explore the focused practice of ambulatory care. Discussion topics were varied, allowing students to gauge the breadth of opportunities offered in ambulatory pharmacy, while also appreciating the scope of skills required for successful and sustainable practice. Students valued the chronic disease state simulation, which provided a unique approach to foster personal attributes.

A review of the treatment of type 2 diabetes in children.

The incidence of type 2 diabetes and obesity in children and adolescents has risen at staggering rates. Studies have shown that treating type 2 diabetes with oral medications in children may be more difficult than treating in adults. Compounding this problem is the fact that most of the medications available for treating type 2 diabetes have not been studied in children. Recently, the American Diabetes Association and the Pediatric Endocrine Society have collaborated to create a guideline for the treatment of type 2 diabetes in children. Similar to the treatment of adults with type 2 diabetes, metformin remains the mainstay of therapy along with diet and exercise. Adjunctive therapy should be based on the limited clinical evidence available as well as on patient preference. In order to avoid detrimental microvascular and macrovascular complications, patients, clinicians, and family members should work together to ensure adequate treatment of type 2 diabetes in children.

Sodium-glucose cotransporter 2 inhibitors: the new option for diabetes mellitus management.

Type 2 diabetes mellitus continues to be a challenging disease to manage successfully. Beyond the first-line option metformin, there are a number of classes of medications from which to select. This article reviews the new sodium-glucose cotransporter 2 inhibitors canagliflozin and dapagliflozin, including their benefits, adverse effects, and potential place in therapy. Upon review, the use of these medications has led to an A1c reduction between -0.37% and -1.16%. These medications also have been shown to reduce A1c when used with insulin. Some adverse effects were noted when using canagliflozin and dapagliflozin, with the most frequent being urinary tract infections and genital mycotic infections. We review the sodium-glucose cotransporter 2 inhibitors approved by the US Food and Drug Administration and their potential roles in the management of type 2 diabetes mellitus.

Otelixizumab: a novel agent for the prevention of type 1 diabetes mellitus.

INTRODUCTION: Type 1 diabetes mellitus is a chronic, progressive autoimmune disorder linked to numerous genetic and environmental factors. Insulin is the only treatment and preventative strategies do not currently exist. An obvious need exists to develop a safe regimen that suppresses the progression of the disease. AREAS COVERED: A MEDLINE search (1966-June 2011) was conducted for English-language articles using the terms 'otelixizumab', 'anti-CD3 antibody' and 'prevention of type 1 diabetes mellitus'. Relevant literature on otelixizumab, an anti-CD3 monoclonal antibody, currently in Phase III clinical trials for prevention of T1DM is discussed. EXPERT OPINION: Studies suggest that a monoclonal antibody directed against CD3 mitigates the deterioration in insulin production and decreases the rise in insulin requirement in recent onset T1DM for up to five years. The benefit was most pronounced in younger patients and in those with higher initial ß-cell function. Adverse effects were significant but transient. Otelixizumab shows great promise but leaves room for improvement. Results of ongoing trials will help define its role in the prevention of T1DM.

Albiglutide: a new GLP-1 analog for the treatment of type 2 diabetes.

IMPORTANCE OF THE FIELD: Despite the wide array of treatments available, a significant number of patients with type 2 diabetes continue to remain uncontrolled. The discovery of the incretin hormones and their role in glucose homeostasis has brought about a new class of medications called the glucagon-like peptide-1 (GLP-1) analogs. This new class of medications provides the benefits of weight loss as well as a lack of hypoglycemia. However, the currently available agents require once or twice daily injections. AREAS COVERED IN THIS REVIEW: Relevant literature will be discussed on albiglutide, a new GLP-1 analog in Phase III clinical trials. Several clinical trials examining the use of albiglutide as combination therapy are currently ongoing. WHAT THE READER WILL GAIN: To date, results of clinical trials suggest that albiglutide may provide a more attractive dosing profile compared with the currently available GLP-1 analogs. TAKE HOME MESSAGE: The results of ongoing trials will help define the role of albiglutide in treating patients with type 2 diabetes.

Sitagliptin as combination therapy in the treatment of type 2 diabetes mellitus.

The American Diabetes Association and The European Association for the Study of Diabetes recommend metformin as the initial agent of choice in the treatment of type 2 diabetes mellitus. Unfortunately, most patients require multiple medications to obtain glycemic control. One of the newest additions to the antidiabetic armamentarium is the class of drugs known as dipeptidyl-peptidase IV (DPP-IV) inhibitors. This novel approach focuses on harnessing the beneficial effects of GLP-1, an incretin hormone released from the gut postprandially. The first DPP-IV inhibitor approved in the United States was sitagliptin. It has been studied in both monotherapy and combination therapy. Combination studies with metformin realize a hemoglobin A1c reduction of 0.65%-1.1%. The combination of the two has a modest positive effect on body weight with the convenience of an oral route of administration. It has also been shown to be highly tolerable, efficacious and with little risk of hypoglycemia. This review will focus on combination therapy with sitagliptin with emphasis on combination with metformin.

Angiotensin II vaccine: a novel approach in the treatment of hypertension.

BACKGROUND: Hypertension affects approximately 65 million Americans, resulting in 30 million office visits per year. Only about one third of patients have blood pressure below goal. Poor adherence to drug therapy is an important contributor to this statistic. An active immunization, which would induce antibodies against angiotensin, could simplify and improve treatment. An ideal regimen would be a few subcutaneous injections per year, which in turn could vastly improve adherence and subsequent outcomes. OBJECTIVE: To discuss Cyt006-AngAb, a novel vaccine targeting angiotensin II, which is chemically linked to recombinant virus-like particles. Emphasis is placed on current progress of this vaccine's clinical trials. METHODS: Relevant literature is discussed. CONCLUSION: Although advances in hypertension vaccines have faced challenges, the angiotensin II vaccine may provide a promising approach in the control of hypertension.