Development of Quality Measures for Inpatient Diabetes Care and Education Specialists: A Call to Action.

ABSTRACT: Diabetes and hyperglycemia are associated with an increased risk of in-hospital complications that lead to longer lengths of stay, increased morbidity, higher mortality, and risk of readmission. Diabetes care and education specialists (DCESs) working in hospital settings are uniquely prepared and credentialed to serve as content experts to facilitate change and implement processes and programs to improve glycemic-related outcomes. A recent survey of DCESs explored the topic of productivity and clinical metrics. Outcomes highlighted the need to better evaluate the impact and value of inpatient DCESs, advocate for the role, and to expand diabetes care and education teams to optimize outcomes. The purpose of this article was to recommend strategies and metrics that can be used to quantify the work of inpatient DCESs and describe how such metrics can help to show the value of the inpatient DCES and assist in making a business case for the role.

Significant publications in diabetes pharmacotherapy and technology in 2020.

INTRODUCTION: The most significant articles on diabetes pharmacotherapy and technology in the peer-reviewed literature from 2020, as determined by a panel of pharmacists with expertise in diabetes care and education, are summarized. AREAS COVERED: Members of the Association of Diabetes Care and Education Specialists Pharmacy Community of Interest were selected to review articles published in prominent peer-reviewed journals in 2020 that most impacted diabetes pharmacotherapy and technology. A list of 37 nominated articles were compiled (22 in diabetes pharmacotherapy and 15 in diabetes technology). Based on discussion among the authors, the articles were ranked based on significant contribution, impact, and diversity to diabetes pharmacotherapy and technology. The top 10 highest ranked publications (n = 6 for diabetes pharmacotherapy and n = 4 in diabetes technology) are summarized in this article. EXPERT OPINION: With the significant number of publications in diabetes care and education, it can be challenging and overwhelming to remain current with published literature. This review article may be helpful in identifying key articles in diabetes pharmacotherapy and technology from the year 2020.

Diabetes: how to manage chronic kidney disease.

Background: Chronic kidney disease (CKD) is a prevalent and progressive condition worldwide, and diabetes is a leading risk factor of this renal disorder. People with diabetes and CKD are at high risk of complications such as cardiovascular events and death. CKD is often unrecognized and undiagnosed amongst people with diabetes. To manage CKD, multiple existing and newer agents have been studied in trials and recommended in clinical practice guidelines. Methods: A narrative review of primary and/or secondary renal outcomes from randomized, controlled trials is summarized in this article. The main objective was to provide the most up-to-date information regarding existing and new pharmacotherapy for the management of CKD amongst people with diabetes, specifically type 2 diabetes (T2D). Discussion: Traditional agents, such as angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, have been used for 20 years to preserve kidney function. Other existing agents have received approval by the FDA for the management of CKD such as dapagliflozin, with a role in reducing intraglomerular pressure. Evidence with sodium-glucose cotransporter 2 inhibitors show a potential class effect on improving renal outcomes, independent on their effect on glycaemic parameters. Recently, finerenone was approved for people with T2D and CKD based on clinical evidence as a non-steroidal mineralocorticoid receptor antagonist. Overall, primary and secondary prevention trials have influenced changes in clinical practice guidelines regarding the use of existing and new pharmacotherapy for CKD. Additional considerations include lifestyle modifications, blood pressure management and achievement of glycaemic targets for people with diabetes and CKD, following adequate screening of glomerular filtration rate and/or severity of albuminuria. Conclusion: Due to more robust evidence, clinical practice guidelines have been modified to reflect high-level recommendations for the management of CKD in people with diabetes, specifically T2D. Additional evidence is needed amongst people with lower glomerular filtration rates and in comparison with the standard of care.

Development and Current Role of Sodium Glucose Cotransporter Inhibition in Cardiorenal Metabolic Syndrome.

ABSTRACT: Sodium-glucose cotransporter-2 inhibitors were approved as adjunct therapy for the management of type 2 diabetes and have become a high-level recommendation for this population with cardiorenal metabolic syndrome. In addition, evidence continues to grow supporting this class of medications for people with heart failure and chronic kidney disease, regardless of diabetes status. This narrative review summarizes the sodium-glucose cotransporter inhibitors for cardiorenal metabolic syndrome.

The Effects of Diabetes Self-Management Education on Quality of Life for Persons With Type 1 Diabetes: A Systematic Review of Randomized Controlled Trials.

PURPOSE: It is well documented that chronic conditions, such as diabetes, impact quality of life (QoL). QoL assessment is essential when developing and evaluating diabetes self-management education support interventions. The aim of this systematic review was to evaluate the evidence and gaps in the research and the impact of diabetes self-management education (DSME) on QoL outcomes in persons with type 1 diabetes mellitus (T1DM). METHODS: A systematic review of English language studies published between January 1, 2007, and March 31, 2020, was conducted using a modified Cochrane review method. Studies were included if they were randomized controlled trials (RCTs), participants had T1DM with or without caregivers, a DSME intervention alone or a component(s) of the ADCES7™ Self-Care Behaviors was described, and QoL was a primary or secondary outcome. A 3-tiered review process was utilized for selecting articles. Retained articles were assessed for risk of bias. RESULTS: Nineteen articles, reporting on 17 RCTs, met inclusion criteria, of which 7 studies reported QoL as the primary outcome and 10 as a secondary outcome. Seven studies detected significant impact of DMSE on QoL outcomes in either the participants or family caregivers, which varied in participant populations, selection of QoL tools (generic vs diabetes-specific), intervention type, intervention length, and type of interventionist. CONCLUSION: DSME has the potential to influence QoL outcomes in people with T1DM. Research using more standardized methods are needed to delineate impact on a broader range of factors that influence QoL for those living with T1DM across the life span and their caregivers.

Clinical review of subcutaneous semaglutide for obesity.

WHAT IS KNOWN AND OBJECTIVE: The purpose of this review paper is to review the efficacy and safety of subcutaneous semaglutide, marketed as Wegovy, a glucagon-like peptide-1 receptor agonist for obesity management. METHODS: A MEDLINE search (1970 to June 2021) was conducted to identify Phase 3 trials of subcutaneous semaglutide for obesity management. Published Phase 3 trials from The Semaglutide Treatment Effect in People with obesity (STEP) program were reviewed and summarized. RESULTS AND DISCUSSION: Based on four Phase 3 trials, subcutaneous semaglutide as 2.4 mg once weekly was compared in efficacy and safety among 5000 randomized participants who were overweight or had obesity. A change in body weight from baseline to end of study was the primary outcome in the STEP program. Participants who received semaglutide had a dose-dependent reduction in body weight from baseline, compared to placebo. Higher percentages of participants had 5%-10% weight reduction from baseline when receiving subcutaneous semaglutide. The patient population was mainly middle-aged female participants with Class II obesity. Additional studies are needed, especially active-comparator trials, to determine the efficacy and safety of semaglutide in a diverse patient population. WHAT IS NEW AND CONCLUSION: Subcutaneous semaglutide is another available option as adjunct therapy to lifestyle modifications for people who are overweight or have obesity based on body weight and body mass index. It resulted in more weight reduction than placebo with gastrointestinal adverse events being the most common safety concerns. Clinical utilization of subcutaneous semaglutide will be determined, as insurance coverage will be a limitation for this new medication.

A cross-sectional study of student pharmacists' attitudes and self-awareness towards obesity and weight.

INTRODUCTION: Neutral attitudes towards people with obesity is a necessity among student pharmacists entering the workforce and caring for this patient population. The purpose of the study was to investigate the perception towards people with obesity among student pharmacists. METHODS: A cross-sectional study using a self-administered questionnaire was sent to 237 student pharmacists. The questionnaire consisted of four demographic questions, the 14-item Fat Phobia Scale (FPS), and the 20-item Attitudes Towards Obese Persons Scale (ATOPS). Statistical analysis was completed to determine any differences between gender, age, and current status in pharmacy school. RESULTS: Eighty-four student pharmacists completed the questionnaire (35.4% response rate). Most participants were female (84.5%) and > 25 years of age (61.9%). Scores indicated an average level of fat phobia with no difference between males and females (mean score 2.8 ± 0.23 and 2.8 ± 0.29, respectively; P = .92). For attitude, the mean scores were - 0.93 ± 0.42 for males and - 0.75 ± 0.59 for females, indicating a neutral attitude towards obesity and no difference between groups (P = .35). There was no difference in age (younger vs. ≥ 25 years of age) in the FPS (P = .06) or ATOPS (P = .36). There was no difference in mean scores of FPS and ATOPS based on current year in pharmacy school (P = .69 and P = .97, respectively). CONCLUSIONS: Student pharmacists had an average level of fat phobia and neutral attitude towards people with obesity regardless of gender, age, and year in pharmacy school.

Pharmacokinetics and Clinical Implications of Oral Semaglutide for Type 2 Diabetes Mellitus.

Since the approval of subcutaneous glucagon-like peptide-1 receptor agonists, this therapeutic class has become a preferred choice for the management of type 2 diabetes due to A1C reduction, minimal risk of hypoglycemia, weight loss, and cardiovascular benefit. An oral option, with gastrointestinal absorption, would overcome any potential fear of injection among patients. Oral semaglutide has been studied in randomized controlled trials within the PIONEER program. From a robust pool of literature with a global patient population, oral semaglutide has been an effective option as monotherapy and combination therapy to improve clinical outcomes, such as A1C and body weight from baseline to week 78, depending on the randomized controlled trial. In addition, a noninferiority result was observed with oral semaglutide versus placebo in a cardiovascular outcomes trial in patients with type 2 diabetes with established cardiovascular disease or risk factors. Similar to injectable glucagon-like peptide 1 receptor agonists, transient nausea and vomiting was seen with oral semaglutide. Overall, this new oral option may be a choice for patients with barriers to injectable therapy. This review evaluates and summarizes the pharmacokinetics, pharmacodynamics, and clinical application of oral semaglutide in patients with type 2 diabetes.

Clinical potential of liraglutide in cardiovascular risk reduction in patients with type 2 diabetes: evidence to date.

Metformin is the first-line therapy for the management of type 2 diabetes. After 3 months of metformin, add-on therapy can be considered if an individual's glycemic control has not been achieved for hemoglobin A1c, fasting blood glucose levels, and postprandial blood glucose levels. Liraglutide is a potential second-line option for the management of type 2 diabetes mellitus, particularly for those who are or may be at a high risk of cardiovascular disease. It can also be used an add-on therapy for those individuals with established cardiovascular disease. Liraglutide has additional benefits, such as no to minimal risk of hypoglycemia and promotion of weight loss through its mechanism of action. This particular article summarizes evidence on cardiovascular biomarkers and surrogate endpoints, along with macrovascular events, with liraglutide therapy. Overall, liraglutide has extensive cardiovascular evidence based on which it could be used as a desirable agent for glycemic control while lowering the risk of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization from heart failure.

Abaloparatide: A new pharmacological option for osteoporosis.

PURPOSE: The efficacy and safety of abaloparatide, a parathyroid hormone-related protein analog for the treatment of osteoporosis in postmenopausal women at high fracture risk, is reviewed. SUMMARY: A MEDLINE search was conducted for full text English-language articles, using the terms abaloparatide, parathyroid hormone, and osteoporosis. Published articles pertinent to the short- and long-term efficacy and safety of abaloparatide among postmenopausal women with osteoporosis were reviewed and summarized. Based on randomized, placebo-controlled and active-comparator studies, abaloparatide can reduce the risk of new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. Abaloparatide can also significantly increase bone mineral density (BMD) at the total hip, femoral neck, and lumbar spine. Patients receiving abaloparatide experience faster and more robust changes in BMD compared to those receiving teriparatide. Overall, abaloparatide is well tolerated with a mild adverse effect profile, including dizziness, headache, nausea, and palpitations. Additionally, there is a lower incidence of hypercalcemia with abaloparatide than with teriparatide. At this time, the differences demonstrated between abaloparatide and teriparatide would not be considered clinically significant. Larger and more robust studies are needed to determine future clinical significance of abaloparatide compared with other agents for use in the postmenopausal osteoporotic population. CONCLUSION: Abaloparatide is an effective anabolic agent to improve bone formation and resorption amongst postmenopausal women with osteoporosis. Based on its clinical evidence, abaloparatide can result in greater BMD increases and less hypercalcemia compared with the only current marketed anabolic agent, teriparatide. Adverse events associated with abaloparatide are generally mild in nature and include nausea, dizziness, headache, and palpitations.

Faster Insulin Aspart: A New Bolus Option for Diabetes Mellitus.

Since the approval of bolus insulin, it has been used frequently in clinical practice for the management of type 1 and 2 diabetes mellitus for postprandial control. Another new product is faster insulin aspart (Fiasp, Novo Nordisk), a fast-acting insulin with 100 units/mL. Several studies have been conducted evaluating the pharmacokinetics and pharmacodynamics of faster insulin aspart, compared with insulin aspart. This new bolus insulin provides greater glucose-lowering effect at 20 min, following subcutaneous administration. Faster insulin aspart had a greater reduction in hemoglobin A1c concentrations from baseline in patients with type 1 diabetes mellitus when compared with insulin aspart, whereas the two bolus insulins were similar in this outcome in patients with type 2 diabetes mellitus. Depending on the trial, the safety profile may differ between these two insulins with severe or confirmed hypoglycemia. Based on the clinical evidence for efficacy and safety, faster insulin aspart can be considered a viable option for those patients with type 1 and 2 diabetes mellitus who desire to inject immediately prior to a meal or within 20 min following a meal. However, additional studies should be completed to determine the role of faster insulin aspart in pregnant and pediatric patients, along with patients prescribed insulin pumps. This article evaluates and summarizes the pharmacokinetics and pharmacodynamics of faster insulin aspart for patients with type 1 or 2 diabetes mellitus, and summarizes its application to clinical practice.

Pharmacokinetics and Clinical Implications of Semaglutide: A New Glucagon-Like Peptide (GLP)-1 Receptor Agonist.

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) came to market in the year 2005, as a new therapeutic classification, for clinical use in the management of type 2 diabetes mellitus (T2DM). Since 2005, there have been six approved products on the market, with the newest product being semaglutide (Novo Nordisk). Several studies have been conducted and completed evaluating its pharmacokinetics as a once-weekly subcutaneous injection. As a dose of 0.5 or 1 mg, semaglutide has a half-life of 7 days; therefore, it would reach steady state in 4-5 weeks. There are few drug interactions and dose adjustments are not necessary. However, similar to other GLP-1 RAs, semaglutide can delay gastric emptying and may impact the absorption of oral medications. Based on clinical trials, semaglutide has been compared with placebo, sitagliptin, exenatide extended release, and insulin glargine as monotherapy or add-on therapy. Semaglutide has resulted in a 1.5-1.9% glycosylated hemoglobin A1c reduction after 30-56 weeks. It also produced 5-10% weight reduction from baseline in clinical efficacy studies. Semaglutide can be another acceptable option for patients with T2DM, and it has a potential role among patients who require weight loss with a low risk of hypoglycemia. This article evaluates the pharmacokinetics of semaglutide and summarizes its application to clinical practice based on efficacy and safety data.

Flibanserin for hypoactive sexual desire disorder in premenopausal women.

Flibanserin is a mixed 5-HT1A agonist and 5-HT2A antagonist for treatment of premenopausal women with hypoactive sexual desire disorder. It is the first FDA-approved treatment for this disorder and can improve the number of satisfying sexual events. The drug has been associated with hypotension and syncope.

Ivabradine for systolic heart failure.

Ivabradine works in the sinoatrial node to prolong diastolic depolarization and reduce heart rate. In patients with chronic systolic heart failure, this drug has reduced the risk of hospitalization when used in combination with other optimal pharmacotherapy.

Lesinurad, a Selective URAT-1 Inhibitor With a Novel Mechanism in Combination With a Xanthine Oxidase Inhibitor, for Hyperuricemia Associated With Gout.

OBJECTIVE: To review the pharmacokinetics, clinical efficacy, safety, and role of lesinurad for the management of hyperuricemia associated with gout. DATA SELECTION: A MEDLINE search (2000 to April 2017) was conducted using the terms hyperuricemia, gout, URAT-1, URAT-1 transporter, and lesinurad. Published articles and scientific posters relevant to the efficacy and safety of lesinurad were reviewed and summarized. DATA SYNTHESIS: Lesinurad was evaluated in 3 randomized, phase 3 clinical trials (CRYSTAL, CLEAR 1 and 2). The primary endpoint for CRYSTAL trial was the percentage of patients achieving serum uric acid (SUA) concentration ≤ 5 mg/dL. The CLEAR 1 and 2 trials had a primary endpoint of percentage of patients achieving SUA concentration ≤ 6 mg/dL. Lesinurad at either 200 or 400 mg/d was superior to xanthine oxidase inhibitor (XOI) monotherapy in reducing the SUA concentration to 5 or 6 mg/dL, when added to either allopurinol or febuxostat. CONCLUSION: Data from phase 3 clinical studies suggest the addition of lesinurad to allopurinol or febuxostat is superior to XOI monotherapy alone in reducing SUA concentrations while increasing the risk of renal-related adverse events. Lesinurad, 200 mg orally per day, would be a safe recommendation, in combination with an XOI, among patients with adequate renal function (i.e., above 45 mL/min) who need additional therapy for inadequately controlled hyperuricemia associated with gout.

Naloxegol for managing opioid-induced constipation.

Naloxegol is a peripherally acting mu-opioid receptor antagonist for opioid-induced constipation in adults with chronic noncancer pain. This drug's once-daily oral formulation can be used as monotherapy and helps to decrease the constipating effects of opioid therapy; however, it has been associated with abdominal pain.

What's new in multiple sclerosis?

INTRODUCTION: Multiple sclerosis (MS) is a chronic disease state that affects and disables many people each year. The most common clinical presentation is relapsing-remitting MS (RRMS). In the past 7 years, new medications have been approved for the treatment of RRMS, thereby providing more treatment options for patients and providers. The purpose of this article is to provide an update on medications for the treatment of MS that have been approved since January 2010. METHODS: A review was performed utilizing CenterWatch to search for medications approved by the US Food and Drug Administration for the treatment of RRMS between January 2010 and April 2017. The package inserts of medications indicated for RRMS were analyzed, and key points were summarized. PubMed and EBSCOhost were utilized to identify articles relevant to RRMS background and treatment. RESULTS: Seven medications with varying mechanisms of action have been approved to treat RRMS since 2010. Pharmacotherapy options include oral and injectable formulations. Efficacy across the agents is comparable, and each agent has safety data from clinical trials. The safety profile varies between oral and injectable agents, but potential adverse effects are important to consider before initiation. Therapeutic selection is based on patient preference, dosing (frequency and route), and safety considerations. DISCUSSION: Multiple therapeutic options are available for the treatment of RRMS. Health care practitioners should be cognizant of the adverse effects, dosing route, and frequency in order to optimally tailor therapy to meet individual patient needs.