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.

Evaluating efficiency of counties in providing diabetes preventive care using data envelopment analysis.

For patients with diabetes, annual preventive care is essential to reduce the risk of complications. Local healthcare resources affect the utilization of diabetes preventive care. Our objectives were to evaluate the relative efficiency of counties in providing diabetes preventive care and explore potential to improve efficiencies. The study setting is public and private healthcare providers in US counties with available data. County-level demographics were extracted from the Area Health Resources File using data from 2010 to 2013, and individual-level information of diabetes preventive service use was obtained from the 2010 Behavioral Risk Factor Surveillance System. 1112 US counties were analyzed. Cluster analysis was used to place counties into three similar groups in terms of economic wellbeing and population characteristics. Group 1 consisted of metropolitan counties with prosperous or comfortable economic levels. Group 2 mostly consisted of non-metropolitan areas between distress and mid-tier levels, while Group 3 were mostly prosperous or comfortable counties in metropolitan areas. We used data enveopement analysis to assess efficiencies within each group. The majority of counties had modest efficiency in providing diabetes preventive care; 36 counties (57.1%), 345 counties (61.1%), and 263 counties (54.3%) were inefficient (efficiency scores < 1) in Group 1, Group 2, and Group 3, respectively. For inefficient counties, foot and eye exams were often identified as sources of inefficiency. Available health professionals in some counties were not fully utilized to provide diabetes preventive care. Identifying benchmarking targets from counties with similar resources can help counties and policy makers develop actionable strategies to improve performance.

Oral Semaglutide: A Review of the First Oral Glucagon-Like Peptide 1 Receptor Agonist.

Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are highly effective at lowering hemoglobin A1c (HbA1c) and facilitating weight loss. Four agents in the GLP-1 RA class, albiglutide, liraglutide, dulaglutide, and semaglutide, also have cardioprotective effects. However, subcutaneous administration of these agents remains a major reason for their underutilization. A new coformulation of semaglutide with sodium N-[8-(2-hydroxybenzoyl) amino caprylate (SNAC) is the first oral GLP-1 RA reviewed by the U.S. Food and Drug Administration (FDA). The SNAC technology prevents destruction of semaglutide in the stomach and facilitates transcellular absorption through the gastric membrane enabling semaglutide to reach systemic circulation intact. The oral formulation of semaglutide was studied in the PIONEER trials, demonstrating similar efficacy to the presently available GLP-1 RAs with regard to HbA1c lowering and weight loss. Although the PIONEER 6 trial suggests positive effects on cardiovascular mortality with oral semaglutide, these benefits may not fully be appreciated until the completion of the SOUL trial.

Smoking Cessation Benefit Utilization: Comparing Methodologies for Measurement using New York State's Medicaid Data.

Introduction: Pharmacotherapy and counseling for tobacco cessation are evidence-based methods that increase successful smoking cessation attempts. Medicaid programs are required to provide coverage for smoking cessation services. Monitoring utilization is desirable for program evaluation and quality improvement. Various methodologies have been used to study utilization. Many factors can influence results, perhaps none more than how smokers are identified. This study evaluated the utilization of smoking cessation services using various methods to estimate the number of smokers within New York State's (NYS's) Medicaid program in 2015. Methods: Estimates of utilization were generated based on Medicaid claims and encounters and four sources of smoking prevalence: two population surveys, one Medicaid enrollee survey, and diagnosis codes. We compared the percentage of (estimated) smokers utilizing cessation services, and the average number of services used, across fee-for-service and managed care populations, and by cessation service category. Results: Statewide, smoking prevalence estimates ranged from 10.9% to 31.5%. Diagnosis codes identified less than 45% of smokers estimated by surveys. A similar number of cessation counseling (199106) and pharmacotherapy services (197728) were used, yet more members utilized counseling (126839) than pharmacotherapy (91433). The estimated percentage of smokers who used smoking cessation services ranged from 15.1% to 43.4%, and the estimated average number of cessation services used ranged from 0.31 to 0.90 per smoker. Conclusion: Smoking prevalence estimates obtained through surveys greatly exceed prevalence observed in diagnosis codes in NYS's Medicaid data. Use of diagnosis codes in the analysis of smoking cessation benefit utilization may result in overestimates. Implications: Selection of a smoking prevalence data source for similar analyses should ultimately be based on completeness of the data and applicability to the population of interest. Evaluation of smoking cessation benefit utilization and the effectiveness of tobacco control campaigns aimed to increase utilization requires a well-defined methodology which ensures reliable baseline data. Comparing utilization estimates across populations or state lines can be misleading, as differences in how estimations were generated can greatly bias observed results.

Influence of Coulomb screening on lateral lasing in VECSELs.

Parasitic lateral lasing in certain optically pumped semiconductor disc lasers drains the gain of the vertical mode and thus causes power scaling degradation and premature rollover in surface emitting operation. We have observed this effect in both multiple quantum wells (MQW) (GaInAs/GaAs) and double heterostructures (DHS) (GaInP/GaAs/GaInP) under pulsed excitation even when the gain chip lateral dimensions are much larger than the diameter of the pump laser. Lateral lasing occurs persistently between cleaved facets at a band-tail wavelength much longer than the peak of the gain. We show that the effect of bandgap renormalization due to Coulomb screening explains this phenomena. Exploiting the simple analytical plasma theory of bulk semiconductors (Banyai & Koch, 1986), we can account for such an effect in double heterostructures.

Two distinct surveillance methods to track hospitalized influenza patients in New York State during the 2009-2010 influenza season.

OBJECTIVE: To better understand the severity of 2009 H1N1 influenza disease, enhanced surveillance of patients hospitalized with influenza was conducted during the 2009-2010 influenza season in New York State through existing Emerging Infections Program surveillance and a newly established sentinel hospital surveillance program. The 2 surveillance systems were compared to determine consistency across surveillance modalities and reveal the strengths and weaknesses of each to accomplish comprehensive influenza surveillance. DESIGN: Similar variables from the aggregate data collected from each system were compared and differences were analyzed in detail. SETTING: New York State. PARTICIPANTS: Hospitalized adult and pediatric patients detected through 2 influenza surveillance programs. MAIN OUTCOME MEASURES: Significant differences in age distribution, timing of illness onset, illness complications, underlying medical conditions, critical care admissions, use of mechanical ventilation, and illness outcomes. RESULTS: Both surveillance systems saw the highest numbers of confirmed influenza infection among patients hospitalized in early fall 2009, with sharp declines thereafter. Sentinel hospital surveillance continued to detect hospitalizations for influenza-like illness that were not due to 2009 H1N1 influenza well into March 2010. Compared to influenza surveillance conducted through the Emerging Infections Program, the sentinel hospital influenza surveillance program tended to detect a sicker population of children and adults, including a higher rate of critical illness and mechanical ventilation, and among adults, higher rates of some underlying medical conditions. There were no differences in disease outcomes detected between the 2 systems. CONCLUSIONS: Although the 2 surveillance systems were complementary, inherent methodologic variations revealed important differences at season conclusion. The lessons learned should be used to determine the best way to allocate resources to meet the needs of future state and national influenza surveillance efforts.

The effectiveness of virtual reality distraction for pain reduction: a systematic review.

Virtual reality technology enables people to become immersed in a computer-simulated, three-dimensional environment. This article provides a comprehensive review of controlled research on the effectiveness of virtual reality (VR) distraction for reducing pain. To be included in the review, studies were required to use a between-subjects or mixed model design in which VR distraction was compared with a control condition or an alternative intervention in relieving pain. An exhaustive search identified 11 studies satisfying these criteria. VR distraction was shown to be effective for reducing experimental pain, as well as the discomfort associated with burn injury care. Studies of needle-related pain provided less consistent findings. Use of more sophisticated virtual reality technology capable of fully immersing the individual in a virtual environment was associated with greater relief. Overall, controlled research suggests that VR distraction may be a useful tool for clinicians who work with a variety of pain problems.

Surface plasmon modes of finite, planar, metal-insulator-metal plasmonic waveguides.

The numerical analysis of finite planar metal-insulator-metal waveguide structures using the transfer-matrix formalism reveals both bound and leaky surface plasmon (SP) modes. The dispersion relations, propagation lengths and confinement factors of these SP modes are presented. The highest energy SP mode consists of non-radiative (bound) and radiative (leaky) portions separated by a spectral gap. The leaky regime is further divided into antenna and reactive mode regions. The antenna mode may be used for both free-space coupling and beam steering devices.

Prognostic significance of blood markers of inflammation in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty and effects of pexelizumab, a C5 inhibitor: a substudy of the COMMA trial.

AIMS: Pexelizumab, a monoclonal antibody inhibiting C5, reduced 90 day mortality and shock in the COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA) trial without apparent reductions in infarct size. Inflammation is a critical component of ST-elevation myocardial infarction (STEMI); this substudy examines prognostic values of selected markers and treatment effects. METHODS AND RESULTS: C-reactive protein, interleukin-6 (IL-6), and tumour necrosis factor-alpha (TNF-alpha) serum levels were assessed in 337 patients enrolled in either the placebo or the pexelizumab 24 h infusion group. Higher C-reactive protein and IL-6 levels at baseline, 24 h, and 72 h were strongly associated with increased subsequent death (P<0.002 at baseline and 24 h, P<0.02 at 72 h); and all baseline marker levels with death or cardiogenic shock (P<0.03) within 90 days. C-reactive protein and IL-6 levels were similar at baseline, but significantly lower 24 h later with pexelizumab, when compared with placebo (17.1 vs. 25.5 mg/L, P=0.03 and 51.0 vs. 63.8 pg/mL, P=0.04, respectively). At 72 h, corresponding levels were similar, whereas TNF-alpha was slightly higher (P=0.04) in the treated group. CONCLUSION: Inflammation markers and their serial changes predict death and shock in patients with STEMI undergoing primary angioplasty. Pexelizumab reduced C-reactive protein and IL-6, suggesting treatment benefits mediated through anti-inflammatory effects.

Enhanced infrared transmission through subwavelength coaxial metallic arrays.

We report the observation of enhanced near-infrared transmission through arrays of subwavelength coaxial metallic structures compared with that through comparable diameter hole arrays as a result of localized electromagnetic modes supported by the complex coaxial unit cell. Polarization and angle-dependent transmission measurements clearly demonstrate the coupling between this localized mode and delocalized surface plasmon modes. A generalized, multiple discrete states Fano line shape provides a good fit to the experimental results.

Prognostic usefulness of white blood cell count and temperature in acute myocardial infarction (from the CARDINAL Trial).

White blood cell (WBC) count and temperature are 2 global measures of inflammation that are systematically gathered and easily identifiable in a clinical setting, unlike many other markers of inflammation being investigated in patients with coronary artery disease. The prognostic usefulness of the WBC count and temperature were evaluated in a large acute myocardial infarction trial, the Complement And ReDuction of INfarct size after Angioplasty or Lytics program. Baseline and serial measurements of WBC counts and temperature were correlated with infarct size and clinical outcome.

Pharmacologic C5-complement suppression reduces blood loss during on-pump cardiac surgery.

BACKGROUND: Inflammation contributes to morbidity following on-pump cardiac surgery. Complement activation during cardiopulmonary bypass has been associated with the postoperative bleeding and tissue injury. This study examines the pharmacology and impact on blood loss of complement C5 suppression with pexelizumab in patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: Pexelizumab, a humanized monoclonal antibody single-chain fragment that binds to the human C5 complement component, was studied in a Phase II multicentered clinical trial. CABG (n = 800) and CABG with concomitant valve surgery (n = 114) patients were evaluated. Patients were randomized to either: pexelizumab bolus (2.0 mg/kg) + placebo infusion; pexelizumab bolus (2.0 mg/kg) + pexelizumab infusion (0.05 mg/kg/hour for 24 hours); or placebo bolus + placebo infusion. Pharmacology, chest tube drainage, and transfusion requirements were assessed. RESULTS: Mean maximum pexelizumab serum concentration was similar for bolus and bolus + infusion-treated patients. Complement-dependent serum hemolytic activity was completely suppressed within 1 hour following pexelizumab bolus, however, suppression was maintained for a longer duration in the bolus + infusion compared to the bolus-only treated patients. A reduction in chest tube drainage was observed for all pexelizumab-treated patients, although transfusion of blood products was similar across all study groups. CONCLUSION: Pexelizumab administration inhibits complement-dependent hemolytic activity and is associated with a reduction in postoperative chest tube drainage in patients undergoing cardiac surgery requiring cardiopulmonary bypass. Further, clinical studies are needed to assess the value of complement attenuation in this setting.

Terminal complement blockade with pexelizumab during coronary artery bypass graft surgery requiring cardiopulmonary bypass: a randomized trial.

CONTEXT: Inflammation and ischemia-reperfusion injury during coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass are associated with postoperative myocardial infarction (MI) and mortality. OBJECTIVE: To determine the efficacy and safety of pexelizumab, a C5 complement inhibitor, in reducing perioperative MI and mortality in CABG surgery. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial, including 3099 patients (> or = 18 years) undergoing CABG surgery with or without valve surgery at 205 hospitals in North America and Western Europe from January 2002 to February 2003. INTERVENTIONS: Patients were randomly assigned to receive intravenous pexelizumab (2.0 mg/kg bolus plus 0.05 mg/kg per hour for 24 hours; n = 1553) or placebo (n = 1546) 10 minutes before undergoing the procedure. MAIN OUTCOME MEASURES: The primary composite end point was the incidence of death or MI within 30 days of randomization in those undergoing CABG surgery only (n = 2746). Secondary analyses included the intent-to-treat analyses of death or MI composite at days 4 and 30 in all 3099 study patients. RESULTS: After 30 days, 134 (9.8%) of 1373 of patients receiving pexelizumab vs 161 (11.8%) of 1359 of patients receiving placebo (relative risk, 0.82; 95% confidence interval, 0.66-1.02; P =.07) died or experienced MI in the CABG surgery only population. In the intent-to-treat analyses, 178 (11.5%) of 1547 patients receiving pexelizumab vs 215 (14.0%) of 1535 receiving placebo died or experienced MI (relative risk, 0.82; 95% confidence interval, 0.68-0.99; P =.03). The trial was not powered to detect a reduction in mortality alone. CONCLUSIONS: Compared with placebo, pexelizumab was not associated with a significant reduction in the risk of the composite end point of death or MI in 2746 patients who had undergone CABG surgery only but was associated with a statistically significant risk reduction 30 days after the procedure among all 3099 patients undergoing CABG with or without valve surgery.

Self-assembly of ordered, robust, three-dimensional gold nanocrystal/silica arrays.

We report the synthesis of a new nanocrystal (NC) mesophase through self-assembly of water-soluble NC micelles with soluble silica. The mesophase comprises gold nanocrystals arranged within a silica matrix in a face-centered cubic lattice with cell dimensions that are adjustable through control of the nanocrystal diameter and/or the alkane chain lengths of the primary alkanethiol stabilizing ligands or the surrounding secondary surfactants. Under kinetically controlled silica polymerization conditions, evaporation drives self-assembly of NC micelles into ordered NC/silica thin-film mesophases during spin coating. The intermediate NC micelles are water soluble and of interest for biolabeling. Initial experiments on a metal-insulator-metal capacitor fabricated with an ordered three-dimensional gold nanocrystal/silica array as the "insulator" demonstrated collective Coulomb blockade behavior below 100 kelvin and established the current-voltage scaling relationship for a well-defined three-dimensional array of Coulomb islands.

Impact of pexelizumab, an anti-C5 complement antibody, on total mortality and adverse cardiovascular outcomes in cardiac surgical patients undergoing cardiopulmonary bypass.

BACKGROUND: During cardiac surgery requiring cardiopulmonary bypass, pro-inflammatory complement pathways are activated by exposure of blood to bio-incompatible surfaces of the extracorporeal circuit and reperfusion of ischemic organs. Complement activation promotes the generation of additional inflammatory mediators thereby exacerbating tissue injury. We examined the safety and efficacy of a C5 complement inhibitor for attenuating inflammation-mediated cardiovascular dysfunction in cardiac surgical patients undergoing cardiopulmonary bypass. METHODS: Pexelizumab (Alexion Pharmaceuticals, Inc, Cheshire, CT), a recombinant, single-chain, anti-C5 monoclonal antibody, was evaluated in a randomized, double-blinded, placebo-controlled, multicenter trial that involved 914 patients undergoing coronary artery bypass grafting with or without valve surgery requiring cardiopulmonary bypass. RESULTS: Pexelizumab was administered intravenously as a bolus (2.0 mg/kg) or bolus plus infusion (2.0 mg/kg plus 0.05 mg/kg/h for 24 hours), and inhibited complement activation. There were no statistically significant differences between placebo-treated and pexelizumab-treated patients in the primary endpoint (composite of death, or new Q-wave, or non-Q-wave [myocardial-specific isoform of creatine kinase > 60 ng/mL] myocardial infarction, or left ventricular dysfunction, or new central nervous system deficit). However, post hoc analysis revealed a reduction in the composite of death or myocardial infarction (myocardial-specific isoform of creatine kinase >/= 100 ng/mL) for the isolated coronary artery bypass grafting, bolus plus infusion subgroup on POD 4 (p = 0.007) and on POD 30 (p = 0.004). CONCLUSIONS: Pexelizumab had no statistically significant effect on the primary endpoint. However, the reduction in death or myocardial infarction (myocardial-specific isoform of creatine kinase >/= 100 ng/mL) as revealed in the post hoc analysis in the isolated coronary artery bypass grafting bolus plus infusion subpopulation, suggests that further investigation of anti-C5 therapy for ameliorating complement-mediated inflammation and myocardial injury is warranted.