The use of the ketogenic diet in the treatment of psychiatric disorders.

INTRODUCTION: The ketogenic diet (KD) is a high-fat, low-carbohydrate, and moderate-protein diet that has shown benefit as a treatment in neurologic disorders and may serve as a therapeutic option in individuals with psychiatric disorders. METHODS: A search was conducted using EBSCOhost and PubMed databases for studies relating to ketogenic or low-carbohydrate diets and psychiatric disorders. RESULTS: A total of 32 experimental or observational studies were identified by initial search strategies, 14 of which met the criteria to be included in this analysis. Although specific diet formulations varied somewhat between studies, they all generally examined low-carbohydrate dietary intake with the goal of producing a ketotic state. The studies included in this review indicated the KD was beneficial in reducing symptoms associated with various psychiatric disorders. DISCUSSION: This review summarizes the available evidence regarding the efficacy of the ketogenic diet in psychiatric disease states. Data from the studies analyzed demonstrated a positive response in individuals who were able to remain on the diet, regardless of the disease state. However, there is a need for more data to clearly define the specific benefits the KD may provide.

A Systematic Review of the Efficacy and Safety of Over-the-Counter Medications Used in Older People for the Treatment of Primary insomnia.

OBJECTIVE: The purpose of this systematic review is to evaluate the available evidence for safety and efficacy of over-the-counter (OTC) sleep aids used for the treatment of insomnia in older people.
DATA SOURCES: PubMed, EBSCO, and International Pharmaceutical Abstracts.
STUDY SELECTION: Five studies were included that involved humans 65 years of age and older being evaluated on OTC sleep aids in the outpatient setting.
DATA EXTRACTION: Data extraction from each study included primary and secondary efficacy endpoints, such as differences in the mean total sleep time, sleep latency, sleep efficiency, and number of awakenings, along with safety endpoints, such as psychomotor ability, cognitive ability, and adverse effect profiles. Both subjective and objective measures of changes in sleep and adverse effects were included.
DATA SYNTHESIS: Diphenhydramine had a statistically significant increase in sedation and decrease in number of awakenings but was not shown to be any less or more safe than compared products. Despite lacking safety issues, valerian was found to have no effect on subjective or objective sleep outcomes. Overall, melatonin had the most evidence and was found to have a statistically significant positive impact on sleep measures without safety issues.
CONCLUSION: Diphenhydramine and melatonin appear to be efficacious in improving some sleep measures while causing minimal adverse effects. However, there are very few studies that examine the use of over-the-counter sleep aids in those 65 years of age and older with primary insomnia. Additional studies are needed in this population.

Cytokine production capabilities of human primary monocyte-derived macrophages from patients with diabetes mellitus type 2 with and without diabetic peripheral neuropathy.

INTRODUCTION: Monocytes from patients with diabetes mellitus type 2 (DM2) are dysfunctional, persistently primed, and prone to a proinflammatory phenotype. This may alter the phenotype of their differentiation to macrophages and result in diabetic peripheral neuropathy (DPN), nerve damage, nerve sensitization, and chronic pain. We have previously demonstrated that CD163 is a molecule that promotes an anti-inflammatory cellular phenotype in human primary macrophages, but this has not been proven in macrophages from patients with DM2 or DPN. Thus, we hypothesize that macrophages from patients with DM2 or DPN display an altered proinflammatory functional phenotype related to cytokine production and that the induction of CD163 expression will promote a more homeostatic phenotype by reducing their proinflammatory responsiveness. PATIENTS AND METHODS: We tested these hypotheses in vitro using blood monocyte-derived macrophages from healthy subjects and patients with DM2 with and without DPN. Cells were incubated in the presence or the absence of 5 µg/mL of lipopolysaccharide (LPS). The concentrations of interleukin-10, interleukin-6, tumor necrosis factor-alpha (TNF-α), TGF-ß, and monocyte chemoattractant protein-1 (MCP-1) were measured using ELISA assays. Macrophages were transfected with an empty vector plasmid or a plasmid containing the CD163 gene using mannosylated polyethylenimine nanoparticles. RESULTS: Our results show that nonstimulated DM2 or DPN macrophages have a constitutive primed proinflammatory state and display a deficient production of proinflammatory cytokines upon a proinflammatory challenge when compared to healthy macrophages. CD163 induction produced an anti-inflammatory phenotype in the healthy control group, and this effect was partial in DM2 or DPN macrophages. CONCLUSION: Our results suggest that diabetic macrophages adopt a complex phenotype that is only partially reversed by CD163 induction. Future experiments are focused on elucidating this differential responsiveness between healthy and diabetic macrophages.

Student pharmacist perceived benefit of a sequential training model for health testing.

PURPOSE: This article describes the health testing training process used at Presbyterian College School of Pharmacy and evaluates perceptions of the sequential training model among students in their first, second, and third professional years. EDUCATIONAL ACTIVITY AND SETTING: After observing student deficiencies in the knowledge and skills necessary for performing health tests, despite receiving didactic training within the core curriculum, faculty members searched for supplemental training programs used by other schools of pharmacy. No literature regarding structured programs was found. Consequently, faculty developed test-specific training modules for a variety of health screenings. Students who participated in the sequential self-learning followed by a live skills assessment were surveyed to determine their perceptions of the training. FINDINGS: During the 2014-2015 academic year, 78 students successfully completed health testing training modules. Of these students, 56 (72%) completed an attitudinal survey designed to assess their perceptions. Nearly 93% of respondents perceived improved confidence after completing the training. Regardless of the year in pharmacy school, 88% of respondents believe they would not have been adequately prepared to conduct the health test(s) without this training. SUMMARY: Student perception and acceptance of health testing training were positive. Using sequential training modules to teach and reinforce the skills necessary for performing health tests can improve student ability and confidence. Consequently, students have the opportunity to impact the health of the community while becoming practice ready in the area of health testing.

Metformin prescribing in low-income and insured patients with prediabetes.

OBJECTIVES: To describe prescribing patterns of metformin in low-income and Medicaid-insured patients with prediabetes and to identify common demographic characteristics and comorbid conditions of low-income and Medicaid-insured patients receiving metformin for treatment of prediabetes. DESIGN: Retrospective observational study. SETTING AND PARTICIPANTS: Patients (18-60 years old) who were enrolled in South Carolina Medicaid and diagnosed with prediabetes between January 2009 and December 2013. MAIN OUTCOME MEASURES: Metformin prescribing to treat prediabetes identified from pharmacy claims. RESULTS: Among 7102 patients who met the study criteria, 7.4% (n = 520) were prescribed metformin for prediabetes. Nearly 45% (n = 238) of eligible patients prescribed metformin initiated treatment within 30 days after diagnosis of prediabetes. Twenty-five percent of those prescribed metformin took 280 days or longer to initiate treatment after diagnosis of prediabetes. Older age, black race, managed care plan, comorbid hypertension and obesity, and longer enrollment period significantly increased the likelihood of metformin prescribing to treat prediabetes. CONCLUSION: Prevalence of metformin prescription to treat prediabetes is less than 8% in low-income and Medicaid-insured patients. Sociodemographic characteristics and comorbid conditions influenced metformin prescribing in the low-income population.

Identification, prevalence, and treatment of painful diabetic neuropathy in patients from a rural area in South Carolina.

Diabetic peripheral neuropathy (DPN) represents significant burdens to many patients and the public health-care system. Patients with diabetes in rural areas have higher risk of developing complications and having less access to proper treatment. We studied a rural population of patients with diabetes who attended a pharmacist-led free clinic for a diabetic education program. Our objectives were to 1) determine the prevalence of DPN and painful diabetic neuropathy (p-DN) in patients with type 2 diabetes; 2) assess the proportion of patients with DPN and p-DN left undocumented upon physician referral to a pharmacist-led free clinic; and 3) determine the appropriateness of pain medication regimen. We performed a retrospective analysis of clinical records of patients from the Presbyterian College School of Pharmacy (PCSP) Wellness Center located in Clinton, SC. Diagnoses of DPN and/or p-DN were obtained from referral notes in the clinical records and compared with results from foot examinations performed in the free clinic and clinical features. Medication regimens were also obtained and compared using American Academy of Neurology (AAN) treatment guidelines. Within our study population (n=111), the prevalence of DPN was 62.2% (national average of 28%-45%) and that of p-DN was 23.4% (national average of 11%-24%). In p-DN patients (n=26), 53.8% (n=14) had a documented diagnosis of p-DN by the referring physician, and 46.2% (n=12) were identified by the pharmacists. A total of 95% (19 of 20) of the patients treated for p-DN received adequate pharmacological agents, though suboptimal as per clinical guidelines. More than 50% of the patients used subtherapeutic doses of their medications. Gabapentin was the most frequently used medication in our population (65.4%). Patients in rural South Carolina had a higher prevalence of DPN and p-DN with >60% undocumented cases of p-DN. More than 95% of treated patients did not receive optimum therapy according to AAN guidelines.

Evaluation of the Prevalence and Effectiveness of Education on Metered-Dose Inhaler Technique.

BACKGROUND: The objectives of this study were: (1) to assess the prevalence of and types of education methods provided to participants who use a metered-dose inhaler (MDI), (2) to determine the prevalence of MDI misuse in adults using objective and subjective assessments, and (3) to determine whether any associations exist between the education method and the participant's ability to properly use an MDI. METHODS: Adult participants who had a current or previous history of MDI use were recruited from retail pharmacies and physician offices in Laurens County, South Carolina. Exclusion criteria included the use of an MDI spacer, inability to speak/understand English, or current acute respiratory illness. Participants completed a survey regarding inhaler use and previous education, a subjective checklist assessment by demonstrating use of an MDI, and an objective assessment by using the Aerosol Inhalation Monitor (AIM). RESULTS: Of 100 participants, 25% reported never having received education about inhaler technique, and 94% were found to have insufficient MDI technique. No association between the method of education and successful MDI technique with the AIM was identified (P = .31). Participants were less likely to correctly use the AIM if they missed >3 steps in the subjective assessment. (P = .032). CONCLUSIONS: Although most participants received inhaler education, inhaler misuse was very common. No associations were found regarding method of education and proper inhaler technique.

Telehealth for diabetes self-management education and support in an underserved, free clinic population: A pilot study.

OBJECTIVES: Primary study objectives were to (1) describe mean change in A1c from baseline of a free clinic population enrolled in telehealth diabetes self-management education and support (DSME/S) services and (2) to compare change in A1C and other clinical outcomes measures with free clinic patients enrolled in a traditional face-to-face DSME/S program. METHODS: An exploratory study design and comparative evaluation of telehealth DSME/S services in a free clinic population was used. Baseline clinical measures were collected upon referral. Diabetes educators met with patients individually over 2-3 months. Clinical outcomes measures were collected within 6 months of program completion. Data from the telehealth group was assessed individually and compared to a free clinic traditional DSME/S program population. RESULTS: Twelve patients completed a telehealth free clinic DSME/S pilot program with a mean ± SD change in A1C from baseline of -1.03 ± 1.53% (P = 0.050). Mean ± SD change in A1C from baseline in the free clinic population participating in traditional face-to-face DSME/S services was -1.42 ± 1.80% (P = 0.001). No significant differences in secondary outcomes measures, including body mass index and blood pressure, were revealed among the study populations. CONCLUSION: Expanding access to care in populations faced with challenges of socioeconomics, limited education, and lower health literacy is a step toward reducing health disparities and positively affecting care. Mean A1C can be improved with telehealth DSME/S services in an underserved, free clinic population.

Progression to Type 2 Diabetes and Its Effect on Health Care Costs in Low-Income and Insured Patients with Prediabetes: A Retrospective Study Using Medicaid Claims Data.

BACKGROUND: Prediabetes is a high-risk factor for progression to diabetes. Without lifestyle changes, such as weight loss and moderate physical activity, 15%-30% of people with prediabetes are projected to develop type 2 diabetes within 5 years. Progression to diabetes increases the financial burden significantly for patients and health care systems. Populations with low socioeconomic status are associated with a higher risk of diabetes. However, knowledge is limited about the effect of transition to diabetes on future costs incurred in low-income populations. OBJECTIVES: To (a) describe the characteristics of low-income and insured patients with prediabetes and (b) examine the effect of progression to type 2 diabetes on health care utilization and costs. METHODS: This study used South Carolina Medicaid claims data (2009-2014) to identify patients (aged ≥18 years) with newly diagnosed prediabetes. All patients were enrolled in Medicaid continuously for at least 1 year before and after the diagnosis of prediabetes and were followed for at least 1 year and up to 6 years. The time to progression to type 2 diabetes was measured by a Kaplan Meier curve, and risk factors associated with onset of type 2 diabetes were identified by Cox regression. Generalized linear models were applied to assess the effect of progression to type 2 diabetes on total health care costs during the first 3-year period. RESULTS: A total of 7,650 patients with prediabetes met the study criteria. During the follow-up period, 30.3% of the study population developed type 2 diabetes within 3 years. Older age, African-American race, fee-for-service plan, comorbid hypertension, obesity, and dyslipidemia were associated with higher risk for onset of type 2 diabetes. Compared with patients who did not progress to type 2 diabetes, the progression to type 2 diabetes increased total health care costs by 22.1% (P < 0.001), 39.1% (P < 0.001), and 47.6% (P < 0.001) during the first 3 years after adjusting for demographic and comorbid conditions. CONCLUSIONS: Age, race, type of Medicaid plan, and diabetes-related comorbidities were associated with risk for progression of prediabetes. Progression to type 2 diabetes significantly increased total health care costs in the first 3 years. Early detection and intervention to prevent or delay onset of type 2 diabetes are needed to control health care utilization and costs. DISCLOSURES: This study was funded by Small Pharmacy Awards for Research and Collaboration, Presbyterian College. The funding resource had no role in the design and conduct of the study, analysis or interpretation of the data, or the preparation or final approval of the manuscript before publication. The authors declare no conflicts of interest. Study concept and design were contributed by Wu, Ward, and Lu, along with Threatt. Wu took the lead in data collection, along with Ward and Lu, with assistance from Threat. Data interpretation was provided by Wu, Ward, Threatt, and Lu. The manuscript was written and revised by Wu, Ward, and Threatt, along with Lu.

Clinical Pharmacokinetics and Pharmacodynamics of Insulin Glargine 300 U/mL.

Concentrated insulin analogs have recently been approved and are available for clinical use in the management of diabetes mellitus. One new product is insulin glargine U-300 (Sanofi), a basal concentrated insulin of 300 U/mL. Several studies have been conducted and completed evaluating blood samples for the pharmacokinetics of insulin glargine U-300 and euglycemic clamp procedures for the pharmacodynamics. This concentrated insulin has a low within-day variability and high day-to-day reproducibility, allowing for a more constant and prolonged duration of action, compared with insulin glargine U-100 (100 U/mL). Insulin glargine U-300 is equally effective, when compared with insulin glargine U-100 for glycemic control in patients with type 1 and 2 diabetes mellitus. Insulin glargine U-300 has a similar efficacy profile to insulin glargine U-100 for glycemic control, yet with lower rates of nocturnal and severe hypoglycemia. Insulin glargine U-300 can be considered an acceptable basal insulin for patients with type 1 and 2 diabetes mellitus, and it has a potential role among patients who are naïve to insulin therapy or require titration of basal insulin. Titration of insulin glargine U-300 would result in less volume and a lower risk of hypoglycemia, compared with insulin glargine U-100. This article evaluates and summarizes the pharmacokinetics and pharmacodynamics of insulin glargine U-300, for patients with type 1 or 2 diabetes mellitus, and summarizes its application to clinical practice.

Utilization of the Newest Vital Sign (NVS) in Practice in the United States.

Health literacy refers to the ability of a patient to obtain, communicate, process, and understand basic information related to health and services. It is estimated that the majority of adult Americans may have difficulty understanding health information. In addition, limited health literacy of patients is linked to over $100 billion in health care costs. Measurement of health literacy may aid in improving communication with patients, and thus to improving outcomes and decreasing costs. The Newest Vital Sign (NVS) is a tool that has been used to assess health literacy in a variety of patients. It has been validated against other measures including the Test of Functional Health Literacy in Adults (TOFHLA). Patients are categorized as high likelihood of limited health literacy, possible limited health literacy, or adequate literacy. The NVS has been used in a variety of settings and tested among a wide range of patient groups. The most common setting for use is in primary care, probably due to the relatively quick assessment of health literacy (within 3 minutes). The NVS has been used in Caucasians, African Americans, Hispanics, and several other ethnicities. Assessment with the NVS has been conducted in adult patients across the age continuum, and with several different health conditions, including diabetes, kidney disease, and pain. This article seeks to review the published uses to date and to provide suggestions for potential uses of the NVS.