MF918

Randall A. Higgins, Sue L. Blodgett and Andrew W. Lenssen, “Alfalfa weevil management in Kansas: II. Non-chemical controls,” Kansas State University, April 1989

Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects.

BACKGROUND AND OBJECTIVES: To describe the safety and tolerability of intravenous meloxicam compared with placebo across all phase II/III clinical trials. METHODS: Safety data and opioid use from subjects with moderate to severe postoperative pain who received ≥1 dose of intravenous meloxicam (5-60 mg) or placebo in 1 of 7 studies (4 phase II; 3 phase III) were pooled. Data from intravenous meloxicam 5 mg, 7.5 mg and 15 mg groups were combined (low-dose subset). RESULTS: A total of 1426 adults (86.6% white; mean age: 45.8 years) received ≥1 dose of meloxicam IV; 517 (77.6% white; mean age: 46.7 years) received placebo. The incidence of treatment-emergent adverse events (TEAEs) in intravenous meloxicam and placebo-treated subjects was 47% and 57%, respectively. The most commonly reported TEAEs across treatment groups (intravenous meloxicam 5-15 mg, 30 mg, 60 mg and placebo, respectively) were nausea (4.3%, 20.8%, 5.8% and 25.3%), headache (1.5%, 5.6%, 1.6% and 10.4%), vomiting (2.8%, 4.6%, 1.6% and 7.4%) and dizziness (0%, 3.5%, 1.1% and 4.8%). TEAE incidence was generally similar in subjects aged \u3e65 years with impaired renal function and the general population. Similar rates of cardiovascular events were reported between treatment groups. One death was reported (placebo group; unrelated to study drug). There were 35 serious adverse events (SAEs); intravenous meloxicam 15 mg (n=5), intravenous meloxicam 30 mg (n=15) and placebo (n=15). The SAEs in meloxicam-treated subjects were determined to be unrelated to study medication. Six subjects withdrew due to TEAEs, including three treated with intravenous meloxicam (rash, localized edema and postprocedural pulmonary embolism). In trials where opioid use was monitored, meloxicam reduced postoperative rescue opioid use. CONCLUSIONS: Intravenous meloxicam was generally well tolerated in subjects with moderate to severe postoperative pain. TRIAL REGISTRATION NUMBERS: NCT01436032, NCT00945763, NCT01084161, NCT02540265, NCT02678286, NCT02675907 and NCT02720692

Reclaiming Coal Surface Mines in Central Appalachia: A Case Study of the Benefits and Costs

Regulatory alternatives for the surface mining industry have come under intense public and political scrutiny in recent years. Recent studies have found that the impacts of federal surface mine reclamation regulations\u27 will be noticeable, but perhaps not as substantial as some had expected. Nationwide, coal production from surface mines would be reduced by about five percent, with a similar increase in underground coal production. The federal reclamation legislation, depending on the regulations eventually adopted for its implementation, is unlikely to be a major disruptive influence in the coal industry or a substantial impediment to the long-run national goal of increased utilization of coal. This study has found that the social benefits from surface mine reclamation under existing Kentucky regulations unambiguously exceed the private costs. The incremental benefits of reclamation to satisfy the federal regulations which seem likely to be promulgated are always positive and exceed the incremental private costs under some assumptions, but not under others

A collaborative primary health care model for children and young people in rural Australia: explorations of cross-sectoral leader action

Background. Cross-sectoral collaborations are considered necessary to address detrimental health, social, educational and economic outcomes that impact marginalised and disadvantaged populations. There is a strong relationship between the health of children and their educational attainment; good health promotes positive learning. This paper reports cross-sectoral executive and senior management level systems changes required to enable the design of a collaborative primary healthcare service model for children and young people in rural Australia. Methods. A descriptive qualitative design was used. Data were collected from executive and senior managers from three organisations (Education, Health and a University Department of Rural Health [n = 6]) through individual semi-structured interviews. Data were analysed using an inductive, thematic approach. The study draws on Lewin’s Model of Change. Results. Three overarching themes were generated from the data: an embedded challenge and experimental solutions; building a shared language and understanding; and the role of relationships and trust. Despite the unique geographical and social context of the study area, strategies emerged from the data on how a solution to an embedded challenge, through design of a primary healthcare model, was established and how the strategies described could be transferred and scaled to other rural and remote communities. Conclusion. Contextual differences make each rural and remote area unique. In this study, strategies that are described in the managing change literature were evident. The authors conclude that drawing on strong management of change principles could mean that a service model designed for one remote community might be transferrable to other communities

Safety, Tolerability, and Pharmacokinetic Properties of Intravenous Delafloxacin After Single and Multiple Doses in Healthy Volunteers

AbstractPurposeThe objective of this report was to determine the pharmacokinetic properties, safety, and tolerability of single and multiple doses of intravenous delafloxacin. In addition, the absolute bioavailability (BA) of the 450-mg tablet formulation of delafloxacin was determined.MethodsThree clinical trials are summarized. The first study was a randomized, double-blind, placebo-controlled, single- (300, 450, 600, 750, 900, and 1200 mg) ascending-dose study of IV delafloxacin in 62 (52 active, 10 placebo) healthy volunteers. The second study was a randomized, double-blind, placebo-controlled study of IV delafloxacin (300 mg) given as a single dose on day 1, followed by twice-daily dosing on days 2 through 14; 12 (8 active, 4 placebo) healthy volunteers were enrolled. The third study was an open-label, randomized, 2-period, 2-sequence crossover study in which 56 healthy volunteers were randomly assigned to 1 of 2 sequences of a single oral dose of delafloxacin (450-mg tablet) or IV delafloxacin (300 mg). Serial blood samples were collected, and plasma pharmacokinetic parameters of delafloxacin were calculated.FindingsDelafloxacin Cmax values increased proportionally with increasing single IV dose for the dose range of 300 to 1200 mg, whereas the AUC values increased more than proportionally to dose for the same dose range. The mean terminal half-life of delafloxacin was approximately 12 hours (ranging from 8 to 17 hours). The volume of distribution (Vd) at steady state was approximately 35 L, which is similar to the volume of total body water. There was minimal accumulation of delafloxacin after twice-daily IV administration of 300 mg with an accumulation ratio of 1.09. The delafloxacin total exposure after a single 1-hour IV infusion of 300 mg and a single oral dose of a 450-mg tablet were equivalent with geometric least square mean ratio (90% CI) of 0.8768 (0.8356–0.9200) for AUC0–∞ and 0.8445 (0.8090–0.8815) for AUC0–t, respectively. The Cmax values of delafloxacin were not equivalent for the 2 formulations with a ratio (90% CI) of 0.5516 (0.5150–0.5908), respectively. The mean absolute bioavailability of delafloxacin was 58.8%.ImplicationsDelafloxacin was well tolerated in healthy volunteers after single and multiple IV doses. The total systemic exposure to IV (300 mg) and oral (450 mg) delafloxacin is comparable, supporting that a switch between the 2 formulations is appropriate

Single and Multiple Ascending-dose Studies of Oral Delafloxacin: Effects of Food, Sex, and Age

AbstractPurposeThe objective of this report is describe the results of 2 studies that examined the pharmacokinetic parameters, safety profile, and tolerability of single and multiple ascending doses of oral delafloxacin and the effects of food, sex, and age on oral delafloxacin pharmacokinetic parameters, safety profile, and tolerability.MethodsThe first study contained 3 parts and used unformulated delafloxacin in a capsule. Part 1 was a randomized, double-blind, placebo-controlled, single (50, 100, 200, 400, 800, 1200, and 1600 mg) ascending-dose study of oral delafloxacin in healthy men. Part 2 was a single-dose crossover study in which 20 men received 250 mg delafloxacin with or without food. Part 2 also included a parallel group, double-blind, placebo-controlled study in 16 women and 16 elderly men and women who were randomized (3:1) to receive 250 mg delafloxacin or placebo. Part 3 was a randomized, double-blind, placebo-controlled, multiple (100, 200, 400, 800, 1200 mg once daily for 5 days) ascending-dose study of oral delafloxacin in healthy men. The second study was a single-dose, randomized, 3-period crossover study in which participants received 900 mg delafloxacin (2 × 450-mg tablets) under fasted conditions, with a high-fat meal, or fasted with a high-fat meal 2 hours after dosing. Serial blood samples were collected, and plasma pharmacokinetic parameters of delafloxacin were determined.FindingsDelafloxacin Cmax and AUC0–∞ increased with increasing oral dose over the dose range of 50 to 1600 mg. The increases in delafloxacin AUC0–∞ were dose proportional at doses of ≥200 mg. Steady state was reached by day 3 of dosing with minimal accumulation of delafloxacin. The Cmax of delafloxacin was decreased slightly in the presence of food. No sex difference in delafloxacin pharmacokinetic parameters was observed. In the elderly men and women, mean delafloxacin Cmax and AUC0–∞ were 35% higher than observed for young adults, which could be partially explained by a decrease in the creatinine clearance in the elderly men and women. Delafloxacin was well tolerated at the tested doses, with gastrointestinal adverse effects observed more commonly at doses ≥1200 mg.ImplicationsDelafloxacin exhibits linear pharmacokinetic parameters that reached steady state after 3 days of daily oral dosing with minimal accumulation. Delafloxacin was well tolerated throughout both studies, with gastrointestinal effects observed at the higher doses (≥1200 mg)

Prevalence of depression and its influence on the quality of life of Jordanians living in residential care facilities

BACKGROUND: As a third-world country experiencing a rise in the elderly population and changes to traditional family structures, improving psychological health is critical to improving quality of life (QoL) in the older adults living in residential care facilities in Jordan. PURPOSE: This study aimed to (a) estimate the prevalence of depression among nursing home (NH) residents in Jordan; (b) measure perceived QoL in these NH residents in the dimensions of mobility, self-care, usual activity, pain and discomfort, and anxiety/depression; and (c) assess the influence of depression on each of these QoL dimensions. METHODS: This cross-sectional study recruited a convenience sample of 155 participants living in a residential care facility in Jordan. The instruments used included a sociodemographic and clinical questionnaire, the Mini-Mental State Examination, a Geriatric Depression Scale (GDS), and the EuroQol, which is a five-dimension, five-level questionnaire. The data were presented as means, standard deviations, and percentages as well as adjusted odds ratios (AORs) with 95% confidence intervals (CIs). RESULTS: A high prevalence of depression was found in the study population, with 72.3% having a score between 6 and 9 on the GDS, which is suggestive of depression. Moreover, 18.1% scored ≥ 10 on the GDS, which is indicative of a nearly continual state of depression. With regard to the QoL dimensions, 84.5% of the participants reported experiencing pain, 81.9% reported anxiety/depression, 80.6% reported problems performing usual activities, 75.5% reported problems with self-care, and 63.2% reported mobility difficulties. Pain, anxiety, and depression were found to be significantly associated with level of depression (AOR = 2.78 and 95% CI [1.18, 6.57], AOR = 5.81 and 95% CI [2.14, 15.78], and AOR = 4.75 and 95% CI [1.87, 12.07], respectively). CONCLUSIONS: Depression is common among NH residents in Jordan and is associated significantly with poor QoL. This study yielded empirical data that may be used to develop strategies to enhance or promote the mental health status and QoL of NH residents in Jordan