Single- and Multiple-Dose Pharmacokinetics of Gefapixant (MK-7264), a P2X3 Receptor Antagonist, in Healthy Adults.

Gefapixant (MK-7264, RO4926219, AF-219) is a first-in-class P2X3 antagonists being developed to treat refractory or unexplained chronic cough. The initial single- and multiple-dose safety, tolerability, and pharmacokinetics of gefapixant at doses ranging from 7.5 to 1800 mg were assessed in four clinical trials.

Potential disruptive effects of zoosporic parasites on peatland-based organic freshwater aquaculture: Case study from the Republic of Ireland.

Irish freshwater aquaculture holds great potential for aiding food security. However, its necessary expansion has been hampered by the adoption of important environmental EU directives. A novel peatland-based recirculating aquaculture multi-trophic pond system (RAMPS) was developed to assess its potential to assist in the sustainable development of industry whilst remaining aligned with environmental protection by adhering to organic aquaculture practices.

Use of next generation sequencing and bioinformatics for profiling freshwater eukaryotic microalgae in a novel peatland integrated multi-trophic aquaculture (IMTA) system: Case study from the Republic of Ireland.

Development of integrated multi-trophic aquaculture (IMTA) systems constitutes a step change in the sustainable production of freshwater fish to meet emerging needs for high-protein foods globally. Recently, there has been a paradigm shift away from harvesting peat as a fuel towards the development of wettable peatland innovation (termed 'paludiculture'), such as aquaculture. Such eco-innovations support carbon sequestration and align with a balanced environmental approach to protecting biodiversity.

Relationships between experiencing anti-fat microaggressions, body appreciation, and perceived physical and mental health.

This study examined whether body appreciation mediates the relationships between anti-fat microaggression experiences and perceived physical and mental health. Using a cross-sectional survey design, our study included 384 adult cisgender women in the United States. We found that anti-fat microaggression experiences had a negative association with body appreciation, and perceived physical and mental health.

Effects of climate and environmental variance on the performance of a novel peatland-based integrated multi-trophic aquaculture (IMTA) system: Implications and opportunities for advancing research and disruptive innovation post COVID-19 era.

Advancing wet peatland 'paludiculture' innovation present enormous potential to sustain carbon-cycles, reduce greenhouse-gas (GHG) gas emissions and to transition communities to low-carbon economies; however, there is limited scientific-evidence to support and enable direct commercial viability of eco-friendly products and services. This timely study reports on a novel, paludiculture-based, integrated-multi-trophic-aquaculture (IMTA) system for sustainable food production in the Irish midlands. This freshwater IMTA process relies on a naturally occurring ecosystem of microalgae, bacteria and duckweed in ponds for managing waste and water quality that is powered by wind turbines; however, as it is recirculating, it does not rely upon end-of-pipe solutions and does not discharge effluent to receiving waters.

Microalgae as a natural ecological bioindicator for the simple real-time monitoring of aquaculture wastewater quality including provision for assessing impact of extremes in climate variance - A comparative case study from the Republic of Ireland.

Aquaculture is one of the fastest growing food producing industries globally, providing ~50% of fish for human consumption. However, the rapid growth of aquaculture presents a range of challenges including balancing environmental impact that can be influenced by variations in climatic conditions. Monitoring of physicochemical parameters is traditionally used to evaluate aquaculture output quality; however, this approach does not indicate the cumulative ecotoxicological effects on receiving waters.

Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin.

Aims: To assess the efficacy, safety and tolerability of ipragliflozin 50 mg once daily added to sitagliptin 50 mg once daily monotherapy in Japanese patients with type 2 diabetes (T2D).

Materials And Methods: The results of two clinical trials are reported. In both trials, patients had glycated haemoglobin (HbA1c) levels of 7.

A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin.

Aims: To investigate the efficacy, safety and tolerability of sitagliptin 50 mg once daily added to ipragliflozin 50 mg once daily monotherapy in Japanese patients with type 2 diabetes (T2D).

Materials And Methods: Japanese patients with T2D and glycated haemoglobin (HbA1c) 7.0% to 10.

A randomized, placebo-controlled study to evaluate the efficacy and safety of adding omarigliptin to insulin therapy in Japanese patients with type 2 diabetes and inadequate glycaemic control.

Aim: To evaluate the efficacy and safety of adding the once-weekly oral dipeptidyl peptidase-4 inhibitor omarigliptin to treatment of Japanese patients with type 2 diabetes and inadequate glycaemic control on insulin monotherapy.

Materials And Methods: In a 52-week clinical trial, Japanese patients on insulin monotherapy were randomized to once-weekly omarigliptin 25 mg (N = 123) or placebo (N = 61) for a 16-week, double-blind, placebo-controlled period. After Week 16, patients continued or switched to omarigliptin for a 36-week open-label period.

Efficacy and Safety of Sitagliptin Compared with Dapagliflozin in People ≥ 65 Years Old with Type 2 Diabetes and Mild Renal Insufficiency.

Introduction: Older patients with type 2 diabetes (T2D) are at increased risk of diabetic nephropathy and mild renal insufficiency. This analysis compared the anti-hyperglycemic efficacy and safety of sitagliptin with dapagliflozin in patients ≥ 65 years of age with T2D and mild renal insufficiency.

Methods: This was a post hoc analysis of data from 410 patients ≥ 65 years old who participated in a 24-week, randomized, double-blind clinical trial (CompoSIT-R [comparison of sitagliptin with dapagliflozin in mild renal impairment]; NCT02532855) in T2D patients with mild renal insufficiency and on metformin ± a sulfonylurea; the primary efficacy end point was change in HbA1c at week 24.

Sexual function in hook-up culture: The role of body image.

Hook-up mobile apps are increasing in popularity and research suggests sexual function may be lower among those who hook-up compared to those who have sex in a longer-term relationship. Sexual function is an important predictor of well-being; however, we know little about the psychosocial antecedents of sexual function, such as body image, among those who use hook-up apps. The current study aims to examine two measures of positive body image and one measure of body image self-consciousness during intimate activity among a sample of adult women and men who have hooked up in the previous month using a hook-up mobile app (N = 243).

Body Appreciation and Health Care Avoidance: A Brief Report.

Research suggests that body image is related to health behaviors and health care use, but possible mechanisms for this relationship remain unclear. The current study examined the presence of a relationship between body appreciation and avoiding the doctor to avoid being weighed, using a diverse sample of women (N = 499). Controlling for body size and determinants of health care utilization, logistic regression results suggested that women with higher body appreciation were less likely to avoid health care to avoid being weighed (odds ratio = 0.

Novel use of peatlands as future locations for the sustainable intensification of freshwater aquaculture production - A case study from the Republic of Ireland.

There has been an increasing interest in enhancing freshwater aquaculture processes without hindering the progress of the Water Framework Directive. This constitutes the first study to describe a new concept in integrated multitrophic aquaculture (IMTA) that uses cutaway peatlands (bogs) to farm rainbow trout and Eurasian perch with associated organic status that is powered by wind energy and utilizes algae and duckweed to treat rearing water. Approximately 5% of Ireland comprises bogs that support natural ecosystems where there is a pressing need to develop alternative innovation to that of burning peat in order to reduce Ireland's carbon emissions.

Novel use of the alga Pseudokirchneriella subcapitata, as an early-warning indicator to identify climate change ambiguity in aquatic environments using freshwater finfish farming as a case study.

Aquaculture is one of the fastest growing food producing industries in the world. This dramatic increase in growth has raised many environmental concerns. Evaluation of fish farm effluent is frequently assessed by physicochemical parameters.

Double-blind, randomized clinical trial assessing the efficacy and safety of early initiation of sitagliptin during metformin uptitration in the treatment of patients with type 2 diabetes: The CompoSIT-M study.

Aims: To characterize the glycaemic efficacy and safety of initiation of the dipeptidyl peptidase-4 inhibitor sitagliptin during metformin dose escalation in people with type 2 diabetes (T2D) not at glycated haemoglobin (HbA1c) goal on a sub-maximal dose of metformin.

Materials And Methods: Study participants with HbA1c ≥58 mmol/mol and ≤97 mmol/mol (≥7.5% and ≤11.

Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study.

Aims: To compare the effects of continuing versus discontinuing sitagliptin when initiating and intensively titrating insulin glargine.

Materials And Methods: Eligible patients had inadequately controlled type 2 diabetes on metformin (≥1500 mg/d) in combination with a dipeptidyl peptidase-4 (DPP-4) inhibitor and/or a sulphonylurea. Those on metformin + sitagliptin were directly randomized; all others were switched to metformin + sitagliptin (discontinuing other DPP-4 inhibitors and sulphonylureas) and stabilized during a run-in period.

Efficacy and safety of sitagliptin added to treatment of patients with type 2 diabetes inadequately controlled with premixed insulin.

To improve understanding of the safety and efficacy of adding sitagliptin to treatment of patients with type 2 diabetes taking premixed insulin, data from patients using premixed insulin ± metformin (screening HbA1c ≥7.5% and ≤11%) in either of two clinical trials in which sitagliptin 100 mg once-daily or placebo was added to various formulations of insulin treatment, were analysed. In both trials, insulin doses were to remain stable throughout the 24-week trial period.

A randomized clinical trial of the efficacy and safety of sitagliptin compared with dapagliflozin in patients with type 2 diabetes mellitus and mild renal insufficiency: The CompoSIT-R study.

Aim: To compare the efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin with the sodium-glucose transporter-2 inhibitor dapagliflozin in patients with type 2 diabetes and mild renal insufficiency.

Materials And Methods: Patients with HbA1c ≥7.0 to ≤9.

Efficacy and Safety of Sitagliptin in Hispanic/Latino Patients with Type 2 Diabetes: A Pooled Analysis from Ten Randomized, Placebo-Controlled Phase 3 Clinical Trials.

Introduction: To assess the efficacy and safety profile of the dipeptidyl-peptidase-4 inhibitor sitagliptin in a population of self-identified Hispanic/Latino patients with type 2 diabetes.

Methods: Data were pooled from ten randomized, double-blind studies in which subjects were treated with sitagliptin 100 mg/day (as mono- or combination therapy) or placebo, and used to evaluate the glycemic efficacy, safety, and tolerability of sitagliptin compared with placebo after 24 weeks of treatment.

Results: A total of 804 Hispanic/Latino patients were included in the analysis.

Characteristics of Elderly Patients Initiating Sitagliptin or Non-DPP-4-Inhibitor Oral Antihyperglycemic Agents: Analysis of a Cross-Sectional US Claims Database.

Introduction: Previous analyses concluded that patients initiating treatment with sitagliptin are older and have more comorbidities than patients initiating treatment with other oral antihyperglycemic agents (OAHAs). However, these studies focused on the general population or subjects ≤ 65 years of age. We sought to compare differences in baseline characteristics of elderly patients (≥ 65 years of age) with T2DM initiating sitagliptin vs.

Body Image Assessment Among Community Mental Health Providers.

Although research suggests an association between body image and mental health, with poor body image related to several mental illnesses, there is no research exploring mental health clinicians' body image screening practices. This study aims to fill this gap among a sample of community mental health providers (N = 216). Using a cross-sectional design, clinicians in Community Health Centers were recruited through email using purposeful and snowball sampling in a Midwest state.

A randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus inadequately controlled by glimepiride and metformin.

Background: Type 2 diabetes (T2D) is a progressive disease that often requires a patient to use multiple antihyperglycemic agents to achieve glycemic control with disease progression. Omarigliptin is a once-weekly dipeptidyl peptidase-4 inhibitor. The purpose of this trial was to assess the efficacy and safety of adding omarigliptin to the treatment regimen of patients with T2D inadequately controlled by dual therapy with metformin and glimepiride.

A randomized, double-blind trial evaluating the efficacy and safety of monotherapy with the once-weekly dipeptidyl peptidase-4 inhibitor omarigliptin in people with type 2 diabetes.

Aims: To assess the efficacy and safety of once-weekly omarigliptin as monotherapy in people with type 2 diabetes mellitus (T2DM).

Methods: People with T2DM not on glucose-lowering medications, or who were washed off monotherapy or low-dose dual therapy, were randomized double-blind to omarigliptin 25 mg (n=165) or matching omarigliptin placebo (n=164) for 24 weeks, followed by a 30-week period to assess continuing efficacy and safety longer-term of omarigliptin during which metformin was added to the placebo group and metformin placebo to the omarigliptin group.

Results: From a mean baseline HbA1c of 8.

Use of Prohibited Medication, a Potentially Overlooked Confounder in Clinical Trials: Omarigliptin (Once-weekly DPP-4 Inhibitor) Monotherapy Trial in 18- to 45-year-olds.

Purpose: The objective of this clinical trial was to assess the efficacy and safety of omarigliptin monotherapy in young adult patients with type 2 diabetes mellitus (T2DM). Unexpected efficacy results in this trial led to a series of investigations that identified the use of prohibited medication by a substantial number of trial patients.

Methods: Patients with T2DM who were ≥18 to <45 years of age and either drug-naive or not on an antihyperglycemic agent for ≥12 weeks with inadequate glycemic control were randomized in a double-blind manner to receive omarigliptin 25 mg once weekly (n = 102) or placebo once weekly (n = 101) for 24 weeks.