Safety and efficacy of switching to biphasic insulin aspart 30/70 (BIAsp 30) under the routine diabetic care in patients with type 2 diabetes: The IMPROVE™ observational study in the Gulf region

AbstractThe IMPROVE™ study was a 26-week, multinational, open-label, non-randomized study, carried out in 11 countries.AimTo evaluate the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in patients with type 2 diabetes under routine clinical practice.Study designThere were no prescribed procedures for this study except for the collection of data.ResultData obtained at baseline and Week 26 in patients from the Gulf region is presented. From the Gulf region, 1613 patients (61% males) were enrolled with a mean age of 50.5years and a mean BMI of 30.4kg/m2. The majority of the patients (57.0%) were treated with OAD only, while 34.3% patients were previously treated with insulin ±OAD and 8.7% were treatment naive. After 26weeks of treatment, the mean HbA1c was reduced by 1.4% from 9.3% at baseline to 7.9% at Week 26. The mean FBG was reduced by 66.6mg/dL from 212.4mg/dL at baseline to 145.8mg/dL at Week 26. No major hypoglycaemic episodes were reported as SADRs during the study. The rate of major hypoglycaemic episodes was reduced from 0.13 episodes/patient year at baseline to 0.05 episodes/patient year at Week 26. A lower risk of minor hypoglycaemia was also observed. Body weight was reduced by 0.6kg from 85.4kg at baseline to 84.7kg at Week 26.ConclusionBIAsp 30 improved glycaemic control without increasing the risk of hypoglycaemic episodes and weight gain after 26weeks’ treatment in patients with type 2 diabetes from the Gulf region

Patients\u27 Perceptions and Patient-Reported Outcomes in Progressive-Fibrosing Interstitial Lung Diseases

The effects of interstitial lung disease (ILD) create a significant burden on patients, unsettling almost every domain of their lives, disrupting their physical and emotional well-being and impairing their quality of life (QoL). Because many ILDs are incurable, and there are limited reliably-effective, life-prolonging treatment options available, the focus of many therapeutic interventions has been on improving or maintaining how patients with ILD feel and function, and by extension, their QoL. Such patient-centred outcomes are best assessed by patients themselves through tools that capture their perceptions, which inherently incorporate their values and judgements. These patient-reported outcome measures (PROs) can be used to assess an array of constructs affected by a disease or the interventions implemented to treat it. Here, we review the impact of ILD that may present with a progressive-fibrosing phenotype on patients\u27 lives and examine how PROs have been used to measure that impact and the effectiveness of therapeutic interventions

Patients\u27 perceptions and patient-reported outcomes in progressive-fibrosing interstitial lung diseases

The effects of interstitial lung disease (ILD) create a significant burden on patients, unsettling almost every domain of their lives, disrupting their physical and emotional well-being and impairing their quality of life (QoL). Because many ILDs are incurable, and there are limited reliably-effective, life-prolonging treatment options available, the focus of many therapeutic interventions has been on improving or maintaining how patients with ILD feel and function, and by extension, their QoL. Such patient-centred outcomes are best assessed by patients themselves through tools that capture their perceptions, which inherently incorporate their values and judgements. These patient-reported outcome measures (PROs) can be used to assess an array of constructs affected by a disease or the interventions implemented to treat it. Here, we review the impact of ILD that may present with a progressive-fibrosing phenotype on patients\u27 lives and examine how PROs have been used to measure that impact and the effectiveness of therapeutic interventions

Patients\u27 Perceptions and Patient-Reported Outcomes in Progressive-Fibrosing Interstitial Lung Diseases

The effects of interstitial lung disease (ILD) create a significant burden on patients, unsettling almost every domain of their lives, disrupting their physical and emotional well-being and impairing their quality of life (QoL). Because many ILDs are incurable, and there are limited reliably-effective, life-prolonging treatment options available, the focus of many therapeutic interventions has been on improving or maintaining how patients with ILD feel and function, and by extension, their QoL. Such patient-centred outcomes are best assessed by patients themselves through tools that capture their perceptions, which inherently incorporate their values and judgements. These patient-reported outcome measures (PROs) can be used to assess an array of constructs affected by a disease or the interventions implemented to treat it. Here, we review the impact of ILD that may present with a progressive-fibrosing phenotype on patients\u27 lives and examine how PROs have been used to measure that impact and the effectiveness of therapeutic interventions

Action of MK‐7264 (Gefapixant) at human P2X3 and P2X2/3 receptors and in vivo efficacy in models of sensitisation

Background & Purpose The P2X3 receptor is an ATP‐gated ion channel expressed by sensory afferent neurons, and is as a target to treat chronic sensitisation conditions. The first‐in‐class, selective P2X3 and P2X2/3 receptor antagonist, the diaminopyrimidine MK‐7264 (Gefapixant), has progressed to Phase III trials for refractory or unexplained chronic cough. We have used patch‐clamp to elucidate the pharmacology and kinetics of MK‐7264 and rat models of hypersensitivity and hyperalgesia to test efficacy in these conditions. Experimental Approach Whole‐cell patch‐clamp of 1321N1 cells expressing human P2X3 and P2X2/3 receptors was used to determine mode of MK‐7264 action, potency and kinetics. The analgesic efficacy was assessed using paw withdrawal threshold and limb weight distribution in rat models of inflammatory, osteoarthritic and neuropathic sensitisation. Key Results MK‐7264 is a reversible allosteric antagonist at human P2X3 and P2X2/3 receptors with IC50 values of 153 and 220nM, respectively. Experiments with the slowly desensitising P2X2/3 heteromer revealed concentration and state‐dependency to wash‐on, with faster rates and greater inhibition when applied before agonist compared to during agonist application. Wash‐on rate (τ value) for MK‐7264 at maximal concentrations was 19s and 146s when applied before and during agonist application, respectively. In vivo, MK‐7264 (30 mg/kg) displayed efficacy comparable to naproxen (20 mg/kg) in inflammatory and osteoarthritic sensitisation models, and gabapentin (100 mg/kg) in neuropathic sensitisation models, increasing paw withdrawal threshold and decreasing weight bearing discomfort. Conclusions and Implications MK‐7264 is a reversible and selective P2X3 and P2X2/3 antagonist, exerting allosteric antagonism via preferential activity at closed channels. Efficacy in rat models supports clinical investigation of chronic sensitisation conditions

Clinical Characteristics of Non-Intensive Care Unit COVID-19 Patients in Saudi Arabia: A Descriptive Cross-sectional Study

Introduction: The ongoing pandemic of the coronavirus disease 2019 (COVID-19) is a global health concern. It has affected more than 5 million patients worldwide and resulted in an alarming number of deaths globally. While clinical characteristics have been reported elsewhere, data from our region is scarce. We investigated the clinical characteristics of mild to moderate cases of COVID-19 in Saudi Arabia. Methods: This is a descriptive, cross-sectional study. Data of 401 confirmed COVID-19 patients were collected from 22 April 2020 to 21 May 2020 at five tertiary care hospitals in Riyadh, Saudi Arabia. The patients were divided into four groups according to age, Group 1: 0-60 years; and their clinical symptoms were compared. Results: The median (IQR) age in years was 10.5 (1.5-16) in group I, 34 (29-41) in group II, 53 (51-56) in group III, and 66 (61-76) in group IV. Most patients were male (80%, n = 322) and of Arabian or Asian descent. The median length of stay in the hospital was 10 (8-17) days (range 3-42 days). The most common symptoms were cough (53.6%), fever (36.2%), fatigue (26.4%), dyspnea (21.9%), and sore throat (21.9%). Hypertension was the most common underlying comorbidity (14.7%), followed by obesity (11.5%), and diabetes (10%). Hypertensive patients were less likely to present with shortness of breath, cough, sputum, diarrhea, and fever. Conclusion: There was no significant difference in the symptoms among different age groups and comorbidities were mostly seen in the older age group. Interestingly, hypertensive patients were found to have milder symptoms and a shorter length of stay. Further larger collaborative national studies are required to effectively understand clinical characteristics in our part of the world to efficiently manage and control the spread of SARS-CoV-2

Clinical, epidemiological, and laboratory characteristics of mild-to-moderate COVID-19 patients in Saudi Arabia: an observational cohort study

Background Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) emerged from China in December 2019 and has presented as a substantial and serious threat to global health. We aimed to describe the clinical, epidemiological, and laboratory findings of patients in Saudi Arabia infected with SARS-CoV-2 to direct us in helping prevent and treat coronavirus disease 2019 (COVID-19) across Saudi Arabia and around the world. Materials and methods Clinical, epidemiological, laboratory, and radiological characteristics, treatment, and outcomes of pediatric and adult patients in five hospitals in Riyadh, Saudi Arabia, were surveyed in this study. Results 401 patients (mean age 38.16 ± 13.43 years) were identified to be SARS-CoV-2 positive and 80% of cases were male. 160 patients had moderate severity and 241 were mild in severity. The most common signs and symptoms at presentation were cough, fever, fatigue, and shortness of breath. Neutrophil and lymphocyte counts, aspartate aminotransferase, C-reactive protein, and ferritin were higher in the COVID-19 moderate severity patient group. Mild severity patients spent a shorter duration hospitalized and had slightly higher percentages of abnormal CT scans and X-ray imaging. Conclusions This study provides an understanding of the features of non-ICU COVID-19 patients in Saudi Arabia. Further national collaborative studies are needed to streamline screening and treatment procedures for COVID-19

Visualisation of Airway Nerves in Chronic Cough: Towards the Identification of the Human Cough Receptor

<p>Immunochemical features of nerves identified in human airways</p