Efficacy and safety of Bacillus clausii (O/C, N/R, SIN, T) probiotic combined with oral rehydration therapy (ORT) and zinc in acute diarrhea in children: a randomized, double-blind, placebo-controlled study in India.

Background: Childhood diarrhea remains a major disease burden, particularly in developing countries, and is a leading cause of death in children aged < 5 years, worldwide. Treatment of acute diarrhea now includes probiotics to potentially reduce the duration and severity of the illness. This phase 3, randomized, placebo-controlled, double-blind study assessed the efficacy and safety of four strains (O/C, N/R, SIN, T) of Bacillus clausii probiotic (Enterogermina®) plus oral rehydration therapy (ORT) and zinc, versus placebo plus ORT and zinc, in infants and children in India with acute moderate diarrhea.

The SAGE study: Global observational analysis of glycaemic control, hypoglycaemia and diabetes management in T1DM.

Aims: To describe glycaemic control and diabetes management in adults with type 1 diabetes (T1DM), in a real-life global setting.

Materials And Methods: Study of Adults' GlycEmia (SAGE) was a multinational, multicentre, single visit, noninterventional, cross-sectional study in adult patients with T1DM. Data were collected at a single visit, analysed according to predefined age groups (26-44, 45-64 and ≥65 years) and reported across different regions.

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis.

Introduction: The aim of this study was to evaluate the efficacy and safety of a new hard-boiled lozenge formulation containing ambroxol 20 mg versus placebo for the relief of sore throat in patients with acute pharyngitis.

Methods: This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter trial conducted between June and September 2018 in South Africa. Patients with a diagnosis of acute pharyngitis, onset ≤ 72 h, and sore throat pain of at least moderate intensity were randomized to receive either ambroxol 20 mg or placebo hard-boiled lozenges.

Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study.

Background: Patient-reported outcomes (PROs) provide clinicians with further understanding of the impact of treatment on patients' daily lives. In addition, real-world studies, which employ broader inclusion criteria than randomized trials, may help to inform prescribing decisions when selecting a disease-modifying therapy (DMT) to treat relapsing forms of MS (RMS). We sought to use PROs to determine patient treatment satisfaction and other treatment outcomes, and report safety and tolerability associated with teriflunomide, in the global, phase 4 Teri-PRO study (NCT01895335).

Insulin regimens and glycemic control in different parts of Europe over 4years after starting insulin in people with type 2 diabetes: Data from the CREDIT non-interventional study.

Aims: A number of insulin regimens are used in type 2 diabetes. This analysis aims to better understand the evolution of insulin therapy in different regions of Europe.

Methods: Data from people starting any insulin were collected in eastern Europe (EEur: Croatia, Russia, Ukraine), northern Europe (NEur: Finland, Germany, UK) and southern Europe (SEur: France, Italy, Portugal, Spain).

Regional Lack of Consistency in the Management of Atrial Fibrillation (from the RECORD-AF Trial).

American and European society guidelines for atrial fibrillation management mostly agree on the utilization of rate and rhythm control strategies and the indications for oral anticoagulant (OAC) use. However, the level of adherence to guidelines in clinical practice may vary by region. In this study, data analysis from The Registry on Cardiac rhythm disorders assessing the control of Atrial Fibrillation (RECORD-AF) registry, an international registry in patients with newly diagnosed atrial fibrillation of <1 year, shows that differences in practice exist between 3 regions, namely Western Europe, Eastern Europe, and North America.

Atrial Fibrillation Management Strategies in Routine Clinical Practice: Insights from the International RealiseAF Survey.

Background: Atrial fibrillation (AF) can be managed with rhythm- or rate-control strategies. There are few data from routine clinical practice on the frequency with which each strategy is used and their correlates in terms of patients' clinical characteristics, AF control, and symptom burden.

Methods: RealiseAF was an international, cross-sectional, observational survey of 11,198 patients with AF.

Four-year evolution of insulin regimens, glycaemic control, hypoglycaemia and body weight after starting insulin therapy in type 2 diabetes across three continents.

Aims: It is of interest to understand how insulin therapy currently evolves in clinical practice, in the years after starting insulin in people with type 2 diabetes. We aimed to describe this evolution prospectively over 4 years, to assist health care planning.

Methods: People who had started any insulin were identified from 12 countries on three continents.

Use of antithrombotics in atrial fibrillation in Africa, Europe, Asia and South America: insights from the International RealiseAF Survey.

Background: The implementation of international guidelines for antithrombotic use in atrial fibrillation (AF) in routine practice is not well known, particularly, in some parts of the world, such as the Middle East and Africa.

Aim: To describe and analyse the use of antithrombotics in patients with AF in routine practice.

Methods: The RealiseAF international cross-sectional survey enrolled 10,523 patients (with at least one documented AF episode in the preceding 12 months) from 831 sites.

Clinical characteristics, management, and control of permanent vs. nonpermanent atrial fibrillation: insights from the RealiseAF survey.

Background: Atrial fibrillation can be categorized into nonpermanent and permanent atrial fibrillation. There is less information on permanent than on nonpermanent atrial fibrillation patients. This analysis aimed to describe the characteristics and current management, including the proportion of patients with successful atrial fibrillation control, of these atrial fibrillation subsets in a large, geographically diverse contemporary sample.

Heart failure in patients with atrial fibrillation is associated with a high symptom and hospitalization burden: the RealiseAF survey.

Background: Atrial fibrillation (AF) and heart failure (HF) often coexist; the consequences of such coexistence are unclear.

Hypothesis: HF in patients with AF is associated with poor outcomes.

Methods: This post hoc analysis of RealiseAF, a survey of AF patients, compared symptoms, hospitalizations, management, and AF control in patients with vs without HF.

Inappropriate use of antiarrhythmic drugs in paroxysmal and persistent atrial fibrillation in a large contemporary international survey: insights from RealiseAF.

Aims: International atrial fibrillation (AF) guidelines have defined optimal drugs for patients with various underlying diseases, but the extent to which real-life practice complies with these guidelines is unknown. This study aimed to evaluate the appropriate use of antiarrhythmic drugs (AADs) in patients with paroxysmal and persistent AF from the RealiseAF survey, according to the 2006 American College of Cardiology/American Heart Association/European Society of Cardiology AF guidelines.

Methods And Results: RealiseAF was an international cross-sectional, observational survey of 10 523 eligible patients from 26 countries on 4 continents, with ≥1 AF episode documented by standard electrocardiogram or by Holter monitoring in the last 12 months.

Symptoms, functional status and quality of life in patients with controlled and uncontrolled atrial fibrillation: data from the RealiseAF cross-sectional international registry.

Background: Rate control and rhythm control are accepted management strategies for atrial fibrillation (AF).

Objective: RealiseAF aimed to describe the success of either strategy and the impact of control on symptomatic status of patients with AF.

Methods: This international, observational, cross-sectional survey of patients with any history of AF in the previous year, recorded AF characteristics, management and frequency of control (defined as sinus rhythm or AF with resting heart rate ≤80 bpm).

Does abdominal obesity have a similar impact on cardiovascular disease and diabetes? A study of 91,246 ambulant patients in 27 European countries.

Aims: Differences in cardiovascular risk factors across Europe provide an opportunity to examine the impact of adiposity on the frequency of diabetes and cardiovascular disease (CVD).

Methods And Results: The International Day for Evaluation of Abdominal obesity (IDEA) study evaluated the prevalence of abdominal obesity, elevated body mass index (BMI), and other cardiometabolic risk factors among primary care patients. Abdominal obesity predicted increased diabetes risk, despite socio-economic, demographic, and risk factor differences.