The aim of this analysis was to identify Young Mania Rating Scale (YMRS) meaningful benchmarks for clinicians (severity threshold, minimal clinically significant difference [MCSD]) using the Clinical Global Impressions Bipolar (CGI-BP) mania scale, provide a clinical perspective randomized trials (RCTs) results. We used cohort patients with acute manic/mixed state bipolar disorders (N = 3459) included in European Longitudinal Evaluation Medication (EMBLEM) study. A receiver-operating...

Abstract Aim To conduct an adjusted indirect treatment comparison (aITC) of the efficacy tirzepatide 5/10/15 mg versus semaglutide 2 in patients with type diabetes. Materials and Methods The primary analysis was a Bucher aITC change from baseline at week 40 HbA1c (%) body weight (kg). Aggregate data SURPASS‐2 study that met inclusion criterion SUSTAIN FORTE metformin‐only treated were used for analysis. Results refined population comprised 238/245/240 240 participants 1 mg, respectively. 222...

This multicenter, open-label, parallel-arm study compared the efficacy and safety of exenatide once weekly (EQW) with titrated insulin detemir in patients type 2 diabetes inadequately controlled metformin (with or without sulfonylureas).

The prevalence of SHOX deficiency in children with short stature (SS) is variable the literature and various genotypes have been identified.The aim our study was to determine frequency distribution a large sample SS France.Children were enrolled 38 French pediatric endocrinology centers either diagnosed Leri-Weill syndrome (LWS), idiopathic (ISS), or disproportionate (DSS).SHOX analysis performed centrally as part Genetics Neuroendocrinology Short Stature International Study observational...

Tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 receptor agonist, is approved for glycaemic control people with type 2 diabetes (T2D). The SURPASS-1 to -5 clinical trials assessed the efficacy of once weekly tirzepatide (5, 10 15 mg) versus placebo or active comparators (semaglutide mg, insulin degludec glargine) in T2D. We evaluated patient-reported outcomes (PROs) that measured overall quality life (QoL), treatment satisfaction weight-related...

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a relatively new class of injectable drugs used in the treatment type 2 diabetes (T2D). This retrospective database study evaluated real-world patterns T2D patients initiating GLP-1 RAs Belgium (BE), France (FR), Germany (DE), The Netherlands (NL) and Sweden (SE). Adult exenatide twice daily (exBID), once weekly (exQW), liraglutide (LIRA) or lixisenatide (LIXI) during 2013 were identified using QuintilesIMS (QuintilesIMS, Durham, NC,...

The relative efficacy and safety of tirzepatide was compared with glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in patients type 2 diabetes mellitus (T2DM) treated basal insulin using a network meta-analysis (NMA). A systematic literature review performed to identify randomized controlled trials GLP-1 RAs T2DM an antihyperglycaemic drug. For the NMA, studies included 100% background therapy titration scheme comparable SURPASS-5 trial. following data were extracted for assessment at...

Abstract Background Improvements in the clinical condition of patients with type 2 diabetes are often accompanied by improvements health-related quality life and other patient-reported outcomes (PROs), but data assessing injectable treatment initiation from patient’s perspective routine practice lacking. We examined PROs initiating CHOICE (CHanges to Outcomes InjeCtablE therapy) study. Methods was a 24-month, prospective observational study conducted six European countries. Patients...

Abstract Background One of the major issues in clinical practice is accurate differential diagnosis between mixed states and depression, often leading to inappropriate prescriptions antidepressants states, as a consequence, increasing risk manic switch suicide. In order better define spectrum it may be useful develop dimensional approach. this context, MAThyS (Multidimensional Assessment Thymic States) scale was built assess activation/inhibition levels all bipolar mood episodes, determine...

The primary objective of the TROPHIES observational study is to estimate duration treatment on dulaglutide or liraglutide without a significant change by 24 months in patients with type 2 diabetes (T2D) initiating their first injectable these glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This manuscript presents 12-month interim data. prospective, non-comparative, T2D Europe, naïve antihyperglycaemic treatments and liraglutide. Data clinical characteristics, GLP-1 RA persistence...

Limited data are available on the relationship between quality of life (QoL) change and significant degrees reduction in glycated haemoglobin (HbA1c) and/or weight loss people with type 2 diabetes (T2D). We explored associations HbA1c targets achieved patient-reported outcomes (PROs) adults T2D treated tirzepatide, a first-in-class once weekly glucose-dependent insulinotropic polypeptide glucagon-like peptide-1 receptor agonist, using pooled from SURPASS-1 to -5 Phase 3 clinical trials.PROs...

To report health-related patient-reported outcomes (PROs) in people with type 2 diabetes (T2D) initiating their first injectable glucose-lowering medication (GLM) two commonly prescribed glucagon-like peptide-1 receptor agonists (GLP-1RAs) from the prospective, observational TROPHIES study (The Real-World Observational Prospective Study of Health Outcomes Dulaglutide and Liraglutide Type Diabetes Patients).TROPHIES was a two-cohort, 24-month conducted France, Germany Italy. Adults T2D...

CHOICE (CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy; NCT00635492) assessed, as its primary objective, the time a ‘significant change’ (defined within this paper) after mellitus initiated their first injectable, glucose-lowering therapy [exenatide twice daily (BID) or insulin] clinical practice six European countries evaluated outcomes during study. was 24-month, prospective, noninterventional observational Patients were invited participate...

Abstract Aim To assess the relationship between baseline body mass index (BMI) and glycaemic control in dulaglutide‐treated patients, a post hoc analysis was conducted on HbA1c BMI data from eight AWARD studies, with total of 5770 patients. Materials methods Changes patients treated 1.5 mg or 0.75 dulaglutide, active comparator placebo, were analyzed each study (AWARD‐1 to −6, −8 − 9) at approximately 6 months (26, 24 28 weeks, respectively). Within study, by following categories: <30,...

Does tirzepatide (TZP) improve HRQoL compared to insulin lispro (iLispro) in adults with type 2 diabetes (T2D) treated basal insulin?

Although patient-reported outcome (PRO) measures provide important information beyond clinical data, studies that assess the PROs of type 2 diabetes mellitus (T2DM) patients initiating injectable glucose-lowering medications in routine practice are limited. We describe perspectives based on a diversified panel generic and disease-specific PRO at time enrollment (baseline) TROPHIES study. is 24-month prospective observational study performed France, Germany, Italy with T2DM who initiated...

The TROPHIES observational study enrolled patients with type 2 diabetes mellitus (T2DM) initiating their first injectable treatment the glucagon-like peptide 1 receptor agonists (GLP-1 RAs) dulaglutide or liraglutide. This manuscript focuses on design, baseline characteristics of population, and factors associated GLP-1 RA choice. is a prospective, observational, 24-month conducted in France, Germany, Italy. Inclusion criteria include adult T2DM, naïve to antihyperglycemic treatments,...

The Impact of Weight on Self-perception Questionnaire (IW-SP) is a three-item patient-reported outcome measure (PROM) instrument assessing the impact body weight self-perception. To date no published threshold for meaningful change exists. objective this study was to estimate minimal important (MIC) IW-SP among people with type 2 diabetes.Responder analyses were conducted using anchor- and distribution-based approaches existing clinical trial data (SURPASS-2). As SURPASS-2 did not include...

To present the final results of TROPHIES study (The real-world observational prospective health outcomes with dulaglutide and liraglutide in patients type 2 diabetes).The prospective, included diabetes initiating their first injectable glucose-lowering medication (GLM), or liraglutide, France, Germany Italy. The primary endpoint was time spent on until a significant treatment change over 24 months. Other endpoints measured persistence treatment, clinical (glycated haemoglobin [HbA1c] weight)...