Background: The EMPA-REG OUTCOME trial showed that empagliflozin, a sodium-glucose co-transporter-2 inhibitor (SGLT2i), reduces the risk of hospitalization for heart failure (HHF) by 35%, on top of standard of care in patients with type 2 diabetes (T2D) and established CV disease (CVD). The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study aims to assess empagliflozin's effectiveness, safety, and healthcare utilization in routine care from 08/2014 through 09/2019. In this first interim analysis, we investigated the risk of HHF among T2D patients initiating empagliflozin vs. sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i). Methods: Within two commercial and one federal (Medicare) claims data sources in the U.S., we identified a 1:1 propensity-score (PS) matched cohort of T2D patients ≥18 years initiating empagliflozin or sitagliptin from 08/2014 through 09/2016. The HHF outcome was defined as a HF discharge diagnosis in the primary position (HHF-specific); a broader definition was based on a HF discharge diagnosis in any position (HHF-broad). Hazard ratios (HR) and 95% confidence intervals (CI) were estimated controlling for over 140 baseline characteristics in each data source and pooled by fixed-effects meta-analysis. Results: After PS-matching, we identified 16,443 patient pairs who initiated empagliflozin or sitagliptin. Average age was approximately 59 years, almost 54% of the participants were males, and approximately 25% had records of existing cardiovascular disease. Compared to sitagliptin, the initiation of empagliflozin decreased the risk of HHF-specific by 50% (HR = 0.50; 95% CI = 0.28-0.91), and the risk of HHF-broad by 49% (HR: 0.51;95% CI: 0.39-0.68), over a mean follow-up of 5.3 months. Results were consistent in patients with and without baseline cardiovascular disease, and for both empagliflozin 10 mg or 25mg daily dose; analyses comparing

ObjectiveTo characterise in details a random sample of multimorbid patients in Switzerland and to evaluate the clustering of chronic conditions in that sample.Methods100 general practitioners (GPs) each enrolled 10 randomly selected multimorbid patients aged ≥18 years old and suffering from at least three chronic conditions. The prevalence of 75 separate chronic conditions from the International Classification of Primary Care-2 (ICPC-2) was evaluated in these patients. Clusters of chronic conditions were studied in parallel.ResultsThe final database included 888 patients. Mean (SD) patient age was 73.0 (12.0) years old. They suffered from 5.5 (2.2) chronic conditions and were prescribed 7.7 (3.5) drugs; 25.7% suffered from depression. Psychological conditions were more prevalent among younger individuals (≤66 years old). Cluster analysis of chronic conditions with a prevalence ≥5% in the sample revealed four main groups of conditions: (1) cardiovascular risk factors and conditions, (2) general age-related and metabolic conditions, (3) tobacco and alcohol dependencies, and (4) pain, musculoskeletal and psychological conditions.ConclusionGiven the emerging epidemic of multimorbidity in industrialised countries, accurately depicting the multiple expressions of multimorbidity in family practices’ patients is a high priority. Indeed, even in a setting where patients have direct access to medical specialists, GPs nevertheless retain a key role as coordinators and often as the sole medical reference for multimorbid patients.

Using this list of 75 chronic conditions most relevant in the context of MM should enhance the validity of studies of MM in FM.

Aim To evaluate the effectiveness of empagliflozin in clinical practice in East Asia in the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) East Asia study. Materials and methods Data were obtained from the Medical Data Vision database (Japan), National Health Insurance Service database (South Korea) and National Health Insurance database (Taiwan). Patients aged ≥ 18 years with type 2 diabetes initiating empagliflozin or a dipeptidyl peptidase‐4 (DPP‐4) inhibitor were 1:1 propensity score (PS) matched into sequentially built cohorts of new users naïve to both drug classes. This design reduces confounding due to switching treatments, time lag and immortal time biases. Outcomes included hospitalization for heart failure (HHF), end‐stage renal disease (ESRD) and all‐cause mortality. Hazard ratios (HRs) and 95% CIs were estimated using Cox proportional models, controlling for > 130 baseline characteristics in each data source and pooled by random‐effects meta‐analysis. Results Overall, 28 712 pairs of PS‐matched patients were identified with mean follow‐up of 5.7‐6.8 months. Compared with DPP‐4 inhibitors, the risk of HHF was reduced by 18% and all‐cause mortality was reduced by 36% with empagliflozin (HR 0.82; 95% CI 0.71‐0.94, and HR 0.64; 95% CI 0.50‐0.81, respectively). Reductions were consistent across countries, and in patients with and without baseline cardiovascular disease. ESRD was also significantly reduced with empagliflozin versus DPP‐4 inhibitors (HR 0.37; 95% CI 0.24‐0.58). Conclusions Empagliflozin treatment was associated with reduced risk for HHF, all‐cause mortality and ESRD compared with DPP‐4 inhibitors in routine clinical practice in Japan, South Korea and Taiwan.

ObjectivesTo assess and compare the self-perceived Health Related Quality of Life (HRQoL) of multimorbid patients and the general population using health utilities (HU) and visual analogue scale (VAS) methods.MethodsWe analyzed data (n = 888) from a national, cross-sectional Swiss study of multimorbid patients recruited in primary care settings. Self-perceived HRQoL was assessed using the EQ-5D-3L instrument, composed of 1) a questionnaire on the five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D dimensions), and 2) a 0–100 (0 = worst- and 100 = best-imaginable health status) VAS. We described the EQ-5D dimensions and VAS and computed HU using a standard pan-European value set. HU and VAS are the two components of the overall HRQoL assessment. We examined the proportions of multimorbid patients reporting problems (moderate/severe) in each EQ-5D dimension, corresponding proportions without problems, and mean HU and VAS values across patient characteristics. To test differences between subgroups, we used chi-square tests for dichotomous outcomes and T-tests (ANOVA if more than two groups) for continuous outcomes. Finally, we compared observed and predicted HU and VAS values.ResultsAll 888 participants answered every EQ-5D item. Mean (SD) HU and VAS values were 0.70 (0.18) and 63.2 (19.2), respectively. HU and VAS were considerably and significantly lower in multimorbid patients than in the general population and were also lower in multimorbid patients below 60 years old and in women. Differences between observed and predicted means (SD) were -0.07 (0.18) for HU and -11.8 (20.3) for VAS.ConclusionsSelf-perceived HRQoL is considerably and significantly affected by multimorbidity. More attention should be given to developing interventions that improve the HRQoL of multimorbid patients, particularly women and those aged below 60 years old.

ObjectivesTo estimate the prevalence of multimorbidity using a list of 75 chronic conditions derived from the International Classification for Primary Care, Second edition and developed specifically to assess multimorbidity in primary care. Our aim was also to provide prevalence data for multimorbidity in primary care in a country in which general practitioners (GPs) do not play a gatekeeping role in the health system.SettingA representative sample of GPs within the Swiss Sentinel Surveillance Network.Participants118 GPs completed a paper-based questionnaire about 25 consecutive patients of all ages between September and November 2015. There were no patient exclusion criteria. Recorded data included date of birth, gender and the patients’ chronic conditions.Primary and secondary outcome measuresWe estimated the prevalence of multimorbidity, defined as ≥2, and ≥3 chronic conditions stratified by gender and age group, and adjusted for clustering by GPs. We also computed the prevalence of each chronic condition individually and grouped by system.ResultsData from 2904 patients were included (mean age (SD)=56.5 (20.5) years; male=43.7%). Prevalence was 52.1% (95% CI 48.6% to 55.5%) for ≥2 and 35.0% (95% CI 31.6% to 38.5%) for ≥3 chronic conditions, with no significant gender differences. Prevalence of two or more chronic conditions was low (6.2%, 95% CI 2.8% to 13.0%) in those below 20 but affected more than 85% (85.8%, 95% CI 79.6% to 90.3%) of those above the age of 80. The most prevalent conditions were cardiovascular (42.7%, 95% CI 39.7% to 45.7%), psychological (28.5%, 95% CI 26.1% to 31.1%) and metabolic or endocrine disorders (24.1%, 95% CI 21.6% to 26.7%). Elevated blood pressure was the most prevalent cardiovascular condition and depression the most common psychological disorder.ConclusionIn a country in which GPs do not play a gatekeeping role within the health system, the prevalence of multimorbidity, as assessed using a list of chronic conditions specifically relevant to primary care, is high and increases with age.

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Aim: To investigate effectiveness and safety outcomes among patients with type 2 diabetes (T2D) initiating empagliflozin versus dipeptidyl peptidase-4 (DPP-4) inhibitor treatment across the broad spectrum of cardiovascular risk. Methods:In a population-based cohort study we identified 39 072 pairs of 1:1 propensity score-matched adult patients with T2D initiating empagliflozin or DPP-4 inhibitors, using data from 2 US commercial insurance databases and Medicare between August 2014 and September 2017. The primary outcomes were a composite of myocardial infarction (MI)/stroke, and hospitalization for heart failure (HHF).Safety outcomes were bone fractures, lower-limb amputations (LLAs), diabetic ketoacidosis (DKA), and acute kidney injury (AKI). We estimated pooled hazard ratios (HRs) and 95% confidence intervals (CIs) adjusting for more than 140 baseline covariates.Results: Study participants had a mean age of 60 years and only 28% had established cardiovascular disease. Compared to DPP-4 inhibitors, empagliflozin was associated with similar risk of MI/stroke (HR 0.99 [95% CI 0.81-1.21]), and lower risk of HHF (HR 0.48 [95% CI 0.35-0.67] and 0.63 [95% CI 0.54-0.74], based on a primary and any heart failure discharge diagnosis, respectively). The HR was 0.52 (95% CI 0.38-0.72) for all-cause mortality (ACM) and 0.83 (95% CI 0.70-0.98) for a composite of MI/stroke/ACM. Empagliflozin was associated with a similar risk of LLA and fractures, an increased risk of DKA ) and a decreased risk of AKI (HR 0.60 [95% CI 0.43-0.85]). Conclusions:In clinical practice, the initiation of empagliflozin versus a DPP-4 inhibitor was associated with a lower risk of HHF, ACM and MI/stroke/ACM, a similar risk of MI/stroke, and a safety profile consistent with documented information.