IntroductionBasal insulin (BI) plays an important role in treating type 2 diabetes (T2D), especially when oral antidiabetic (OAD) medications are insufficient for glycemic control. We conducted a retrospective, observational study using electronic medical records (EMR) data from the IBM® Explorys database to evaluate the probability of achieving glycemic control over 24 months after BI initiation in patients with T2D in the USA.MethodsA cohort of 6597 patients with T2D who started BI following OAD(s) and had at least one valid glycated hemoglobin (HbA1c) result recorded both within 90 days before and 720 days after BI initiation were selected. We estimated the changes from baseline in HbA1c every 6 months, the quarterly conditional probabilities of reaching HbA1c < 7% if a patient had not achieved glycemic control prior to each quarter (Q), and the cumulative probability of reaching glycemic control over 24 months.ResultsOur cohort was representative of patients with T2D who initiated BI from OADs in the USA. The average HbA1c was 9.1% at BI initiation, and decreased robustly (1.5%) in the first 6 months after initiation with no further reductions thereafter. The conditional probability of reaching glycemic control decreased rapidly in the first year (26.6% in Q2; 17.6% in Q3; 8.6% in Q4), and then remained low (≤ 6.1%) for each quarter in the second year. Cumulatively, about 38% of patients reached HbA1c < 7% in the first year; only approximately 8% more did so in the second year.ConclusionOur study of real-world data from a large US EMR database suggested that among patients with T2D who initiated BI after OADs, the likelihood of reaching glycemic control diminished over time, and remained low from 12 months onwards. Additional treatment options should be considered if patients do not reach glycemic control within 12 months of BI initiation.FundingSanofi Corporation.

This technique improves on methods, which draw only two blood specimens to assess nicotine intake. Understanding how nicotine boost differs in SCZ from CON may explain high levels of addiction and low success in cessation in smokers with SCZ.

Background People with schizophrenia are frequent and heavy smokers. Methods The objective of this study was to measure serum nicotine levels and ad libitum smoking behavior for 24 + 2h using the CReSS micro topography device in 75 smokers with schizophrenia (SCZ) and compare these to 86 control smokers (CON) without mental illness. Mean values of repeatedly measured topography variables were compared using three-level nested linear models to adjust for between subject differences and the double nested data. Results Smokers with SCZ smoked more cigarettes in the 24 h period and took an average of 2.8 more puffs per cigarette than CON (p < 0.001). The time between puffs, or interpuff interval (IPI), was shorter in SCZ by an average of 6.5 s (p < 0.001). The peak flow rate was higher in SCZ by an average of 4.9 ml/s (p < 0.05). Smokers with SCZ spent an average of 1.0 min less time smoking a single cigarette vs. CON (p < 0.001). Smokers with SCZ also had shorter IPI and more puffs per cigarette in an analysis of first cigarette of the day. For all subjects, a decrease in IPI by 1s was associated with an increase in serum nicotine of 0.19 ng/ml and in cotinine of 5.01 ng/ml (both p < 0.05). After controlling for diagnosis group, higher craving scores on QSU Factor 2 (urgent desire to smoke) were associated with shorter IPI. Discussion Smokers with schizophrenia demonstrate more intense cigarette puffing that is associated with greater nicotine intake. This pattern may provide insight into other heavily dependent smokers.

Background Real-world data for patients with chronic kidney disease (CKD), specifically pertaining to clinical management, metabolic control, treatment patterns, quality of life (QoL) and dietary patterns, are limited. Understanding these gaps using real-world, routine-care data will improve our understanding of the challenges and consequences faced by patients with CKD and facilitate the long-term goal of improving their management and prognosis. Methods DISCOVER CKD follows an enriched hybrid study design, with both retrospective and prospective patient cohorts, integrating primary and secondary data from patients with CKD from China, Italy, Japan, Sweden, the UK and USA. Data will be prospectively captured over a 3-year period from &gt;1000 patients with CKD who will be followed-up for at least 1 year via electronic case report form entry during routine clinical visits and via a mobile/tablet-based application, enabling capture of patient-reported outcomes (PROs). In-depth interviews will be conducted in a subset of ∼100 patients. Separately, secondary data will be retrospectively captured from &gt;2,000,000 patients with CKD, extracted from existing datasets and registries. Results The DISCOVER CKD programme captures and will report on patient demographics, biomarker and laboratory measurements, medical history, clinical outcomes, healthcare resource utilization, medications, dietary patterns, physical activity and PROs (including QoL and qualitative interviews). Conclusion The DISCOVER CKD programme will provide contemporary real-world insight to inform clinical practice, and improve our understanding of the epidemiology and clinical and economic burden of CKD, as well as determinants of clinical outcomes and PROs from a range of geographical regions in a real-world CKD setting.

Background Long-term clinical outcome data from patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) are lacking. We characterized patients with NDD-CKD and anaemia using real-world data from the US. Methods This retrospective longitudinal observational study evaluated integrated Limited Claims and Electronic Health Record Data (IBM Health, Armonk, New York), including patients ≥18 years with ≥2 estimated glomerular filtration rate (eGFR) measures &lt;60 mL/min/1.73 m2 ≥90 days apart. Anaemia was defined as the first observed haemoglobin &lt;10 g/dL within 6-months pre- and post-CKD index date. Data were analysed from January 2012 to June 2018. Patients with documented iron-deficiency anaemia at baseline were excluded. Results Comprising 22,720 patients (57.4% female, 63.9% CKD stage 3, median haemoglobin 12.5 g/dL), median (interquartile range) follow-up for patients with and without anaemia were 2.9 (1.5–4.4) and 3.8 (2.2–4.8) years, respectively. The most prevalent comorbidities were dyslipidaemia (57.6%), type 2 diabetes mellitus (38.8%) and uncontrolled hypertension (20.0%). Overall, 23.3% of patients had anaemia, of whom 1.9% and &lt;0.1% received erythropoiesis-stimulating agents (ESAs) or intravenous iron, respectively. Anaemia prevalence increased with CKD stage from 18.2% (stage 3a) to 72.8% (stage 5). Patients with anaemia had a higher incidence rate of hospitalizations for heart failure (1.6 versus 0.8 per 100 patient-years), CKD stage advancement (43.5 versus 27.5 per 100 patient-years), and a 40% eGFR decrease (18.1 versus 7.3 per 100 patient-years) versus those without anaemia. Conclusions Anaemia, frequently observed in NDD-CKD and associated with adverse clinical outcomes, is rarely treated with ESAs and intravenous iron. These data suggest that opportunities exist for improved anaemia management in patients with NDD-CKD.