Association of Patient Profile with Glycemic Control and Hypoglycemia with Insulin Glargine 300 U/mL in Type 2 Diabetes: A Post Hoc Patient-Level Meta-Analysis

ABSTRACT Aims: To examine the association of baseline patient characteristics with study outcomes in people with type 2 diabetes receiving insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100), over a 6-month period. Methods: A post hoc patient-level metaanalysis using data from three multicenter, randomized, open-label, parallel-group, phase 3a studies of similar design, in people previously receiving either basal and prandial insulin, basal insulin ? oral antihyperglycemic drugs, or no prior insulin (EDITION 1, 2 and 3, respectively). The endpoints, glycated hemoglobin (HbA1c), hypoglycemia, body weight change, and insulin dose were investigated by subgroups: age (\65 and C 65 years), body mass index (BMI; \ 30 and C 30 kg/m2), age at onset (\40, 40–50, and [ 50 years), and diabetes duration (\ 10 and C 10 years). Results: Reduction in HbA1c was comparable between insulins, regardless of subgroup. The lower risk of C 1 nocturnal (00:00–05:59 h) confirmed (B 3.9 mmol/L [B 70 mg/dL]) or severe hypoglycemic event with Gla-300 versus Gla-100 was also unaffected by participant characteristics. While heterogeneity of treatment effect between diabetes duration subgroups was seen for the risk of C 1 confirmed (B 3.9 mmol/L [B 70 mg/dL]) or severe hypoglycemic event at any time (24 h), treatment effect consistently favored Gla-300; no evidence of heterogeneity was observed for the other subgroups. Annualized rates of confirmed (B 3.9 mmol/L [B 70 mg/dL]) or severe hypoglycemia and body weight change were not influenced by participant characteristics; a similar pattern was observed with insulin dose. Conclusions: Comparable glycemic control was observed with Gla-300 versus Gla-100, with less hypoglycemia, regardless of age, BMI, age at onset or diabetes duration. Funding: Sanofi. Plain Language Summary: Plain language summary available for this article. Keywords: Glycated Hemoglobin A; Hypoglycemia; Insulin Glargine; Type 2 Diabetes PLAIN LANGUAGE SUMMARY Treatments for patients with type 2 diabetes aim to reduce the levels of blood glucose and can include injections with insulin. However, care must be taken to prevent blood glucose levels falling too low (a state called hypoglycemia). Previous studies have shown that insulin glargine 300 units/mL (Gla-300) provides similar reductions in blood glucose levels as insulin glargine 100 units/mL (Gla-100) but is less likely to cause hypoglycemia. However, different patients may respond differently to treatments depending on their individual clinical and biological characteristics. The aim of this study was to evaluate how different profiles of patients with type 2 diabetes responded to Gla-300 and Gla-100 injections. Patients were grouped by different ages, weights, age at diabetes diagnosis, and number of years since diagnosis of diabetes. We found that Gla-300 and Gla-100 reduced glycated hemoglobin (HbA1c; a marker of blood glucose control over the previous 2–3 months) similarly, regardless of how patients were grouped. However, patients treated with Gla-300 were less likely to experience hypoglycemia than those treated with Gla-100, and this association was also true regardless of different patient characteristics. We therefore concluded that Gla-300 is an effective and safe treatment in patients with type 2 diabetes, regardless of their age, weight, age at diabetes diagnosis, and years since diagnosis

Outcomes from elective colorectal cancer surgery during the SARS-CoV-2 pandemic

This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic

Global disparities in surgeons’ workloads, academic engagement and rest periods: the on-calL shIft fOr geNEral SurgeonS (LIONESS) study

: The workload of general surgeons is multifaceted, encompassing not only surgical procedures but also a myriad of other responsibilities. From April to May 2023, we conducted a CHERRIES-compliant internet-based survey analyzing clinical practice, academic engagement, and post-on-call rest. The questionnaire featured six sections with 35 questions. Statistical analysis used Chi-square tests, ANOVA, and logistic regression (SPSS® v. 28). The survey received a total of 1.046 responses (65.4%). Over 78.0% of responders came from Europe, 65.1% came from a general surgery unit; 92.8% of European and 87.5% of North American respondents were involved in research, compared to 71.7% in Africa. Europe led in publishing research studies (6.6 ± 8.6 yearly). Teaching involvement was high in North America (100%) and Africa (91.7%). Surgeons reported an average of 6.7 ± 4.9 on-call shifts per month, with European and North American surgeons experiencing 6.5 ± 4.9 and 7.8 ± 4.1 on-calls monthly, respectively. African surgeons had the highest on-call frequency (8.7 ± 6.1). Post-on-call, only 35.1% of respondents received a day off. Europeans were most likely (40%) to have a day off, while African surgeons were least likely (6.7%). On the adjusted multivariable analysis HDI (Human Development Index) (aOR 1.993) hospital capacity > 400 beds (aOR 2.423), working in a specialty surgery unit (aOR 2.087), and making the on-call in-house (aOR 5.446), significantly predicted the likelihood of having a day off after an on-call shift. Our study revealed critical insights into the disparities in workload, access to research, and professional opportunities for surgeons across different continents, underscored by the HDI

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Reducing the environmental impact of surgery on a global scale: systematic review and co-prioritization with healthcare workers in 132 countries

Abstract Background Healthcare cannot achieve net-zero carbon without addressing operating theatres. The aim of this study was to prioritize feasible interventions to reduce the environmental impact of operating theatres. Methods This study adopted a four-phase Delphi consensus co-prioritization methodology. In phase 1, a systematic review of published interventions and global consultation of perioperative healthcare professionals were used to longlist interventions. In phase 2, iterative thematic analysis consolidated comparable interventions into a shortlist. In phase 3, the shortlist was co-prioritized based on patient and clinician views on acceptability, feasibility, and safety. In phase 4, ranked lists of interventions were presented by their relevance to high-income countries and low–middle-income countries. Results In phase 1, 43 interventions were identified, which had low uptake in practice according to 3042 professionals globally. In phase 2, a shortlist of 15 intervention domains was generated. In phase 3, interventions were deemed acceptable for more than 90 per cent of patients except for reducing general anaesthesia (84 per cent) and re-sterilization of ‘single-use’ consumables (86 per cent). In phase 4, the top three shortlisted interventions for high-income countries were: introducing recycling; reducing use of anaesthetic gases; and appropriate clinical waste processing. In phase 4, the top three shortlisted interventions for low–middle-income countries were: introducing reusable surgical devices; reducing use of consumables; and reducing the use of general anaesthesia. Conclusion This is a step toward environmentally sustainable operating environments with actionable interventions applicable to both high– and low–middle–income countries

Intensifying Insulin Therapy: What Options Are Available to Patients with Type 2 Diabetes?

The progressive nature of type 2 diabetes (T2D) requires practitioners to periodically evaluate patients and intensify therapy when glycemic targets become unattainable with their current treatment regimen. Traditional first- and second-line antidiabetic agents such as metformin and the sulfonylureas do not prevent the characteristic decline in beta-cell function associated with T2D; insulin replacement therapy can therefore quickly become a necessity in some patients. Basal insulin initiation provides an excellent platform to which rapid-acting prandial insulin doses can easily be added, potentially in a stepwise manner, as disease progresses. Premix insulin regimens are another effective intensification option following basal insulin initiation, but are most effective in insulin-naïve patients. The use of insulin in combination with modern T2D agents, such as the incretin-based therapies, has the potential to improve glycemic control while limiting insulin-associated weight gain and hypoglycemia. Further clinical data and approval are required before practitioners can fully endorse this novel approach

Osteoma of the frontoethmoidal sinuses: craniofacial resection and reconstructive strategy.

none3Frontoethmoidal involvement by benign tumors may lead to aesthetic and functional sequelae. The key for removal of such lesions is a proper planned craniofacial approach based on the preoperative evaluation. If total extirpation requires resection of part of the forehead or orbit, immediate reconstruction is mandatory. In recent years, craniofacial techniques and strategies have become popular. Among these are the use of split cranial bone, rotation of skull bones, the use of galeal-pericranial flaps, and the introduction of internal rigid fixation. We present a case of frontoethmoidal osteoma treated with a combined craniofacial approach. For the reconstruction, modern principles of craniofacial surgery have been applied.noneL. Clauser;F. Meneghini;D. CurriClauser, Luigi; F., Meneghini; D., Curr

Insulin degludec: a novel ultra-long-acting basal insulin for use in Type 1 and 2 diabetes

The prevalence of diabetes, a chronic disease that currently poses a significant health burden in both developed and developing countries, is expected to increase significantly over the foreseeable future. In Type 1 diabetes, insulin replacement is absolutely imperative; in Type 2 diabetes, many patients will eventually require insulin replacement therapy to compensate for progressive -cell failure and maintain blood glucose control. Even though currently available insulin analog preparations more closely mimic physiologic insulin needs when compared with neutral protamine Hagedorn insulin, many patients with diabetes still experience unacceptable glycemic control, in part owing to limitations in insulin therapy, such as hypoglycemia risk, weight gain and the need for patients to adjust their lifestyle to their insulin therapy. Insulin degludec, appropriately labeled as an ultra-long-acting basal insulin, promises to achieve similar blood glucose control to currently available preparations (glargine and detemir insulin), with a reduced risk of hypoglycemia and greater flexibility in the day-to-day timing of insulin administration. Greater flexibility in basal insulin administration and/or reducing hypoglycemia risk in insulin-requiring patients with Type 1 or 2 diabetes may facilitate insulin management for patients and physicians