ABSTRACT
The aim of this study was to assess the impact of osteopathic manipulative treatment (OMT) on newborn babies admitted at a neonatal intensive care unit (NICU). This was an observational, longitudinal, retrospective study. All consecutive admitted babies were analyzed by treatment (OMT vs. usual care). Treatment group was randomly assigned. Between-group differences in weekly weight change and length of stay (LOS) were evaluated in the overall and preterm populations. Among 1249 babies (48.9% preterm) recorded, 652 received usual care and 597 received OMT. Weight increase was more marked in the OMT group than in the control group (weekly change: +83 g vs. +35 g; p < 0.001). Similar trends were found in the subgroup of preterm babies. A shorter LOS was found in the OMT group vs. the usual care group both in overall population (average mean difference: -7.9 days, p = 0.15) and in preterm babies (-12.3 days; p = 0.04). In severe preterm babies, mean LOS was more than halved as compared to the control group. OMT was associated with a more marked weekly weight increase and, especially in preterm babies, to a relevant LOS reduction: OMT may represent an efficient support to usual care in newborn babies admitted at a NICU.
ABSTRACT
INTRODUCTION: Real-world evidence on the effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. We have therefore evaluated the effectiveness and safety of IDeg, including impact on metabolic control, glycemic variability, weight gain and hypoglycemia, in patients with type 1 diabetes under routine clinical practice conditions. METHODS: This was an observational longitudinal multicenter study. A retrospective chart review of all patients with type 1 diabetes who were switched from basal insulin to IDeg was performed, and temporal trends in clinical outcomes were assessed. RESULTS: Data obtained from 195 patients, with a median age of 42.8 [interquartile range (IQR) 24.6-56.4] years and a median diabetes duration of 16 (IQR 10.0-28) years, were analyzed. Median follow-up was 9.5 (IQR 7.7-11.3) months. Improvements were found in glycated hemoglobin (- 0.34%; p < 0.0001), fasting blood glucose (- 24.82 mg/dL; p < 0.0001), post-prandial glucose (- 17.23 mg/dL; p = 0.0009), glycemic variability as indicated by standard deviation of blood glucose (- 5.67 mg/dL; p < 0.0001) and high blood glucose index (- 3.77; p < 0.0001). Body weight and body mass index remained substantially stable during the follow-up (- 0.18 kg; p = 0.56 and - 0.12; p = 0.42, respectively). Risk of nocturnal hypoglycemia decreased by 52% [incidence rate ratio 0.48; 95% confidence interval (CI) 0.29-0.77] and risk of total hypoglycemic episodes by 41% (incidence ratio 0.59; 95% CI 0.45-0.83). Basal and short-acting insulin doses decreased by - 1.4 and - 3.1 IU, respectively. CONCLUSION: Switching patients with type 1 diabetes to IDeg from other basal insulins was associated with relevant improvements in metabolic control and glycemic variability without weight gain; the risk of hypoglycemic episodes also significantly declined. FUNDING: Novo Nordisk S.p.A. unconditional grant.
ABSTRACT
Despite many articles regarding the antihemorrhagic treatment and prophylaxis, there is a lack of experience about how to best conduct major surgical procedures in patients with congenital factor XIII (FXIII) deficiency. Here we report a case of surgery (right inguinal hernia, complicated by heaviness and pain) performed in a patient with FXIII deficiency, receiving recombinant FXIII prophylaxis (Catridecacog 35 UI/kg every 28±2 days). Our experience shows that Catridecacog can be used safely and effectively not only for continued prophylaxis but also in surgery and adds to the very limited body of evidence currently available on surgery in this bleeding disorder.
ABSTRACT
INTRODUCTION: Real-world evidence on effectiveness and safety of insulin degludec (IDeg) in patients with diabetes is a priority. The aim of the study was to evaluate patterns of use and the long-term effectiveness and safety of IDeg in routine clinical practice. METHODS: This was an observational longitudinal study. A retrospective chart review of all patients with type 2 diabetes treated with IDeg was performed and temporal trends in clinical outcomes were assessed. All data was stratified by treatment modality: the switch group consisted of patients already treated with another basal insulin before initiating IDeg; the add-on group consisted of basal insulin-naïve patients. RESULTS: Overall, 247 patients were analyzed (55 in the add-on group and 192 in the switch group), mean age 67.0 ± 10.9 years ,and diabetes duration 16.3 ± 8.9 years. Median (interquartile range) follow-up was 9.7 (8.0-11.9) months. In the add-on group, improvements were found in glycated hemoglobin (HbA1c) (- 1.68%; p < 0.0001), fasting blood glucose (FBG) (- 64.7 mg/dL; p < 0.0001), post-prandial glucose (PPG) (- 81.1 mg/dl; p < 0.0001), and glycemic variability (i.e., standard deviation of blood glucose) (- 11.6 mg/dl; p = 0.04). Even in the switch group, improvements were found in HbA1c (- 0.57%; p < 0.0001), FBG (- 28.1 mg/dL; p < 0.0001), and PPG (- 22.6 mg/dl; p = 0.001). Body weight increase during the follow-up was not statistically significant vs. baseline in both groups. Benefits on overall, nocturnal, and severe hypoglycemia were found in the switch group. CONCLUSION: These real-world data documented that initiating IDeg or switching to IDeg from other basal insulins in type 2 diabetes was associated with significant improvement in metabolic control without significant weight gain; a decrease in the risk of hypoglycemia was observed when switching to IDeg from another basal insulin.
