Aims
This study assessed comparative effectiveness of glargine 300 U/mL (Gla-300) versus degludec 100 U/mL (Deg-100) in insulin-naïve patients with T2D.
Methods
This is a retrospective, multicenter, ...non-inferiority study based on electronic medical records. All patients initiating Gla-300 or Deg-100 were 1:1 propensity score-matched (PSM). Linear mixed models were used to assess the changes in continuous endpoints. Incidence rates (IR) of hypoglycemia were compared using Poisson’s regression models.
Results
Nineteen centers provided data on 357 patients in each PSM cohort. HbA1c after 6 months (primary endpoint) decreased by − 1.70% (95%CI − 1.90; − 1.50) in Gla-300 group and − 169% (95%CI − 1.89; − 1.49) in Deg-100 group, confirming non-inferiority of Gla-300 versus Deg-100. Fasting blood glucose (BG) decreased by ~60 mg/dl in both groups; body weight remained unchanged. In both groups, the mean starting dose was 12U (0.15U/kg) and it was slightly titrated to 16U (0.20U/kg). IR (episodes per patient-months) of BG ≤70 mg/dl was 0.13 in Gla-300 group and 0.14 in Deg-100 group (
p
=0.87). IR of BG <54 mg/dL was 0.02 in both groups (
p
=0.49). No severe hypoglycemia occurred.
Conclusion
Initiating Gla-300 or Deg-100 was associated with similar improvements in glycemic control, no weight gain and low hypoglycemia rates, without severe episodes during 6 months of treatment.
Background
Weight loss is a milestone in the prevention of chronic diseases associated with high morbility and mortality in industrialized countries. Very-low calorie ketogenic diets (VLCKDs) are ...increasingly used in clinical practice for weight loss and management of obesity-related comorbidities. Despite evidence on the clinical benefits of VLCKDs is rapidly emerging, some concern still exists about their potential risks and their use in the long-term, due to paucity of clinical studies. Notably, there is an important lack of guidelines on this topic, and the use and implementation of VLCKDs occurs vastly in the absence of clear evidence-based indications.
Purpose
We describe here the biochemistry, benefits and risks of VLCKDs, and provide recommendations on the correct use of this therapeutic approach for weight loss and management of metabolic diseases at different stages of life.
This study aimed to investigate the relationship between cardio-ankle vascular index (CAVI) and diabetic retinopathy (DR) in Caucasian patients with type 2 Diabetes Mellitus (T2DM).
This was a ...cross-sectional study of 299 T2DM patients admitted to Endocrine Unit of Foggia. DR was diagnosed using the International Clinical Disease Severity Scale of American Academy of Ophthalmology. The VaSera VS-1500N was used to measure CAVI. Because age is the most powerful determinant of arterial stiffness and affects the progression of DR, we divided the whole sample into two subgroups: above (older) and below (younger) 70 years.
The mean age of patients was 60.4 ± 12.6 years and the mean CAVI value was 8.6 ± 1.7. In the whole population DR was diagnosed in 74 (24.7%) patients. CAVI value was clearly higher in patients with DR (9.5 ± 1.6) than in those without (8.7 ± 1.7) (P = 0.001) although this difference was not any more significant when adjusted by age and gender (P = 0.067). In the multivariate model taking into account several possible confounders, the correlation between DR and CAVI remained significant only in younger subjects. In the same subgroup we found a significant association between the stages of DR and CAVI (p = 0.019 adjusted by age and gender).
This study shows that CAVI is significantly higher in younger patients with DR than in those without, with a relationship between the stages of DR and CAVI in the same subgroup. Physicians should pay attention to sub-clinical macroangiopathy in younger T2DM patients who have DR.
Purpose
The use of sodium-glucose-cotransporter-type-2 inhibitors (SGLT2i) was associated in previous studies with an improved vascular function in non-human experimental models. We therefore sought ...to evaluate possible changes in endothelial function assessed by flow-mediated dilation (FMD) in patients with chronic heart failure (CHF) and type-2 diabetes mellitus (T2DM), switching from other oral hypoglycemic agents to SGLT2i in an observational study.
Methods
Twenty-two consecutive outpatients with CHF and T2DM were enrolled after switching to SGLT2i therapy, and compared with 23 consecutive controls from the same registry comparable for principal clinical characteristics. In all patients, endothelial function was assessed by FMD at baseline and after 3 months of follow-up.
Results
Three months of therapy with SGLT2i were associated with a statistically significant improvement in endothelial function (19.0 ± 5.7% vs 8.5 ± 4.1%,
p
< 0.0001); baseline levels of FMD were comparable between groups (p n.s.). Therapy with SGLT2i was significantly associated to improved FMD levels even at multivariable stepwise regression analysis (
p
< 0.001).
Conclusions
Switch to SGLT2i in patients with CHF and T2DM was associated in an observational non-randomized study with an improved endothelial function.
Data on second generation basal insulin (2BI) in people with type 2 diabetes (T2D) generated by clinical trials still need confirmation in real-world clinical settings. This study aimed at assessing ...the comparative effectiveness of 2BI Glargine 300 U/mL (Gla-300) vs. Degludec 100 U/mL (Deg-100) in T2D Italian patients switching from first generation basal insulins (1BI).
This was a retrospective, non-inferiority, multicenter study. Patients switching to Gla-300 or Deg-100 from 1BI were 1:1 propensity score matched (PSM). Changes during 6 months in continuous endpoints were assessed through linear mixed models. Incidence rates (IR) of hypoglycemia (episodes per patient-months) were compared using Poisson regression.
Each PSM cohort included 593 patients. HbA1c decreased from baseline (8.7%) to 6 months by −0.58% (95%CI -0.69;-0.47) in Gla-300 group and −0.50% (95%CI -0.61;-0.39) in Deg-100 group, confirming the non-inferiority of Gla-300 vs. Deg-100. No between-group differences emerged: FBG was reduced by about 20 mg/dl with both 2BI, mean dose of 2BI (24.5 U, 0.3 U/Kg at the first prescription) was suboptimally titrated during 6 months (+1.34 U in Gla-300 and + 1.76 U in Deg-100), body weight showed minor changes.
IR of hypoglycemia <54 mg/dl was 0.32 (95%CI 0.21; 0.49) in Gla-300 group and 0.19 (95%CI 0.11; 0.33) in Deg-100 group (p = 0.14).
In subjects with T2D, switching to 2BI from 1BI was associated with similar improvements in glycemic control, low hypoglycemia rates and no weight gain in real-life setting. Clinical inertia, represented by late treatment intensification and suboptimal titration, represents a major issue in Italy.
•Comparative effectiveness data on 2° generation basal insulins (2BI) in type 2 diabetes are needed.•Switch to Glargine 300 U/mL (Gla-300) or Degludec 100 U/mL (Deg-100) was compared.•The study confirmed the non-inferiority of Gla-300 vs. Deg-100 on metabolic control.•Low hypoglycemia rates and no weight gain were documented with both 2BIs.•Late treatment intensification and suboptimal titration represent major issues.
Abstract
Aims
Diabetes is the most common comorbidity of HF patients. SGLT2 inhibitors has been shown to reduce hospitalization in patients with HF. The cardioprotective mechanisms of gliflozines ...have not been elucidated. The aim of our study was to evaluate the effect of SGLT2 inhibitors on right and left ventricular function in T2DM patients with HF.
Methods and results
One hundred and fifteen consecutive outpatients with CHF and T2DM were screened in the Daunia Heart Failure Registry. Seventy-eight of them were enrolled and followed up between May 2019 and September 2020. All patients underwent conventional, TDI and strain echocardiography in an ambulatory setting, at the beginning and after 3 months of therapy with SGLT2 inhibitors. Seventy-eight consecutive outpatients with CHF and T2DM (mean age 67.4 ± 8.4 years, male: 83%) were enrolled in the study. Thirty-eight of them started the treatment with SGLT2 inhibitors, while the remaining forty continued their original therapy. After 3 months of therapy, LVEF, LVEDD, and LVESD statistically improved (respectively, from 39.68 ± 7.78% to 45.08 ± 9.04%, P: 0.001 and 57.32 ± 9.76 mm to 54.16 ± 6.54 mm, P: 0.01 and from 47.51 ± 1.58 mm to 43.24 ± 8.12, P: 0.0008). Changes in left ventricular function and dimensions were not significant in patients who did not started a therapy with SGLT2 inhibitors. There was a statistically significant reduction of E/E′ (from 16.51 ± 22.55 to 9.73 ± 3.35, P: 0.0007) in patients with treatment with SGLT2i. Moreover, there was an improvement of right ventricular function, due to a statistically significant reduction of PAPs and increase of TAPSE (respectively, from 30.63 ± 8.80 to 24.00 ± 8.35, P: 0.008; from 19.16 ± 2.54 to 21.18 ± 2.84, P: 0.0003) and S′ (10.42 ± 2.09 to 12.91 ± 2.50, P: 0.000) 3 months after the administration of SGLT2 inhibitors therapy vs. the control group.
Conclusions
In a real-world scenario, our results showed that the treatment with SGLT-2 inhibitors in patients with CHF and diabetes is associated with an echocardiographic biventricular function improvement.
Three different flavoring methods of olive oil were tested employing two different herbs, thyme and oregano. The traditional method consist in the infusion of herbs into the oil. A second scarcely ...diffused method is based on the addition of herbs to the crushed olives before the malaxation step during the extraction process. The third innovative method is the implementation of the ultrasound before the olive paste malaxation. The objective of the study is to verify the effect of the treatments on the quality of the product, assessed by means of the chemical characteristics, the phenol composition and the radical scavenging activity of the resulting oils. The less favorable method was the addition of herbs directly to the oil. A positive effect was achieved by the addition of herbs to the olive paste and other advantages were attained by the employment of ultrasound. These last two methods allow to produce oils “ready to sell”, instead the infused oils need to be filtered. Moreover, the flavoring methods applied during the extraction process determine a significant increment of phenolic content and radical scavenging activity of olive oils. The increments were higher when oregano is used instead of thyme. Ultrasound inhibited the olive polyphenoloxidase, the endogenous enzyme responsible for olive oil phenol oxidation. This treatment of olive paste mixed with herbs before malaxation was revealed as the most favorable method due to the best efficiency, reduced time consumption and minor labor, enhancing the product quality of flavored olive oil.
Primary cerebral tumors rarely provoke sudden death. The incidence is often underestimated with reported frequencies in the range of 0.02 to 2.1% in medicolegal autopsy series. Furthermore, primary ...cerebral melanoma is an uncommon neoplasm. It represents approximately 1% of all melanoma cases and 0.07% of all brain tumors. This neoplasm is very aggressive, and its annual incidence is about 1 in 10 million people. In the present study, a 20-year-old male was admitted to hospital with vomiting, headache, paresthesia and aggressive behavior. A computed tomography (CT) scan of the head was performed showing a hyperdense nodule in the right parietal lobe with inflammation of the Silvian fissure. A complete autopsy was performed 48 h after death. A blackish material was displayed on the skull base, and posterior fossa. Microscopic examination diagnosed primary brain melanoma. A systematic review of the literature was also performed where no previous analogous cases were found. The forensic pathologist rarely encounters primary cerebral melanoma, and for these reasons, it seemed appropriate to describe this case as presenting aspecific clinical symptoms and leading to sudden unexpected death. Histopathological observations are reported and discussed to explain this surprising sudden death caused by a primary cerebral melanoma.
Dear Editor, Teleconsulting - defined as real-time consultation between doctors by exploiting video conferencing technology over the Internet network - is exponentially being implemented through the ...western world lastly triggered by COVID-19 pandemic...
A true umbilical cord knot can be defined as an entwining of a segment of the umbilical cord. These knots are usually due to fetal slippage through a loop of the cord. A true knot is a rare event ...with a rate ranging from 0.1% to 2.1% of all umbilical cords at delivery. However, in 1.4% to 2.7% of such pregnancies, a true knot causes intrauterine fetal death (IUFD). Wharton’s jelly and hydrostatic pressure of the umbilical vessels usually do not allow knots to completely tighten, but just before or during labor, a previously loose knot can tighten and cause asphyxia. Prenatal diagnosis of such an alteration is difficult and, even if diagnosed, there is no consensus on the therapy. We describe a case of a true umbilical cord knot that led to IUFD of a female fetus at the 40th week of gestation.
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