scholarly journals Switching from Neutral Protamine Hagedorn Insulin to Insulin Glargine 300 U/mL Improves Glycaemic Control and Reduces Hypoglycaemia Risk: Results of a Multicentre, Prospective, Observational Study

2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
B. Wolnik ◽  
D. Wiza ◽  
T. Szczepanik ◽  
A. Syta ◽  
T. Klupa
Keyword(s):  
Body Weight ◽  
Observational Study ◽  
Insulin Glargine ◽  
Basal Insulin ◽  
Prospective Observational Study ◽  
Insulin Dose ◽  
Significant Proportion ◽  
Moderate Increase ◽  
Nph Insulin ◽  
Neutral Protamine Hagedorn

Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality worldwide and is an important public health issue. A significant proportion of insulin-treated patients with T2DM do not reach target glycated haemoglobin (HbA1c) values, which ultimately increases their risk of long-term microvascular and macrovascular complications. One potential option to improve diabetes control in these patients may be the use of new insulin formulations including second-generation basal insulin analogues such as insulin glargine 300 U/mL (Gla-300). Several published randomised controlled trials have assessed the clinical effectiveness of Gla-300, mostly versus insulin glargine 100 U/mL as well as insulin degludec. However, there is limited information about the real-world effectiveness of Gla-300 when patients are transitioned directly from neutral protamine Hagedorn (NPH) human basal insulin. The primary objective of this study was to evaluate the effectiveness of Gla-300, defined as the percentage of participants with an HbA1c reduction of ≥0.5%, 6 months after switching from NPH insulin, in participants with T2DM. Secondary objectives included the safety assessment based on the percentage of patients experiencing ≥1 episodes and the number of hypoglycaemic episodes by category: severe, symptomatic, symptomatic confirmed, diurnal or nocturnal, change in body weight, and insulin dose. A total of 469 participants completed the 6-month observation period. Mean baseline HbA1c was 9.19%. The percentage of participants with a ≥0.5% improvement in HbA1c from baseline was 71.7% at 6 months. Mean HbA1c decreased at 3 and 6 months by 0.77% (±0.98) and 1.01% (±1.12), respectively (p<0.00001 versus baseline), while fasting glycaemia decreased by 32 mg/dL and 37 mg/dL, respectively (p<0.00001 versus baseline). There were moderate increases in the doses of both Gla-300 and, if used, short-acting insulins during the 6 months of observation. The percentage of participants with ≥1 hypoglycaemia event during the preceding 4 weeks decreased significantly from baseline to 3 and 6 months, as did the proportion with symptomatic hypoglycaemia at night (p<0.00001 versus baseline). No participants had severe hypoglycaemia after a switch to Gla-300. Body mass, waist and hip circumferences, and waist : hip ratio did not change significantly. In conclusion, this large, prospective, observational study demonstrated that switching from NPH insulin to Gla-300 resulted in a significant improvement in HbA1c, with only a moderate increase in insulin dose, a decreased risk of hypoglycaemia, and no increase in body weight.

Insulin Dosage Adjustments After Initiation of GLP-1 Receptor Agonists in Patients With Type 2 Diabetes

2021 ◽  
pp. 089719002199362
Author(s):  
Mandy Chen ◽  
Etty Vider ◽  
Roda Plakogiannis
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Insulin Therapy ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Retrospective Chart Review ◽  
Insulin Dosage ◽  
History Of ◽  
Bolus Insulin

Background: Combination of insulin and GLP-1RAs have shown reductions in the HbA1c, body weight, and the risk of hypoglycemia. To date, there are conflicting data regarding the effect of GLP-1RAs on insulin dosage(s). Objective: The objective of this study was to evaluate adjustments of insulin doses upon initiation of GLP-1RAs. Methods: This was a retrospective chart review of patients on insulin therapy initiated on GLP-1RAs at NYU Langone Health. Patients were included in the study if they were at least 18 years of age, history of type 2 diabetes, and were on concurrent basal or mixed insulin therapy. 45 patients met inclusion criteria and were included in the study analysis. The primary endpoint was the median change in overall basal insulin doses. Secondary endpoints included median changes in total basal, mixed, and bolus insulin doses, oral antidiabetic medications and GLP-1RA doses, HbA1c, body weight, fasting glucose, and creatinine clearance. Safety results included any adverse reactions to insulin and/or GLP-1RA. Results: In the per-protocol analysis, there was a significant reduction in overall total basal insulin doses from baseline to week 24 (50 units vs. 44 units, p < 0.05). There was a median reduction in patients receiving glargine (50 units vs. 44 units) and detemir (29 units vs. 21.5 units). Conclusions: Use of GLP-1RAs after 24 weeks resulted in a statistically significant reduction in overall total basal insulin dosages from baseline. The median HbA1C in our patient population was >8%. Consider a ≥10% reduction in the overall basal insulin dose upon initiation of GLP-1RA in patients with a HbA1C >8%.

Feasibility and efficacy of ghost ileostomy in typhoid ileal perforations: A prospective observational study

2021 ◽  
pp. 004947552110070
Author(s):  
Prabhat Shukla ◽  
Uday Somashekar ◽  
Dileep S Thakur ◽  
Reena Kothari ◽  
Dhananjaya Sharma
Keyword(s):  
Body Weight ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Loop Ileostomy ◽  
Morbidity And Mortality ◽  
Ghost Ileostomy ◽  
Faecal Diversion

Loop ileostomy is commonly performed for typhoid ileal perforations as temporary faecal diversion. This is associated with several stoma-related complications and also requires further surgery for its closure. Thus, we were prompted to conduct a prospective observational study on the safety, feasibility and efficacy of ghost ileostomy in typhoid ileal perforations. After dealing with the perforation, a ghost ileostomy was performed in 10 selected patients with favourable circumstances; otherwise, a conventional loop ileostomy was performed in 19 patients. The two groups were comparable (p > 0.05) for morbidity and mortality except for stoma-related complications, seen only in the loop ileostomy group. Body weight was better preserved in the ghost ileostomy group. One patient in the ghost ileostomy group required conversion to loop ileostomy owing to signs of intra-peritoneal suture leak, without any detriment to outcome. Our study shows safety, feasibility and efficacy of ghost ileostomy in selected patients with typhoid ileal perforations, thus avoiding loop ileostomy in one-third of patients.

scholarly journals Usefulness of the prostate health index in predicting the presence and aggressiveness of prostate cancer among Korean men: a prospective observational study

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jae Yoon Kim ◽  
Ji Hyeong Yu ◽  
Luck Hee Sung ◽  
Dae Yeon Cho ◽  
Hyun-Jung Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Specific Antigen ◽  
Significant Proportion ◽  
Health Index ◽  
Free Psa ◽  
Prostate Health Index ◽  
Total Psa ◽  
Prostate Health

Abstract Background We aimed to evaluate the usefulness of the Beckman Coulter prostate health index (PHI) and to compare it with total prostate-specific antigen (PSA) levels and related derivatives in predicting the presence and aggressiveness of prostate cancer (PCa) in the Korean population. Methods A total of 140 men who underwent their first prostate biopsy for suspected PCa were included in this prospective observational study. The diagnostic performance of total PSA, free PSA, %free PSA, [–2] proPSA (p2PSA), %p2PSA, and PHI in detecting and predicting the aggressiveness of PCa was estimated using the receiver operating characteristic curve (ROC) and logistic multivariate regression analyses. Results Of 140 patients, PCa was detected in 63 (45%) of participants, and 48 (76.2%) of them had significant cancer with a Gleason score (GS) ≥ 7. In the whole group, the area under the curve (AUC) for ROC analysis of tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.63, 0.57, 0.69, 0.69, 0.72, and 0.76, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p = 0.005). For PCa with GS ≥ 7, the AUCs for tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.62, 0.58, 0.41, 0.79, 0.86, and 0.87, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p < 0.001). In the subgroup with tPSA 4–10 ng/mL, both %p2PSA and PHI were strong independent predictors for PCa (p = 0.007, p = 0.006) and significantly improved the predictive accuracy of a base multivariable model, including age, tPSA, fPSA and %fPSA, using multivariate logistic regression analysis. (p = 0.054, p = 0.048). Additionally, at a cutoff PHI value > 33.4, 22.9% (32/140) of biopsies could be avoided without missing any cases of aggressive cancer. Conclusions This study shows that %p2PSA and PHI are superior to total PSA and %fPSA in predicting the presence and aggressiveness (GS ≥ 7) of PCa among Korean men. Using PHI, a significant proportion of unnecessary biopsies can be avoided.

scholarly journals Lixisenatide is effective and safe as add-on treatment to basal insulin in Asian individuals with type 2 diabetes and different body mass indices: a pooled analysis of data from the GetGoal Studies

2021 ◽  
Vol 9 (1) ◽  
pp. e002290
Author(s):  
Wenhuan Feng ◽  
Weimin Wang ◽  
Ran Meng ◽  
Guangyu Wu ◽  
Minlu Zhang ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Body Mass ◽  
Basal Insulin ◽  
Insulin Dose ◽  
Study Endpoint ◽  
Baseline Body Mass Index ◽  
Efficacy And Safety ◽  
Multivariable Regression

IntroductionThis analysis aims to investigate the efficacy and safety of once-daily lixisenatide add-on treatment to basal insulin in Asian individuals with type 2 diabetes, by baseline body mass index (BMI).Research design and methodsData from all Asian participants in the placebo-controlled GetGoal-Duo 1, GetGoal-L, and GetGoal-L-C Studies were pooled and categorized according to the following BMI subgroups:<25 kg/m2, 25–<30 kg/m2 and ≥30 kg/m2. Efficacy and safety of lixisenatide versus placebo were evaluated among BMI subgroups. Multivariable regression analyses were also conducted to explore the potential influence of BMI on efficacy outcomes after adjusting for baseline characteristics.Results555 participants were included (mean age 53.9 years, 52.4% men). No significant differences in treatment effect between the BMI subgroups were observed for the changes from baseline to 24 weeks in glycated hemoglobin (HbA1c), fasting plasma glucose, postprandial glucose (PPG), PPG excursion, body weight, BMI, and basal insulin dose with lixisenatide, as well as the change in basal insulin dose at study endpoint and the proportion of participants achieving an HbA1c <7% at 24 weeks (all p values for interaction >0.15). In the multivariable regression analysis, participants in the lowest BMI group had a smaller reduction in body weight over the 24-week treatment period relative to the highest BMI group (p=0.023).ConclusionsThis post hoc analysis indicates that lixisenatide improved glycemic control regardless of baseline BMI and was well tolerated in Asian individuals unable to achieve their HbA1c target on basal insulin±oral antidiabetic drugs.

scholarly journals Current Practice and Barriers to an Early Antimicrobial Conversion from Intravenous to Oral among Hospitalized Patients at Jimma University Specialized Hospital: Prospective Observational Study

2019 ◽  
Vol 2019 ◽  
pp. 1-8
Author(s):  
Alemseged Beyene Berha ◽  
Gizat Molla Kassie
Keyword(s):  
Observational Study ◽  
Prospective Observational Study ◽  
Current Practice ◽  
Significant Proportion ◽  
Severe Infection ◽  
Hospitalized Patients ◽  
P Values ◽  
Specialized Hospital ◽  
Jimma University ◽  
Clinical Stability

Objective. The aim of the present study was to explore the current practice and its barriers to an early antimicrobial conversion from intravenous (IV) to oral (PO) therapy among hospitalized patients.Method. Hospital based prospective observational study was conducted to assess the practice of an early antimicrobial IV to PO conversion and its barriers using medical chart and case-specific physicians’ interviews, respectively, from February to September, 2014. Patient charts and medication records were reviewed for appropriateness of IV to PO conversion program every 24hrs using a pretested data collection abstraction format. Independent samplest-test was used to compare the duration of therapy and time to clinical stability between converted and nonconverted patients. Two-tailed P values of < 0.05 were regarded as statistically significant.Results. One hundred forty-two patients were included in the study, of whom two-thirds (67.6%) of the patients were eligible for IV to PO antimicrobial conversion. However, only 20.9% of patients’ timely conversion was made. A shorter duration of IV therapy was recorded for converted (2.80±1.87) versus nonconverted patients (8.50±6.32), (P=0.009). The most important barriers of not converting IV to PO in clinically stable patients were presence of comorbidity; clinicians perceived that the patient should always complete IV course of antimicrobials as a standard practice.Conclusion. Conversion from IV to PO antimicrobials was found to be unnecessarily delayed in a significant proportion of patients hospitalized with moderate to severe infection due to a range of different barriers. Addressing these issues has the potential to reduce inappropriate antimicrobial use and resistance.

scholarly journals Nocturnal Glucose Metabolism after Bedtime Injection of Insulin Glargine or Neutral Protamine Hagedorn Insulin in Patients with Type 2 Diabetes

2008 ◽  
Vol 93 (10) ◽  
pp. 3839-3846 ◽  
Author(s):  
Thomas Linn ◽  
Britta Fischer ◽  
Nedim Soydan ◽  
Michael Eckhard ◽  
Julia Ehl ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Insulin Glargine ◽  
Fasting Blood Glucose ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Nph Insulin ◽  
Double Blind ◽  
Glucose Levels ◽  
Neutral Protamine Hagedorn

Aims/Hypothesis: Insulin glargine is a long-acting human insulin analog often administered at bedtime to patients with type 2 diabetes. It reduces fasting blood glucose levels more efficiently and with less nocturnal hypoglycemic events compared with human neutral protamine Hagedorn (NPH) insulin. Therefore, bedtime injections of insulin glargine and NPH insulin were compared overnight and in the morning. Methods: In 10 type 2 diabetic patients, euglycemic clamps were performed, including [6,6′]2H2 glucose, to study the rate of disappearance (Rd) and endogenous production (EGP) of glucose during the night. On separate days at bedtime (2200 h), patients received a sc injection of insulin glargine, NPH insulin, or saline in a randomized, double-blind fashion. Results: Similar doses of both insulins had different metabolic profiles. NPH insulin had a greater effect on both Rd and EGP in the night compared with insulin glargine. By contrast, in the morning, insulin glargine was more effective, increasing Rd by 5.8 μmol/kg−1·min−1 (95% confidence interval 4.7–6.9) and reducing EGP −5.7 (−5.0 to −6.4) compared with NPH insulin. Nearly 80% of the glucose lowering effect in the morning was due to insulin glargine’s reduction of EGP. Its injection was associated with one-third lower morning glucagon levels compared with NPH insulin (P = 0.021). Conclusion/Interpretation: Nocturnal variations of EGP and Rd explain the reduced incidence of hypoglycemia and lower fasting glucose levels reported for insulin glargine compared with human NPH insulin.

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