Goal achievement of HbA1c and LDL-cholesterol in a randomized trial comparing colesevelam with ezetimibe: GOAL-RCT.

AIM: To compare the efficacy and safety of colesevelam and ezetimibe as second-line low density lipoprotein-cholesterol (LDL-c)-lowering options in type 2 diabetes (T2D). MATERIALS AND METHODS: GOAL-RCT is a 24-week, open-label, randomized, pragmatic clinical trial. Subjects with T2D with uncontrolled HbA1c (7.1%-10%) and LDL-c (>2.0 mmol/L) were randomized 1:1 to colesevelam 3.75 g or ezetimibe 10 mg daily. The primary composite outcome was the proportion of participants achieving an LDL-c target of ≤2.0 mmol/L and HbA1c target of ≤7.0%. Intention to treat analysis was performed. RESULTS: Two hundred subjects were enrolled: mean age 59 ± 10 years; mean HbA1c 8.0%; mean LDL-c 2.5 mmol/L; 97% on statin therapy. The primary composite outcome was achieved by similar proportions of participants with colesevelam (14.6%) and ezetimibe (10.5%) (Pnon-inferiority < .001, Psuperiority = .41). LDL-c reduction from baseline was less with colesevelam compared with ezetimibe (14.0% vs. 23.2%, P < .01), as was the proportion of subjects achieving an LDL-c target of ≤2.0 mmol/L (47.6% and 67.0%, respectively; P = .007). Mean HbA1c was reduced with colesevelam (-0.26 ± 0.10%), while no change was observed with ezetimibe (difference P = .06). Adverse events and discontinuation rates were higher for colesevelam (20.2% and 31.1%) compared with ezetimibe (7.2% and 6.2%), respectively. CONCLUSIONS: Among subjects with T2D, the initiation of colesevelam or ezetimibe led to similar achievement of primary composite outcome (LDL-c and HbA1c within target), with ezetimibe recording a greater LDL-c reduction and better tolerability than colesevelam.

Corneal endothelium in paediatric patients with uveitis: a prospective longitudinal study.

PURPOSE: To study the longitudinal effect of anterior chamber inflammation on the corneal endothelium in children. METHODS: In this prospective longitudinal observational study, children (aged <18 years) with anterior chamber inflammation and those at risk of developing uveitis due to juvenile idiopathic arthritis (JIA) were included. Changes in central endothelial cell density (ECD) and morphological variables were determined by non-contact specular microscopy, and their correlations with uveitis activity and surgical interventions were analysed. RESULTS: Ninety-nine eyes of 99 children (mean age (±SD): 10.0±4.1 years) with a history of anterior chamber inflammation were recruited. Mean follow-up was 12.3±3.5 months. Eleven children, who were under surveillance but had not developed JIA-associated uveitis were included as controls. While there were no significant differences in mean ECD between controls and subjects without prior surgery (group 1) at all time points, those who had prior ophthalmic surgery (group 2) displayed significantly lower ECD than the controls at recruitment (p=0.002) and at follow-up (p=0.004). However, longitudinal ECD assessments did not show significant changes in either group (group 1, p=0.07, group 2, p=0.54). On regression analysis, once the patient's age was adjusted for, only the occurrence of intraocular procedures during the study (r=0.43, adjusted p=0.03) was associated with a significant annual rate of ECD loss. CONCLUSION: During the study period, longitudinal ECD changes among children with uveitis were associated with intraocular surgery for uveitis-related complications but not uveitis activity. By reducing the need for surgical intervention, the corneal endothelium in these children may be preserved.

Endothelial cell density in children with posterior polymorphous corneal dystrophy: a longitudinal case-control study.

OBJECTIVE: To evaluate longitudinal endothelial cell characteristics of children with posterior polymorphous corneal dystrophy (PPCD). METHODS: In this prospective case-control study, children with PPCD were followed with slit-lamp photography and non-contact specular microscopy. Patient's eyes were subdivided according to the clinical subtypes of PPCD (vesicular, band, diffuse, and unaffected) and the number of lesions present on the posterior corneal surface. Findings were then compared with age-matched controls. RESULTS: Thirty eyes of 15 patients with PPCD with a mean age 10.5 ± 3.1 years were analysed. Mean follow-up was 3.0 ± 1.0 years. PPCD morphology was vesicular in 40%, diffuse in 37%, band type in 10% and 13% had no detectable lesions despite contralateral involvement. Fourteen eyes (47%) had ≥5 endothelial lesions. Patients with PPCD had significantly lower endothelial cell densities (ECD) at recruitment (1918.9 ± 666.3 vs. 3340.1 ± 286.5 cells/mm2, p < 0.007) and at final follow-up (1793.1 ± 684.6 vs. 3265.2 ± 304.3 cells/mm2, p < 0.007) compared to age-matched controls. The lowest ECDs were found in eyes with diffuse type PPCD and those with ≥5 posterior corneal lesions, while clinically unaffected eyes in patients with confirmed PPCD in fellow eye had a normal ECD. However, the rates of annual ECD decline were not significantly different between eyes with PPCD in general, between the subgroups of PPCD and the normative groups. CONCLUSION: Endothelial cell density is significantly reduced among children with PPCD and depends on the clinical subtype and the number of posterior corneal lesions present. However, annual ECD loss is similar between normal eyes and those with PPCD.

Real-World Health Outcomes of Insulin Glargine 300 U/mL vs Insulin Glargine 100 U/mL in Adults With Type 1 and Type 2 Diabetes in the Canadian LMC Diabetes Patient Registry: The REALITY Study.

OBJECTIVES: This study evaluated real-world clinical outcomes of patients with type 1 diabetes (T1D) and type 2 diabetes (T2D) initiating or transferring to insulin glargine 300 U/mL (Gla-300) vs insulin glargine 100 U/mL (Gla-100). METHODS: This is a retrospective cohort study using data from the Canadian LMC Diabetes Patient Registry. The 4 following cohorts were analyzed: 1) insulin-naïve patients with T2D who initiated Gla-300 or Gla-100, 2) patients with T2D who switched from neutral protamine Hagedorn (NPH) or detemir to Gla-300 or Gla-100, 3) patients with T2D who switched from Gla-100 to Gla-300 and 4) patients with T1D who switched from Gla-100, NPH or detemir to Gla-300. RESULTS: Of 376 propensity score-matched insulin-naïve patients, 6-month reduction in glycated hemoglobin (A1C) was similar between Gla-300 (-1.78%±1.85%; p<0.001) and Gla-100 (-1.74%±1.87%; p<0.001). In 114 propensity score-matched patients who switched from NPH or detemir, 6-month reduction in A1C was similar between Gla-300 (-0.78%±1.14%) and Gla-100 (-0.70%±1.57%). The 396 patients who switched from Gla-100 to Gla-300 had a significant reduction in A1C (-0.45%±1.39%; p<0.001). In 196 patients with T1D who switched from Gla-100, NPH or detemir to Gla-300, there was a significant reduction in A1C of -0.17%±1.19% (p=0.04). CONCLUSIONS: In a real-world clinical setting, insulin-naïve patients who initiated Gla-300 or Gla-100 showed similar changes in A1C and weight. Patients with T1D or T2D using Gla-300 transferred from another basal insulin had significant reductions in A1C with no change in weight or insulin dose.

Assessment of self-management in patients with diabetes using the novel LMC Skills, Confidence and Preparedness Index (SCPI).

AIMS: The LMC Skills, Confidence & Preparedness Index (SCPI) is an electronic tool designed to meet ISOQOL standards and (a) assess three dimensions: knowledge, confidence and preparedness; (b) provide a clinically meaningful measure; (c) provide immediate feedback to the healthcare provider. Internal consistency and external validity have been previously reported in a refractory diabetes cohort. This larger evaluation, broader in glycemic control, sought to assess clinical relevance to glycemia. METHODS: Participants with type 1 and type 2 diabetes were recruited from LMC Diabetes and Endocrinology specialist clinics, from April to October 2016. Participants completed the SCPI using a tablet. Demographic and laboratory data were extracted from the LMC Diabetes Patient Registry. RESULTS: In total, 529 patients met inclusion criteria and were included in psychometric analyses; 518 patients with established diabetes (>6 months) were assessed for SCPI - glycemia correlations. SCPI scores were found to have a high degree of validity, internal consistency, and test-retest reliability. Most importantly, the tool showed good external validity in its relation to glycemic control, both in tertile analysis, demonstrating a threshold effect consistent with a 'moderate' degree of poor control; and in overall correlation with HbA1c for the total SCPI score and two subscales (Skills and Confidence). CONCLUSIONS: The SCPI tool is a quick (25 items), easy to use measure of three domains - knowledge, confidence and preparedness. The instant scoring and specific feedback, as well as the relationship to glycemic control should provide significant value in the patient assessment in the diabetes clinic.

Endothelial Cell Loss in Obstetric Forceps-Related Corneal Injury: A Longitudinal Specular Microscopic Study.

PURPOSE: To assess the impact of ocular trauma associated with obstetric forceps delivery on the corneal endothelium in children. METHODS: Five patients who attended the Hospital for Sick Children, Toronto, between 2013 and 2016 with a diagnosis of unilateral obstetrical forceps-related corneal injury were included. Clinical presentation, best-corrected visual acuity, corneal endothelial cell density (ECD, cells/mm), and measures of cellular morphology were obtained. RESULTS: The mean follow-up duration was 30 ± 10 months. Mean ECD in the affected eye at initial assessment was significantly lower than that of the fellow eye (2576 ± 733 vs. 3481 ± 288 cells/mm, P = 0.02). At final follow-up, mean ECD was 3293 ± 175 and 1907 ± 524 cells/mm in the normal and affected eyes, respectively (P = 0.004). The mean annual rate of the ECD decrease was higher in the affected eyes than in the normal eyes (9.1% ± 4.2% vs. 2.0% ± 2.5%), although this difference was not statistically significant (P = 0.06). CONCLUSIONS: In children with forceps-related corneal injury, lower ECD with a higher annual decrease can be assessed with specular microscopy for risk stratification and parental counseling purposes.

Predictors of early attrition and successful weight loss in patients attending an obesity management program.

BACKGROUND: Our objective was to identify factors that are independently associated with early attrition and successful weight loss (WL) in an obesity-management program. METHODS: Participants were 9,498 patients enrolled in treatment at the Wharton Weight Management Clinic for at least 6 months. Predictors of early attrition (<6 months) and successful WL (≥5 %) were analyzed using relative risk (RR) in men and women separately. Pearson's correlation was used to determine the relationship between WL and treatment time Weight loss and attrition analysis was restricted to patients who had more than two visits (n = 5415). RESULTS: Older individuals had lower early attrition (RR Range:0.74-0.92, P < 0.05) and greater WL success (RR Range:1.40-1.65, P < 0.05) than younger individuals. Males with hypertension and females with depression had greater early attrition (RR Range:1.09-1.20, P < 0.05) and lower WL success (RR Range:0.48-0.57, P < 0.05) than those without these health conditions. Males with lower education had greater early attrition (RR = 1.11[1.03-1.19]) than males with higher education, but did not differ in WL. Females who smoked had greater early attrition (RR = 1.06[1.01-1.11]) than females who did not smoke, but did not differ in WL. Ethnicity was not related to early attrition, however, females of Black and Other ethnicities had lower WL success compared to White females (RR Range:0.58-0.74, P < 0.05). After adjusting for treatment time, all above associations were no longer significant and treatment time remained as the only independent predictor of WL success (P < 0.0001). CONCLUSION: As WL is positively and independently related with treatment time, individuals at risk for early attrition may need alternative treatment options, in order to improve patient retention and improve WL success.

Calorie Estimation in Adults Differing in Body Weight Class and Weight Loss Status.

PURPOSE: Ability to accurately estimate calories is important for weight management, yet few studies have investigated whether individuals can accurately estimate calories during exercise or in a meal. The objective of this study was to determine if accuracy of estimation of moderate or vigorous exercise energy expenditure and calories in food is associated with body weight class or weight loss status. METHODS: Fifty-eight adults who were either normal weight (NW) or overweight (OW), and either attempting (WL) or not attempting weight loss (noWL), exercised on a treadmill at a moderate (60% HRmax) and a vigorous intensity (75% HRmax) for 25 min. Subsequently, participants estimated the number of calories they expended through exercise and created a meal that they believed to be calorically equivalent to the exercise energy expenditure. RESULTS: The mean difference between estimated and measured calories in exercise and food did not differ within or between groups after moderate exercise. After vigorous exercise, OW-noWL overestimated energy expenditure by 72% and overestimated the calories in their food by 37% (P < 0.05). OW-noWL also significantly overestimated exercise energy expenditure compared with all other groups (P < 0.05) and significantly overestimated calories in food compared with both WL groups (P < 0.05). However, among all groups, there was a considerable range of overestimation and underestimation (-280 to +702 kcal), as reflected by the large and statistically significant absolute error in calorie estimation of exercise and food. CONCLUSIONS: There was a wide range of underestimation and overestimation of calories during exercise and in a meal. Error in calorie estimation may be greater in overweight adults who are not attempting weight loss.