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Background: We aimed to determine the efficacy and safety of adding ezetimibe (Ez) to simvastatin (S) in a post-acute coronary syndrome (ACS) population in a prespecified on-treatment analysis., Methods: We evaluated 17,706 post-ACS patients from the IMPROVE-IT trial who had low-density lipoprotein cholesterol values between 50 and 125 mg/dL and who received Ez 10 mg/d with S 40 mg/d (Ez/S) or placebo with simvastatin 40 mg/d (P/S). The primary composite end point was cardiovascular death, myocardial infarction, unstable angina, coronary revascularization ≥30 days postrandomization, or stroke. The on-treatment analysis included patients who received study drug for the duration of the trial or experienced a primary end point or noncardiovascular death within 30 days of drug discontinuation., Results: Mean low-density lipoprotein cholesterol values at 1 year were 71 mg/dL for P/S and 54 mg/dL for Ez/S (absolute difference -17 mg/dL = -24%; P < .001). The 7-year Kaplan-Meier estimate of the primary end point occurred in 32.4% in the P/S arm and 29.8% in the Ez/S arm (absolute difference 2.6%; HR adj 0.92 [95% CI 0.87-0.98]; P = .01). The absolute treatment effect favoring Ez/S was 30% greater than in the intention-to-treat analysis of IMPROVE-IT., Conclusions: This analysis provides additional support for the efficacy and safety of adding Ez to S in this high-risk, post-ACS population., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) is evaluating the potential benefit for reduction in major cardiovascular (CV) events from the addition of ezetimibe versus placebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol (LDL-C) ≤ 125 mg/dL., Methods: The primary composite end point is CV death, nonfatal myocardial infarction (MI), nonfatal stroke, rehospitalization for unstable angina (UA), and coronary revascularization (≥ 30 days postrandomization). The simvastatin monotherapy arm's LDL-C target is <70 mg/dL. Ezetimibe was assumed to further lower LDL-C by 15 mg/dL and produce an estimated ~8% to 9% treatment effect. The targeted number of events is 5,250., Results: We enrolled 18,144 patients with either ST-segment elevation MI (STEMI, n = 5,192) or UA/non-ST-segment elevation MI (UA/NSTEMI, n = 12,952) from October 2005 to July 2010. Western Europe (40%) and North America (38%) were the leading enrolling regions. The STEMI cohort was younger and had a higher percentage of patients naive to lipid-lowering treatment compared with the UA/NSTEMI cohort. The UA/NSTEMI group had a higher prevalence of diabetes, hypertension, and prior MI. Median LDL-C at entry was 100 mg/dL for STEMI and 93 mg/dL for UA/NSTEMI patients., Conclusions: This trial is evaluating LDL-C lowering beyond previously targeted LDL-C levels. The results depend on achieving the desired separation of LDL-C with ezetimibe and on the assumption that ezetimibe's lowering of LDL-C will have similar event reduction efficacy as the LDL-C lowering from a statin. The results could affect future therapies and guidelines., (Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.)

Objective: To compare predicted and measured resting energy expenditure (REE) in young children (birth to 3 years) with failure to thrive (FTT)., Methods: REE (kcal/d) was measured by indirect calorimetry and compared with predicted REE from 3 sex and age group equations: World Health Organization (WHO), Schofield weight-based (SCH-WT), and Schofield weight- and height-based (SCH-WT-HT). The clinical characteristics associated with inaccuracy of predicted REE were examined., Results: Forty-five subjects (47% female) were evaluated. Their clinical characteristics (mean +/- SD) included age 1.2 +/- 0.7 years, length/height z score -2.1 +/- 1.3, weight z score -2.7 +/- 1.0, and measured REE 438 +/- 111 kcal/d. All prediction equations were within 10% accuracy <50% of the time. However, SCH-WT-HT did not significantly differ from measured REE (450 +/- 138 vs 438 +/- 111 kcal/d, P =.2) and was least likely to underestimate REE. Younger age and more severe growth failure (based on weight, length/height, or both) were associated with underestimation of REE by prediction equations., Conclusion: REE should be measured in young infants and children with moderate to severe FTT when knowledge of caloric needs is required for optimal clinical care. The SCH-WT-HT equation was least likely to underestimate REE and is therefore preferred when REE cannot be measured in this group of children.

Objective: Although the prevalence of obesity among children in the United States is rapidly increasing, third party payer reimbursement for evaluation and management may be limited. The purpose of this analysis is to evaluate third party payer reimbursement rates for a pediatric weight management program for obese children and associations among child characteristics (eg, degree of obesity), insurance policy type, and reimbursement rates., Study Design: Cross-sectional survey in a tertiary care pediatric medical center. Reimbursement rate of charges for initial evaluation and management and patient characteristics were evaluated for children 2 years or older enrolled in the Children's Hospital Weight Management Program., Results: From October 17, 1995, to December 23, 1997, 191 children were evaluated in the Children's Hospital Weight Management Program. The children were on average 10.1 0.3 years old, with a mean body mass index z-score of 4.9 0.2; 46% were black, and 65% were female. The median reimbursement rate was 11% and varied widely (0% to 100%). Reimbursement rates differed significantly among policy types. Reimbursement rates did not differ between boys and girls or white and black children, nor were reimbursement rates associated with the degree of obesity., Conclusions: Despite the need for weight management services for obese children, these low reimbursement rates preclude the long-term financial viability of such programs without external support or a significant proportion of patients who can pay "out-of-pocket."

Objective: To evaluate the growth of hypercholesterolemic children completing an innovative, physician-initiated, home-based nutrition education program or standard nutrition counseling that aims to lower dietary fat intake., Study Design: From suburban pediatric practices, 261 3.9- to 9.9-year-old children with elevated cholesterol levels and 81 children with nonelevated cholesterol levels were identified. The children with hypercholesterolemia were randomly assigned to the home-based education program, standard nutrition counseling, or an at-risk control group. Height, weight, skinfold measures, and dietary intake were evaluated at baseline, 3, 6, and 12 months; changes in anthropometric measures among treatment groups were compared over time., Results: The intervention groups demonstrated significant decreases in fat and saturated fat intake after the interventions; however, weight z-score, height z-weight-for-height-median, and sum of skinfolds did not vary among the treatment groups over the year. At baseline, height z-score, weight z-score, and weight-for-height-median were positively associated with caloric intake, whereas weight z-score, weight-for-height-median, and sum of skinfolds were positively associated with fat intake. When the groups were combined and the children were grouped by average fat intake quintiles, no association between fat intake and changes in weight z-score, height z-score, or weight-for-height-media was observed. Differences over time in sum of skinfolds among fat intake quintile groups (suggesting a negative association between fat intake and body fat) that approached statistical significance (p = 0.06) were observed., Conclusions: These results support the safety, with respect to growth, of physician-initiated dietary intervention and lower fat diets for children with hypercholesterolemia. In addition, low dietary fat intake was associated with lower body fat.

Growth and development after the cessation of prolonged parenteral nutrition (PN) has not been fully evaluated. Growth, body composition, and nutritional and developmental status were documented in nine children (five boys, four girls) 2 to 6 years old (mean 4.9 +/- 1.0 years) who had previously received long-term PN (mean 14.6 +/- 11.4 months). PN had been discontinued in all subjects for at least 6 months (mean 3.4 +/- 1.4 years); they were receiving oral feedings only. One subject had a significantly low height-for-age, and another had a low percent ideal body weight; five subjects had low total body fat. Serum vitamin A was low in six subjects. Seventy-two-hour fecal fat analysis was abnormal in two of eight subjects. Abnormal bone mineral density was present in four of nine subjects. Psychomotor development was normal in all nine subjects. Two had functional difficulties in swallowing. One or more abnormalities were present in all nine subjects. These findings suggest that children who require prolonged PN in early life are at risk for abnormalities in growth and nutritional status in later childhood; they require long-term dietary, growth, and nutritional monitoring.

Objective: To describe the age-related changes in cardiovascular disease risk factors in young, hypercholesterolemic (HC) children., Methods: Hypercholesterolemic (n = 227) and nonhypercholesterolemic (NHC) (n = 80) children between the ages of 4 and 10 years were identified. Height, weight, skin-fold and blood pressure measurements, and total cholesterol levels were measured. The HC group also had insulin levels evaluated. The groups were compared by analysis of variance. Simple Spearman correlations evaluated the associations between factors within each group., Results: The HC and NHC groups had similar mean ages, heights, and weights, both contained 51% girls, and all were white subjects. Percent weight-for-height median, and biceps, triceps, suprailiac and subscapular skin-fold measurements were all larger for the HC group. A significant age interaction demonstrated that the HC group's larger suprailiac and sum of skin-fold measures were expressed in the 8.0- to 9.9-year-old children, but not the 4.0- to 5.9-year-olds. For both groups, systolic blood pressure was associated with the measures of adiposity. For the HC group, insulin levels were also associated with adiposity., Conclusions: These results suggest that: (1) children with HC have greater body fat, (2) the expression of the hypercholesterolemia precedes the expression of increased body fat, (3) body fat increases with age, and (4) altered insulin and blood pressure levels are expressed in association with the increased body fat in children with HC. Confirmation with longitudinal data is necessary.