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Biomedical subjects

A M Tershakovec

Publications and source records attributed to A M Tershakovec.

At least 19 recordsLinked to original sources
PubMed2006

Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies.

OBJECTIVE: To compare the efficacy of etoricoxib 30 mg with the generally maximum recommended dose of celecoxib, 200 mg, in the treatment of osteoarthritis (OA) in two identically designed studies. METHODS: Two multi-centre, 26-week, double-blind, placebo-controlled, non-inferiority studies were conducted, enrolling patients who were prior non-steroidal anti-inflammatory drug (NSAID) or acetaminophen users. There were 599 patients in study 1 and 608 patients in study 2 randomized 4:4:1:1 to etoricoxib 30 mg qd, celecoxib 200 mg qd or one of two placebo groups for 12 weeks. After 12 weeks, placebo patients were evenly distributed to etoricoxib or celecoxib based on their initial enrollment randomization schedule. The primary hypothesis was that etoricoxib 30 mg would be at least as effective as celecoxib 200 mg for the time-weighted average change from baseline over 12 weeks for Western Ontario and McMaster (WOMAC) Pain Subscale, WOMAC Physical Function Subscale and Patient Global Assessment of Disease Status. Active treatments were also assessed over the full 26 weeks. Adverse experiences were collected for safety assessment. RESULTS: In both studies, etoricoxib was non-inferior to celecoxib for all three efficacy outcomes over 12 and 26 weeks; both were superior to placebo (P < 0.001) for all three outcomes in each study over 12 weeks. The safety and tolerability of etoricoxib 30 mg qd and celecoxib 200 mg qd were similar over 12 and 26 weeks. CONCLUSIONS: Etoricoxib 30 mg qd was at least as effective as celecoxib 200 mg qd and had similar safety in the treatment of knee and hip OA; both were superior to placebo. ClinicalTrials.gov Identifiers: NCT00092768; NCT00092791.

Adult↗
PubMed2006

Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies.

OBJECTIVE: To compare the lower osteoarthritis (OA) dose of rofecoxib to the recommended dose of celecoxib in two identically designed studies. METHODS: Patients with knee OA were randomized (2:2:1 ratio: rofecoxib 12.5 mg once daily (qd), celecoxib 200 mg qd, or placebo, respectively). The primary endpoint was patient global assessment of response to therapy (PGART) averaged over 6 weeks on a five-point scale. Rofecoxib would be declared at least as effective as celecoxib if the lower bound of the 95% confidence interval (95% CI) for difference in means was no lower than -0.5. Additional endpoints included Pain and Physical Function subscales of the Western Ontario and McMaster (WOMAC) OA Index. Adverse experiences (AEs) were recorded and combined from the two studies for analysis. RESULTS: Study 1 enrolled 395 patients (rofecoxib, n = 160; celecoxib, n = 157; placebo, n = 78). Study 2 enrolled 413 patients (rofecoxib, n = 159; celecoxib, n = 169; placebo, n = 85). Rofecoxib 12.5 mg was at least as effective as celecoxib 200 mg by PGART (Study 1 difference -0.09 [95% CI: -0.32, 0.14] and Study 2 difference 0.02 [95% CI: -0.20, 0.24]), and both were significantly (p < 0.001) more effective than placebo. Comparable efficacy was also seen for WOMAC Pain and Physical Function subscales with the active treatments. There was a significantly higher (p < 0.05) incidence of serious AEs with celecoxib than rofecoxib or placebo, none of which was drug-related. There were no significant differences in the pre-specified measurements of safety including drug-related AEs or discontinuations due to AEs, and the medications demonstrated similar safety as assessed by spontaneous reporting. CONCLUSIONS: Rofecoxib 12.5 mg and celecoxib 200 mg provided comparable efficacy over 6 weeks, and both were significantly more efficacious than placebo. The medications demonstrated similar safety compared to one another and placebo. The primary limitations of these studies were that they were only 6 weeks long and were powered for efficacy. Therefore, conclusions about long-term safety cannot be inferred.

Aged↗
PubMed2003

Body composition and metabolic factors in obese children and adolescents.

OBJECTIVE: Body composition is associated with metablic factors in adults; however, data are limited regarding obese children. This study was undertaken to assess body composition, regional fat distribution, and metabolic factors in obese 6-18-y-old children and adolescents. DESIGN: Cross-sectional assessment. SUBJECTS: Thirty-six obese children and adolescents, (mean+/-s.e.m.) age 11.8+/-0.5 y, BMI 34.1+/-1.2 kg/m(2). MEASUREMENTS: Body composition was assessed by dual energy X-ray absorptiometry and computerized tomography. Fasting insulin, glucose and leptin levels, and the homeostasis model assessment of insulin sensitivity (HOMA-IR) were assessed. RESULTS: The girls had significantly lower glucose levels than the boys. The ethnic group differences (African American children vs white children) in fat mass, total CT fat, subcutaneous CT fat, insulin level, leptin level, and higher HOMA-IR were not significant after adjusting for age or pubertal stage. These differences in abdominal fat and subcutaneous abdominal fat were also not independent of total body fat or BMI. No ethnic group differences in visceral abdominal fat were noted. Insulin level and HOMA IR were associated with leptin level (independent of fat mass) and fat mass. Leptin level was associated with fat mass, total CT fat, and subcutaneous CT fat; however the associations between the CT fat measures and leptin were not independent of total body fat mass. CONCLUSIONS: Neither visceral abdominal fat, subcutaneous abdominal fat, insulin levels, or insulin resistance differed by ethnic group when adjusted for age or pubertal status. This contrasts with findings in adults and non-obese children which suggest lower levels of visceral fat and higher insulin levels and insulin resistance in African American children and adolescents.

Adolescent↗
PubMed2003

Acupuncture for the treatment of obesity: a review of the evidence.

Although acupuncture is being utilized to treat a variety of important health problems, its usefulness in obesity management has not yet been fully evaluated. The aim of this review paper was to survey and critically evaluate the descriptive and controlled trials of acupuncture for enhancing weight loss. The underlying principles of acupoint stimulation are described, with an emphasis on auricular (ear) acupuncture, the method most often chosen for obesity studies. The difficulties of selecting suitable placebo controls are highlighted. To date, most trials have been descriptive in nature, of short duration (< or = 12 weeks), and designed using nonstandard treatment protocols. Despite the unique challenges involved, further careful study of acupuncture's potential usefulness as an adjunct in weight management is recommended. An agenda for future research in this area is provided.

Acupuncture Therapy↗
PubMed2000

Diet quality of young children who received nutrition education promoting lower dietary fat.

OBJECTIVE: : To evaluate the impact of nutrition education promoting lower dietary fat on the overall diet quality in children using a multidimensional index that measures nutrient and food intakes in relation to US dietary recommendations. DESIGN: : Prospective cohort study with two intervention and two control groups. Children with elevated low density lipoprotein (LDL) cholesterol were randomized to one of two intervention groups or an at-risk control group. The intervention children received either the parent-child autotutorial (PCAT) programme, a 10-week home-based self-instruction nutrition education programme, or nutrition counselling from a registered dietitian. Children with non-elevated plasma cholesterol formed the not-at-risk control group. Dietary and blood data were collected at baseline and at 3 months. SETTING: : Paediatric practices in suburbs north of Philadelphia, PA. SUBJECTS: : Two hundred and twenty-seven 4-10-year-old children with elevated LDL cholesterol between the 80th and 98th percentiles, and 76 age- and gender-matched children with non-elevated plasma cholesterol, were studied. RESULTS: : Children who received PCAT or counselling significantly improved their overall diet quality (-0.6 and -0.4 change in diet quality index (DQI) scores) compared with at-risk control children. Children who received either form of nutrition education were more likely to meet the recommendations for three components of the DQI (total fat, saturated fat, sodium) (OR >1.7), but did not improve their intakes of three components of the DQI (vegetables and fruits, complex carbohydrates, calcium) at 3 months. CONCLUSIONS: : Nutrition education promoting lower dietary fat improved children's overall diet quality. However, several dietary behaviours important for long-term health remained unchanged.

Analysis of Variance↗
PubMed2000

Resting energy expenditure and prediction equations in young children with failure to thrive.

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.

Body Height↗
PubMed2000

Early risk factors for increased adiposity: a cohort study of African American subjects followed from birth to young adulthood.

BACKGROUND: Obesity is an increasing concern in the United States. Effective prevention of obesity requires the risk factors to be well defined. African Americans have a high risk of obesity. OBJECTIVE: The objective of this study was to identify risk factors, present at birth, for increased adiposity in adulthood in an African American population. DESIGN: In this retrospective analysis of a prospective cohort study, anthropometric and socioeconomic variables were collected at birth. A representative sample of 447 African American subjects was followed up until young adulthood, when skinfold thickness was measured. Associations between the independent variables and increased adiposity (skinfold thickness above the 85th percentile) were explored by using unadjusted and adjusted analyses. RESULTS: Three variables measured at birth were independently associated with adiposity in young adulthood, explaining 12% of the variance. The odds ratios (with 95% CIs) of these variables for increased adiposity were 2.7 (1.2, 6.2) for female sex, 4.0 (1.4, 11. 2) for first-born status, and 1.15 (1.06, 1.25) for each unit increment in maternal prepregnancy body mass index (BMI; in kg/m(2)). After adjustment for these variables, birth weight for gestational age and socioeconomic variables were not associated with adiposity. CONCLUSIONS: This cohort study of African American subjects was the first to identify first-born status as an independent risk factor for increased adiposity in adulthood in a US population. The results of the study strengthen previous reports of the effect of female sex and maternal BMI on adulthood obesity. Identification of risk factors early in life may help target prevention toward high-risk children and allow healthy lifestyles to be established before the onset of obesity.

Adolescent↗
PubMed1999

Insurance reimbursement for the treatment of obesity in 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."

Black or African American↗
PubMed1999

Nutrition interventions in childhood for the prevention of chronic diseases in adulthood.

As it becomes increasingly evident that the seeds of many adult disorders are planted in childhood, it is important that pediatric care providers 1) recognize risk factors for adult disease in children and 2) institute effective interventions. Many adult medical conditions are significantly related to or influenced by nutritional factors. This review evaluates three areas in preventive and therapeutic pediatric nutrition: obesity, lipid disorders, and osteoporosis.

Child↗
PubMed1998

Psychosocial factors in nutrition education for hypercholesterolemic children.

The goals were to assess psychosocial effects of labeling children as hypercholesterolemic and to measure changes in child well-being as a function of participation in nutrition education interventions. Older (6-10 years old) and younger (4-6 years old) children with (> 4.55 mmol/l; > 176 mg/dL) and without elevated total cholesterol levels were identified by cholesterol screening. Psychosocial functioning (self-esteem, perceived dietary competence, health beliefs, parental control of eating) was assessed and at-risk children were randomized into a home-based, self-contained nutrition education program (the Parent-Child Autotutorial, or PCAT program), dietary counseling with a registered dietician, or an at-risk control group. At three, six, and twelve months following baseline, children's psychosocial functioning again was assessed; parents also provided data at baseline, three months, and twelve months. Analyses of data from 189 at-risk and 74 not-at-risk children revealed that: (a) Older hypercholesterolemic children reported poorer health beliefs than non-labeled children; (b) Older girls in nutrition education programs reported lower self-esteem than control group girls; (c) Older children's feelings of efficacy at choosing a healthful diet were positively related to their health beliefs and self-esteem; (d) Younger children's reports of parents' dietary control were negatively related to children's feelings of acceptance; and (e) Parents of older children in the PCAT program reported increases over time in children's ability to choose a healthful diet. The quasi-experimental design means that conclusions about negative labeling effects should be drawn cautiously, but the evidence suggests that education interventions can have an impact on child efficacy and potentially child adjustment. Factors associated with adverse reactions to labeling (parental control or feelings of efficacy) should be taken into account in the development of intervention programs for children.

Adolescent↗
PubMed1998

Age-related changes in cardiovascular disease risk factors of hypercholesterolemic children.

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.

Adipose Tissue↗
PubMed1998

Long-term growth and development in children after home parental nutrition.

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.

Anthropometry↗
PubMed1998

Growth of hypercholesterolemic children completing physician-initiated low-fat dietary intervention.

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.

Body Height↗
PubMed1998

One-year follow-up of nutrition education for hypercholesterolemic children.

OBJECTIVES: This study evaluated retention of the effect of a home-based, practitioner-initiated nutrition education model. METHODS: Children with elevated low-density lipoprotein (LDL) cholesterol levels were randomly assigned to one of two nutrition interventions or to an at-risk control group. Intervention effects were evaluated 3, 6, and 12 months postbaseline. RESULTS: The parent-child autotutorial group demonstrated significant increases in knowledge and, along with the counseling group, decreases in total and saturated fat intake. Also, the autotutorial and counseling groups retained a majority of their initial LDL cholesterol decrease. CONCLUSIONS: Knowledge of heart-healthful eating and dietary fat intake as well as dietary change can be affected and retained via home-based, practitioner-initiated nutrition interventions with hypercholesterolemic children, although some form of ongoing intervention may be necessary to produce lasting decreases in LDL cholesterol levels.

Adult↗
PubMed1998

Intravenous amino acids, cholestasis and kwashiorkor.

Kwashiorkor dermatosis has not been reported in children on parenteral nutrition (PN). We report a case of kwashiorkor developing in a partially PN dependent patient with cholestasis, when amino acids were removed from the PN solution in an effort to control the cholestasis. Although the kwashiorkor dermatosis improved within 24 hours after the addition of amino acids (1 g/kg) to the PN solution, the cholestasis worsened.

Amino Acids↗
PubMed1997

Effects of family history of heart disease, apolipoprotein E phenotype, and lipoprotein(a) on the response of children's plasma lipids to change in dietary lipids.

We examined the effects of family history of coronary artery disease (CAD), apolipoprotein E (apo E) phenotype, and lipoprotein(a) [Lp(a)] on the response of plasma lipids to change in dietary lipid intake after 3 mo of nutrition education in 125 children aged 4-10 y. The subjects were healthy children with elevated low-density-lipoprotein (LDL)-cholesterol concentrations who participated in the Children's Health Project, a nutrition-education program designed to lower plasma cholesterol by means of dietary modifications in accordance with recommendations of the National Cholesterol Education Program. Dietary and plasma lipids were measured by three 24-h recalls and assessments of two fasting plasma samples collected before and 3 mo after the start of intervention. Family history of CAD was determined by questionnaires administered to parents at baseline. Apo E phenotyping was done with isoelectric focusing followed by immunostaining; Lp(a) was measured with two-site immunoradiometric assays of frozen aliquots of plasma samples collected at baseline and 3 mo. After adjustment for intervention group, age, sex, and body mass index, analysis of covariance showed that baseline plasma lipid concentrations were the strongest independent predictors of change in plasma lipids after 3 mo. Plasma total and LDL-cholesterol concentrations in children with less family history of CAD were significantly more responsive to change in dietary cholesterol than concentrations in children with a stronger family history of CAD. Neither apo E phenotype nor Lp(a) significantly influenced change in plasma lipids independently or interactively with change in dietary lipids.

Apolipoproteins E↗
PubMed1997

The effect of changes in dietary fat on the food group and nutrient intake of 4- to 10-year-old children.

OBJECTIVE: To determine how young children changed their overall diet when they changed their fat intake after 3 months of participating in a nutrition education demonstration study designed to lower low-density lipoprotein cholesterol and cardiovascular risk. METHODS: Three 24-hour dietary recalls were collected from 303 4- to 10-year-old children at baseline and 3 months later. At both times, mean number of servings from food groups, grams of fat contributed from food groups, and intake of calories and nutrients were calculated and compared among quartiles of children formed according to change in their percent of calories from total fat after 3 months. RESULTS: Children who reduced their percent of calories from total fat most (ie, by an average of 8.5%) after 3 months consumed fewer servings from meats, eggs, dairy, fats/oils, and breads but tended to increase their number of servings from lower-fat foods within those food groups, particularly from dairy foods. These children also increased their mean intake of fruits, vegetables, and desserts, and maintained average intakes of all nutrients (except vitamin D) in excess of two thirds of the respective recommended dietary allowance. CONCLUSIONS: Young children who reduced their percent of calories from total fat in accordance with the current National Cholesterol Education Program recommendations accomplished this by reducing their overall intake of higher-fat foods, replacing higher-fat foods with lower-fat foods within several food groups, particularly within the dairy group (eg, drinking skim milk instead of whole milk) and by consuming more servings of fruits, vegetables, and very-low-fat desserts. These behaviors did not compromise their mean calorie or nutrient intakes, showing that it is possible for young children to lower their fat intake safely to reduce their risk of future heart disease.

Child↗