Optimal Lipid Modification: the Rationale for Combination Therapy

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Optimal Lipid Modification: The Rationale for Combination Therapy

James M Backes1, Cheryl A Gibson2, Patricia A Howard31Department of Pharmacy Practice, Lipid, Atherosclerosis, Metabolic and LDL Apheresis Center, University of Kansas Medical Center, Kansas City, KS, USA; 2Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA; 3Department of Pharmacy Practice, University of Kansas School of Pharmacy, Kansas City, KS, USABackground: An emphasis on more aggressive lipid-lowering, particularly of low-density lipoprotein cholesterol, to improve patient outcomes has led to an increased use of combination lipid-lowering drugs. This strategy, while potentially beneficial, has triggered concerns regarding fears of adverse effects, harmful drug interactions, and patient nonadherence.Objective: To present key data regarding combination lipid-altering therapy including use, rationale, major trials, benefits, potential adverse effects, compliance issues, and limitations. Method: Literature was obtained from MEDLINE (1966 – June 2005) and references from selected articles.Results: A substantial body of evidence from epidemiological data and clinical trials indicates that aggressive lipid modification, especially low-density lipoprotein reduction, is associated with reduced cardiovascular events. Numerous studies utilizing various combinations of cholesterol-lowering agents including statin/fibrate, statin/niacin, statin/bile acid resin, and statin/ezetimibe have demonstrated significant changes in the lipid profile with acceptable safety. Long-term trials of combination therapy evaluating clinical outcomes or surrogate markers of cardiovascular disease, while limited, are promising.Conclusion: Combining lipid-altering agents results in additional improvements in lipoproteins and has the potential to further reduce cardiovascular events beyond that of monotherapy.Keywords: combination therapy, coronary heart disease, hypercholesterolemia, lipid-lowering, low-density lipoprotein, statin

Feasibility and acceptability of a televideo physical activity and nutrition program for recent kidney transplant recipients

This work is licensed under a Creative Commons Attribution 4.0 International License.Background Post-transplant weight gain affects 50–90% of kidney transplant recipients adversely affecting survival, quality of life, and risk for diabetes and cardiovascular disease. Diet modification and physical activity may help prevent post-transplant weight gain. Methods for effective implementation of these lifestyle modifications are needed. The objective of this study is to assess the feasibility and acceptability of a remotely delivered nutrition and physical activity intervention among kidney transplant recipients. Secondary aims were to estimate the effectiveness of the intervention in producing changes in physical activity, qualify of life, fruit and vegetable intake, and consumption of whole grains and water from baseline to 6 months. Methods A randomized controlled study for stable kidney transplant recipients between 6 and 12 months post-transplantation was conducted. Participants were randomly assigned 1:1 to a technology-based, lifestyle modification program (intervention) or to enhanced usual care (control). Results The first 10 kidney transplant recipients screened were eligible and randomized into the intervention and control groups with no significant between-group differences at baseline. Health coaching attendance (78%) and adherence to reporting healthy behaviors (86%) were high. All participants returned for final assessments. The weight in controls remained stable, while the intervention arm showed weight gain at 3 and 6 months. Improvements were found for physical activity, quality of life, and fruit and vegetable intake in both groups. All participants would recommend the program to other transplant recipients. Conclusions Our data suggest that a remotely delivered televideo nutrition and physical activity intervention is feasible and valued by patients. These findings will aid in the development of a larger, more prescriptive, randomized trial to address weight gain prevention

The Effects of Physical Activity on Learning Behaviors in Elementary School Children: A Randomized Controlled Trial

This work is licensed under a Creative Commons Attribution 4.0 International License.Research in education and developmental psychology indicates that behavioral engagement in learning is a critical predictor of children’s academic success. In an effort to improve academic achievement, school administrators are continually in search of methods to increase behavioral engagement. Previous research has indicated that classroom-based physical activity (PA) lessons have a positive impact on academic achievement. However, little research has been done in assessing the impact of such interventions on the behavioral engagement of students with learning behavior difficulties. This study assesses the impact of classroom-based PA on teacher-rated classroom behaviors of students with identified learning behavior difficulties. Two schools (one intervention, one control) participating in a larger, cluster-randomized trial provided scores on a teacher-administered classroom behavior scale. This scale was used to collect information on 15 characteristics identified as being essential to behavioral engagement. Participants included male and female students in second and third grade classrooms who were identified by their classroom teacher and school counselor as having difficulties with learning behaviors. Mixed linear modeling for repeated measures was used to examine the changes over time in the classroom behavior scores. The intervention group showed significant improvement over time in classroom behavior while the control group showed no change or a slight degradation over time (i.e., group × time interaction, F[2132] = 4.52, p = 0.01). Schools must meet the diverse needs of students today, including those who exhibit less than optimal learning behaviors. Combined with the evidence that PA is linked to several health and cognitive-behavior benefits, providing classroom-based PA that is incorporated within the curriculum provides common ground for all students to participate. It is a potential solution to increasing behavioral engagement, and in turn stimulating and enhancing learning

A Chronic Care Model Program Incorporating Group Office Visits for Obesity Treatment in Primary Care

Background. Obesity is a chronic disease of epidemic proportions. Primary care providers are on the front line of diagnosing and treating obesity and need better tools to deliver top-notch obesity care. Methods. A pilot randomized trial was conducted to test a chronic care model (CCM) program for obesity compared to usual care. Primary care patients, 18 years and older, with a body mass index (BMI) between 27 and 45 were enrolled. Sixteen weekly 90-minute group office visits were structured with the first 30 minutes encompassing individualized clinical assessments and the final 60 minutes containing the group-based standardized intensive lifestyle training. The primary outcome was weight change at 16 weeks. Secondary outcomes were weight change at 24 weeks, change in diet and physical activity behaviors, self-efficacy for weight control behaviors, and physiologic markers of cardiovascular risk at 16 and 24 weeks. Results. The participants (19 in the active arm and 10 in the control arm) were 49.8 ± 11.5 years old (mean ± SD), 97% women, 55% white, and 41% black. Weight change in the control arm at week 16 was 0.25+ 2.21 kg (mean + SD) and that for the active arm was -5.74 + 4.50 kg (n=16). The difference between the two arms was significant (p = 0.0002). Both the intent-to-treat analysis using the last observation carried forward approach and the analysis including completers only provided similar siginificant results. Conclusions. This study demonstrated that a CCM program incorporating group office visits was feasible and effective for obesity treatment in primary care settings

A Randomized, Controlled, Supervised, Excerise Trial in Young Overweight Men and Women: The Midwest Exercise Trial II (MET2)

We evaluated weight loss response to 16 months of supervised exercise (45 minutes/d, 5 d/wk, 75% heart-rate-reserve) in sedentary, overweight/obese participants without energy restriction in the Midwest Exercise Trial (MET1). Results indicated men lost weight, women did not. The gender differences were associated with differences in the energy expenditure of exercise (EEEx) (men = 667 ± 116; women = 439 ± 88 kcal/session) when exercise was prescribed by frequency, intensity and duration. MET2 is a randomized control trial designed and powered to examine differences in weight loss and gender in response to EEEx for men and women of 400 or 600 kcal/session, 5d/wk, for 10 months without energy restriction. One hundred forty one participants will be randomized to 1 of 2 exercise groups or a non-exercise control. EEEx will be verified by indirect calorimetry monthly during the intervention. This study will evaluate: (1) the weight change response to two levels of EEEx versus non-exercise control; (2) gender differences in weight response to two levels of EEEx; (3) potential compensatory changes in energy intake and/or daily physical activity that may explain the observed weight changes. Results from this study may impact how exercise is prescribed for weight loss and prevention of weight regain and may clarify if men and women differ in response to exercise

Effects of Growth Hormone Treatment in Adults with Prader-Willi Syndrome

OBJECTIVE: Since limited data exist on adults with Prader-Willi syndrome (PWS) and growth hormone (GH) treatment, we report our experience on the effects of treatment for one year on body composition, physical activity, strength and energy expenditure, diet, general chemistry and endocrine data with quality of life measures. DESIGN: We studied 11 adults with PWS (6F:5M; average age = 32 yrs) over a 2 year period with GH treatment during the first year only. Electrolytes, IGF-I, glucose, thyroid, insulin, lipids, body composition, physical activity and strength, diet, energy expenditure and quality of life data were collected and analyzed statistically using linear modeling at baseline, at 12 months following GH therapy and at 24 months after treatment cessation for 12 months. RESULTS: Total lean muscle mass was significantly increased (p < 0.05) during GH treatment along with moderate-vigorous physical activity and plasma IGF-I and HDL levels, but returned to near baseline after treatment. Percent body fat decreased during the 12 months of GH treatment but increased after treatment. CONCLUSIONS: Previously reported beneficial effects of GH treatment in children with PWS were found in our adults regarding body composition, physical activity and plasma HDL and IGF-I levels. Several beneficial effects diminished to near baseline after cessation of GH treatment for 12 months supporting the continuation of treatment in PWS into adulthood and possibly adults not previously treated during childhood

Development of NASA's Small Fission Power System for Science and Human Exploration

Exploration of our solar system has brought many exciting challenges to our nations scientific and engineering community over the past several decades. As we expand our visions to explore new, more challenging destinations, we must also expand our technology base to support these new missions. NASAs Space Technology Mission Directorate is tasked with developing these technologies for future mission infusion and continues to seek answers to many existing technology gaps. One such technology gap is related to compact power systems (1 kWe) that provide abundant power for several years where solar energy is unavailable or inadequate. Below 1 kWe, Radioisotope Power Systems have been the workhorse for NASA and will continue to be used for lower power applications similar to the successful missions of Voyager, Ulysses, New Horizons, Cassini, and Curiosity. Above 1 kWe, fission power systems become an attractive technology offering a scalable modular design of the reactor, shield, power conversion, and heat transport subsystems. Near term emphasis has been placed in the 1-10kWe range that lies outside realistic radioisotope power levels and fills a promising technology gap capable of enabling both science and human exploration missions. History has shown that development of space reactors is technically, politically, and financially challenging and requires a new approach to their design and development. A small team of NASA and DOE experts are providing a solution to these enabling FPS technologies starting with the lowest power and most cost effective reactor series named Kilopower that is scalable from approximately 1-10 kWe

A televideo exercise and nutrition program for children with acute lymphoblastic leukemia in maintenance therapy: design and methods

Changes in nutrient intake and decreased exercise resulting from cancer therapies as well as their side effects may be contributing factors in the increased body weight and differences in physical fitness observed in survivors of childhood acute lymphoblastic leukemia (ALL). This article will describe the study protocol for an intervention program designed to improve the physical activity and nutrition behaviors of ALL survivors. Twenty-four children aged between 4 years and 12 years with ALL will be randomized to a 6-month technology-based exercise and nutrition program (TLC4ALLKids) or to enhanced usual care (eUC). The participants randomized to the TLC4ALLKids will participate in weekly, 1-hour coaching sessions on nutrition and physical activity and 1-hour physical activity classes delivered by group video conferencing. Participants will be provided with iPad tablets loaded with video conferencing software and the Healthy Lifestyle Tracking calendar to track daily nutrition and physical activity goals and weight. Both groups will be provided with Fitbit™ Zip to monitor physical activity. To assess feasibility, participant recruitment (achievement of proposed sample size), attendance (per weekly online sessions/assessment sessions), and adherence (number of families at 3 and 6 months) will be evaluated. Outcome measures to assess the intervention will include anthropometrics (weight, height, and waist circumference), physical activity (accelerometry), energy and macronutrient intake (food records), sleep habits (Children's Sleep Habits Questionnaire), and quality of life (Pediatric Quality of Life Inventory) will be obtained at baseline, 3 months, and 6 months. Semi-structured interviews will be used to gather information about ways to improve the program and overcome barriers to participation. If successful, the TLC4ALLKids intervention will provide a means to educate and improve the health behaviors of ALL survivors that can be delivered remotely and conveniently to participants

Weight management by phone conference call: A comparision with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial

State-of-the-art treatment for weight management consists of a behavioral intervention to facilitate decreased energy intake and increased physical activity. These interventions are typically delivered face-to-face (FTF) by a health educator to a small group of participants. There are numerous barriers to participation in FTF clinics including availability, scheduling, the expense and time required to travel to the clinic site, and possible need for dependent care. Weight management clinics delivered by conference call have the potential to diminish or eliminate these barriers. The conference call approach may also reduce burden on providers, who could conduct clinic groups from almost any location without the expenses associated with maintaining FTF clinic space. A randomized trial will be conducted in 395 overweight/obese adults (BMI 25–39.9 kg/m2) to determine if weight loss (6 months) and weight maintenance (12 months) are equivalent between weight management interventions utilizing behavioral strategies and pre-packaged meals delivered by either a conference call or the traditional FTF approach. The primary outcome, body weight, will be assessed at baseline, 6, 12 and 18 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity and will be assessed on the same schedule. In addition, a cost analysis and extensive process evaluation will be completed