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Phoenix, AZ, United States

Kutner J.S.,Aurora University | Taylor D.H.,Duke University | Ritchie C.S.,San Francisco Veterans Affairs Medical Center | Ritchie C.S.,University of California at San Francisco | And 26 more authors.
JAMA Internal Medicine | Year: 2015

IMPORTANCE For patients with limited prognosis, some medication risks may outweigh the benefits, particularly when benefits take years to accrue; statins are one example. Data are lacking regarding the risks and benefits of discontinuing statin therapy for patients with limited life expectancy. OBJECTIVE To evaluate the safety, clinical, and cost impact of discontinuing statin medications for patients in the palliative care setting. DESIGN, SETTING, AND PARTICIPANTS Thiswas a multicenter, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease, recent deterioration in functional status, and no recent active cardiovascular disease. Participants were randomized to either discontinue or continue statin therapy and were monitored monthly for up to 1 year. The study was conducted from June 3, 2011, toMay 2, 2013. All analyses were performed using an intent-to-treat approach. INTERVENTIONS Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group. Patients in the continuation group continued to receive statins. MAIN OUTCOMES AND MEASURES Outcomes included death within 60 days (primary outcome), survival, cardiovascular events, performance status, quality of life (QOL), symptoms, number of nonstatin medications, and cost savings. RESULTS A total of 381 patients were enrolled; 189 of these were randomized to discontinue statins, and 192 were randomized to continue therapy. Mean (SD) age was 74.1 (11.6) years, 22.0% of the participants were cognitively impaired, and 48.8% had cancer. The proportion of participants in the discontinuation vs continuation groups who died within 60 days was not significantly different (23.8% vs 20.3%; 90%CI,-3.5%to 10.5%; P =.36) and did not meet the noninferiority end point. Total QOL was better for the group discontinuing statin therapy (mean McGill QOL score, 7.11 vs 6.85; P =.04). Few participants experienced cardiovascular events (13 in the discontinuation group vs 11 in the continuation group). Mean cost savings were $3.37 per day and $716 per patient. CONCLUSIONS AND RELEVANCE This pragmatic trial suggests that stopping statin medication therapy is safe and may be associated with benefits including improved QOL, use of fewer nonstatin medications, and a corresponding reduction in medication costs. Thoughtful patient-provider discussions regarding the uncertain benefit and potential decrement in QOL associated with statin continuation in this setting are warranted. © Copyright 2015 American Medical Association. All rights reserved. Source

Epstein D.R.,Phoenix Veterans Affairs Health Care System | Epstein D.R.,Arizona State University | Sidani S.,Ryerson University | Bootzin R.R.,University of Arizona | Belyea M.J.,Arizona State University
Sleep | Year: 2012

Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term= Behavioral+Intervention+for+Insomnia+in+Older+Adults&rank=1. Source

Keller C.,Arizona State University | Todd M.,Arizona State University | Ainsworth B.,Arizona State University | Records K.,Arizona State University | And 4 more authors.
Journal of Obesity | Year: 2013

Background. Weight gain during the childbearing years and failure to lose pregnancy weight after birth contribute to the development of obesity in Latinas. Design and Methods. Madres para la Salud (Mothers for Health) is a 12-month prospective, randomized controlled trial exploring a social support intervention with moderate-intensity physical activity to effect changes in body fat, systemic and fat tissue inflammation, and depression symptoms in sedentary postpartum Latinas. This paper describes the initial body composition of the sample, social support, and neighborhood contextual correlations of overweight and obese Latina mothers within the first 6 months after birth. Results. The mean body mass index was 29.68 with 38.56% bioelectrical impedence analysis for body fat. Elements of the environment (e.g., opportunities to walk) received middle or high scores. Access to healthy food was positively related to favorability of the walking environment. Waist-to-hip ratio was uncorrelated with other obesity-related indices. Conclusions. The body adiposity of these Latina mothers was coupled with low levels of social support from family and friends and neighborhood characteristics that were unfavorable to walking. © 2013 Colleen Keller et al. Source

Harman S.M.,Phoenix Veterans Affairs Health Care System
Fertility and Sterility | Year: 2014

Cardiovascular disease (CVD) is the most common cause of death in women. Before the Women's Health Initiative (WHI) hormone trials, evidence favored the concept that menopausal hormone treatment (MHT) protects against CVD. WHI studies failed to demonstrate CVD benefit, with worse net outcomes for MHT versus placebo in the population studied. We review evidence regarding the relationship between MHT and CVD with consideration of mechanisms and risk factors for atherogenesis and cardiac events, results of observational case-control and cohort studies, and outcomes of randomized trials. Estrogen effects on CVD risk factors favor delay or amelioration of atherosclerotic plaque development but may increase risk of acute events when at-risk plaque is present. Long-term observational studies have shown ∼40% reductions in risk of myocardial infarction and all-cause mortality. Analyses of data from randomized control trials other than the WHI show a ∼30% cardioprotective effect in recently menopausal women. Review of the literature as well as WHI data suggests that younger and/or more recently menopausal women may have a better risk-benefit ratio than older or remotely menopausal women and that CVD protection may only occur after >5 years; WHI women averaged 63 years of age (12 years postmenopausal) and few were studied for >6 years. Thus, a beneficial effect of long-term MHT on CVD and mortality is still an open question and is likely to remain controversial for the foreseeable future. © 2014 American Society for Reproductive Medicine, Published by Elsevier Inc. All rights reserved. Source

Bootzin R.R.,University of Arizona | Epstein D.R.,Phoenix Veterans Affairs Health Care System
Annual Review of Clinical Psychology | Year: 2011

Sleep disturbance is intricately entwined with our sense of well-being, health, emotion regulation, performance and productivity, memory and cognitive functioning, and social interaction. A longitudinal perspective underscores the conclusion that persistent sleep disturbance, insomnia, at any time during the life span from infancy to old age has a lasting impact. We examine how insomnia develops, the evidence for competing explanations for understanding insomnia, and the evidence about psychological and behavioral treatments that are used to reduce insomnia and change daytime consequences. There are new directions to expand access to treatment for those who have insomnia, and thus a critical analysis of pathways for dissemination is becoming increasingly important. Copyright © 2011 by Annual Reviews. All rights reserved. Source

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