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Effectiveness and tolerability of orlistat and liraglutide in patients with obesity in a real-world setting: The XENSOR Study.
Gorgojo-Martínez, JJ, Basagoiti-Carreño, B, Sanz-Velasco, A, Serrano-Moreno, C, Almodóvar-Ruiz, F
International journal of clinical practice. 2019;(11):e13399
Abstract
AIMS: To evaluate in a real-world setting the effectiveness of two drugs, orlistat and liraglutide, in patients with overweight or obesity and insufficient weight loss (WL) after a lifestyle modification programme. METHODS Retrospective, observational cohort study comparing clinical outcomes of orlistat 120 mg three times a day and liraglutide (up to 3 mg daily) in adult patients with BMI ≥30 kg/m2 or ≥27 kg/m2 with at least a weight-related comorbidity who had failed to lose at least 5% of their weight after 6 months of lifestyle modification. The co-primary end-points, assessed at 3-6 months and at the end of the follow-up, were weight change from baseline, proportion of patients who lost at least 5% of their baseline weight and adjusted differences in WL between both drugs. RESULTS Five hundred patients, 400 in the group of orlistat (age 47.0, weight 107.8 kg) and 100 in the group of liraglutide (age 51.9 years, weight 105.1 kg), were included. Treatment with both drugs significantly reduced weight, fasting plasma glucose, systolic BP, low-density lipoprotein-cholesterol and alanine transaminase over a median follow-up period of 7 months. WL with liraglutide (-7.7 kg) was significantly greater than that observed with orlistat (-3.3 kg), and more individuals lost at least 5% of their baseline weight with liraglutide (64.7%) than with orlistat (27.4%). Rates of prediabetes significantly decreased with liraglutide in comparison to orlistat. CONCLUSIONS In this real-world study, liraglutide showed a greater effectiveness in WL compared with orlistat and improved several obesity-associated metabolic and cardiovascular risk factors.
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Efficacy and Safety of Lipase Inhibitor Orlistat in Japanese with Excessive Visceral Fat Accumulation: 24-Week, Double-Blind, Randomized, Placebo-Controlled Study.
Shirai, K, Fujita, T, Tanaka, M, Fujii, Y, Shimomasuda, M, Sakai, S, Samukawa, Y
Advances in therapy. 2019;(1):86-100
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Abstract
INTRODUCTION Orlistat is an inhibitor of pancreatic lipase and is used as an anti-obesity drug in many countries. However, there are no data available regarding the effects of orlistat on visceral fat accumulation in Japanese subjects. Therefore, this comparative, placebo-controlled, double-blind, randomized study aimed to evaluate the efficacy and safety of orlistat in Japanese participants with excessive visceral fat accumulation and without dyslipidemia, diabetes mellitus, and hypertension ("metabolic diseases"). METHODS The study population included Japanese participants with excessive visceral fat accumulation (waist circumference ≥ 85 cm in males and ≥ 90 cm in females, which corresponds to a visceral fat area of 100 cm2) and without metabolic diseases. Following a 12-week observation term, participants were randomized to the orlistat 60 mg group (n = 100) or placebo group (n = 100). Both drugs were administered orally three times daily for 24 weeks. Participants were also counseled to improve their diet and to maintain exercise throughout the study. Visceral fat area, subcutaneous fat area, waist circumference, body weight, body mass index, adverse reactions, laboratory tests, and blood pressure were regularly assessed. RESULTS Visceral fat area, waist circumference, and body weight were significantly reduced in the orlistat group (mean ± standard error, - 13.50 ± 1.52%, - 2.51 ± 0.25%, and - 2.79 ± 0.30%, respectively) compared to the placebo group (- 5.45 ± 1.50%, - 1.55 ± 0.26%, and - 1.22 ± 0.28%, respectively) at the last assessment. The main adverse reactions were defecation-related symptoms including oily spotting and flatus with discharge, resulting from the pharmacological effects of orlistat. Most adverse reactions were mild, and none were serious or severe. CONCLUSION Orlistat administration reduced visceral fat area, waist circumference, and body weight in Japanese participants with excessive visceral fat and without metabolic diseases. In addition, safety was confirmed with a tolerable profile. Orlistat may be useful to reduce excessive visceral fat accumulation when used in combination with diet and exercise. TRIAL REGISTRATION Japan Pharmaceutical Information Center identifier, JapicCTI-184005. FUNDING Taisho Pharmaceutical Co., Ltd.
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Early Weight Loss in Behavioral Treatment Predicts Later Rate of Weight Loss and Response to Pharmacotherapy.
Tronieri, JS, Wadden, TA, Chao, AM, Pearl, RL, Alamuddin, N, Berkowitz, RI
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2019;(3):290-295
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BACKGROUND Early weight loss (EWL) in the first 1-2 months of behavioral treatment is a strong predictor of later total weight loss. It is not clear whether participants with lower early losses lose less in ongoing treatment or simply fail to overcome the smaller initial loss. Furthermore, no study has tested whether EWL in behavioral treatment predicts response to a different treatment modality, such as pharmacotherapy. METHODS Data were from 170 participants with obesity (baseline BMI = 40.8 ± 5.8 kg/m2, 87.6% female; 71.3% Black) enrolled in a two-phase trial. Data from the weight loss phase, which provided weekly lifestyle counseling and a meal replacement diet, were used to examine the relationship between 4-week EWL and subsequent rate of weight loss in behavioral treatment. Data from the maintenance phase, in which 137 participants who had lost ≥5% of initial weight were randomized to 52 weeks of maintenance counseling with lorcaserin or placebo, were used to determine whether EWL with behavioral treatment affects the benefit of pharmacotherapy. RESULTS EWL in the first 4 weeks of behavioral treatment (3.6 ± 1.7%) predicted greater total losses at Week 14 (r2 = 0.61, p < .001) and a faster rate of weight loss in the subsequent 9 weeks of the program (p < .001). During the maintenance phase, lower EWL in behavioral treatment predicted a greater benefit of lorcaserin, in comparison with placebo, for the maintenance of a ≥5% loss at Weeks 24 and 52. CONCLUSIONS These findings support recommendations to modify treatment for individuals with low EWL.
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Recent trends in anti-obesity and anti-inflammatory studies in modern health care.
Na, EJ, Kim, DJ, Kim, JH, Kim, GR
Technology and health care : official journal of the European Society for Engineering and Medicine. 2019;(5):519-530
Abstract
BACKGROUND This study was planned to investigate the research trends related to naturally derived anti-inflammatory and anti-obesity components. The main purpose of this study was to find out and develop natural health cosmetic ingredients which has high effects on lipid degradation, moisturizing and elasticity enhancement. OBJECTIVE We all hope this research provided systematic and practical data that can suggest an opportunity to further develop new products. METHODS This is a descriptive research which classified the natural and traditional components that have important obesity management effects based on the experimental technique (in vitro and in vivo). we investigated the effects of 13 natural raw materials selected through preliminary investigation on lipid metabolism related enzyme activity. We first introduced Ainsliaea acerifolea, Onion, pear, Sanguisorba, Limonium tetragonum, Cornus walteri, Loquat, and Loquat-which have recently been shown to be effective in anti-obesity tests, and then described the research methods by showing the effects of onion extracts, Glasswort, Pine Cone (Korean white pine), Orostachys japonicus, African mangoes, Pepper, and Clathratum (sea weed), which actually had effects on anti-obesity in the in vivo experiment. RESULTS As a result of investigating the effect of 13 natural raw materials selected through a preliminary investigation on lipid metabolism related enzyme activity, the study found nature-derived ingredients which induce anti-inflammatory and enhance the anti-obesity enzyme activity, and ingredients showing myriads of biological activities such as anti-oxidant, body fat reduction, lowering of blood cholesterol, and weight control. CONCLUSION In this paper, we would like to delve into the possibility of using natural components with natural lipid-lowering effect, and systematically and practically study if they can actually be helpful to develop new cosmetic products.
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Neuroprotective and Anti-Obesity Effects of Tocotrienols.
Fukui, K
Journal of nutritional science and vitaminology. 2019;(Supplement):S185-S187
Abstract
Vitamin E is a natural lipophilic vitamin, and the most famous function of vitamin E is an antioxidant activity. Because we have α-tocopherol transfer protein, many vitamin E-related reports are about α-tocopherol. Recently, other vitamin E isoforms, tocotrienols are focusing. Because tocotrienols have unique biological functions such as induction of apoptosis, neuroprotective and anti-obesity effects. Tocotrienols contain in annatto, palm, whole wheat and rice bran. Rice is a typical food in the East Asian countries and Japan. Recently, intake of whole rice is a popular in young women of Japan. Previously, we demonstrated that treatment with tocotrienols on the neuronal cells shows a strong antioxidant effect compared to the tocopherols. In this review, I introduce about neuroprotective and anti-obesity effects of tocotrienols. I would like to show daily intake of whole rice is very good for our health in this review.
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Precision Medicine in Weight Loss and Healthy Living.
Severin, R, Sabbahi, A, Mahmoud, AM, Arena, R, Phillips, SA
Progress in cardiovascular diseases. 2019;(1):15-20
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Obesity affects 600 million people globally and over one third of the American population. Along with associated comorbidities, including cardiovascular disease, stroke, diabetes, and cancer; the direct and indirect costs of managing obesity are 21% of the total medical costs. These factors shed light on why developing effective and pragmatic strategies to reduce body weight in obese individuals is a major public health concern. An estimated 60-70% of obese Americans attempt to lose weight each year, with only a small minority able to achieve and maintain long term weight loss. To address this issue a precision medicine approach for weight loss has been considered, which places an emphasis on sustainability and real-world application to individualized therapy. In this article we review weight loss interventions in the context of precision medicine and discuss the role of genetic and epigenetic factors, pharmacological interventions, lifestyle interventions, and bariatric surgery on weight loss.
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Current Options for the Pharmacotherapy of Obesity.
Gouni-Berthold, I, Berthold, HK
Current pharmaceutical design. 2019;(18):2019-2032
Abstract
650 millions of adults are obese worldwide - in the US alone, forty percent of the adults are obese. Although the obesity pandemic is constantly expanding at very high costs for health care systems, the currently available options of pharmacotherapy for obesity are rather limited. Despite intensive research efforts, the vast majority of the anti-obesity drugs developed up to now have a rather limited efficacy and/or safety profile. In the last fifty years, various drugs reached advanced states of clinical development but were either never marketed or were initially approved but withdrawn later due to safety issues. However, the understanding of the pathophysiology of obesity has been steadily improving and new, promising drugs targeting various selective obesityassociated and energy-homeostasis-related pathways are now available. When lifestyle changes alone fail to combat, then additional pharmacotherapy with an acceptable efficacy and safety profile could provide a useful therapeutic option.
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Incorporating Weight Loss Medications Into Hepatology Practice for Nonalcoholic Steatohepatitis.
Do, A, Kuszewski, EJ, Langberg, KA, Mehal, WZ
Hepatology (Baltimore, Md.). 2019;(4):1443-1456
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There is an urgent need for practical approaches to patients with nonalcoholic steatohepatitis (NASH). Total body weight loss (TBWL) is an important approach, as its effects are amplified in the liver, with 10% TBWL resulting in a 50% loss of liver triglycerides and improvement in all aspects of NASH histology. Lifestyle changes are the first step in addressing TBWL, but uncommonly result in the range required to improve liver histology in NASH (7%-10%). Weight loss medications (WLMs) are an effective additional tool because they can provide TBWL in the 7%-10% range, have a well-characterized clinical profile, have clear guidelines, and meet approved criteria for their use (body mass index greater than 27 kg/m2 ) for most NASH patients. Use of WLMs requires shared decision making with the patient, which hepatologists, due to their understanding of the natural history of NASH, are uniquely positioned to provide. WLMs do present the challenge of incorporating new medications into the hepatology clinic, but this will be necessary with all medications to manage NASH. WLMs provide a practical intervention that can be incorporated into hepatology clinics and can be offered to most NASH patients. NASH-specific medicines in clinical trials offer partial histological responses, and TBWL will likely enhance this. Conclusion: WLMs provide the hepatologist with effective and welcome clinical intervention beyond the diagnosis and staging of NASH and provide patients with a sense of empowerment about the treatment of their liver disease.
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Changes in health-related quality of life with intensive behavioural therapy combined with liraglutide 3.0 mg per day.
Chao, AM, Wadden, TA, Walsh, OA, Gruber, KA, Alamuddin, N, Berkowitz, RI, Tronieri, JS
Clinical obesity. 2019;(6):e12340
Abstract
This study examined the effects of intensive behavioural therapy (IBT) for obesity (IBT-alone), IBT plus liraglutide 3.0 mg/day (IBT-liraglutide), and IBT-liraglutide combined with 12 weeks of a portion-controlled diet (Multicomponent) on changes in general health-related (HR) quality of life (QoL) and weight-related QoL. Adults with obesity (79.3% female; 54.0% white; 44.7% black; mean age = 47.6 ± 11.8 years and body mass index = 38.4 ± 4.9 kg/m2 ) were randomized to IBT-alone (n = 50), IBT-liraglutide (n = 50) or Multicomponent (n = 50). General HRQoL was measured with the Short Form-36 (SF-36), and weight-related QoL was assessed with the Impact of Weight on Quality of Life-Lite scale. At week 52, participants in the three groups lost 6.1 ± 1.3%, 11.5 ± 1.3% and 11.8 ± 1.3% of initial body weight, respectively. Both liraglutide-treated groups were significantly more likely than IBT-alone to achieve clinically meaningful improvements in total weight-related QoL. They also both achieved greater improvements than IBT-alone in weight-related public distress and in general mental health, as measured by the SF-36 mental component summary score. Independent of treatment group, greater categorical weight loss was associated with greater improvements in several domains of both general and weight-related QoL. The addition of liraglutide to IBT appeared to improve aspects of both general HRQoL and weight-related QoL.
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Mendelian obesity, molecular pathways and pharmacological therapies: a review.
Paolacci, S, Borrelli, A, Stuppia, L, Campanile, FC, Dallavilla, T, Krajčovič, J, Veselenyiova, D, Beccari, T, Unfer, V, Bertelli, M, et al
European review for medical and pharmacological sciences. 2019;(3):1357-1378
Abstract
OBJECTIVE In this qualitative review we analyze the major pathways and mechanisms involved in the onset of genetically-determined obesity (Mendelian obesity), identifying possible pharmacological treatments and trials. MATERIALS AND METHODS We searched PubMed with the keywords (obesity[Title/Abstract]) AND mutation[Title/Abstract], and OMIM with the keyword "obesity". In both cases, we selected non-syndromic Mendelian obesity. We then searched ClinicalTrials.gov with the following criteria: "recruitment status: active, not recruiting and completed"; "study type: interventional (clinical trial)"; "study results: with results"; type of intervention: "drug or dietary supplement". RESULTS From the PubMed and OMIM searches we obtained a total of 15 genes associated with monogenic Mendelian obesity. From ClinicalTrials.gov we retrieved 46 completed or active trials of pharmacological treatments. CONCLUSIONS We summarized the molecular bases of Mendelian obesity and searched for any clinical trials completed or underway for the treatment of severe forms of obesity. Most Mendelian obesities are linked to dysfunctions in the leptin/melanocortin signaling pathway, and most of the possible drugs target this pathway in order to improve energy expenditure and reduce food intake.