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1.
Dietary intake of glucono-δ-lactone attenuates skin inflammation and contributes to maintaining skin condition.
Kuwano, T, Kawano, S, Kagawa, D, Yasuda, Y, Inoue, Y, Murase, T
Food & function. 2018;(3):1524-1531
Abstract
Skin properties are influenced by both external (e.g., ultraviolet [UV], chemicals, and bacteria) and internal factors (e.g., nutrition and hormones). Therefore, some dietary supplements are expected to improve skin conditions. Glucono-δ-lactone (GDL) is widely used as a food additive and is naturally present in wine, honey, and other foods. The aim of this study was to assess whether GDL improves skin condition and inflammation. In a double-blind, placebo-controlled study, 40 healthy Japanese male volunteers were randomly assigned to either the GDL (2000 mg day-1) or placebo group. A significant difference was found in the rates of change in transepidermal water loss (TEWL) from the baseline to 6 months between the placebo and GDL groups (P < 0.05). Facial lightness (L*) significantly increased by 1.6% only in the GDL group at 6 months compared with the baseline. The value of the elasticity parameter, Ua/Uf, of dietary GDL significantly increased (6.2% at 2 months and 5.4% at 6 months). Besides these, dietary GDL suppressed UVB-induced erythema (a*) and pigmentation (L*). Dietary GDL has anti-inflammatory effects on the skin and prevents/improves skin disorders caused by seasonal change.
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2.
The effects of anti-obesity intervention with orlistat and sibutramine on microvascular endothelial function.
Al-Tahami, BA, Ismail, AA, Bee, YT, Awang, SA, Salha Wan Abdul Rani, WR, Sanip, Z, Rasool, AH
Clinical hemorheology and microcirculation. 2015;(4):323-34
Abstract
INTRODUCTION Obesity is associated with impaired microvascular endothelial function. We aimed to determine the effects of orlistat and sibutramine treatment on microvascular endothelial function, anthropometric and lipid profile, blood pressure (BP), and heart rate (HR). METHODS 76 subjects were recruited and randomized to receive orlistat 120 mg three times daily or sibutramine 10 mg daily for 9 months. Baseline weight, BMI, BP, HR and lipid profile were taken. Microvascular endothelial function was assessed using laser Doppler fluximetry and iontophoresis process. Maximum change (max), percent change (% change) and peak flux (peak) in perfusion to acetylcholine (ACh) and sodium nitroprusside (SNP) iontophoresis were used to quantify endothelium dependent and independent vasodilatations. RESULTS 24 subjects in both groups completed the trial. After treatment, weight and BMI were decreased for both groups. AChmax, ACh % change and ACh peak were increased in orlistat-treated group but no difference was observed for sibutramine-treated group. BP and total cholesterol (TC) were reduced for orlistat-treated group. HR was reduced for orlistat-treated group but was increased in sibutramine-treated group. CONCLUSION 9 months treatment with orlistat significantly improved microvascular endothelial function. This was associated with reductions in weight, BMI, BP, HR, TC and low density lipoprotein cholesterol. No effect was seen in microvascular endothelial function with sibutramine.
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3.
Effect of orlistat on weight loss, hormonal and metabolic profiles in women with polycystic ovarian syndrome: a randomized double-blind placebo-controlled trial.
Moini, A, Kanani, M, Kashani, L, Hosseini, R, Hosseini, L
Endocrine. 2015;(1):286-9
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4.
Influence of eating behaviors on short-term weight loss by orlistat and anorectic agent.
Kim, KK, Suh, HS, Hwang, IC, Ko, KD
Eating behaviors. 2014;(1):87-90
Abstract
Little data exists concerning whether eating behaviors determine the response to orlistat treatment, especially with added anorectic agents. This study was a sub-investigation of a 12-week randomized controlled trial for the additive effect of orlistat on sibutramine treatment. The analysis presented here was restricted to 98 women who had fulfilled the protocol. The Dutch eating behavior questionnaire and three-factor eating questionnaire were used to assess eating behaviors. Scores of emotional eating, external eating, disinhibition and hunger are significantly interrelated. Using multiple logistic analysis with adjustment for potential confounders, such as age, initial BMI and the other 2 eating behavior scores, traits of emotional eating (OR 0.30, 95% CI 0.13-0.74) and disinhibition (OR 0.61, 95% CI 0.40-0.82) have a significant influence on prediction for additional 5% weight loss in the treatment with orlistat and sibutramine. Subjects with less vulnerability to emotional cues had significantly more weight loss with orlistat treatment and anorectic agents.
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5.
Orlistat improves endothelial function in obese adolescents: a randomised trial.
Yu, CC, Li, AM, Chan, KO, Chook, P, Kam, JT, Au, CT, So, RC, Sung, RY, McManus, AM
Journal of paediatrics and child health. 2013;(11):969-975
Abstract
AIM: To investigate the effect of orlistat on endothelial function in obese adolescents. METHODS Single-blind 10-week controlled trial of 67 normolipidaemic obese adolescents randomised into three groups. Group 1 (diet alone), Group 2 (diet and orlistat), Group 3 (diet, orlistat and exercise). Endothelial function measured by flow-mediated dilatation (FMD) of the brachial artery, anthropometric parameters, blood pressure, fasting blood lipids, insulin and glucose levels were recorded at baseline and at 10 weeks. RESULTS Sixty four subjects completed the study. Groups were comparable at baseline. FMD increased significantly with orlistat (Groups 2 and 3) but not in Group 1. Orlistat treatment resulted in significantly reduced bodyweight, body mass index (BMI), waist circumference, total and low-density lipoprotein (LDL) cholesterol levels. High-density lipoprotein cholesterol levels were unchanged. Triglyceride and insulin levels were significantly reduced in all three groups. The reduction in cholesterols did not correlate with reductions in weight and BMI. A slight reduction of body fat, both with and without orlistat treatment, correlated with reduction in BMI after adjustment for baseline values. Blood pressure was unaltered by orlistat. Calorie intake was reduced with orlistat, and the decrease noted in % fat and increase in % carbohydrate was significant only in those taking orlistat. The addition of exercise (Group 3 compared with Group 2) altered no parameter. CONCLUSIONS Orlistat improves endothelial function and reduces bodyweight, BMI, fasting total and LDL-cholesterol in obese adolescents when combined with dietary control. Improvement in endothelial function if maintained could reflect long-term cardiovascular benefit.
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6.
The effect of multiple doses of ketoconazole or rifampin on the single- and multiple-dose pharmacokinetics of vorapaxar.
Kosoglou, T, Statkevich, P, Kumar, B, Xuan, F, Schiller, JE, Johnson-Levonas, AO, Young, S, Cutler, DL
Journal of clinical pharmacology. 2013;(5):540-9
Abstract
This randomized, open-label, parallel-group study evaluated the effects of multiple-dose ketoconazole or rifampin on the single- and multiple-dose pharmacokinetics of vorapaxar. Healthy subjects randomly received one of the following three treatments (N = 12/group): (1) ketoconazole 400 mg once daily (QD) for 28 days (Days 1-28) and single-dose vorapaxar 20 mg on Day 7 followed by vorapaxar 2.5 mg QD for 21 days (Days 8-28); (2) rifampin 600 mg QD for 28 days (Days 1-28) and single-dose vorapaxar 20 mg on Day 7 followed by vorapaxar 2.5 mg QD for 21 days (Days 8-28); and (3) placebo QD for 28 days (Days 1-28) and single-dose vorapaxar 20 mg on Day 7 followed by vorapaxar 2.5 mg QD for 21 days (Days 8-28). Ketoconazole increased the steady-state vorapaxar AUC(0-24 h) and C(max) by approximately twofold (GMR [90% CI]: 196% [173,222]; 193% [166,223], respectively), while rifampin decreased vorapaxar AUC(0-24 h) and C(max) by approximately 50% (GMR [90% CI]: 45.5% [40,52]; 61.4% [52,72], respectively) versus vorapaxar alone. Potent CYP3A4 inhibitors or inducers may cause moderate increases or decreases in vorapaxar exposure, respectively, which may have safety and/or efficacy implications; therefore, their concomitant use with vorapaxar is not recommended.
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7.
Effect of vorapaxar on myocardial infarction in the thrombin receptor antagonist for clinical event reduction in acute coronary syndrome (TRA·CER) trial.
Leonardi, S, Tricoci, P, White, HD, Armstrong, PW, Huang, Z, Wallentin, L, Aylward, PE, Moliterno, DJ, Van de Werf, F, Chen, E, et al
European heart journal. 2013;(23):1723-31
Abstract
AIMS: The TRA·CER trial compared vorapaxar, a novel platelet protease-activated receptor (PAR)-1 antagonist, with placebo in 12 944 patients with high-risk non-ST-segment elevation acute coronary syndromes (NSTE ACS). In this analysis, we explored the effect of vorapaxar on myocardial infarction (MI). METHODS AND RESULTS A blinded, independent central endpoint adjudication committee prospectively defined and classified MI according to the universal MI definition, including peak cardiac marker value (creatine kinase-MB [CK-MB] and/or troponin). Because the trial failed to meet its primary endpoint, these analyses are considered exploratory. During a median follow-up of 502 days, 1580 MIs occurred in 1319 patients. The majority (n = 1025, 64.9%) were type 1 (spontaneous) MI, followed by type 4a [percutaneous coronary intervention (PCI)-related] MI (n = 352; 22.3%). Compared with placebo, vorapaxar reduced the hazard of a first MI of any type by 12% [hazard ratio (HR), 0.88; 95% confidence interval (CI), 0.79-0.98; P = 0.021] and the hazard of total number of MIs (first and subsequent) by 14% (HR, 0.86; 95% CI, 0.77-0.97; P = 0.014), an effect that was sustained over time. Vorapaxar reduced type 1 MI by 17% (HR, 0.83; 95% CI, 0.73-0.95; P = 0.007). Type 4a MIs were not significantly reduced by vorapaxar (HR, 0.90; 95% CI, 0.73-1.12; P = 0.35). Vorapaxar effect was consistent across MI sizes defined by peak cardiac marker elevations and across key clinical subgroups; however, in patients not treated with thienopyridine at baseline (HR, 0.65; 95% CI, 0.46-0.92) compared with patients who received thienopyridine (HR, 0.91; 95% CI, 0.81-1.02), there was a trend towards a higher effect (Pint = 0.077). CONCLUSION The PAR-1 antagonist vorapaxar was associated with a reduction of MI, including total number of infarctions. This reduction was sustained over time and was mostly evident in type 1 MI, the most common type of MI observed.
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8.
Efficacy of orlistat 60 mg on weight loss and body fat mass in US Army soldiers.
Smith, TJ, Crombie, A, Sanders, LF, Sigrist, LD, Bathalon, GP, McGraw, S, Young, AJ
Journal of the Academy of Nutrition and Dietetics. 2012;(4):533-40
Abstract
A higher body mass index is associated with exercise-related injuries and increased risk for musculoskeletal and connective tissue disorders, which are relevant to military personnel. Studies show the efficacy of orlistat 60 mg for promoting weight and body fat loss in civilians; however, its efficacy among predominantly young, male soldiers is unknown. This study's objective was to examine the effect of a 6-month, standard education-based weight-management program with and without orlistat 60 mg on changes in weight and body fat in overweight soldiers. Data were collected for this randomized, controlled trial from March 2008 to November 2010 at Fort Bragg, NC. Participants were enrolled in an education-based weight management program (n=435; 75% men) and were randomized to placebo or orlistat 60 mg, three capsules daily with meals. All participants were recommended to maintain a reduced-energy, low-fat diet. Among study completers (14% retention rate; placebo n=22, orlistat n=35) members of both groups lost significant weight from baseline (placebo -3.0±5.2 kg; orlistat -3.2±4.7 kg; P<0.01), but only the orlistat group lost fat mass (-2.5±3.9 kg; P<0.001), whereas the placebo group lost lean mass (-1.4±2.7 kg; P <0.01). An intent-to-treat analysis (?1 follow-up body weight measure) demonstrated that the orlistat group lost more fat mass vs the placebo group (-1.3±2.9 kg vs ?0.6±1.8 kg, respectively; P<0.05), but less lean mass (-0.2±2.0 kg vs -0.8±1.8 kg, respectively; P<0.01). Orlistat 60 mg may be an effective adjunct to an education-based weight management program in a mostly young, male soldier population.
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9.
Orlistat in clozapine- or olanzapine-treated patients with overweight or obesity: a 16-week open-label extension phase and both phases of a randomized controlled trial.
Tchoukhine, E, Takala, P, Hakko, H, Raidma, M, Putkonen, H, Räsänen, P, Terevnikov, V, Stenberg, JH, Eronen, M, Joffe, G
The Journal of clinical psychiatry. 2011;(3):326-30
Abstract
OBJECTIVE To explore long-term effects of orlistat in adult clozapine- or olanzapine-treated patients with DSM-IV-diagnosed schizophrenia and overweight or obesity who tolerate orlistat. METHOD Orlistat or placebo was added to clozapine or olanzapine in stable doses in a 16-week randomized controlled trial. Open-label orlistat was added to the antipsychotics during a 16-week extension phase for those completing the double-blind phase. No low-calorie diet or participation in behavioral programs was required. Body weight (primary outcome) and some metabolic parameters were measured prospectively. Analyses were performed for those completing both phases (ie, population differing from that reported earlier). The study was conducted from 2004 through 2005. RESULTS During the open-label phase, the 44 patients experienced mean ± SD body weight loss of -1.29 ± 3.04 kg, P = .007. During both phases, men (but not women) showed a weight loss of -2.39 ± 5.45 kg, P = .023. Some subgroups showed desirable changes in several metabolic parameters. Prolonged (32 weeks) orlistat treatment yielded no additional benefits as compared to short (16 weeks) treatment. CONCLUSIONS In clozapine- or olanzapine-treated overweight or obese patients able to take orlistat on a long-term basis, the drug, with no concomitant hypocaloric diet or behavioral interventions, caused moderate weight loss only in men. However, some metabolic benefits may be achieved independently of weight changes. In patients who do not respond to orlistat within the first 16 weeks, continuation treatment may provide no additional benefits. TRIAL REGISTRATION controlled-trials.com Identifier: ISRCTN65731856.
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10.
A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss.
Yancy, WS, Westman, EC, McDuffie, JR, Grambow, SC, Jeffreys, AS, Bolton, J, Chalecki, A, Oddone, EZ
Archives of internal medicine. 2010;(2):136-45
Abstract
BACKGROUND Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared. METHODS Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, <20 g of carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (<30% energy from fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters. RESULTS The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, -9.5%) and the O + LFD (-8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (-5.9 vs 1.5 mm Hg) and diastolic (-4.5 vs 0.4 mm Hg) blood pressures (P < .001 for both comparisons). High-density lipoprotein cholesterol and triglyceride levels improved similarly within both groups. Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A(1c) levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant. CONCLUSION In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00108524.