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Orlistat

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1. Efficacy and Safety of Lipase Inhibitor Orlistat in Japanese with Excessive Visceral Fat Accumulation: 24-Week, Double-Blind, Randomized, Placebo-Controlled Study. (PubMed)

Efficacy and Safety of Lipase Inhibitor Orlistat in Japanese with Excessive Visceral Fat Accumulation: 24-Week, Double-Blind, Randomized, Placebo-Controlled Study. 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").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

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2019 Advances in therapy

2. Dose-ranging study of an orlistat tablet formulation. (PubMed)

Dose-ranging study of an orlistat tablet formulation. Examine inhibition of dietary fat absorption with orlistat tablets (24, 36, 48, 72, and 144 mg) vs. 60-mg orlistat capsule.83 overweight/obese subjects randomized to 1 of 6 open-label treatments. Pre- vs. post-treatment fecal fat analysis was conducted.Mean percent fecal fat (60-mg capsule, 16.8%; 48-mg tablet, 16.5%) was similar (ratio of geometric mean and 90% CI: 60-mg capsule/48-mg tablet, 1.05 (0.79, 1.39)). Fecal fat excretion was ~2.5 (...) times greater with 144-mg vs. 24-mg tablets. No new safety concerns emerged.Dietary fat excretion increases with increasing orlistat tablet dose.
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2018 International journal of clinical pharmacology and therapeutics

3. Effect of Diane-35, alone or in combination with orlistat or metformin in Chinese polycystic ovary syndrome patients. (PubMed)

Effect of Diane-35, alone or in combination with orlistat or metformin in Chinese polycystic ovary syndrome patients. To evaluate the effect of Diane-35, alone or in combination with orlistat or metformin, on androgen and body fat percentage parameters in Chinese overweight and obese polycystic ovary syndrome (PCOS) patients with insulin resistance.A total of 240 PCOS women were randomly allocated to receive Diane-35 alone (D group), Diane-35 plus orlistat (DO group), Diane-35 plus metformin (...) (DM group), or Diane-35 plus orlistat plus metformin (DOM group). Serum TT, DHEA-S, androstenedione, SHBG, FT, FAI, body fat, and body fat percentage were assessed at baseline and after 12 weeks of treatment.Significant changes in serum TT, SHBG, and FAI were observed in all treatment groups compared with baseline. DHEA-S and androstenedione significantly decreased in the DO, DM, and DOM groups after treatment. FT only significantly decreased in the DOM group. Body fat and body fat percentage

2018 Archives of gynecology and obstetrics

4. Pharmacologic and Pharmacodynamic Equivalence of 2 Formulations of Orlistat. (PubMed)

Pharmacologic and Pharmacodynamic Equivalence of 2 Formulations of Orlistat. We sought to establish the bioequivalence of 2 weight-loss aids: orlistat 27-mg chewable tablet and orlistat 60-mg capsule, measured pharmacodynamically as percentage fecal fat excretion. Two open-label, single-center, randomized, 3-period, 3-treatment crossover studies were conducted in adults with body mass index 25-33 kg/m2 . For each 9-day treatment period, subjects received orlistat 27-mg chewable tablet, 60-mg

2018 Clinical pharmacology in drug development

5. Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial (PubMed)

Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial Obese women have fewer oocytes retrieved, an increased cancelation rate, a higher miscarriage rate, and a lower live birth rate after assisted reproductive technology (ART) treatment compared with women with normal weight. Weight loss before ART treatment can significantly improve pregnancy rates and/or live births. An orlistat plus diet (...) intervention could promote weight loss, but there is no evidence from randomized clinical trials evaluating the effect of orlistat preconceptional treatment on pregnancy outcome in overweight and obese women.We are conducting a multicenter, randomized placebo-controlled, double-blind clinical trial in overweight and obese women aged 20-40 years undergoing in-vitro fertilization and embryo transfer (IVF-ET) with or without intracytoplasmic sperm injection, to evaluate whether orlistat treatment for 1-3

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2018 Trials

6. Orlistat Therapy for Children with Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial. (PubMed)

Orlistat Therapy for Children with Type 1 Hyperlipoproteinemia: A Randomized Clinical Trial. Patients with type 1 hyperlipoproteinemia (T1HLP), a rare genetic disorder, have extreme chylomicronemia and recurrent episodes of acute pancreatitis. Currently, the only therapeutic option is to consume an extremely low-fat diet because the triglyceride-lowering medications are not efficacious.To determine the efficacy of orlistat, a gastric and pancreatic lipase inhibitor, in reducing serum (...) triglyceride levels in patients with T1HLP.We conducted a randomized, open-label, clinical trial with a four-period, two-sequence ("orlistat" and "off orlistat" for 3 months), crossover study design.Two unrelated young Asian Indian males (11 and 9 years old) with T1HLP due to homozygous large GPIHBP1 deletions were enrolled at the UT Southwestern Medical Center. The patients were randomized to receive 3 months of orlistat or no therapy (off), then crossed over to the other arm, and this sequence

2018 Journal of Clinical Endocrinology and Metabolism

7. Effects of orlistat on blood pressure: a systematic review and meta-analysis of 27 randomized controlled clinical trials.

Effects of orlistat on blood pressure: a systematic review and meta-analysis of 27 randomized controlled clinical trials. Obesity and high blood pressure (BP) are strongly related and weight loss is mightily associated with a significant BP decrease. The aim of the present meta-analysis was to evaluate and quantify the BP decrease associated with orlistat use in randomized controlled trials. The search included PubMed-Medline, Scopus, Web of Science and Google Scholar databases by up to June 05 (...) , 2017, to identify randomized controlled trials investigating the impact of orlistat on blood pressure. Quantitative data synthesis was performed using a random-effects model, with weighed mean difference and 95% confidence interval as summary statistics. Meta-regression and leave-one-out sensitivity analyses were performed to assess the modifiers of treatment response. Our meta-analysis included 27 randomized controlled clinical trials which comprehended overall 8150 subjects (4419 in the orlistat

2018 Journal of the American Society of Hypertension : JASH

8. Efficacy of orlistat in non-alcoholic fatty liver disease: A systematic review and meta-analysis (PubMed)

Efficacy of orlistat in non-alcoholic fatty liver disease: A systematic review and meta-analysis In the present meta-analysis, the efficacy and safety of orlistat in the treatment of non-alcoholic fatty liver (NAFLD) and non-alcoholic steatohepatitis (NASH) were evaluated. PubMed, Embase, the Cochrane Library, Web of Science, and Wan Fang data were searched for controlled trials of orlistat in patients with NAFLD or NASH, published before August 2017. Three randomized controlled trials and four (...) ), homeostasis model assessment of insulin resistance index (MD=-1.05; P=0.04) and body mass index (MD=-1.97; P=0.02), but not in liver fibrosis score (SMD=-0.14; P=0.71). On sub-analyses of the different patient groups, no significant differences were observed in patients with NASH. Taken together, these findings demonstrate that orlistat could serve as a therapeutic drug to improve biochemical indicators of liver damage, but not as first-choice drug for the management of NAFLD or NASH; thus suggesting

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2018 Biomedical reports

9. Orlistat/Phentermine Versus Placebo/Phentermine

Orlistat/Phentermine Versus Placebo/Phentermine Orlistat/Phentermine Versus Placebo/Phentermine - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Orlistat/Phentermine Versus Placebo/Phentermine The safety (...) , which in turn leads to an weight gain and a deterioration in physical performance. Among the drugs used for obesity, orlistat has been approved for long-term use, and phentermine, the most commonly used drug, has been approved for short-term use. However, phentermine can increase blood pressure and pulse rate. Meanwhile, several studies have shown that orlistat, a pancreatic lipase inhibitor, lowers blood pressure and pulse rate and diminish LDL-cholesterol. Lowering LDL-C could lead to improved

2018 Clinical Trials

10. The effect of orlistat and weight loss diet on plasma ghrelin and obestatin. (PubMed)

The effect of orlistat and weight loss diet on plasma ghrelin and obestatin. The objective of this study was to evaluate the effect of weight loss with hypocaloric diet and orlistat treatment in addition to hypocaloric diet on gut-derived hormones ghrelin and obestatin.A total of 52, euglycemic and euthyroid, obese female patients were involved in the study. The patients were assigned to two groups: Group 1 (n = 26) received hypocaloric diet alone and Group 2 (n = 26) received orlistat (...) significantly in both groups (Group 1: pGhrelin: 0.047, pobestatin: 0.001 and Group 2: pGhrelin: 0.028, pobestatin: 0.006), ghrelin/obestatin ratio did not change significantly. When the changes in anthropometric assessments and laboratory parameters were compared, no significant difference was observed between the two groups. Furthermore, no correlation was observed between ghrelin or obestatin and any other hormonal and metabolic parameters.Weight loss with diet and diet plus orlistat is both associated

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2018 Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences

11. Orlistat-loaded solid SNEDDS for the enhanced solubility, dissolution, and in vivo performance (PubMed)

Orlistat-loaded solid SNEDDS for the enhanced solubility, dissolution, and in vivo performance The present study aimed to develop orlistat-loaded solid self-nanoemulsifying drug delivery system preconcentrate (SSP) with the minimum use of lipid excipients for the enhanced solubility, in vitro dissolution, lipase inhibition, and in vivo performance.In the screening of solubilizing vehicles, Solutol HS15 and Lauroglycol 90 were selected as the surfactant and oil phase, respectively. A pseudo (...) -ternary phase diagram composed of Solutol HS15, Lauroglycol 90, and orlistat as an anti-obesity agent and lipid component was constructed, and the SSP regions were confirmed in terms of the particle size distribution in water, melting point by differential scanning calorimetry, and crystallinity by X-ray diffraction.Physicochemical interaction between Solutol HS15 and orlistat resulted in SSP with various melting points in the range of 26°~33°C. The representative maximum orlistat-loaded SSP (orlistat

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2018 International journal of nanomedicine

12. Metabolic and Inflammatory Changes with Orlistat and Sibutramine Treatment in Obese Malaysian Subjects. (PubMed)

Metabolic and Inflammatory Changes with Orlistat and Sibutramine Treatment in Obese Malaysian Subjects. Obesity is associated with numerous health problems, particularly metabolic and cardiovascular complications. This study aimed to assess the effects that, nine months of pharmacological intervention with orlistat or sibutramine, on obese Malaysians' body weight and compositions, metabolic profiles and inflammatory marker.Seventy-six obese subjects were randomly placed into two groups (...) . The first group received three daily 120 mg dosages of orlistat for nine months (n=39), and the second group received a once daily 10 or 15 mg dosage of sibutramine for nine months (n=37). Baseline measurements for weight, body mass index (BMI), waist circumference (WC), body fat percentage (BF), visceral fat (VF), adiponectin, fasting plasma glucose (FPG), fasting insulin, pancreatic B cell secretory capacity (HOMA%B), insulin sensitivity (HOMA%S), insulin resistance (HOMA-IR) and serum high

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2017 Journal of Nippon Medical School = Nippon Ika Daigaku zasshi

13. Orlistat (The Lipase Inhibitor) Therapy in Overweight and Obese Subfertile Women. (PubMed)

Orlistat (The Lipase Inhibitor) Therapy in Overweight and Obese Subfertile Women. This experimental study was carried out to evaluate the efficacy of orlistat (a pancreatic lipase inhibitor) therapy over lifestyle change on weight reduction and ovulation in overweight and obese subfertile women. It was carried out in Department of Gynecology and Obstetrics, Bangabandhu Sheikh Mujib Medical University (BSMMU) Dhaka, Bangladesh from August 2015 to January 2016. Subfertile obese and overweight (...) received capsule Orlistat 120 mg twice daily for 3 months period. Group II was counseled for life style modification only. Post treatment weight measurement and TVS on day 12 and 14 were done after completion of intervention. Then pre and post-treatment parameters were assessed between two groups. Mean age was (27.31±4.58) years in Group I and (26.20±4.71) years in Group II. Majority patients, (78.3%) in Group I and (76.7%) in Group II had oligomenorrhoea. Hirsuitism was observed in (25%) in Group I

2017 Mymensingh medical journal : MMJ

14. Effect of orlistat on plasma lipids and body weight: a systematic review and meta-analysis of 33 randomized controlled trials. (PubMed)

Effect of orlistat on plasma lipids and body weight: a systematic review and meta-analysis of 33 randomized controlled trials. Orlistat, an inhibitor of intestinal lipase, promotes body weight reduction. The lipid-lowering efficacy of orlistat is controversial and the effect of orlistat-induced body weight reduction on lipid changes has not been explored in meta-regression analyses. A systematic literature search was conducted to identify randomized controlled trials investigating the efficacy (...) of orlistat on plasma total, low-density lipoprotein and high-density lipoprotein cholesterol, triglycerides and lipoprotein(a) levels. Thirty-three studies were included in the meta-analysis (5522 and 4210 participants in the orlistat therapy and control groups, respectively). Orlistat reduced body weight (weighted mean difference: -2.12, p <0.001), total-cholesterol (weighted mean difference: -0.30mmol/L, p <0.001), low-density lipoprotein cholesterol (weighted mean difference: -0.27mmol/L, p <0.001

2017 Pharmacological Research

15. Supplementation with dairy calcium and/or flaxseed fibers in conjunction with orlistat augments fecal fat excretion without altering ratings of gastrointestinal comfort. (PubMed)

Supplementation with dairy calcium and/or flaxseed fibers in conjunction with orlistat augments fecal fat excretion without altering ratings of gastrointestinal comfort. Orlistat is a lipase inhibitor which reduced absorption of dietary fat by ~30% thereby inducing a weight loss; however, side effects occur as a consequence of increased colonic fat content. To test the hypothesis that most gastrointestinal side events induced by treatment with orlistat could be prevented/ameliorated (...) by concomitant use of natural dietary components, flaxseed fiber (FF) and/or dairy calcium (Ca), binding liquid fats to more solid complexes.A randomized controlled dietary intervention study. Thirty-eight obese adults completed a 1-week run-in period, where all participants were treated with orlistat (60 mg t.i.d) and were hereafter randomized to 12 weeks dietary supplementation with/without 5 g FF (FF+/FF-) and/or 1200 mg dairy calcium (Ca+/Ca-) in conjunction with orlistat. All feces were collected for 3

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2017 Nutrition & metabolism

16. Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity. (PubMed)

Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity. The efficacy of a non-prescription drug to support weight loss programs has yet to be compared. This clinical trial investigates the comparability of orlistat 60 milligram (mg) and polyglucosamine.Sixty-four overweight or obese subjects were included in a two-center double-blind study. One center was in Germany (...) [center 1] and the other was in Italy [center 2]. The subjects (26 in center 1 and 38 in center 2) were recommended to follow a calorie deficit of about 2000 kilojoules/day and to increase their physical activity to 3 metabolic equivalent hours (MET h)/day. In both centers, subjects were randomized to receive polyglucosamine (2 tablets x 2) or orlistat (1 capsule x 3) for a period of 12 weeks. Weight loss was considered as a main variable together with the reduction of 5 per cent (%) of body weight

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2017 BMC obesity

17. Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. (PubMed)

Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. The quality of harms reporting in journal publications is often poor, which can impede the risk-benefit interpretation of a clinical trial. Clinical study reports can provide more reliable, complete, and informative data on harms compared to the corresponding journal publication. This case study compares the quality and quantity of harms data reported in journal (...) publications and clinical study reports of orlistat trials.Publications related to clinical trials of orlistat were identified through comprehensive literature searches. A request was made to Roche (Genentech; South San Francisco, CA, USA) for clinical study reports related to the orlistat trials identified in our search. We compared adverse events, serious adverse events, and the reporting of 15 harms criteria in both document types and compared meta-analytic results using data from the clinical study

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2017 Trials

18. Anti-Lipase Potential of the Organic and Aqueous Extracts of Ten Traditional Edible and Medicinal Plants in Palestine; a Comparison Study with Orlistat (PubMed)

Anti-Lipase Potential of the Organic and Aqueous Extracts of Ten Traditional Edible and Medicinal Plants in Palestine; a Comparison Study with Orlistat Background: Herbs have played a fundamental and essential role in the humans life since ancient times, especially those which are used as food and/or folk medicinedue to both their nutritive and curative properties.This study aimed to investigate new antilipase agents from tentraditional Palestinian edible and medicinal plants through inhibition (...) of the absorption of dietary lipids. Methods: The anti-lipase activity for ten plants was evaluated and compared with the reference compound Orlistat by using the porcine pancreatic lipase inhibitory test which was conducted by using a UV-visible spectrophotometer. Results: The aqueous extracts of Vitis vinifera and Rhus coriaria had the highest antilipase effects with IC50 values 14.13 and 19.95 mcg/mL, respectively. Meanwhile, the organic extract of Origanum dayi had an IC50 value 18.62 mcg/mL. V. vinifera

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2017 Medicines

19. Effect of orlistat on periostin, adiponectin, inflammatory markers and ultrasound grades of fatty liver in obese NAFLD patients (PubMed)

Effect of orlistat on periostin, adiponectin, inflammatory markers and ultrasound grades of fatty liver in obese NAFLD patients Orlistat is recommended in the treatment of obesity, which is an independent risk factor for nonalcoholic fatty liver disease (NAFLD). The reported findings of orlistat in NAFLD are divisive. Recently, periostin is identified as an important regulatory molecule in the pathogenesis of obesity-induced fatty liver. Therefore, this study aimed to evaluate the potential (...) effects of orlistat in the treatment of NAFLD. A 16-week prospective observational study was conducted, with obese NAFLD patient (n=77) receiving orlistat (120 mg capsules, three times a day) with hypocaloric diet or hypocaloric diet only. Grades of fatty liver were determined using ultrasound (US) echogenicity of liver; serum levels of periostin, adiponectin, tumor necrosis factor (TNF)-α and interleukin-6 were determined using ELISA kits at 0 and 16 weeks. Correlations of US grades of fatty liver

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2017 Therapeutics and clinical risk management

20. Gelidium elegans Regulates the AMPK-PRDM16-UCP-1 Pathway and Has a Synergistic Effect with Orlistat on Obesity-Associated Features in Mice Fed a High-Fat Diet (PubMed)

Gelidium elegans Regulates the AMPK-PRDM16-UCP-1 Pathway and Has a Synergistic Effect with Orlistat on Obesity-Associated Features in Mice Fed a High-Fat Diet The incidence of obesity is rising at an alarming rate throughout the world and is becoming a major public health concern with incalculable social and economic costs. Gelidium elegans (GENS), also previously known as Gelidium amansii, has been shown to exhibit anti-obesity effects. Nevertheless, the mechanism by which GENS is able to do (...) this remains unclear. In the present study, our results showed that GENS prevents high-fat diet (HFD)-induced weight gain through modulation of the adenosine monophosphate-activated protein kinase (AMPK)-PR domain-containing16 (PRDM16)-uncoupling protein-1 (UCP-1) pathway in a mice model. We also found that GENS decreased hyperglycemia in mice that had been fed a HFD compared to corresponding controls. We also assessed the beneficial effect of the combined treatment with GENS and orlistat (a Food and Drug

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2017 Nutrients

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