Safety Of Orlistat Research Articles

Efficacy and safety of orlistat in controlling the progression of prediabetes to diabetes: A meta-analysis and systematic review.

The aim of this study is to examine the impact of the Orlistat on glucose levels and glucose tolerance in individuals with prediabetes, as well as assess its efficacy and safety in preventing the progression to diabetes. For achieving the appropriate randomized controlled trials, we enrolled the public datas from the following electronic databases: The Cochrane library, Embase, China National Knowledge Infrastructure, VIP, Wan-Fang, and China Biology Medicine disc. The article focused on the orlistat intervention of glucose tolerance and glycemic status in prediabetic patients. We restricted the publication time from the creation to May 2023. Six subjects were included in the study, with a total of 1076 participants (532 in the control group vs 544 in the experimental group). The results indicated that the orlistat can reduce the fasting blood glucose [relative risk (RR) = -2.18, 95% confidence intervals (CI) (-2.471, -1.886)], as well as the 2 hour postprandial blood glucose [RR = -1.497, 95% CI (-1.811, -1.183)]. Furthermore, it can prevent the impaired glucose tolerance patients to type 2 diabetes mellitus [RR = 0.605, 95% CI (0.462, 0.791)], and reversal the impaired glucose tolerance [RR = 2.092, 95% CI (1.249, 3.503)]. In prediabetic people, the orlistat can control weight, reduce the fasting blood glucose and the 2 hour postprandial blood glucose, and then delay the progression of diabetes. However, due to the quantitative restrictions, additional high-quality study needs to be conducted to improve the reliability of the results.

Effectiveness, persistence of use, and safety of orlistat and liraglutide in a group of patients with obesity

ABSTRACT Background To determine the effectiveness, persistence of use, adverse reactions, interactions of orlistat and liraglutide taken for weight loss by a group of obese patients in Colombia. Research design and methods A retrospective follow-up study of a cohort of patients with obesity treated with orlistat or liraglutide. Sociodemographic, clinical, and pharmacological variables were identified. The effectiveness for weight loss at 12-16 and 52 weeks, persistence of use, and safety were determined. Results A total of 294 patients were followed up. At 12-16 weeks after starting orlistat and liraglutide, weight losses of -1.2kg (p=0.002) and -4.1kg (p<0.001) were observed, respectively, and at 52 weeks, reductions of -1.6kg (p=0.208) and -7.8kg (p<0.001) were observed. A total of 8.8% and 31.3% of patients treated with orlistat and liraglutide, respectively, persisted with treatment 1 year after initiation. A total of 17.3% had adverse drug reactions. Older adults with grade II or III obesity who performed physical activity and those treated with liraglutide were more likely to have lost at least 5% of their body weight at 12-16 weeks. Conclusion Orlistat and liraglutide users presented weight loss at 12–16 weeks. However, this effect was greater and sustained with liraglutide, especially when combined with physical activity.

Comparision of Efficacy and Safety of Orlistat vs Placebo in Obese Patients in Pakistan.

IntroductionObesity has become a rising health concern in Pakistan. Several primary measures, such as dietary restrictions and regular exercise, are taken to limit the severe consequences of obesity. Still, such measures alone have been proven to be often short term and therefore, inadequate. In this study, we will evaluate the role of pharmacological management via orlistat in obesity.Methods and MaterialsA total of 120 patients were enrolled in this study and were divided randomly into two groups (drug arm and placebo arm) of 60 patients each. A standard dose of 120 mg capsules of orlistat given three times a day was administered to the participants of the drug arm group. A placebo was given to the participants in the second group. Baseline investigations were conducted on day 0 of the study, and follow-up visits were planned to take place in week 24 for all participants. Any side effects or adverse events were inquired about and documented in these visits.ResultsIn the orlistat arm, we noted a significant reduction in both body mass index (BMI) (0.04) and waist circumference (0.04). Reduction in weight was more in the orlistat arm than in the placebo arm. However, it is non-significant when compared between day 0 and week 24. Adverse events, such as oily spotting (31.91%), flatus with discharge (27.65%), faecal urgency (25.53%) and fatty stool (35.553%), were significantly higher in the orlistat arm.ConclusionOrlistat has shown positive results in reducing weight, BMI and waist circumference; however, patients should be counselled about potential side effects caused by the mechanism of action of Orlistat.

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

IntroductionOrlistat 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”).MethodsThe 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.ResultsVisceral 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.ConclusionOrlistat 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 RegistrationJapan Pharmaceutical Information Center identifier, JapicCTI-184005.FundingTaisho Pharmaceutical Co., Ltd.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-018-0835-5) contains supplementary material, which is available to authorized users.

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 single-arm trials were included. The involved participants with NAFLD or NASH (330 patients) were analyzed for clinical outcomes including alteration in hepatic histological variables and biomarkers of liver function. Improvements were observed in levels of alanine aminotransferase [standard mean difference (SMD)=-1.41; P=0.01], aspartate aminotransferase (SMD=-2.06; P=0.0005), γ-glutamyl transpeptidase (SMD=-1.91; P=0.05), glucose [mean difference (MD)=-0.51; P=0.01], triglycerides (MD=-0.93; P=0.01), 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 a novel palliative drug only for the treatment of NAFLD.

Evaluation of efficacy and safety of orlistat in obese patients

Context:Rapidly rising prevalence of obesity is alarming. Obesity predisposes to co-morbidities like hypertension, type 2 diabetes mellitus, dyslipidemias, thus substantially rising healthcare expenditure. Lifestyle modifications alone have very limited success, necessitating the addition of pharmacotherapy to it.Objective:Present study was carried out to evaluate the efficacy and safety of orlistat in obese patients.Materials and Methods:Eighty obese (BMI>30) patients according to inclusion and exclusion criteria were randomized into either of the two groups. Group 1 received orlistat 120 mg three times a day and group 2 received placebo three times a day. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL, LDL were measured at baseline and then at 8th, 16th and 24th week. ADR reported by patients were recorded. For safety evaluation various hematological and biochemical parameters were assessed. Z test was used for analysis of data.Results:Compared to placebo, orlistat caused significant reduction (P<0.05) in weight (4.65 kg vs 2.5 kg; orlistat vs placebo, respectively), BMI (1.91 kg/m2 vs 0.64 kg/m2) and waist circumference (4.84 cm vs 2 cm), cholesterol (10.68 mg vs 6.18 mg) and LDL level (5.87 mg vs 2.33 mg). In the orlistat group, the GI side effects like loose stools, oily stools/spotting, abdominal pain and fecal urgency were observed.Conclusion:Orlistat is an effective and well-tolerated antiobesity drug, which can be employed as an adjunct to therapeutic lifestyle changes to achieve and maintain optimal weight.

US FDA reviewing safety of orlistat

US FDA reviewing safety of orlistat

Efficacy, safety and tolerability of orlistat, a lipase inhibitor, in the treatment of adolescent weight excess

The treatment of childhood and adolescent obesity is difficult and the outcome of behavioral interventions remains unsatisfactory. Several pharmacological approaches, used in conjunction with comprehensive behavioral interventions designed to improve diet and decrease inactivity have been developed and extensively studied, mainly in adults. Orlistat is a lipase inhibitor that reduces dietary fat absorption by a third. It is the only pharmacological agent approved in the pediatric age group for the treatment of obesity. The goal of this article is to review the efficacy and safety of orlistat in adolescents, with emphasis on its effects on weight and body mass index, body composition and liposoluble vitamins during growth.

Orlistat vs Placebo in the Inhibition of Dietary Fat in Obese Adult Nigerian Volunteers

Objective: To compare the efficacy and safety of orlistat (120mg tid) versus placebo in the inhibition of dietary fat absorption in healthy adult Nigerian volunteers. Method: This was a double blind randomised cross-over study, with each arm of the cross-over lasting 4 weeks with a one week placebo run-in period before and in-between treatment. Four males and 16 females, with a mean BMI of 35.1 and a mean age of 40.08 years, participated in the study. Prior to allocation to treatment, subjects were given placebo for a 7-day period, while receiving a moderate hypocaloric supporting diet as prescribed for each individual by the dietician. During this period, a 72-hour faeces was collected from each subject for estimation of baseline faecal fat excretion. Additionally blood and urine samples were collected for evaluation of plasma lipid profile, haemogram, blood chemistry and urinalysis. Subjects were assigned to treatment according to their enrolment number i. e. subject no. 1 received treatment labelled DBN 1. Each subject was given a weekly pack of medication as specified in the label. The subjects took one capsule three times a day with the prescribed diet. At the end of each week of treatment, subjects were required to submit 24-hr faeces for faecal fat estimation. Blood samples were collected at week 5 and week 10 for haematological profile, lipid profile, blood chemistry and liver function tests. At each weekly clinical visit, subjects were questioned closely on the incidence of any adverse event, they also discussed their diet with the dietician. At the end of the study the emergency code envelopes were opened and the subjects were assigned into groups according to the treatment sequence, the sequence Placebo/ Orlistat were assigned group 1 and Orlistat/ Placebo group 2. Results: The difference in faecal fat excretion with orlistat compared to placebo was significant (p

Comment: Low-Dose Orlistat Effects on Body Weight of Mildly to Moderately Overweight Individuals: A 16 Week, Double-Blind, Placebo-Controlled Trial

Background:Lifestyle measures are considered the first line of therapy for treating overweight individuals, but many are unable to achieve a meaningful weight loss.Objective:To determine the efficacy and safety of orlistat 60 mg, given 3 times daily, for weight loss in mildly to moderately overweight individuals.Methods:A multicenter, 16 week, randomized, double-blind, placebo-controlled study was conducted in 391 overweight subjects at 20 US centers. The main outcome measure was change in weight from baseline to week 16; secondary measures included changes in body mass index, waist circumference, blood pressure, and fasting lipoprotein and glucose levels.Results:Subjects in both groups lost weight over the treatment period; however, orlistat-treated subjects lost significantly more weight than placebo-treated subjects beyond 2 weeks of treatment. Weight loss from baseline to week 16 was significantly greater in participants receiving orlistat versus those receiving placebo (3.05 vs 1.90 kg; p < 0.001, in...

Efficacy and safety comparative evaluation of orlistat and sibutramine treatment in hypertensive obese patients

The aim of our study was to comparatively evaluate the efficacy and safety of orlistat and sibutramine treatment in obese hypertensive patients, with a specific attention to cardiovascular effects and to side effects because of this treatment. Patients were enrolled, evaluated and followed at three Italian Centres of Internal Medicine. We evaluated 115 obese and hypertensive patients. (55 males and 60 females; 26 males and 29 females, aged 50 +/- 4 with orlistat; 28 males and 30 females, aged 51 +/- 5 with sibutramine). All patients took antihypertensive therapy for at least 6 months before the study. We administered orlistat or sibutramine in a randomized, controlled, double-blind clinical study. We evaluated anthropometric variables, blood pressure and heart rate (HR) during 12 months of this treatment. A total of 113 completed the 4 weeks with controlled energy diet and were randomized to double-blind treatment with orlistat (n = 55) or sibutramine (n = 58). Significant body mass index (BMI) improvement was present after 6 (p < 0.05), 9 (p < 0.02), and 12 (p < 0.01) months in both groups, and body weight (BW) improvement was obtained after 9 (p < 0.05) and 12 (p < 0.02) months in both groups. Significant waist circumference (WC), hip circumference (HC) and waist/hip ratio (W/H ratio) improvement was observed after 12 months (p < 0.05, respectively) in both groups. Significant systolic blood pressure (SBP) and diastolic blood pressure (DBP) improvement (p < 0.05) was present in orlistat group after 12 months. Lipid profile [total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and triglycerides] reduction (p < 0.05, respectively) was observed in orlistat group and triglyceride reduction (p < 0.05) in sibutramine group after 12 months. No significant change was observed in sibutramine group during the study. No significant HR variation was obtained during the study in both groups. Of the 109 patients who completed the study, 48.1% of patients in the orlistat group and 17.5% of patients in the sibutramine group had side effects (p < 0.05 vs. orlistat group). Side-effect profiles were different in the two treatment groups. All orlistat side effects were gastrointestinal events. Sibutramine caused an increase in blood pressure (both SBP and DBP) in two patients, but it has been controlled by antihypertensive treatment. The vitamin changes were small and all mean vitamin and beta-carotene values stayed within reference ranges. No patients required vitamin supplementation. Both orlistat and sibutramine are effective on anthropometric variables during the 12-month treatment; in our sample, orlistat has been associated to a mild reduction in blood pressure, while sibutramine assumption has not be associated to any cardiovascular effect and was generically better tolerated than orlistat.