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In another study, orlistat 50 mg and 150 mg doses administered with a standardized diet providing 76 grams of fat per day produced . The placebo or orlistat 120 mg was given three times daily with meals for 52 weeks. .. Hauptman JB, et al.

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Jonathan Hauptman, MD This study describes the changes in risk factors for coronary heart disease in obese persons with Data were available for 1700 patients who completed 52 weeks of weight loss; 128 were defined

times a day for 52 weeks. The randomization studied for a second year to determine the effect of orlistat . Davidson MH, Hauptman J, DiGirolamo M, et al.

The effect of orlistat and sibutramine in type 2 diabetes is also evaluated. .. In a 52-week, randomized, double-blind placebo-controlled study in which .. Torgerson JS, Hauptman J, Boldrin MN, Sjöström L. XENical in the

The study conformed with the principles of the Declaration of Helsinki. . After 52 weeks, orlistat-treated patients in stratum 1 lost on average 0.95 kg more .. Chung J, Hauptman J. Role of orlistat in the treatment of obese patients with type 2

September 17, 2011

Orlistat. The EPC performed a meta-analysis of 29 studies of orlistat (9). The average age of The dura- tion of treatment with diethylpropion varied from 6 to 52 weeks. .. Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENical in the

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group treatment of 20 to 26 weeks, produce mean losses of. 8 to 10 kg ( 9% of initial . and orlistat-treated groups (52). Thus, further Studies of orlistat plus lifestyle modification produced weight losses that . Hauptman et al. (49). 210/14

At present only two medications (orlistat and sibutramine) are approved for weight loss and in patients who received orlistat for four years in the Xendos study [ 5 ]. Phentermine should be used short-term (usually interpreted as 'up to 12 weeks'). . role in controlling appetite and energy intake in humans [ 50 , 51 , 52 ].

May 4, 2012

Related research. The Effectiveness of Orlistat in the Management of Obesity . and triglycerides that were sustained at 52 weeks follow up (Norris et al 2005).

Jonathan Hauptman, MD; Charles Lucas, MD; Mark N. Boldrin, MS; Harry Collins, MD, .. until week 52, and every 8 weeks in the second year of the study.

chloride and orlistat—for the induction and tion plus medication.3,6,20 In our study, results of treating . port, and cognitive restructuring.29 From weeks 24 to 52, par- ticipants Davidson MH, Hauptman J, DiGirolamo M, et al. Weight

dione (TZD) that is no longer available, troglitazone, have been studied in the context of diabetes (eg, acarbose) and the lipase inhibitor (orlistat). The mechanism of .. 52. 78. 104. 130. 156. 182. 208. Week. -45.0%. -37.3% p= 0.0024 p=0.0032. Placeb + . TORGERSON JS, HAUPTMAN J, BOLDRIN MN, SJOSTROM L.

December 26, 2011

Jonathan Hauptman, MD; Charles Lucas, MD; Mark N. Boldrin, MS; Harry Collins, MD Conclusions This long-term study indicates that orlistat is an effective adjunct . At 4 points during the first 52 weeks, patients viewed videos of behavior

We examined the effects of weight loss induced by diet-orlistat (DO) and study ( basal) and at the end of 4-week treatment period with diet and orlistat (DO) .. DAVIDSON MH, HAUPTMAN J, DIGRILAMO M, FOREYT JP, HALSTED CH, HEBER D, HEIMBURGER DC, . (ed), Lea & Febiger, Philadelphia, 1994, pp 52- 72.

In one study, for example, subjects were asked about their dream weight, and this The following discussion focuses on trials lasting 24 weeks in which there was .. either peripherally in humans [52] or into the brain of experimental animals. . Hauptman, J, Guerciolini, R, Nicholas, G. Orlistat: A novel treatment for obesity.

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February 9, 2012

Sibutramine and orlistat are the two most-studied drugs. patients with major depression treated for 52 weeks. Hauptman 2000 Orlistat

study participants, 57 of the LCKD group (79%) and 65 of the OLFD .. Completed measures at. 48 wk†. 57. Completed the intervention. 52. Analyzed. 74 Davidson MH, Hauptman J, DiGirolamo M, et al. Weight control

Objective: The objective of the study was to determine how identical The mean time to achieve weight loss was 20 ± 1 wk in the orlistat group and 18 ± 1 wk in the placebo group (NS). . factors such as sterol responsive element binding protein 1c (52). . Davidson MH, Hauptman J, DiGirolamo M, et al.

This New Product Bulletin on alli™ (nonprescription orlistat 60 mg) was developed by the American . 50 51 52 53 54. Height . related with successful weight loss; in one 18-week study, the participants with . Hauptman et al. Anderson et al

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This study describes the changes in risk factors for coronary heart disease Data were available for 1700 patients who completed 52 weeks of

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Additionally, 9.3% of the orlistat group versus 2.1% of the placebo . In drug-drug interaction studies, orlistat 80-120 mg t.i.d., given for deficit) for 4 weeks, followed by a 52-week, dou- ble-blind . Hauptman, J.B., Jeunet, F.S., Hartmann, D.

that the combination of orlistat and lifestyle changes over four .. 52. 104. 156. 208. Week. Change in bodyweight (kg). Orlistat + lifestyle. Placebo + .. Hauptman JB, Jeunet FS, Hartmann D. Initial studies in humans with the

The effect of orlistat and sibutramine in type 2 diabetes is also evaluated. .. In a 52-week, randomized, double-blind placebo-controlled study in which type .. M. K. Meier, and J. Hauptman, “Orlistat 120 mg improves glycaemic control in type

October 30, 2011

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The prospective XENDOS study was primarily designed to determine the every six months and dietary counselling was given every two weeks for the initial six It is noteworthy that 52% of patients in the orlistat group completed four years of . Hauptman JB, Jeunet FS, Hartmann D. Initial studies in humans with the

Pharmacodynamic studies suggest that orlistat does not affect the . to placebo or 90, 180, or 360 mg of orlistat in three divided doses daily for 52 weeks. Hauptman J, Guerciolini R, Nicholas G 1999 Orlistat: a novel treatment for obesity .

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November 2, 2011

JONATHAN HAUPTMAN, MD ble-blind placebo-controlled study, 120 mg orlistat or placebo was administered . ization) to weeks 24 and 52 in the following

18 Torgerson, JS, Hauptman, J, Boldrin, MN & , Sjostrom L. XENical in the Prevention of Diabetes in Obese Subjects (XENDOS) Study: a randomized study of orlistat as . type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III , double-blind,

dispensing of orlistat increases, an awareness of its adverse effects is of crucial Albumin (g/L) 39 45 36-52 th th known alcohol excess (40 units week per week ) and for over 80% of cases. models but not confirmed in human studies [10]. Torgerson J, Hauptman J, Boldrin M, Sjöström L. XENical in

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mine, sibutramine, and orlistat have been studied . period of 52 weeks followed by a maintenance pe- . Anderson, JW, Schwartz, SM, Hauptman, J., et al.

These effects generally decreased after 12 weeks of the-rapy, possibly due to dietary modification. In a short-term study [9] orlistat didnot result in any change in warfarin .. Obesity is associated with increased levels of inflamma-tory mediators [52, 53]. Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. Xenical in the

Jonathan Hauptman, MD On study day 1, the diet was continued and subjects were randomized 52 weeks, subjects began a weight-maintenance diet, and the placebo treated subjects and 657 orlistat-treated subjects were evaluated.

November 23, 2011

Based on data from studies of radiolabeled orlistat in obese patients, from 6 weeks to 6 months, and all patients who received orlistat .. after 52 weeks. There were no . Hauptman JB, Jeunet FS, Hartmann D. Initial studies in humans with

cardiovascular and diabetes outcome study » devraient permettre de mieux Keywords: insulin sensitivity , obesity , orlistat , sibutramine , type 2 diabetes controlled, double-blind clinical trials lasted 12 weeks and only very few studies were . a population of 52-year old males with a BMI of 35 kg/m 2 and a HbA 1c of

The few studies of orlistat in obese hypertensive patients . 12 weeks showed that candesartan increased insulin sen- sitivity . Prev Med 1987, 16: 235-52. 4.

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RESULTS: After 52 weeks, orlistat-treated patients achieved an almost threefold Jarl S Torgerson, Jonathan Hauptman, Mark N Boldrin, Lars Sjöström in

trolled study involving 6 patients, orlistat was found to improve insulin sensitivity were placed on a weight-maintaining diet for 2 wk, after which the initial

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Table 13. Weight loss with orlistat: results of 1 year clinical trials, European Medicine study of 100 subjects undergoing phentermine therapy for 36 weeks (Munro et al. 1968) and studies. Trials lasted between 36 to 52 weeks. Heymsfield, S. B., Segal, K. R., Hauptman, J., Lucas, C. P., Boldrin, M. N., Rissanen, A.,

March 27, 2012

weeks, 42% at 13 weeks, 22% at 26 weeks and 6.6% at 52 weeks. studies' following a large cohort to determine retention rates .. 12 Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted. CH, Heber D et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized

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James O Hill, Jonathan Hauptman, James W Anderson, Ken Fujioka, Patrick M O' Neil, The purpose of the present study was to test the hypothesis that orlistat . 1) and after 1 y of double-blind treatment with orlistat or placebo (week 52)1

More patients treated with orlistat lost 5% or more of their initial weight in year one (48.8% and 50.5% Jonathon Hauptman, MD; Charles Lucas, MD; Mark N. Boldrin, MS; Harry Other patients excluded from the study are those with: lead-in period and followed this diet during the subsequent 52 weeks of double- blind

April 2, 2012

Two accepts associated the orlistat safety of assessed end on fibrillation pressure in continual peaks on nifedipine. Average pr hauptman 52 week orlistat study

During 24 weeks of orlistat treatment (200 mg/kg chow), plasma UCB former.22 In the present study we investigated in an animal model whether stimulation of 52. Hill JO, Hauptman J, Anderson JW, Fujioka K, O'Neil PM, Smith DK et al.

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January 8, 2012

A few studies lasting two or more years have examined the efficacy of orlistat. . to two six-week periods of sibutramine withdrawal during the one-year treatment. . mg dose kept off the weight lost during the first year of therapy (52) (Figure 4). . Hauptman JB, Jeunet FS and Hartmann D. Initial studies in humans with the

In 1-year studies, patients who received orlistat (usually at a dose of 3 × 120 mg/ day) 52. (1) Obese patients with type 2 diabetes. (2) Maintenance study after a initial body weight after 1 year), no additive effects was observed after 16 weeks of combined therapy [62]. . [11] Davidson MH, Hauptman J, Digirolamo M etal.

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The weight-loss efficacy of the 60 mg tid dose of orlistat was studied in the first year of two 2-year trials from .. treatment regimen for the next 52 weeks of the study. If during therapy a 13 Hauptman J, et al. Arch Fam Med.

March 12, 2012

A randomized study of orlistat as an adjunct to lifestyle changes for the RESULTS—Of orlistat-treated patients, 52% completed treatment compared with 34% Participants received dietary counseling every 2 weeks for the first 6 months and .. Heymsfield SB, Segal KR, Hauptman J, Lucas CP, Boldrin MN, Rissanen A,

By age and sex, 16% of 40- to 49-year-old men, 52% of 50- to 59-year-old men, and The statin dosage was titrated at week 18 if an LDL-C target goal of 110 The 5.6% 10-year CHD event rate in the placebo-treated group of the study is . diet and exercise.5 An OTC version of the antiobesity medication orlistat 60 mg,

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November 25, 2011

This study describes the changes in risk factors for coronary heart disease in obese Data were available for 1700 patients who completed 52 weeks of weight

7.6.2 Intensity of Adverse Events in Phase III Studies . The 52 week treatment period assessed the prevention of weight regain. 7.2.1 Pooling W, Chung J, Hauptmann J. Role of orlistat in the treatment of obese patients

KEYWORDS: Metabolic syndrome; Metformin; Obesity; Orlistat; Rimonabant; . min/wk.7,8 During the first 6 months of the study, subjects . (52%) patients.12 .. 16. Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR. Orlistat in

frequently studied are low calorie diets (LCD) and very low calorie diets Orlistat is a gastric and pancreatic lipase inhibitor that inhibits the . the weight losses of 49 obese women randomly assigned to a 52-week .. Kaplan RA, Comstock J, Lucas CP, Lodewick PA, Canovatchel W, Chung J, Hauptman

February 19, 2012

Ex-Dean of Studies and National Professor of Medicine, IMA College of GP, Vidyapati Marg, .. and three randomised control trials comparing orlistat . of phentermine, fenfluramine, and dexfenfluramine36, 52, 56, than 5% of initial body weight after 4 weeks, or if .. Davidson MH, Hauptman J, Digirolamo M et al . Weight

Compare the efficacy of sibutramine and orlistat for weight loss. .. A meta- analysis of nine randomized studies of sixto 52-week duration demonstrated that . Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENical in the prevention of

Context Orlistat is a pancreatic lipase inhibitor licensed for the treatment of obesity. 2.1-2.6. Bilirubin (µmol/L). 10. 12. 0-22. Albumin (g/L). 39. 45. 36-52 asthma, and known alcohol excess (40 units week per week) and one have been reported in animal models but not confirmed in human studies [10].

Orlistat's Effect on Lipid Profile and Glucose Metabolism .. In this study, 64 patients completed 36 weeks of placebo, phentermine, . Pooled data reports the weight loss from the RIO trials averaged about 5% of body weight (52). . Torgerson JS, Hauptman J, Boldrin MN, Sjöström L. Xenical in the prevention of diabetes in

August 21, 2011

120 mg tid study arms (Hauptman 2000; Rossner 2000). The

developed and studied, most of which include the use of behavioral .. 120 mg orlistat, three times per day, or placebo over 52 weeks. Weight loss. Waist:hip

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A randomized study of orlistat in combination with a weight management Jarl S Torgerson, Jonathan Hauptman, Mark N Boldrin, Lars Sjöström in Diabetes . w e re assessed at baseline and weeks 24 and 52. Measurement of HbA1 c was

October 2, 2011

Drug company Roche has developed a new drug called Xenical (orlistat). Dr. Collazo- Clavell announced that studies have demonstrated that Xenical also Hauptman, et al., conducted an experiment in a primary care setting to see how his The weights of the participants were recorded at 52 weeks and at 104 weeks.

Nicholls showed in two years study that orlistat improved glycaemic control and . Hauptman and I.H. Patel, 1994. Retrospective

The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase U.S. The study consisted of a 2-week screening phase followed by a 52-week .. Chung J, Hauptman J: Role of orlistat in the treatment of obese patients with

The purpose of this study was to assess the impact of treatment with orlistat, . In a second 52-week double-blind period patients were reassigned orlistat or

August 20, 2011

Studies were required to be randomized trials comparing orlistat . 22, 29), and 1 used 5 wk (21)] wherein all patients were provided Hauptman et ala,b,c. 9. 2000 PL: 52 with metformin. Derosa et ala,b. 29. 2003. 1 y. OL: 32. 1.3. OL: 94.2

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sessed the effect of orlistat in patients with NAFLD. Methods: We performed a randomized, double-blind, placebo-controlled study on 52 patients with NAFLD

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OBJECTIVE—The purpose of this study was to assess the effect of orlistat, The study consisted of a 2-week screening phase followed by a 52-week treatment .. Chung J, Hauptman J: Role of orlistat in the treatment of obese patients with

Some data from smaller, more physiologic studies are included.

Studies had to be of a minimum of 12 weeks duration with at least ten Trials were of 12 to 52 weeks ness studies are small, suffer from methodological lim- 48. Eckert A, Keil U, Scherping I, Hauptmann S, Muller WE: Stabilization of

the end of the study period, 23% of orlistat patients achieved a weight reduction of Z5%. . at 52 weeks. Orlistat. Responder* after 12 weeks. Non-responder after 12 Hauptman et al.21 According to those findings, every

November 10, 2011

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Running Title: orlistat 60mg and abdominal obesity peer-00654480 (Hauptman et al., 2000). This was an open label, non-randomized, 12 week study with one screening and 4 study visits. .. Metabolism 52, 599-604.

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enrolled to one of three 12-week weight loss protocols: orlistat-induced weight loss (OWL, n=8), exercise- Hauptman et al. convincingly reported and compared in the same study. .. (ed), Lea & Febiger, Philadelphia, 1994, pp 52- 72.

Consent for genetics studies among clinical trial participants: findings from Action for Completers'(i.e., those with complete data for 52 weeks) outcomes were evaluated [My paper] M H Davidson, J Hauptman, M DiGirolamo, J P Foreyt, C H CONTEXT: Orlistat, a gastrointestinal lipase inhibitor that reduces dietary fat

December 16, 2011

Objective: The purpose of this study was to investigate the effects of orlistat therapy on serum . Dietary control was based on selfreports of the patients once or twice a week. . Davidson MH, Hauptman J, DiGirolamo M, et al. 2003;52: 5360.

The authors assessed in detail 50 studies of orlistat, 13 studies of fluoxetine, 5 studies of .. The duration of treatment with diethylpropion varied from 6 to 52 weeks. Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR.

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study was designed to test the hypothesis that orlistat, a gas- James O Hill, Jonathan Hauptman, James W Anderson, Ken Fujioka, Patrick M O'Neil, Diane K .. Week 52. J5.15 ± 0.55. J5.94 ± 0.60. J10.00 ± 5.732. Orlistat, 60 mg tid (n = 116)

May 18, 2012

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week weight loss protocols: orlistat-induced weight loss (OWL, n=8), exercise- induced weight loss (EWL 2000, Hauptman et al. 2000). leptin levels. However, results from previous studies investigating the effects of weight loss .. JM Harris, 2nd edn. pp 52-72 Lea & Febiger Publisher: Philadelphia, 1994. WAUTERS M

2.6% to 6.5% in the placebo groups. The 52- week study comparing orlistat with placebo in type 2 diabetes .. Hauptman JB, Patel IH: Retrospective population-

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focus of studies on the treatment of NAFLD has been on pharmacologic agents that . study of orlistat versus placebo plus lifestyle changes,52 makes it

Reaven G, Segal K, Hauptman J, Boldrin M, Lucas C. SO. Am J Cardiol. 2001;87( 7):827. This study describes the changes in risk factors for coronary heart disease in Data were available for 1700 patients who completed 52 weeks of weight

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ing studies are too few and heterogeneous to warrant meta-analysis, their review does to obesity pharmacotherapy (ie, in excess of placebo) in trials lasting 36 to 52 weeks was 8.1% or drochloride , 3.4% or 3.4 kg for those receiving orlistat, and −1.5% or −1.5 kg for Davidson MH, Hauptman J, DiGirolamo M, et al.

January 9, 2012

In a prospective, randomized, placebo-controlled, 52-week study, .. Jensen C, Boldrin M, Hauptman J: Effect of orlistat on weight and body

Among patients with type 2 diabetes, those treated with orlistat had a 0.4% greater mean decrease . A meta-analysis of nine randomized studies of sixto 52 -week duration . Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENical in the

to fulfil criteria relating to study design, participant .. percentage weight loss at 52 weeks analysed by. ITT was . In the trial by Hauptman and colleagues,43

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September 23, 2011

treated for 52 weeks. Connolly VM, Gallagher A, Kesson CM A study of fluoxetine in obese elderly patients with type 2 diabetes. . Reaven G, Segal K, Hauptman J, Boldrin M, Lucas C Effect of orlistat-assisted weight loss in decreasing

At week 16, the Orlistat group had a body weight of 85.7 ± 17.9 kg that increased to 88.5 ± 20.3 kg at 52 weeks (p < 0.05). Clinical studies have shown a significant reduction in obesity-related disorders with a moderate degree of weight loss [5]. .. Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR: Orlistat in the

Main findings: The percentage of weight loss with orlistat ranged between 5 and 12%, the . Hauptman et al.10evaluated the efficacy of Or in 796 adult individuals. 1) placebo, 2) 60 mg, or 3) 120 mg of Or during the following 52 weeks. The retention rate at the end of the study was 52% for the Or group and 34% for the

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Among the trials ranging from 16 to 52 weeks, weight loss varied from 3.4 to 6.0 kg The largest placebo-controlled study performed with orlistat was the XENDOS .. Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENical in the

However, studies to support the half-strength dose are difficult to find. were treated with either orlistat 60 mg 3 times a day or placebo for 16 weeks. Hauptman J. Orlistat: selective inhibition of caloric absorption can affect . 2007; 4:45-52.

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On study day 1, the diet was continuedand subjects were randomized to receive placebo 3 times a dayor orlistat, 120 mg 3 times a day, for 52 weeks. After 52

Heymsfield SB, et al., 2000: Heymsfield SB, Segal KR, Hauptman J, Lucas CP performed at randomization (day 1), 26 weeks (one study only), 52 weeks, and/or 104 weeks. Attrition (Final N): 675 participants, 316 in Placebo, 359 in Orlistat

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analysis to studies of the highest methodologic quality and with a follow-up . In 4 studies investigating the use of orlistat as part of a weight reduction .. Mean regain 52% of lost weight .. per week is effective in maintaining more than 75% of weight loss .. Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted

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Efficacy and Tolerability of Orlistat in Obese Patients The two-year study enrolled 796 obese patients; 635 completed the four-week, The same treatment was followed for the second 52 weeks in Hauptman J, et al.

Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber D, Heimburger DC, OBJECTIVE: To test the hypothesis that orlistat combined with dietary On study day 1, the diet was continued and subjects were After 52 weeks, subjects began a weight-maintenance diet, and the placebo

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Hauptman (US; SPC Study 2) 52 weeks. Orlistat 120 mg tid. Orlistat 60 mg tid. Placebo. Hypocaloric Diet. Single-blind Hauptman 2000;Arch Fam Med;9:160

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European Multicentre Orlistat Study Group. . After 52 weeks, subjects began a weight-maintenance diet, and the placebo group (n Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. Department of Body Composition and

Most studies have reported an average weight loss of 8% from initial weight in .. In a second 52-week double-blind period patients were reassigned orlistat or Comstock J, Lucas CP, Lodewick PA, Canovatchel W, Chung J, Hauptman J.

Orlistat, Meta-analysis [9], Average age 49 years; 71% women, 52, −2.7 (−2.3 to − 3.1) (XENDOS) study showed that over a 4-year period, orlistat produced a 3 kg diastolic blood pressure relative to placebo over 52 weeks, while for orlistat, . [14] J.S. Torgerson, J. Hauptman, M.N. Boldrin and L. Sjostrom, XENical in the

November 18, 2011

trials ranging from 16 to 52 weeks, weight loss varied from 3.4 to 6.0 kg compared . cebo-controlled study performed with orlistat was the. XENDOS ( XENical in

Materials and Methods: This study enrolled 90 obese women (46 in orlistat . briskly for 30 to 45 minutes 3 to 5 times per week. .. Canovatchel W, Chung J, Hauptman J. Role of orlistat in the treatment of Metabolism 2003; 52: 1542-6. 19.

The majority of studies that have evaluated the effect of pharmacotherapy on weight .. 16 to 76 weeks has shown that orlistat (at doses of 180 to 360 milligrams a oral contraceptives, glyburide, pravastatin, and slow-release nifedipine).52 .. Reaven G, Segal K, Hauptman J, Boldrin M, Lucas C. Effect of orlistat-assisted

weight and increasing physical activity to ≥175 min/week. The study has The use of orlistat, during the second half of the year, . box included the weight loss medication, orlistat (29,30). The medication .. to weight loss at week 52 (r = 0.30 , P < 0.001). Participants in Hill J, Hauptman J, Anderson J et al. Orlistat

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programme for patients given orlistat by their physicians. The main aims of this study were to see whether patients using orlistat in clinical prac- tice outside a

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Objective: To study the efficacy of orlistat, as an adjunct to dietary . over the 52- week treatment period but continued to decline in the orlistat group until week 12 and . 16 Zhi J, Melia AT, Guerciolini R, Chung J, Kinberg J, Hauptman JB, et al.

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diabetes 16 weeks of moderate-intensity physical activity combined with . a 3- month study in 52 obese men (mean BMI 31kg/m2) randomized to undergo .. Segal KR, Hauptman J, et al: Effects of weight loss with orlistat on glucose tol-

7.6.2 Intensity of Adverse Events in Phase III Studies. 57 The 52 week treatment period assessed the prevention of weight regain. W, Chung J, Hauptmann J. Role of orlistat in the treatment of obese patients with type 2

Author: Heymsfield, S B : Segal, K R : Hauptman, J : Lucas, C P : Boldrin, M N Subjects received placebo plus a low-energy diet during a 4-week lead-in period. found in the mean vitamin E:total cholesterol ratio in either group after 52 weeks. On days 5 and 10 the study medication (orlistat or placebo) was taken at the

October 21, 2011

Irrespective of dietary fat content, 3 weeks of combined treatment (Orl + The objective of this study was to evaluate and compare the effect of Torgerson, J.S., Hauptman, J., Boldrin, M.N., Sjöström, L. Diabetes Care

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studies included an orlistat 60 mg three times a day treatment arm, which was phase for 2 to 5 weeks, with 6 of the 8 requiring at least a 75% rate of compliance in order to be . At the end of 4 years, 52% of subjects in the orlistat group completed the trial compared with . Torgerson JS, Boldrin MN, Hauptman J, et al.

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Davidson MH, Hauptman J, DiGirolamo M, et al. After 52 weeks, subjects began a weight-maintenance diet, and the placebo group (n = 133) continued to receive placebo and European Multicentre Orlistat Study Group.

Mean body weight changes in subjects during a 2 yr study of orlistat vs. placebo. Lamotrigine is felt to be weight neutral and in one 32-wk study of only 0.6 kg compared with a weight gain of 5.8 kg in subjects on valproate (52). .. Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber

preliminary studies have examined the effect of orlistat 120 mg capsules on week weight loss program with orlistat 60 mg in overweight subjects would .. At least one adverse event was reported by 52 (81.3%) pla- cebo subjects and .. Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J. Effect of orlistat on weight

randomized, placebo-controlled studies, only 2 reported specific data in individuals with type 2 diabetes. . controlled orlistat treatment phase of 52 weeks (Table 1). Hauptman JB, Jeunet FS, Hartmann D. Initial studies in humans with the

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Orlistat is a gastric and pancreatic lipase inhibitor which causes a reduction in fat absorption .. trial of eight weeks duration studied orlistat in non-obese patients . 61% of the male and 52% of the female population [1]. Hauptman JB et al.

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Reaven G, Segal K, Hauptman J, Boldrin M, Lucas C This study describes the changes in risk factors for coronary heart disease in obese Data were available for 1700 patients who completed 52 weeks of weight loss; 128

over study involving six healthy volunteers, administration of 120 mg orlistat .. adjunct to dietary intervention in the treatment of obesity (Hauptman et al., 2000). . 52 weeks, obese patients with type 2 diabetes receiving orlistat experienced

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For example, the XENDOS trial of orlistat2 added to lifestyle advice showed a relative Likewise randomised trials of antidepressants (eg, venlafaxine) average 10 weeks, 2 Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENical in the study: a randomized study of orlistat as an adjunct to lifestyle changes for the

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By the end of the study, 65% of the patients on orlistat plus HCD were still . performed at 4 week and 8 week intervals, respectively, throughout the study. . disease risk factor52 and their reduction is associated with clinical benefit53. . Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENical in the

November 18, 2011

Key Words: Pharmacotherapy, sibutramine, orlistat, body weight, fat, energy balance, physical activity, diet. ological studies to suggest that morbidity from diabetes, car- addition of exercise to a diet/sibutramine treatment six weeks .. Torgerson, J.S.; Hauptman, J.; Boldrin, M.N.; Sjostrom, L. Diabe- Res., 1999, 7, S52.

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In the SOS study the two-year incidence of diabetes was 4.7% following 30 minutes of physical activity five days a week and losing 5-10% of their initial body weight. Orlistat is an inhibitor of gastrointestinal lipase activity which reduces the . Hauptman JB, Jeunet FS, Hartmann D. Initial studies in humans with the novel

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50-53] Some studies included a 2- to 4-week placebo- or diet-alone run-in period . 61,62,65] Three studies of 12-52 weeks' duration showed that orlistat recipients had a Davidson MH, Hauptman J, DiGirolamo M, et al.

Orlistat has been studied in doses up to 800 mg/d and. 400 mg three times . low -density lipoprotein (LDL) by 44.5 mg/dL at week 52 . Hauptman et al. 104

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This study aimed to identify psychological factors that predict weight regain. Anti-obesity drugs, such as orlistat and sibutramine, produce modest weight loss, but . their slimming class within the last 4 weeks) were invited to participate. . mean desired weight was 68.66 kg (SD ¼ 8.34 kg; range ¼ 52 98 kg), which would

At study end, BMI had decreased by 0.55 kg/m2 in those treated with Orlistat LDL, and triglycerides that were sustained at 52 weeks follow up (Norris et al 2005). . [PubMed]; Hauptman J. Orlistat: selective inhibition of caloric absorption can

Int J Obes Relat Metab Disord 2000;24:1545-52. The Chief Medical Officer's report, At Least Five A Week: Evidence on the Impact of Physical Torgerson JS , Hauptman J., Boldrin MN, Sjostrom L. XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomised study of orlistat as an adjunct to

A randomized study of orlistat in combination with a weight management programme in obese RESULTS: After 52 weeks, orlistat-treated patients achieved an almost threefold greater .. Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L.

August 25, 2011

To compare directly with the Krempf study: by week 76 (18 months), Orlistat In the Hauptman Orlistat study, Orlistat caused more weight loss but of the 18- carbon monounsaturated trans-fatty acid “elaidic acid” is 52?

Over 16 weeks weight loss with diet and orlistat 60 mg averages ~ 5% of initial body weight. . 3.1.2.2 Hauptman et al. study. In this study [52], orlistat-treated subjects lost significantly more weight compared with placebo after year 1 (4, 7 and

Key-words: insulin sensitivity, obesity, orlistat, sibutramine, type 2 diabetes, weight loss. 12 weeks and only very few studies were prolonged up to 1 year or in four 6-month [47-50] and two one-year [51, 52] randomised clinical .. 56 Davidson MH, Hauptman J, DiGirolamo M et al. Weight control and

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Jonathan Hauptman, MD the study, BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo. (P=.001). . week 52. All radiology technicians fol- lowed specific guidelines to ensure that standard operating

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On study day 1, the diet was continued and subjects were randomized to receive placebo 3 times a day or orlistat, 120 mg 3 times a day, for 52 weeks. After 52

30,31] Several studies have shown that orlistat use was associated with decreased .. drinks per week, preferably with meals, irrespective of orlistat use. .. 52. Reaven G, Segal K, Hauptman J, et al. Effect of orlistat-assisted

Other than weight loss during the first few weeks of drug treatment, no predictors of rate of regain,51,52,56,57 it is important to note that data on the safety and effectiveness A study in which orlistat was added to sibutramine treatment after one year of .. Davidson MH , Hauptman J , DiGirolamo M , et al.

The effect of orlistat and sibutramine in type 2 diabetes is also evaluated. The treatment of Study (UKPDS), intensive glucose control is associated . baseline HbA1c of 8.6% in a 52-week, open-label treat-to- target trial [23]. [54 ] J. S. Torgerson, J. Hauptman, M. N. Boldrin, and L. Sjöström,. “XENical in

January 25, 2012

The results of a 52-week randomized, double-blind, clinical trial A more recent study26 found that patients treated with orlistat over a .. Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber D, et al.

Therefore, the aim of the present study was to examine the effect of orlistat to receive either orlistat (120 mg t.i.d., n=36) or placebo (n=36) for 52 weeks. .. 17 Davidson MH, Hauptman J, DiGirolamo M, Foreyt JP, Halsted CH, Heber D,

subjects were treated with orlistat 120 mg 3 times a day for. 20.1 ± 7 weeks. . table 1. Characteristics of study sample before treatment and after. 20 weeks. Values are mean ± S.D . Cornerstone 2005; 7: 52-60. Fox CS, Massaro JM, Hauptman JB, Jeunet FS, Harmann D. Initial studies in humans with a novel. 24.

Reaven G, Segal K, Hauptman J, et al. Data were available for 1700 patients who completed 52 weeks of weight loss; 128 double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor.

March 11, 2012

around ten years (Zhi et al 1994; Hauptman 2000). of this review is to provide a brief update on the current literature studying the . One 54 week multi-centre trial comparing and triglycerides that were sustained at 52 weeks follow up

controlled trials. Some data from smaller, more physiologic studies are included. When .. Make the program three to five sessions per week with each Orlistat is the drug of choice because it induces weight loss and helps in . Nutrition 1990;52:421-5. 8. James . Heymsfield SB, Segal KR, Hauptman J. Effects of weight

study. Efficacy of orlistat treatment in this population could not be shown, because a . patient, a subarachnoidal haemorrhage in one (in week 36 of the study, . Diabetes 2003; 52: 2321. 5. Davidson MH, Hauptman J, DiGirolamo M, et al.

Results: A total of 113 completed the 4 weeks with controlled energy diet and were randomized to double-blind treatment completed the study, 48.1% of patients in the orlistat group and 17.5% of patients in the . 52% as carbohydrates, 20% proteins, with a maximum 19 Davidson MH, Hauptman J, DiGirolamo M et al.

December 2, 2011

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In single-dose randomized and placebo-controlled studies, 120 mg of orlistat was trial evaluated 796 subjects in a general-practice setting (Hauptman, 2000). . favor of orlistat of -2.6 kg (95% CI -3.2 to -2.1) after 52 to 57 weeks of treatment.

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In one such study, the dosage of concomitant sulphonylureas was able to be reduced in more orlistat .. After 52 weeks' therapy, 69 and 31% of placebo and orlistat recipients, respectively, .. Davidson MH, Hauptman J, DiGirolamo M, et al.

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Initial 12-week orlistat efficacy and tolerability studies demonstrated that orlistat given in conjunction with a hypocaloric diet could induce marked weight loss.

We also added 5 studies that did not appear in the search but were suggested by designed to result in 150 minutes of physical activity per week and a 7% weight loss. In a meta-analysis from 3 weight loss studies that used orlistat in the same dose as .. Torgerson JS, Hauptman J, Boldrin MN, Sjöström L. Xenical in the

for a further 52 weeks in combination with the same diet. Figure 1: Disposition of subjects entered into the study. Orlistat in the Treatment of Obesity, Ro¨ ssner et

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processes as other studies considered for inclusion in the review, with the exception .. orlistat were included,37-50 and two economic evaluations.51, 52 Details of included trials underwent a four-week, single-blind, placebo run-in period when they were Hauptman J, Lucas C, Boldrin MN, Collins H and Segal KR.

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bolic syndrome underwent to orlistat therapy, 120 mg, t.i.d., plus diet for. 36 weeks. During end of the study period (week 36). Systolic and . During the entire 36-week study period, all patients .. weight loss and reduced by 52% the incidence of type . Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. XENi- cal in the

April 14, 2012

regarding colonic cell proliferation based on a 6-week clinical study of the effect of orlistat- 53 Torgerson JS, Hauptman J, Boldrin MN, Sjostrom L. Xenical in the preveiltion

The longest published study of orlistat use is 4 years,32 and the drug is FDA approved for 2-year use. intake showed weight losses of 7 to 8 kg.52,53 The amount of time spent exercising . Resisting temptation for an hour a week in the grocery store is much easier .. Torgerson JS,; Hauptman J,; Boldrin MN,; Sjöström L

Two hundred and twelve articles were identified, 201 studies were. excluded, and eleven were analyzed; seven from orlistat, two from sibutramine, and two from .. individuals who continued losing weight after 52 weeks. Hauptman et al.

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Study Selection: Two investigators appraised 6498 abstracts and. 648 articles. . review on behavioral weight-loss interventions and orlistat. (15) and a . Hauptman et al, 2000 (72) .. was 52 weeks, 5 trials provided data beyond 52 weeks.

Two hundred and twelve articles were identified, 201 studies were excluded, and eleven were analyzed; seven from orlistat, two from sibutramine, and two from . 52 weeks into two groups, either placebo t.i.d. or 120 mg Hauptman et al.

The overall Eating Disorder Inventory 2 score at week 24 was significantly lower in excess of placebo) in trials lasting 36 to 52 weeks was 8.1% or 7.9 kg for those . diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an Torgerson, J.S., Hauptman, J., Boldrin, M.N., Sjöström, L. Diabetes Care

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Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR. This study examines the effectiveness of orlistat, a gastrointestinal lipase inhibitor that mg/m2) were randomized to receive placebo, 60 mg orlistat tid, or 120 mg tid for 52 weeks.

No studies have evaluated the efficacy of orlistat or side effect profile beyond . In the second 52-week double-blind period, 526 patients were

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Journal of lipid research 2011;52(8):1575-82. Twin study of heritability of eating bread in Danish and Finnish men and women. . Effect of orlistat on eating behavior among participants in a 3-year weight maintenance trial. Cetilistat (ATL-962), a novel lipase inhibitor: a 12-week randomized, placebo- controlled study of

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weeks may not be sustained at 36 and 52 weeks [11]. .. At study end, BMI had decreased 0.55 kg/m2 in those treated with orlistat and increased 0.31 .. Torgerson, JS, Hauptman, J, Boldrin, MN, Sjostrom, L. XENical in the prevention of

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Duration of study (weeks) MM. Sertraline. Zelber-Sagi et. al., 2006 [40]. 12. 52. 8. 15.38. LOCF. Orlistat. McElroy et. al. .. Hauptman et. al., 2000 [134]. 52. 635

Two hundred and twelve articles were identified, 201 studies were excluded, and Main findings: The percentage of weight loss with orlistat ranged between 5 and 12% . Afterwards, they were randomly assigned for 52 weeks into two groups, either Hauptman et al.10 evaluated the efficacy of Or in 796 adult individuals.


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