human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objective To assess the effect of orlistat plus diet compared with diet alone in promoting weight loss and blood pressure reduction in hypertensive , overweight/obese patients . Design A pragmatic r and omized , controlled trial . Setting Hypertension clinic of a university hospital . Patients Hypertensive patients aged 18–75 years with a body mass index greater than 25 kg/m2 . Interventions Orlistat 360 mg/day combined with a hypocaloric diet ( treatment group ) , or a calorie-restricted diet alone ( control group ) . Main outcome measures Primary outcomes were reductions in weight and blood pressure . Secondary outcomes were decreases in lipid and glucose concentrations . A subgroup analysis of the main outcomes among diabetic and non-diabetic patients was also performed . Results A total of 204 patients were included in the intention-to-treat analysis . After 12 weeks the orlistat group lost , on average , 3.7 kg and the control group lost 2.0 kg in weight ( P < 0.001 ) . Systolic ( SBP ) and diastolic ( DBP ) blood pressures decreased by 15.3 and 11.4 mmHg , respectively , in the group given orlistat plus a hypocaloric diet and by 11.6 and 5.2 mmHg , respectively , in the control group given the calorie-restricted diet alone ( P = 0.25 and P = 0.0004 , respectively ) . Fasting glucose ( 0.82 and 0.17 mmol/l , P = 0.01 ) and total cholesterol ( 0.85 and 0.56 mmol/l , P = 0.05 ) were reduced to a greater extent with orlistat than with diet alone . The mean reduction in triglycerides with orlistat plus the hypocaloric diet was 0.75 mmol/l and that in the control group was 0.30 mmol/l ( P = 0.28 ) ; the increases in high-density lipoprotein cholesterol were 0.05 and 0.00 mmol/l , respectively , in the two groups ( P = 0.17 ) . Treatment improved blood pressure and glucose control in the individuals with diabetes , but not in those without diabetes . Conclusion In both groups there was a reduction in weight , blood pressure and metabolic parameters . The orlistat group performed better in reducing weight , DBP , glucose and cholesterol . Results show that even a small reduction in weight helps to control blood pressure and glucose . The cost – benefit of the use of orlistat should be evaluated for hypertensive obese patients CONTEXT The prevalence of overweight and obesity in children and adolescents is increasing rapidly . In this population , behavioral therapy alone has had limited success in providing meaningful , sustained weight reduction , and pharmacological treatment has not been extensively studied . OBJECTIVE To determine the efficacy and safety of orlistat in weight management of adolescents . DESIGN , SETTING , AND PATIENTS Multicenter , 54-week ( August 2000-October 2002 ) , r and omized , double-blind study of 539 obese adolescents ( aged 12 - 16 years ; body mass index [ BMI ] > or=2 units above the 95th percentile ) at 32 centers in the United States and Canada . INTERVENTIONS A 120-mg dose of orlistat ( n = 357 ) or placebo ( n = 182 ) 3 times daily for 1 year , plus a mildly hypocaloric diet ( 30 % fat calories ) , exercise , and behavioral therapy . MAIN OUTCOME MEASURES Change in BMI ; secondary measures included changes in waist and hip circumference , weight loss , lipid measurements , and glucose and insulin responses to oral glucose challenge . RESULTS There was a decrease in BMI in both treatment groups up to week 12 , thereafter stabilizing with orlistat but increasing beyond baseline with placebo . At the end of the study , BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo ( P = .001 ) . Compared with 15.7 % of the placebo group , 26.5 % of participants taking orlistat had a 5 % or higher decrease in BMI ( P = .005 ) ; 4.5 % and 13.3 % , respectively , had a 10 % or higher decrease in BMI ( P = .002 ) . At study end , weight had increased 0.53 kg with orlistat and 3.14 kg with placebo ( P<.001 ) . Dual-energy x-ray absorptiometry showed that this difference was explained by changes in fat mass . Waist circumference decreased in the orlistat group but increased in the placebo group ( -1.33 cm vs + 0.12 cm ; P<.05 ) . Generally mild to moderate gastrointestinal tract adverse events occurred in 9 % to 50 % of the orlistat group and in 1 % to 13 % of the placebo group . CONCLUSIONS In combination with diet , exercise , and behavioral modification , orlistat statistically significantly improved weight management in obese adolescents compared with placebo . The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group OBJECTIVE : To evaluate the effectiveness of a culturally appropriate lifestyle intervention combined with orlistat in producing weight loss with obese Mexican-American women . SUBJECTS : Mexican-American women ( N=108 ) , aged 21–65 y , with a body mass index ( BMI ) ≥27 kg/m2 were r and omized to 1 y of treatment with  orlistat and a culturally tailored lifestyle modification intervention ( OLM ; n=56 ) or a wait-list control group ( WLC ; n=52 ) . DESIGN : A r and omized , controlled , open-label 12-month study . Orlistat was dosed at 120 mg , three times per day . The OLM intervention included behavior modification , a low-fat ( ≤30 % of total daily calories ) diet , and moderate physical activity ( ≥150 min/week).MEASUREMENT : Primary outcomes included changes in body weight ( kg ) , BMI , waist circumference , blood pressure , glucose , and lipids . RESULTS : A total of 72 ( 37 OLM , 35 WLC ) and 66 participants ( 32 OLM , 34 WLC ) completed the 6- and 12-month follow-ups , respectively . Repeated- measures ANOVA demonstrated a significant time × treatment interaction ( Wilks ' λ=12.61 ; P<0.001 ) , indicating that OLM-treated patients achieved significant weight loss relative to the WLC group during the study ( mean percentage weight loss±s.e.m . ; −8.1%±1.2 vs −1.6%±0.7 at 6 months and −8.8%±1.5 vs −0.2%±1.0 at 12 months , respectively ) . OLM-treated patients also experienced significant reductions in waist circumference , low-density-lipoprotein , and total cholesterol . CONCLUSIONS : This study demonstrates the effectiveness of an intervention combining orlistat and lifestyle modification with Mexican-American women , a population with substantial risk for obesity BACKGROUND Long-term maintenance of weight loss remains a therapeutic challenge in obesity treatment . OBJECTIVE This multicenter , double-blind , placebo-controlled study was design ed to test the hypothesis that orlistat , a gastrointestinal lipase inhibitor , is significantly more effective than a placebo in preventing weight regain . DESIGN Obese subjects who lost > or = 8 % of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet ( 4180-kJ/d deficit ) with no adjunctive pharmacotherapy  were r and omly assigned to receive placebo , 30 mg orlistat , 60 mg orlistat , or 120 mg orlistat 3 times daily for 1 y in combination with a maintenance diet to help prevent weight regain . Of 1313 recruited subjects [ body mass index ( in kg/m2 ) : 28 - 43 ] , 729 subjects lost > or = 8 % of their initial body weight during the 6-mo weight-loss lead-in period and were enrolled in the double-blind phase . RESULTS After 1 y , subjects treated with 120 mg orlistat 3 times daily regained less weight than did placebo-treated subjects ( 32.8 + /- 4.5 % compared with 58.7 + /- 5.8 % regain of lost weight ; P < 0.001 ) . Moreover , more subjects in the 120-mg orlistat group than in the placebo group regained < or = 25 % of lost weight ( 47.5 % of subjects compared with 29.9 % ) . In addition , orlistat treatment ( 120 mg 3 times daily ) was associated with significantly greater reductions in total and LDL-cholesterol concentrations than was placebo ( P < 0.001 ) . CONCLUSION The use of orlistat during periods of attempted weight maintenance minimizes weight readjustment and facilitates long-term improvement in obesity-related disease risk factors The objective of this study was to quantify the effectiveness of orlistat plus a reduced calorie diet on decreasing cardiovascular disease risk in obese individuals with elevated low-density lipoprotein ( LDL ) cholesterol concentrations , and to compare the beneficial effects in patients with hypercholesterolemia only ( type IIA ) with those in subjects with combined dyslipidemia ( type IIB ) . Hypercholesterolemic patients treated with orlistat lost more weight ( mean + /- SEM 9.9 + /- 0.4 vs 6.1 + /- 0.5 kg , p = 0.0001 ) and had greater decreases in plasma cholesterol ( p = 0.0001 ) , LDL cholesterol ( p = 0.0001 ) , triglycerides ( p = 0.06 ) , glucose ( p = 0.07 ) , and insulin ( p = 0.02 ) concentrations compared with the diet-only treated patients . The greater degree of weight loss in orlistat-treated subjects was similar irrespective of the form of dyslipidemia , and plasma total and LDL cholesterol and insulin levels decreased to a significantly greater degree ( p < 0.05 ) in those patients who received orlistat and who had either type IIA and IIB dyslipidemia . However , triglyceride and insulin concentrations decreased and high-density lipoprotein ( HDL ) cholesterol increased to a significantly greater degree following orlistat-assisted weight loss in patients with type IIB compared with type IIA subjects , which was associated with a significantly greater decrease in the ratio of LDL/HDL cholesterol . Thus , weight loss in response to a reduced calorie diet in obese hypercholesterolemic patients was associated with a significant decrease in plasma LDL cholesterol levels . The beneficial metabolic effects of weight loss were accentuated in response to orlistat administration , and the improvement was greatest in patients with combined dyslipidemia ( type IIB ) Aim : 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 Background : Orlistat reduces energy uptake by the impairment of fat digestion and some evidence indicates it also lowers plasma cholesterol OBJECTIVE The aim of this study was to assess obese patients with hypercholesterolemia whom were prescribed a st and ardized diet , comparing the action of orlistat , fluvastatin , orlistat with fluvastatin , and placebo on anthropometric measurements , blood pressure ( BP ) , and lipid profile . METHODS This was a 1-year , r and omized , double-blind , placebo-controlled trial . The patients were prescribed a controlled-energy diet and were r and omly allocated to receive placebo , orlistat 120 mg TID ( O group ) , fluvastatin 80 mg/d ( F group ) , or olistat 120 mg TID with fluvastatin 80 mg/d ( OF group ) . Clinical measurements ( body weight , body mass index [ BMI ] , waist circumference , and BP ) and lipid profile assessment ( total cholesterol [ TC ] , low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , and triglycerides [ TGs ] ) were performed at baseline and after 6 months and 1 year of treatment . RESULTS The study included 99 obese patients with hypercholesterolemia ( 48 men and 51 women ; mean [ SD ] age , 51 [ 9 ] years ) . There were no significant differences between groups in baseline demographic , BP , or plasma lipid values . Three patients dropped out ( 2 women in the O group and 1 man in the OF group ) due to adverse events related to orlistat treatment , including gastrointestinal events ( oily spotting and fecal urgency ) .  Ninety-six patients completed the study . There were significant differences from baseline ( mean [ SD ] ) in BMI , waist circumference reduction ( WCR ) , and body weight loss ( BWL ) at 6 months in the OF group ( 29.9 [ 1.1 ] kg/m(2 ) , 2.7 [ 0.8 ] cm , and 7.4 [ 0.9 ] kg 
    Output:
    
agent
Orlistat  reduced body weight ( weighted mean difference : −2.12 , p < 0.001 ) , total‐cholesterol ( weighted mean difference : −0.30 mmol/L , p < 0.001 ) , low‐density lipoprotein cholesterol ( weighted mean difference : −0.27 mmol/L , p < 0.001 ) , high‐density lipoprotein cholesterol ( weighted mean difference : −0.034 mmol/L , p < 0.001 ) and triglyceride ( weighted mean difference : −0.09 mmol/L , p < 0.001 ) concentrations , while no effect on lipoprotein(a ) was observed .
Total‐ and low‐density lipoprotein cholesterol‐lowering were associated negatively with duration of orlistat treatment and positively with body weight changes .
In conclusion , Orlistat treatment slightly reduces cholesterol and triglyceride levels , but not lipoprotein(a ) levels .
Total‐ and low‐density lipoprotein cholesterol levels reductions are more consistent in patients with greater body weight reduction and shorter duration of orlistat treatment .
We investigated the efficacy of orlistat on plasma lipids and body weight in a meta‐ analysis of 33 studies including 9732  participants .Orlistat  was associated with a slight but significant decrease in body weight , plasma cholesterol and triglyceride concentrations , whereas plasma Lp(a ) levels were not affected by orlistat treatment .
Greater body weight reduction and lower duration of orlistat treatment promoted more consistent plasma total‐ and LDL‐cholesterol lowering
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objective To assess the effect of orlistat plus diet compared with diet alone in promoting weight loss and blood pressure reduction in hypertensive , overweight/obese patients . Design A pragmatic r and omized , controlled trial . Setting Hypertension clinic of a university hospital . Patients Hypertensive patients aged 18–75 years with a body mass index greater than 25 kg/m2 . Interventions Orlistat 360 mg/day combined with a hypocaloric diet ( treatment group ) , or a calorie-restricted diet alone ( control group ) . Main outcome measures Primary outcomes were reductions in weight and blood pressure . Secondary outcomes were decreases in lipid and glucose concentrations . A subgroup analysis of the main outcomes among diabetic and non-diabetic patients was also performed . Results A total of 204 patients were included in the intention-to-treat analysis . After 12 weeks the orlistat group lost , on average , 3.7 kg and the control group lost 2.0 kg in weight ( P < 0.001 ) . Systolic ( SBP ) and diastolic ( DBP ) blood pressures decreased by 15.3 and 11.4 mmHg , respectively , in the group given orlistat plus a hypocaloric diet and by 11.6 and 5.2 mmHg , respectively , in the control group given the calorie-restricted diet alone ( P = 0.25 and P = 0.0004 , respectively ) . Fasting glucose ( 0.82 and 0.17 mmol/l , P = 0.01 ) and total cholesterol ( 0.85 and 0.56 mmol/l , P = 0.05 ) were reduced to a greater extent with orlistat than with diet alone . The mean reduction in triglycerides with orlistat plus the hypocaloric diet was 0.75 mmol/l and that in the control group was 0.30 mmol/l ( P = 0.28 ) ; the increases in high-density lipoprotein cholesterol were 0.05 and 0.00 mmol/l , respectively , in the two groups ( P = 0.17 ) . Treatment improved blood pressure and glucose control in the individuals with diabetes , but not in those without diabetes . Conclusion In both groups there was a reduction in weight , blood pressure and metabolic parameters . The orlistat group performed better in reducing weight , DBP , glucose and cholesterol . Results show that even a small reduction in weight helps to control blood pressure and glucose . The cost – benefit of the use of orlistat should be evaluated for hypertensive obese patients CONTEXT The prevalence of overweight and obesity in children and adolescents is increasing rapidly . In this population , behavioral therapy alone has had limited success in providing meaningful , sustained weight reduction , and pharmacological treatment has not been extensively studied . OBJECTIVE To determine the efficacy and safety of orlistat in weight management of adolescents . DESIGN , SETTING , AND PATIENTS Multicenter , 54-week ( August 2000-October 2002 ) , r and omized , double-blind study of 539 obese adolescents ( aged 12 - 16 years ; body mass index [ BMI ] > or=2 units above the 95th percentile ) at 32 centers in the United States and Canada . INTERVENTIONS A 120-mg dose of orlistat ( n = 357 ) or placebo ( n = 182 ) 3 times daily for 1 year , plus a mildly hypocaloric diet ( 30 % fat calories ) , exercise , and behavioral therapy . MAIN OUTCOME MEASURES Change in BMI ; secondary measures included changes in waist and hip circumference , weight loss , lipid measurements , and glucose and insulin responses to oral glucose challenge . RESULTS There was a decrease in BMI in both treatment groups up to week 12 , thereafter stabilizing with orlistat but increasing beyond baseline with placebo . At the end of the study , BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo ( P = .001 ) . Compared with 15.7 % of the placebo group , 26.5 % of participants taking orlistat had a 5 % or higher decrease in BMI ( P = .005 ) ; 4.5 % and 13.3 % , respectively , had a 10 % or higher decrease in BMI ( P = .002 ) . At study end , weight had increased 0.53 kg with orlistat and 3.14 kg with placebo ( P<.001 ) . Dual-energy x-ray absorptiometry showed that this difference was explained by changes in fat mass . Waist circumference decreased in the orlistat group but increased in the placebo group ( -1.33 cm vs + 0.12 cm ; P<.05 ) . Generally mild to moderate gastrointestinal tract adverse events occurred in 9 % to 50 % of the orlistat group and in 1 % to 13 % of the placebo group . CONCLUSIONS In combination with diet , exercise , and behavioral modification , orlistat statistically significantly improved weight management in obese adolescents compared with placebo . The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group OBJECTIVE : To evaluate the effectiveness of a culturally appropriate lifestyle intervention combined with orlistat in producing weight loss with obese Mexican-American women . SUBJECTS : Mexican-American women ( N=108 ) , aged 21–65 y , with a body mass index ( BMI ) ≥27 kg/m2 were r and omized to 1 y of treatment with  orlistat and a culturally tailored lifestyle modification intervention ( OLM ; n=56 ) or a wait-list control group ( WLC ; n=52 ) . DESIGN : A r and omized , controlled , open-label 12-month study . Orlistat was dosed at 120 mg , three times per day . The OLM intervention included behavior modification , a low-fat ( ≤30 % of total daily calories ) diet , and moderate physical activity ( ≥150 min/week).MEASUREMENT : Primary outcomes included changes in body weight ( kg ) , BMI , waist circumference , blood pressure , glucose , and lipids . RESULTS : A total of 72 ( 37 OLM , 35 WLC ) and 66 participants ( 32 OLM , 34 WLC ) completed the 6- and 12-month follow-ups , respectively . Repeated- measures ANOVA demonstrated a significant time × treatment interaction ( Wilks ' λ=12.61 ; P<0.001 ) , indicating that OLM-treated patients achieved significant weight loss relative to the WLC group during the study ( mean percentage weight loss±s.e.m . ; −8.1%±1.2 vs −1.6%±0.7 at 6 months and −8.8%±1.5 vs −0.2%±1.0 at 12 months , respectively ) . OLM-treated patients also experienced significant reductions in waist circumference , low-density-lipoprotein , and total cholesterol . CONCLUSIONS : This study demonstrates the effectiveness of an intervention combining orlistat and lifestyle modification with Mexican-American women , a population with substantial risk for obesity BACKGROUND Long-term maintenance of weight loss remains a therapeutic challenge in obesity treatment . OBJECTIVE This multicenter , double-blind , placebo-controlled study was design ed to test the hypothesis that orlistat , a gastrointestinal lipase inhibitor , is significantly more effective than a placebo in preventing weight regain . DESIGN Obese subjects who lost > or = 8 % of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet ( 4180-kJ/d deficit ) with no adjunctive pharmacotherapy  were r and omly assigned to receive placebo , 30 mg orlistat , 60 mg orlistat , or 120 mg orlistat 3 times daily for 1 y in combination with a maintenance diet to help prevent weight regain . Of 1313 recruited subjects [ body mass index ( in kg/m2 ) : 28 - 43 ] , 729 subjects lost > or = 8 % of their initial body weight during the 6-mo weight-loss lead-in period and were enrolled in the double-blind phase . RESULTS After 1 y , subjects treated with 120 mg orlistat 3 times daily regained less weight than did placebo-treated subjects ( 32.8 + /- 4.5 % compared with 58.7 + /- 5.8 % regain of lost weight ; P < 0.001 ) . Moreover , more subjects in the 120-mg orlistat group than in the placebo group regained < or = 25 % of lost weight ( 47.5 % of subjects compared with 29.9 % ) . In addition , orlistat treatment ( 120 mg 3 times daily ) was associated with significantly greater reductions in total and LDL-cholesterol concentrations than was placebo ( P < 0.001 ) . CONCLUSION The use of orlistat during periods of attempted weight maintenance minimizes weight readjustment and facilitates long-term improvement in obesity-related disease risk factors The objective of this study was to quantify the effectiveness of orlistat plus a reduced calorie diet on decreasing cardiovascular disease risk in obese individuals with elevated low-density lipoprotein ( LDL ) cholesterol concentrations , and to compare the beneficial effects in patients with hypercholesterolemia only ( type IIA ) with those in subjects with combined dyslipidemia ( type IIB ) . Hypercholesterolemic patients treated with orlistat lost more weight ( mean + /- SEM 9.9 + /- 0.4 vs 6.1 + /- 0.5 kg , p = 0.0001 ) and had greater decreases in plasma cholesterol ( p = 0.0001 ) , LDL cholesterol ( p = 0.0001 ) , triglycerides ( p = 0.06 ) , glucose ( p = 0.07 ) , and insulin ( p = 0.02 ) concentrations compared with the diet-only treated patients . The greater degree of weight loss in orlistat-treated subjects was similar irrespective of the form of dyslipidemia , and plasma total and LDL cholesterol and insulin levels decreased to a significantly greater degree ( p < 0.05 ) in those patients who received orlistat and who had either type IIA and IIB dyslipidemia . However , triglyceride and insulin concentrations decreased and high-density lipoprotein ( HDL ) cholesterol increased to a significantly greater degree following orlistat-assisted weight loss in patients with type IIB compared with type IIA subjects , which was associated with a significantly greater decrease in the ratio of LDL/HDL cholesterol . Thus , weight loss in response to a reduced calorie diet in obese hypercholesterolemic patients was associated with a significant decrease in plasma LDL cholesterol levels . The beneficial metabolic effects of weight loss were accentuated in response to orlistat administration , and the improvement was greatest in patients with combined dyslipidemia ( type IIB ) Aim : 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 Background : Orlistat reduces energy uptake by the impairment of fat digestion and some evidence indicates it also lowers plasma cholesterol OBJECTIVE The aim of this study was to assess obese patients with hypercholesterolemia whom were prescribed a st and ardized diet , comparing the action of orlistat , fluvastatin , orlistat with fluvastatin , and placebo on anthropometric measurements , blood pressure ( BP ) , and lipid profile . METHODS This was a 1-year , r and omized , double-blind , placebo-controlled trial . The patients were prescribed a controlled-energy diet and were r and omly allocated to receive placebo , orlistat 120 mg TID ( O group ) , fluvastatin 80 mg/d ( F group ) , or olistat 120 mg TID with fluvastatin 80 mg/d ( OF group ) . Clinical measurements ( body weight , body mass index [ BMI ] , waist circumference , and BP ) and lipid profile assessment ( total cholesterol [ TC ] , low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , and triglycerides [ TGs ] ) were performed at baseline and after 6 months and 1 year of treatment . RESULTS The study included 99 obese patients with hypercholesterolemia ( 48 men and 51 women ; mean [ SD ] age , 51 [ 9 ] years ) . There were no significant differences between groups in baseline demographic , BP , or plasma lipid values . Three patients dropped out ( 2 women in the O group and 1 man in the OF group ) due to adverse events related to orlistat treatment , including gastrointestinal events ( oily spotting and fecal urgency ) .  Ninety-six patients completed the study . There were significant differences from baseline ( mean [ SD ] ) in BMI , waist circumference reduction ( WCR ) , and body weight loss ( BWL ) at 6 months in the OF group ( 29.9 [ 1.1 ] kg/m(2 ) , 2.7 [ 0.8 ] cm , and 7.4 [ 0.9 ] kg 
    Output:
    