***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*** 
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    Input: AIM To assess the efficacy and tolerability of sibutramine 15 mg once daily as a weight reduction agent in overweight and obese patients ( body mass index ( b.m.i . ) > 26 kg/m2 ) with type 2 diabetes when given with a customised , reduced-calorie diet , and to evaluate the influence of weight loss on diabetic control . METHODS R and omised , placebo-controlled , double-blind , parallel-group , 12-week study conducted at two hospital-based obesity/diabetes clinics . Patients were men and women aged 30 - 65 years , with b.m.i . > 26 kg/m2 and < or = 35 kg/m2 and treated or untreated type 2 diabetes diagnosed > or = 6 months previously . Each patient was given sibutramine 15 mg or placebo once daily and advised to follow a customised diet of 500 kcal/day less than the individual 's energy needs . The principal measure of efficacy was change in body weight ( b.w . ) . Additional efficacy measurements were changes in b.m.i . , body composition as measured by dual-energy X-ray absorptiometry , and change in waist and hip measurements . Changes in diabetic control were assessed by blood glucose levels fasting and after a st and ard test meal , fasting insulin level , and glycosylated haemoglobin level . Adverse events ( AEs ) were monitored at each visit , and routine laboratory safety tests were done at 4-week intervals . RESULTS Ninety-one patients were r and omised into the study , 44 to placebo and 47 to sibutramine 15 mg once daily . Eighty-three patients ( 91 % ) completed the study , 40 ( 91 % ) on placebo and 43 ( 91 % ) on sibutramine .  Mean weight reduction from baseline was statistically significantly greater with sibutramine than with placebo at every measurement and at the end of the study ( 2.4 vs. 0.1 kg at week 12 ; p < 0.001 ; intent-to-treat ) . The proportion of patients who lost > 5 % of their baseline b.w . was 19 % in the sibutramine group and 0 % in the placebo group ( p < 0.001 ; 95 % confidence interval : 9 , 30 ) . Patients receiving sibutramine lost significantly more fat mass compared with those receiving placebo , as a percentage ( 1.0 % vs. 0.1 % ; p < 0.05 ) and in absolute terms ( 1.8 vs. 0.2 kg , p < 0.001 ) . Loss of lean mass was not significantly different between the groups . Mean peak blood glucose concentration after a st and ard test meal decreased by 1.1 mmol/l in the sibutramine treatment group but increased by 0.5 mmol/l in the placebo group ( p = 0.04 ; difference in means , 1.6 , 95 % confidence interval : -3.3 , -0.1 ) . Mean fasting blood glucose decreased by 0.3 mmol/l with sibutramine and increased by 1.4 mmol/l with placebo .  Mean glycosylated haemoglobin levels decreased by 0.3 % units with sibutramine treatment , and were unchanged with placebo . However , more sibutramine-treated patients ( 33 % ) than placebo-treated patients ( 5 % ) achieved decreases in glycosylated haemoglobin of 1 % unit or more ( p < 0.05 ) . Sibutramine 15 mg was safe and well tolerated , and AEs were mostly mild or moderate in severity . No significant differences were found between treatment groups in blood pressure . No clinical ly significant conduction or rhythm abnormalities were observed on ECG . CONCLUSIONS Sibutramine 15 mg once daily with a customised , reduced-calorie diet significantly reduced weight compared with placebo in overweight and obese patients ( b.m.i . > 26 kg/m2 ) with type 2 diabetes . Sibutramine was well tolerated , and significant improvement in diabetic control was seen in conjunction with weight reduction on sibutramine treatment AIMS Orlistat promotes weight loss in overweight and obese patients with Type 2 diabetes receiving hypoglycaemic treatment , but has not been investigated in patients with newly diagnosed and previously untreated Type 2 diabetes . We evaluated the efficacy of 24 weeks ' treatment with orlistat , combined with a mildly reduced-calorie diet , on weight loss and glycaemic control in overweight and obese patients with newly diagnosed and previously untreated Type 2 diabetes . METHODS A total of 249 Chinese patients ( body mass index 25 - 40 kg/m2 ) with recently diagnosed Type 2 diabetes were r and omized to placebo ( n=124 ) or orlistat 120 mg ( n=125 ) three times daily ; all patients followed a mildly reduced-calorie diet .  Patients had HbA1c 6.5 - 8.5 % ( mean 7.3 % ) and had never received any glucose-lowering medication . RESULTS Orlistat-treated patients achieved significantly greater weight loss at the study end than placebo-treated patients ( -5.4 vs. -2.4 kg ; P<0.0001 ) . More orlistat than placebo patients lost > or=5 % ( 60.5 vs. 26.8 % ; P<0.0001 ) and > or=10 % of their body weight ( 20.2 vs. 4.9 % ; P=0.0002 ) . A significantly greater decrease in HbA(1c ) from baseline was obtained with orlistat than placebo ( -1.0 vs. -0.6 % ; P=0.0008 ) . Orlistat-treated patients achieved a significantly greater decrease in fasting plasma glucose ( -1.3 vs. -0.5 mmol/l ; P=0.0003 ) and in the 2-h oral glucose tolerance test ( -4.1 vs. -1.4 mmol/l ; P<0.0001 ) than placebo recipients . Also , more orlistat- than placebo-treated patients improved from diabetic status to normal or impaired glucose tolerance ( 44.3 vs. 32.5 % ; P=0.0763 ) after 24 weeks . Orlistat also produced improvements in lipid profiles and waist circumference . CONCLUSIONS In combination with a mildly reduced-calorie diet , orlistat significantly reduces body weight , and improves glycaemic control and several cardiovascular risk factors in overweight and obese Chinese patients with newly diagnosed Type 2 diabetes Obesity is associated with major health risks and a high economic burden impacting on health care systems . This study utilises the latest evidence from r and omised clinical trials ( RCTs ) to explore and to assess the cost effectiveness of sibutramine in combination with diet and lifestyle advice compared to diet and lifestyle advice alone for the treatment of obese subjects without comorbidities at baseline in Germany . New evidence from recently published RCTs and post-marketing surveillance studies , including health economic data as well as quality of life ( QoL ) data , were used to model the long-term outcomes of weight management with sibutramine in German practice . German healthcare costs and new data from over 8,000 patients were analysed based on a recently published model . These new RCT data were used to model weight losses , proportion of responders to treatment , utilities by weight loss and variability in weight regain post-treatment . Costs and QoL benefits associated with weight loss ( using SF-36 data from sibutramine trials ) , reduced incidence of coronary heart disease ( using Framingham equations ) and diabetes were used to estimate the cost per quality adjusted life year of sibutramine treatment . For 1,000 patients treated with sibutramine for 1 year , extrapolating outcomes over 4 further years , sibutramine is estimated to save 4.18 CHD events , 2.58 diabetes incident cases and give 51.5 more quality -adjusted life years ( QALYs ) . The cost-utility analysis ( CUA ) estimates € 13,706 per QALY gained . Results are sensitive to changes in weight loss , rate of weight regain and discounting rate . Although the non-pharmacological weight management programme in the comparator arm yielded higher weight losses than generally observed in clinical practice , these results demonstrate that additional sibutramine treatment is a cost effective therapy for an obese population without comorbidities in Germany . The CUA results are within the range generally accepted as cost effective and should be viewed as conservative when generalizing to setting s offering st and ard non-pharmacological treatment The 1990 guidelines for adult weight published by the U.S. Department of Agriculture [ 1 ] recommend higher weights than previous st and ards . In particular , the guidelines for increased weight ( about 7 kg on average ) for persons age 35 years and older , with allowance for major weight gain in midlife , have stimulated much debate [ 2 - 4 ] . The basis for these recommendations is unclear . The report by And res [ 5 ] on which the recommendations may be based is fundamentally flawed because it ignored cigarette smoking . Although no apparent biological rationale exists for suggesting that persons increase their weight as they grow older , the health consequences of weight gain during adult life have not been clearly documented . In general , a strong association between body mass index and the risk for noninsulin-dependent diabetes mellitus has been observed . However , few studies have examined the consequences of weight gain during various periods of life . From a public health perspective , weight and weight gain are more easily understood than body mass index . Also , using change in weight as a basis for recommendations is attractive because it allows for differences in frame size , which are difficult to characterize . For these reasons , we quantified the relations between change in adult weight and the risk for noninsulin-dependent diabetes mellitus among women during 14 years of follow-up . We previously reported the relation between body mass index and clinical diabetes in this cohort after 8 years of follow-up [ 6 ] . Methods Established in 1976 , the Nurses ' Health Study cohort consists of 121 700 female registered nurses aged 30 to 55 years who responded to a mail question naire about their medical history and health behaviors .  Additional details have been reported elsewhere [ 7 ] . The participants for our study were the 114 824 women who did not have diagnosed diabetes mellitus , coronary heart disease , stroke , or cancer when the cohort was enrolled in 1976 . On the basis of a sub sample of participants , we estimate that 98 % of the participants are white , a percentage that reflects the ethnic background of women trained as registered nurses before 1977 [ 8 ] . Ascertainment of Risk Factors Height and weight were ascertained on the 1976 question naire . On biennial follow-up question naires , we inquired about current weight and asked for information on whether diabetes mellitus , coronary heart disease , cancer , or other major illnesses had been diagnosed during the 2 years since the previous question naire . In 1980 , we asked women to record their weight at age 18 years , and in 1982 we inquired about a history of diabetes in the participants ' mothers , fathers , brothers , or sisters . Weight reported by the participants in this study has been shown to be highly valid in two sample s of Boston-area study participants . Self-reported current weight was highly correlated with measured weight ( Spearman correlation coefficient , 0.97 ) ; the average measured weight was 1.5 kg lower [ 9 , 10 ] . In a sub study done in a cohort of nurses aged 27 to 44 years , recalled weight at age 18 years was compared with self-reported weights at ages 17 to 21 years that were recorded on nursing-school physical examination forms . The mean recalled self-reported body mass index was 21.6 kg/m2 compared with an index of 22.1 kg/m2 noted on the examination records ( mean difference in weight , 1.4 kg ) . The Pearson correlation coefficient for weight was 0.87 and was independent of current age . Participants in the Nurses ' Health Study cohort weighed , on average , 3 kg less than a national sample of women in 1976 [ 11 ] . We used body mass index ( weight in kg divided by height in m2 ) as an index of relative weight and grouped it into 10 categories using whole-number cutpoints . We divided weight change between age 18 years and 1976 into eight categories . A body mass index of 24.0 kg/m2 represents the 50th percentile for middle-aged , white U.S. women , and an index of 29.0 kg/m2 represents the 75th percentile [ 11 ] . Diagnosis of Diabetes Mellitus We mailed supplementary question naires on  symptoms , diagnostic tests , and therapy for hypoglycemia  to women who responded positively on any follow-up question naire to the query Have you had physician-diagnosed diabetes mellitus ? The supplementary question naires were mailed in 1984 to women who reported that diabetes had been diagnosed between 1976 and 1984 and in 1986 , 1988 , and 1990 to women who reported diabetes on the question naires in those years . We excluded women who reported that diabetes had been diagnosed before they entered the study in 1976 . An incident case of diabetes was confirmed if at least one of the following was reported on the supplementary question naire : 1 ) one or more classic symptoms ( thirst , polyuria , weight loss , hunger , pruritus ) plus a fasting plasma glucose level of at least 140 mg/dL ( 7 
    Output:
    
Overall , the results show that the active drug interventions are all effective at reducing weight and BMI compared with placebo .
The results of the cost-effectiveness analyses suggest that sibutramine 15 mg dominates the other three active interventions and the net benefit analyses show that sibutramine 15 mg is the most cost-effective alternative for thresholds > £ 2000 per quality -adjusted life-year ( QALY ) .
The MTC of anti-obesity treatments shows that all the active treatments are effective at reducing weight and BMI .
The economic results show that , compared with placebo , the treatments are all cost-effective when using a threshold of £ 20,000 per QALY , and , within the limitations of the data available , sibutramine 15 mg dominates the other three interventions .