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1.  Orlistat. No hurry.... 
Canadian Family Physician  1999;45:2331-passim.
Treatments for obesity are disappointing. None has yet shown an effect on morbidity and mortality. Nondrug treatments are poorly assessed. Stable long-term weight loss necessitates long-term management. Orlistat (Xenical, Hoffman-La Roche), a gastrointestinal lipase inhibitor, is indicated, in combination with a low-calorie diet, for management of obesity. The assessment file is bulky and methodologically sound, at least in terms of the weight loss end point. During medium-term trials (12 to 24 months), orlistat administered at a dose of 120 mg three times daily and combined with dietary intervention had a moderate positive effect on body weight (-3.5 kg on average). No longer-term trials have been done. It is unknown whether this drug affects morbidity and mortality linked to obesity. In clinical trials, patients treated with orlistat had an increased frequency of breast cancer. This potential risk is currently being assessed in a specific trial. Gastrointestinal adverse effects are frequent. Treatment is costly.
PMCID: PMC2328609  PMID: 10540693
2.  Efficacy and Tolerability of the Association of Sibutramine and Orlistat for Six Months in Overweight and Obese Patients 
Journal of Obesity  2010;2010:602537.
Objective. To assess the efficacy and tolerability of the association sibutramine (10–20 mg/day) and orlistat (120 mg 2-3 times a day) in the treatment of obesity in a six-month open trial. Methods. 446 overweight and obese patients who sought treatment for obesity in a private clinic were assessed every 2 weeks during a period of 3 and 6 months. Results. After 3 months, the mean weight loss was 10.5 kg (−9.8% of the initial weight, n = 263), and after 6 months, the mean weight loss was 13.9 kg (−12.8% of the initial weight, n = 97). The tolerability of such association was quite acceptable and coherent with the action mechanism of each component. Conclusions. The association of orlistat and sibutramine is quite efficient and it seems to promote a higher rate of weight loss than that reported in clinical studies performed with each drug separately.
doi:10.1155/2010/602537
PMCID: PMC2943097  PMID: 20871858
3.  Depressive symptoms and childhood sleep apnea syndrome 
Background
The relationship between sleep and mood regulation is well known, and some reports suggest a key role of sleep-related breathing disorders (SRBD) in the development of the symptomatology of depression, even if no conclusive data are actually found in the clinical literature. The aim of this study was to assess the relationship between SRBD and depressive symptoms in a population of school-aged children.
Methods
The study population comprised 94 children affected by SRBD and 107 healthy children. To identify the severity of SRBD, an overnight respiratory evaluation was performed. All subjects filled out the Italian version of the Children Depression Inventory (CDI) to screen for the presence of depressive symptoms.
Results
The group with SRBD showed higher CDI scores than the group without SRBD, with a positive correlation found between CDI scores, apnea-hypopnea index, and oxygen desaturation index values. Logistic regression showed that an apnea-hypopnea index ≥ 3 and an oxygen desaturation index ≥ 1 could be risk factors for development of depressive symptoms. According to receiver-operating characteristic curve analysis, the cutoff point for the apnea-hypopnea index that could cause a pathological CDI score (≥19) was >5.66, and the cutoff point for the oxygen desaturation index was >4.2. The limitations of this study are that our data are derived from one single psychometric test and not from a complete psychiatric evaluation, and our subjects came from a small group in southern Italy.
Conclusion
Our results suggest the importance of mood assessment in children affected by SRBD.
doi:10.2147/NDT.S35974
PMCID: PMC3430390  PMID: 22977304
depression; sleep-related breathing disorders; cardiorespiratory monitoring; children
4.  Sleep Fragmentation and Intermittent Hypoxemia Associated with Decreased Insulin Sensitivity in Obese Adolescent Latino Males 
Pediatric research  2012;72(3):293-298.
Background
Although sleep-related breathing disorder (SRBD) has been linked to insulin resistance in adults, this has not been as well established in children. We hypothesized that the severity of SRBD in adolescents was associated with metabolic impairment.
Methods
Polysomnography was performed on obese, Latino males referred for snoring. The frequently sampled intravenous glucose tolerance test (FSIVGTT) was used to assess glucose homeostasis. Total body dual-energy X-ray absorptiometry (DEXA) was used to quantify adiposity.
Results
22 males (mean age 13.4±SD 2.1 years, BMI z-score 2.4±0.3, obstructive apnea hypopnea index (OAHI) 4.1±3.2) were studied. After correcting for age and adiposity in multiple regression models, Log frequency of desaturation (defined as ≥3% drop in oxygen saturation from baseline) negatively correlated with insulin sensitivity. Sleep efficiency was positively correlated with glucose effectiveness (SG-the capacity of glucose to mediate its own disposal). The Log total arousal index was positively correlated with Log homeostasis model assessment (HOMA-IR).
Conclusions
Sleep fragmentation and intermittent hypoxemia are associated with metabolic impairment in obese adolescent Latino males independent of age and adiposity. We speculate that SRBD potentiates the risk for development of metabolic syndrome and type 2 diabetes in the obese adolescent population.
doi:10.1038/pr.2012.73
PMCID: PMC3427473  PMID: 22669298
5.  Risk of colorectal cancer after initiation of orlistat: matched cohort study 
Objective To examine the risk of colorectal cancer after orlistat initiation in the UK population.
Design Retrospective matched cohort study.
Setting Data from the UK Clinical Practice Research Datalink from September 1998 to December 2008.
Participants 33 625 adults aged 18 years or over who started treatment with orlistat; each orlistat initiator was matched to up to five non-initiators (n=160 347) on age, sex, body mass index, and calendar time.
Main outcome measures Associations between orlistat initiation and the risk of colorectal cancer, assessed by calculating hazard ratios with propensity score adjusted Cox proportional hazard models.
Results Of 193 972 patients with a median age of 47 (interquartile range 37-57) years, 77% were women and approximately 90% were obese (body mass index ≥30). Orlistat initiators were more likely to have a previous history of diabetes or hypertension and to receive prescriptions for anti-diabetes drugs, statins, and aspirin compared with non-initiators. In the intention to treat analysis, 57 colorectal cancer events were identified among orlistat initiators and 246 among non-initiators, with median follow-up times of 2.96 and 2.86 years, respectively. The calculated incidence rate of colorectal cancer per 100 000 person years was 53 (95% confidence interval 41 to 69) for orlistat initiators and 50 (44 to 57) for non-initiators. Orlistat initiation was not associated with a higher risk of colorectal cancer (adjusted hazard ratio 1.11, 95% confidence interval 0.84 to 1.47). Findings were robust in the as treated analyses and in patients who were aged 50 years or over, were morbidly obese, or had a history of diabetes.
Conclusions This study found no evidence of an increased risk of colorectal cancer after the initiation of orlistat. It is limited by the relatively short follow-up time, and the possibility of adverse effects of long term orlistat use on risk of colorectal cancer cannot be excluded.
doi:10.1136/bmj.f5039
PMCID: PMC3754767  PMID: 23982291
6.  Randomized Clinical Trials of Weight-Loss Maintenance: A Review 
The problem of overweight and obesity has reached epidemic proportions in the U.S. and globally, and the high prevalence is due in part to the recidivism associated with weight-loss treatment. Approximately one third of lost weight is often regained in the first year after treatment and, at times, continues. Because a plethora of co-morbid diseases are associated with obesity, in particular, cardiovascular disease, hypertension and hyperlipidemia, clinicians and researchers have attempted to find useful strategies for maintaining weight loss. This review presents the findings from 42 randomized clinical trials of weight-loss maintenance from 1984 through 2007 utilizing interventions that include 1) the Internet, 2) strategies after a very-low-calorie diet, 3) pharmacotherapy, 4) behavioral strategies, 5) physical activity, and 6) alternative strategies. The results of the reviewed trials revealed that treatment with orlistat or sibutramine combined with dietary modification, caffeine or protein supplementation, consuming a diet lower in fat, adherence to physical activity routines, prolonged contact with participants, problem-solving therapy and the alternative treatment acupressure were efficacious in reducing weight regain after weight-loss treatment. The limitations of some studies may reduce the robustness of their findings, and future studies are necessary to replicate and support these results so that individuals are able to maintain weight loss and retain the health benefits associated with a lower weight.
doi:10.1097/01.JCN.0000317471.58048.32
PMCID: PMC2676575  PMID: 19114803
weight loss maintenance; weight loss; obesity; overweight
7.  Predictive Significance of Changes in Dietary Restraint in Obese Patients with Binge Eating Disorder During Treatment 
Objective
To examine whether changes in different aspects of dietary restraint in obese patients with binge eating disorder (BED) participating in a treatment study predict outcomes.
Method
Fifty obese patients with BED in a randomized controlled study of orlistat administered with cognitive-behavioral-therapy, guided-self-help (CBTgsh) completed dietary restraint measures at baseline, during- and post-treatment, and 3-month follow-up.
Results
Change in the restraint scale of the Eating Disorder Examination-Questionnaire did not predict binge abstinence or 5% weight loss. Increased flexible restraint subscale of the Three Factor Eating Questionnaire (TFEQ) during treatment significantly predicted binge abstinence at post-treatment and 3-month follow-up and 5% weight loss at post-treatment. Change in the rigid restraint subscale of the TFEQ predicted binge abstinence at post-treatment.
Discussion
Our findings clarify further pathologic and adaptive aspects of restraint and suggest the importance of enhancing flexible restraint in order to improve both binge eating and weight loss outcomes.
doi:10.1002/eat.20849
PMCID: PMC3025064  PMID: 20957705
8.  The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study 
Purpose
Comparing the effects of metformin or orlistat on hormone, lipid profile and ovulation status in obese women with polycystic ovary syndrome.
Methods
A total of 80 women were prospectively recruited to receive either metformin (n = 40) or orlistat (n = 40). Weight, BMI, waist, serum LH, total serum testosterone and lipid profile were assessed at baseline and after 3 months. The subjects’ ovulatory status was assessed after 3 months.
Results
There was no significant difference in ovulation between the two treatment groups (30% vs 15%). Treatment with either drug showed a significant decline in body weight, BMI (Body Mass Index), and waist circumference, but the degree of decline in both groups was the same. Patients who were treated with orlistat, showed a significant reduction in total testosterone and serum lipid. Women in metformin group showed a significant reduction in serum LH.
Conclusions
Both metformin and orlistat showed a similar effect on weight loss and ovulation rates.
doi:10.1007/s10815-011-9564-2
PMCID: PMC3162050  PMID: 21484319
Metformin; Orlistat; PCOS; Weight loss; Waist circumference
9.  Anti-Obesity Drugs: A Review about Their Effects and Safety 
Diabetes & Metabolism Journal  2012;36(1):13-25.
The current recommendations for the treatment of obese people include increased physical activity and reduced calories intake. When the behavioral approach is not sufficient, a pharmacologic treatment is recommended. In past years, numerous drugs have been approved for the treatment of obesity; however, most of them have been withdrawn from the market because of their adverse effects. In fact, amphetamine, rimonabant and sibutramine licenses have been withdrawn due to an increased risk of psychiatric disorders and non-fatal myocardial infarction or stroke. Even if orlistat is not as effective as other drugs in reducing body weight, orlistat is presently the only available choice for the treatment of obesity because of its safety for cardiovascular events and positive effects on diabetic control. Hopefully, more effective and better tolerated anti-obesity drugs will be developed through an improved understanding of the multiple mechanisms and complex physiological systems targeting appetite.
doi:10.4093/dmj.2012.36.1.13
PMCID: PMC3283822  PMID: 22363917
Anti-obesity agents; Obesity; Safety
10.  36 year old man presenting with pancreatitis and a history of recent commencement of orlistat case report 
Nutrition Journal  2006;5:19.
Background
Orlistat is an anti-obesity drug licensed in the United Kingdom for 7 years. We present a case of a patient who developed pancreatitis four days after commencing orlistat.
Case presentation
A 36 year old man presented to hospital with acute severe pancreatitis four days after starting a course of Orlistat, a lipase inhibitor used in the treatment of obesity. A diagnosis of drug related pancreatitis was made by exclusion of other causes of pancreatitis; he was a teetotaller, had a normal serum calcium, had no family history of pancreatitis or hyperlipidaemia, no history of trauma and had no evidence of gallstones on Computerised Tomography scan (CT).
Conclusion
Orlistat was the only drug that had been started recently and has been associated with pancreatitis previously. We found no case reports of similar cases, however 99 cases of orlistat related pancreatitis have been reported to the Food and Drug Administration (FDA), but no causative link has been found in clinical trials by the drug company. It is therefore not on the list of possible complications or side effects of the drug.
doi:10.1186/1475-2891-5-19
PMCID: PMC1560153  PMID: 16938137
11.  Efficacy of Orlistat as an Adjunct to Behavioral Treatment in Overweight African American and Caucasian Adolescents with Obesity-related Co-morbid Conditions 
This pilot study compared the efficacy of orlistat as an adjunctive treatment for obesity between African American and Caucasian adolescents. 20 obese adolescents with obesity-related co-morbid conditions underwent measurements of body composition, glucose homeostasis by frequently sampled intravenous glucose tolerance test (FSIGT), and fasting lipids before and after 6-months’ treatment with orlistat 120mg TID in conjunction with a comprehensive behavioral program.
Weight (p< 0.05), BMI (p<0.001), total cholesterol (p<0.001), LDL cholesterol (p<0.001), fasting insulin (p<0.02) and fasting glucose (p<0.003) were lower after treatment. Insulin sensitivity, measured during the FSIGT, improved significantly (p<0.02), as did fasting indices such as the homeostasis model assessment for insulin resistance (p<0.01). African American subjects exhibited significantly less improvement in weight (p<0.05), BMI (p<0.01), waist circumference (p=0.03), and insulin sensitivity (p=0.05). Improvements in cholesterol were not significantly different between African Americans and Caucasians.
We conclude that Caucasians lost more weight and had greater improvements in insulin sensitivity than African Americans, but both exhibited improvements in plasma lipids. The true benefit of orlistat treatment over a comprehensive behavioral program remains to be determined in placebo-controlled trials.
PMCID: PMC3341614  PMID: 15112907
obesity; weight loss; adolescence; pharmacotherapy; orlistat; diabetes; lipids
12.  Central sleep related breathing disorders - diagnostic and therapeutic features 
Three classes of central SRBD are distinguished: 1. Central sleep apnea (CSA), 2. Cheyne-Stokes Respiration as a subgroup of CSA and 3. central hypoventilation syndromes. Reduced or completely absent central respiratory drive without upper airway obstruction is the common feature of central SRBD. Hypoventilation syndromes most often occur secondary in patients with neuromuscular, pulmonary or sceletal diseases or in patients with massive obesity. In patients with hypoventilation during sleep nocturnal and exertional dyspnea and headaches are frequently reported symptoms. Excessive daytime sleepiness is the key symptom in patients with central sleep apnea syndrome. Cheyne-Stokes Respiration is frequent in heart failure patients but in many cases does not cause symptoms specific for the breathing disorder. If there are symptoms or if ambulatory recording of breathing during sleep suggests a sleep related breathing disorder, polysomnography is then performed to definitively rule out or confirm the diagnosis and to initiate treatment, if needed. The indication for treatment in asymptomatic patients with central sleep apnea and Cheyne-Stokes Respiration may be difficult, as there are very little data concerning the long-term benefit in these patients. Symptomatic patients and those with severe central sleep apnea should be treated. Oxygen and CPAP may be effective in 20-30% of patients each. If these treatment options are ineffective, non-invasive pressure support ventilaiton can be used. In patients suffering from hypoventilation syndromes the treatment of choice is non-invasive pressure support ventilaiton combined with supplemental oxygen, if required.
PMCID: PMC3199804  PMID: 22073076
13.  Treatment of Obesity in Children and Adolescents 
The prevalence of childhood and adolescent obesity continues to rise in the United States (US). Immediate health consequences are being observed, and long-term risks are mounting within the pediatric population, secondary to obesity. The hallmark of prevention and treatment of obesity in children and adolescents includes lifestyle modification (i.e., dietary modification, increased physical activity, and behavioral modifications). However, when intensive lifestyle modification is insufficient to reach weight loss goals, adjunctive pharmacotherapy is recommended. Among the group of weight-loss medications, orlistat is the only US Food and Drug Administration (FDA)-approved prescription drug for the treatment of overweight and obese adolescents. Other medications, including metformin, need larger studies to establish their role in treatment. No single approach to management of pediatric obesity is the answer, given the complexity of the disorder and the many reasons for failure. Evidence of weight loss medications in addition to lifestyle modification supports short-term efficacy for treatment of obese children and adolescents, although long-term results remain unclear.
doi:10.5863/1551-6776-17.1.45
PMCID: PMC3428187  PMID: 23185143
adolescents; children; obese; obesity; overweight
14.  Obesity in adults 
Clinical Evidence  2010;2010:0604.
Introduction
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, cardiovascular disease, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years. Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of drug treatments in adults with obesity? What are the effects of bariatric surgery in adults with morbid obesity? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 34 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: bariatric surgery versus medical interventions; biliopancreatic diversion; diethylpropion; gastric bypass; gastric banding; mazindol; orlistat (alone and in combination with sibutramine); phentermine; rimonabant; sibutramine (alone and in combination with orlistat); sleeve gastrectomy; and vertical banded gastroplasty.
Key Points
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, CVD, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years.Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Orlistat, phentermine, rimonabant, and sibutramine may promote modest weight loss (an additional 1-7 kg lost) compared with placebo in obese adults having lifestyle interventions, but they can all cause adverse effects. Sibutramine may be more effective at promoting weight loss compared with orlistat, although not in obese people with type 2 diabetes or hypertension.We don't know whether combining orlistat and sibutramine treatment leads to greater weight loss than with either treatment alone.We don't know whether diethylpropion and mazindol are effective at promoting weight loss in people with obesity.Orlistat has been associated with GI adverse effects.Phentermine has been associated with heart and lung problems.Sibutramine has been associated with cardiac arrhythmias and cardiac arrest. In January 2010, the European Medicines Agency suspended marketing authorisation of sibutramine in the European Union because of the increased risk of non-fatal myocardial infarctions and strokes.Rimonabant has been associated with an increased risk of psychiatric disorders.
Bariatric surgery (gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding) may increase weight loss compared with no surgery in people with morbid obesity.
Compared with each other, we don't know whether gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding is the most effective surgery or the least harmful. We don't know whether sleeve gastrectomy is effective. Bariatric surgery may result in loss of over 20% of body weight, which may be largely maintained for 10 years.Operative and postoperative complications are common, and on average 0.28% of people die within 30 days of surgery. Mortality may be as high as 2% in some high-risk populations. However, surgery may reduce long-term mortality compared with no surgery.
PMCID: PMC2907622
15.  Obesity in adults 
Clinical Evidence  2011;2011:0604.
Introduction
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, cardiovascular disease, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years. Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of drug treatments in adults with obesity? What are the effects of bariatric surgery in adults with morbid obesity? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 39 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: bariatric surgery versus medical interventions, biliopancreatic diversion, diethylpropion, gastric bypass, gastric banding, mazindol, orlistat (alone and in combination with sibutramine), phentermine, sibutramine (alone and in combination with orlistat), sleeve gastrectomy, and vertical banded gastroplasty.
Key Points
About one third of the US population and one quarter of the UK population are obese, with increased risks of hypertension, dyslipidaemia, diabetes, CVD, osteoarthritis, and some cancers. Fewer than 10% of overweight or obese adults aged 40 to 49 years revert to a normal body weight after 4 years.Nearly 5 million US adults used prescription weight-loss medication between 1996 and 1998, but one quarter of all users were not overweight.
Orlistat, phentermine, and sibutramine may promote modest weight loss (an additional 1–7 kg lost) compared with placebo in obese adults having lifestyle interventions, but they can all cause adverse effects. Sibutramine may be more effective at promoting weight loss compared with orlistat, although not in obese people with type 2 diabetes or hypertension.We don't know whether combining orlistat and sibutramine treatment leads to greater weight loss than with either treatment alone.We don't know whether diethylpropion and mazindol are effective at promoting weight loss in people with obesity.Orlistat has been associated with GI adverse effects.Phentermine has been associated with heart and lung problems.Sibutramine has been associated with cardiac arrhythmias and cardiac arrest. In January 2010, the European Medicines Agency suspended marketing authorisation of sibutramine in the European Union because of the increased risk of non-fatal myocardial infarctions and strokes.In October 2010, the FDA requested the withdrawal of sibutramine from the US market because of the increased risk of adverse cardiovascular events.Rimonabant has been associated with an increased risk of psychiatric disorders.
Bariatric surgery (gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding) may increase weight loss compared with no surgery in people with morbid obesity.
Compared with each other, we don't know whether gastric bypass, vertical banded gastroplasty, biliopancreatic diversion, or gastric banding is the most effective surgery or the least harmful. We don't know whether sleeve gastrectomy is effective. Bariatric surgery may result in loss of >20% of body weight, which may be largely maintained for 10 years.Operative and postoperative complications are common, and on average 0.28% of people die within 30 days of surgery. Mortality may be as high as 2% in some high-risk populations. However, surgery may reduce long-term mortality compared with no surgery.
PMCID: PMC3217730  PMID: 21411021
16.  Pharmacology of Vagal Afferent Influences on Disordered Breathing During Sleep 
Respiratory physiology & neurobiology  2008;164(1-2):197-203.
Sleep related breathing disorders (SRBD) are a significant public health concern, with a prevalence in the US general population of ∼2% of women and ∼4% of men. Although significant strides have been made in our understanding of these disorders with respect to epidemiology, risk factors, pathogenesis and consequences, work to understand these factors in terms of the underlying cellular, molecular and neuromodulatory processes remains in its infancy. Current primary treatments are surgical or mechanical, with no drug treatments available. Basic investigations into the neurochemistry and neuropharmacology of sleep-related changes in respiratory pattern generation and modulation will be essential to clarify the pathogenic processes underlying SRBD and to identify rational and specific pharmacotherapeutic opportunities. Here we summarize emerging work suggesting the importance of vagal afferent feedback systems in sleep related respiratory pattern disturbances and pointing toward a rich but complex array of neurochemical and neuromodulatory processes that may be involved.
doi:10.1016/j.resp.2008.06.021
PMCID: PMC2642895  PMID: 18694851
17.  Macrocytic Anemia and Thrombocytopenia Induced by Orlistat 
Introduction:
The overall incidence of obesity and its prevalence is increasing continuously. The obesity is a cardiovascular risk factor whose importance is increasing too. It is associated with many chronic conditions such as type II diabetes mellitus or cardiovascular diseases. The obesity is also implicated as a risk factor for several kinds of cancer such as esophagus, pancreas, colon, rectum, breast cancer in menopausal women. The treatment of the obesity may reduce the incidence of these diseases. The mainstray of the treatment of obesity is changing the lifestyles, but obesity´s treatment may need drug therapy or even though surgical treatment.
Orlistat is a specific inhibitor of gastrointestinal lipases, which stops fat absortion. It is used along with a hypocaloric diet, for obesity´s treatment. The beneficial effects of orlistat include weight loss, the improvement of blood pressure´s control, it may delay the development of diabetes mellitus, and it may reduce HbA1c.
Case Report:
Besides the interaction with other drugs (mainly warfarin and amiodarone).
Orlistat´s mainly side effects are gastrointestinal disorders such as the existence of oily spotting from the rectum, abdominal pain or discomfort, fecal urgency. There are also side effects at other levels, like flu symptoms, hypoglycemia, heathache or upper respiratory infections. There are other side effects with very low incidence but clinically relevant like pancreatitis, subacute liver failure, severe liver disease, myopathy, or tubular necrosis secondary to oxalate nephropathy induced by Orlistat.
Discussion:
In this case report appears a new adverse effect of Orlistat that has not been described above: thrombopenia and macrocytic anemia.
doi:10.5812/ijem.6721
PMCID: PMC3968980  PMID: 24719628
Anti-Obesity Agents; Obesity; Obesity, Morbid; Thrombocytopenia
18.  Taking Orlistat: Predicting Weight Loss over 6 Months 
Journal of Obesity  2010;2011:806896.
This study explored the predictors of weight loss following orlistat with a focus on both baseline variables and changes in beliefs and behaviours occurring over the course of taking the drug. Patients (n = 566) prescribed orlistat completed a questionnaire at baseline and after 6 months concerning their weight, beliefs and behaviours. By 6 months the majority had lost some weight and showed improvements in diet. Many had also stopped taking the drug and a large minority reported using it flexibly as a lifestyle drug. Those who lost most weight showed a decrease in beliefs in a medical solution, a decrease in unhealthy eating, an increased belief in treatment control and an increased belief that the unpleasant consequences are both due to their eating behaviour and just part of the drug. When taken with fatty food orlistat causes symptoms such as anal leakage and oily stools. These may encourage some patients to focus on the behavioural aspects of their weight problem thus promoting the dietary changes needed for both short and longer term weight loss. When prescribing orlistat, clinicians should encourage patients to see the consequences as an education as a means to promote the effectiveness of this form of medical management.
doi:10.1155/2011/806896
PMCID: PMC2989378  PMID: 21113309
19.  Impact of Orlistat-Induced Weight Loss on Diastolic Function and Heart Rate Variability in Severely Obese Subjects with Diabetes 
Journal of Obesity  2010;2011:394658.
Objective. Determine the impact of Orlistat-induced weight loss on metabolic profile and cardiovascular function in severely obese patients with type 2 diabetes. Methods. Twenty-nine patients were randomized either to a nonplacebo control group or to a treatment group with Orlistat thrice a day. Metabolic profile, anthropometric parameters, heart rate variability indices, and echocardiographic variables were measured before and after a 12-week treatment period. Results. Treatment with Orlistat induced a modest but significant weight loss compared to controls (3.7 ± 3.0 versus 0.5 ± 2.2 kg, resp.; P = .003). There was significant decrease in fasting glycemia (7.9 ± 3.0 versus 6.7 ± 2.2 mmol/L; P = .03) and significant improvements in left ventricular diastolic function (P = .03) and in the sympathovagal balance (LF/HF ratio) (P = .04) in the Orlistat group. Conclusion. These results suggest that a modest weight loss improves fasting glycemia, left ventricular diastolic function, and sympathovagal balance in severely obese patients with type 2 diabetes.
doi:10.1155/2011/394658
PMCID: PMC3021886  PMID: 21253512
20.  Postprandial Effect of Orlistat on the Peaking of Lipid Level After Sequential High Fat Meals 
Background
Postprandial lipemia has been found to be strongly associated with atherosclerosis due to its atherogenic and thrombogenic lipoprotein changes. This phenomenon occurs even in normal subjects especially after high fat meals. Orlistat, an anti- obesity drug, has been shown to address postprandial lipemia after a single high fat meal.
Objectives
To compare the effects of orlistat and placebo on the postprandial lipid levels after sequential high-fat meals in healthy individuals with normal fasting lipid levels.
Patients and Methods
Thirty-one healthy adult volunteers with normal fasting lipid levels were fed 50% fat meals (3 meals and 2 snacks of pre-weighted butter and bread). The subjects were blindly randomized to receive either placebo or orlistat 120 mg before each main meal. The outcome parameters were total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and very-low–density lipoprotein (VLDL) cholesterol levels measured at fasting (0 h) and every 2 h thereafter, until the sixteenth hour. Additionally, we estimated the lipid levels at the fifth and ninth hour.
Results
The non-orlistat group showed a significant postprandial rise in the levels of TG and VLDL, which began 4 h after breakfast (P < 0.05); this rise in levels was sustained until 9 h after breakfast for TG and up to 10 h after breakfast for VLDL. In contrast, only one significant rise in both TG and VLDL levels (at 4 h after breakfast) was noted in the orlistat group. The maximum mean difference from the baseline TG level for the orlistat group was lower than that for the non-orlistat group (0.22 mmol/L vs. 0.756 mmol/L, respectively). Similarly, the maximum mean difference from the baseline VLDL level from baseline in the orlistat group was only 0.099 mmol/L, which was lower than that in the non-orlistat group (0.588 mmol/L). LDL levels rose to a lesser extent in the orlistat group than in the non-orlistat group (0.268 vs. 0.362 mmol/L). The TC levels did not show a postprandial rise; instead, the levels reduced in both groups, with the orlistat group showing a higher reduction than the non-orlistat group (-0.288 vs. -0.188 mmol/L). The orlistat group did not show any significant differences in the HDL measurements.
Conclusions
Administration of orlistat abolished the significantly sustained postprandial rise of TG and VLDL levels in healthy individuals who were fed sequential 50% fat meals.
doi:10.5812/ijem.2920
PMCID: PMC3693615  PMID: 23843804
Orlistat; Lipids; Postprandial Lipemia; Fatty Meal; Cardiovascular Disease
21.  Pharmacological Approaches for Management of Child and Adolescent Obesity 
Overweight and obesity among children and adolescents continue to be a global public health epidemic. Current national data on childhood and adolescent obesity show alarming statistics of overweight and obese children and adolescents. This epidemic runs across various continents and affects various ethnic populations. The current weight management practices involve dietary modification, behavioral change therapies involving exercise, pharmacological therapy and surgical intervention. The purpose of this current review is to focus on pharmacological therapy i.e. role of sibutramine and orlistat in childhood and adolescent weight management. An open search of PUBMED database was made with search 'key words' such as 'orlistat' or 'sibutramine' or "pharmacological approaches" and "child obesity" and "adolescent obesity". This yielded a total of 20 articles. All of these articles have been summarized in the current review. Sibutramine functions by promoting satiety and increases energy expenditure by inhibiting reuptake of noradrenaline and serotonin. Most of the studies, reviews and trials conducted using sibutramine among adolescents and children show limited short-term efficacy. The long-term effects of sibutramine use are not yet studied due to the severity of its side-effects profile. Orlistat was approved by Food and Drug Administration for adolescent weight reduction. Despite its approval, it has a limited role in adolescent and pediatric obesity reduction due to the purported malabsorption of fat soluble vitamins and its side-effect profile. Obesity and adolescent weight management in present times mainly deals with dietary modification with superadded behavioral therapies promoting exercise. There is insufficient evidence as of now if these alone would cause adequate weight reduction and weight maintenance. Pharmacotherapy i.e use of drugs like sibutramine and orlistat has a limited role in the current fight against childhood and adolescent obesity. Extreme side-effects, close monitoring and lack of long-term studies involving these drugs, suggest questionable efficacy in current times. Future research studies involving pharmacological agents need to not only have immense scientific rigor during preliminary analyses but should also translate their efficacy in practical and clinical settings.
Keywords
Obesity; Overweight; Adolescents; Pharmacological; sibutramine; Orlistat
doi:10.4021/jocmr2010.05.288w
PMCID: PMC3104647  PMID: 21629521
22.  Should weight-loss supplements be used for pediatric obesity? 
Canadian Family Physician  2009;55(3):257-259.
ABSTRACT
QUESTION In my clinic I have a large population of overweight and obese children. There is a range of weight-loss supplements marketed for the adult population. What natural health products for treatment of obesity are effective and can be used in children?
ANSWER Weight-loss supplements lack sufficient data supporting their efficacy and safety, even in adults. Most weight-loss supplements cannot be recommended at this time for children. Options for obese adolescents include increasing consumption of fibre with diet or using fibre supplements, such as glucomannan. Dietary fibres can also prevent side effects of orlistat, the only medication available for treatment of obese adolescents.
PMCID: PMC2654846  PMID: 19282532
23.  Weight Considerations in Pharmacotherapy for Type 2 Diabetes 
Journal of Obesity  2010;2011:984245.
Obesity has been increasing in prevalence worldwide and the majority of patients with type 2 diabetes are either overweight or obese. Diabetes management in this population has been difficult since a number of antidiabetes agents are associated with weight gain. The effects of various antidiabetes agents and antiobesity agents on glycemic control and body weight will be reviewed. Briefly, sulfonylureas, thiazolidinediones, and insulin are associated with weight gain, whereas metformin and amylin analogs are weight neutral or associated with modest weight loss. Dipeptidyl-peptidase-4 inhibitors are weight neutral, whereas glucagon-like peptide-1 analogs are associated with weight loss. The effect of orlistat and sibutramine in type 2 diabetes is also evaluated. The treatment of diabetes should not only focus on glycemic control as its sole intention, but it should factor in the effect of these various agents on weight, as well, since obesity aggravates insulin resistance, beta cell failure, and cardiovascular risk.
doi:10.1155/2011/984245
PMCID: PMC2946585  PMID: 20885921
24.  Feasibility and indicative results from a 12-month low-energy liquid diet treatment and maintenance programme for severe obesity 
The British Journal of General Practice  2013;63(607):e115-e124.
Background
There is no established primary care solution for the rapidly increasing numbers of severely obese people with body mass index (BMI) > 40 kg/m2.
Aim
This programme aimed to generate weight losses of ≥15 kg at 12 months, within routine primary care.
Design and setting
Feasibility study in primary care.
Method
Patients with a BMI ≥40 kg/m2 commenced a micronutrient-replete 810–833 kcal/day low-energy liquid diet (LELD), delivered in primary care, for a planned 12 weeks or 20 kg weight loss (whichever was the sooner), with structured food reintroduction and then weight-loss maintenance, with optional orlistat to 12 months.
Result
Of 91 patients (74 females) entering the programme (baseline: weight 131 kg, BMI 48 kg/m2, age 46 years), 58/91(64%) completed the LELD stage, with a mean duration of 14.4 weeks (standard deviation [SD] = 6.0 weeks), and a mean weight loss of 16.9 kg (SD = 6.0 kg). Four patients commenced weight-loss maintenance omitting the food-reintroduction stage. Of the remaining 54, 37(68%) started and completed food reintroduction over a mean duration of 9.3 weeks (SD = 5.7 weeks), with a further mean weight loss of 2.1 kg (SD = 3.7 kg), before starting a long-term low-fat-diet weight-loss maintenance plan. A total of 44/91 (48%) received orlistat at some stage. At 12 months, weight was recorded for 68/91 (75%) patients, with a mean loss of 12.4 kg (SD = 11.4 kg). Of these, 30 (33% of all 91 patients starting the programme) had a documented maintained weight loss of ≥15 kg at 12 months, six (7%) had a 10–15 kg loss, and 11 (12%) had a 5–10 kg loss. The indicative cost of providing this entire programme for wider implementation would be £861 per patient entered, or £2611 per documented 15 kg loss achieved.
Conclusion
A care package within routine primary care for severe obesity, including LELD, food reintroduction, and weight-loss maintenance, was well accepted and achieved a 12-month-maintained weight loss of ≥15 kg for one-third of all patients entering the programme.
doi:10.3399/bjgp13X663073
PMCID: PMC3553637  PMID: 23561690
healthcare economics and organizations; morbid obesity; orlistat; primary health care
25.  Do Differences in Sleep Architecture Exist between Persons with Type 2 Diabetes and Nondiabetic Controls? 
Background
It has been shown previously that the suppression of slow-wave sleep (SWS) markedly reduced insulin sensitivity and led to an impairment of glucose tolerance. We hypothesized that a decreased amount of SWS is a feature peculiar to subjects with type 2 diabetes.
Method
A retrospective case-control study analyzed polysomnographic recordings and covariate data of 22 type 2 diabetic and 22 nondiabetic subjects [n = 44; 8 women, 36 men, aged 57.5 ± 5.5 years, body mass index (BMI) 33.8 ± 5.9 kg/m2, apnea–hypopnea index (AHI) 29.6 ± 22.2 episodes/hr] matched individually for sex, race, age, BMI, and severity of sleep-related breathing disorders (SRBD). We assessed differences in sleep architecture between the study group and the control group. Primary end points included the percentage of total sleep time spent in each sleep stage.
Results
Despite similar age and severity of SRBD, subjects with type 2 diabetes demonstrated a significantly decreased amount of SWS (3.9 ± 5.95% vs 8.4 ± 4.57%; p = 0.012), increased percentage time in rapid eye movement sleep (24.1 ± 12.14% vs 13.8 ± 6.96%; p = 0.005), and higher arousal index (44.3 ± 19.53/hr vs 35.7 ± 12.67/hr; p = 0.037) compared to nondiabetic controls. After adjustment for sex, BMI, AHI, and smoking, age and presence of type 2 diabetes were independent predictors of the decreased SWS percentage (p = 0.001). Variables in this model accounted for 34% of the variance in the SWS percentage in our cohort.
Conclusions
Results demonstrated distinct differences in sleep architecture in our cohort with decreased amounts of SWS in type 2 diabetes. These findings suggest that polysomnographic recognition of altered sleep architecture may be partially implicated in the early detection of persons with type 2 diabetes.
PMCID: PMC2864170  PMID: 20307395
polysomnography; sleep architecture; sleep-related breathing disorders; slow-wave sleep; type 2 diabetes

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