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Sibutramine

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361. The Practical Guide: Identification, Evaluation, and Treatment of Overweight and Obesity in Adults

important enough to warrant pharmacotherapy at a BMI of 27 to 29.9 kg/m 2 are hypertension, dyslipidemia, CHD, type 2 diabetes, and sleep apnea. Two drugs approved for weight loss by the FDA for long-term use are sibutramine and orlistat. However, sibutramine should not be used in patients with a history of hyperten- sion, CHD, congestive heart failure, arrhythmias, or stroke. Certain patients may be candidates for weight loss surgery. Each component of weight loss therapy should be introduced

2000 The Obesity Society

362. Randomized trial of lifestyle modification and pharmacotherapy for obesity. Full Text available with Trip Pro

Randomized trial of lifestyle modification and pharmacotherapy for obesity. Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This practice is likely to limit therapeutic benefits.In this one-year trial, we randomly assigned 224 obese adults to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in eight visits of 10 to 15 (...) minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestyle-modification counseling (i.e., combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen.At one year, subjects who received combined therapy lost a mean (+/-SD) of 12.1+/-9.8

2005 NEJM Controlled trial quality: uncertain

363. What is the evidence that orlistat helps obese patients to lose weight?

compared with placebo in obese adults, in both those who did and who did not have diabetes, hyperlipidaemia, and hypertension. Two RCTs found that orlistat was less effective than sibutramine in achieving weight loss. [Two other RCTs found a similar reduction in body mass index or weight from baseline with orlistat and sibutramine]. Adverse effects such as diarrhoea, flatulence, bloating, and abdominal pain occurred in a high proportion of people taking orlistat. We found insufficient evidence

2008 TRIP Answers

364. How long should we continue to prescribe reductil for once a patient has achieved a BMI below 30. Is there any evidence re when and how to stop it in patients who achieve significant weight loss?

we continue to prescribe reductil for once a patient has achieved a BMI below 30. Is there any evidence re when and how to stop it in patients who achieve significant weight loss? NICE in their technology appraisal on guidance on the use of sibutramine for obesity in adults (1) states: “ Treatment is not recommended beyond the licensed indication of 12 months.” The SPC for reductil (2) notes: “ Reductil 10 mg / 15 mg should only be given for periods up to one year. Data on use over one year (...) is limited.” The Prodigy guideline on obesity (3) answers the question of how long to continue treatment with sibutramine , this notes: “ Treatment with sibutramine should be discontinued if there is less than 2 kg weight loss after 4 weeks of treatment at 15 mg daily. Treatment should be continued after 3 months only if there is weight loss of at least 5% of initial body weight. The maximum period of treatment with sibutramine is 12 months.” sibutramine, this states: “Evidence more recent than

2006 TRIP Answers

365. What drug alternatives are there for weight loss other than Xenical? The patient has PCOS.

longer to conceive. - Women who have a BMI of more than 29 who are not ovulating should be informed that losing weight is likely to increase their chance of conception. - Women should be informed that participating in a group programme involving exercise and dietary advice leads to more pregnancies than weight loss advice alone.” The Norman paper [2] mentioned above can be viewed as a free full-text and this includes a section on drug interventions, stating: “Sibutramine and orlistat are two weight

2007 TRIP Answers

366. What are the actual incidences of psychiatric problems with reductil? How safe is it to use in patients who have recently come off SSRIs for a moderately severe depressive disorder?

of psychiatric problems with reductil? How safe is it to use in patients who have recently come off SSRIs for a moderately severe depressive disorder? We found no trials that have examined psychiatric problems associated with reductil. The BNF lists psychiatric illness as a contra-indication for sibutramine hydrochloride. The summary of product characteristics (SPC) (1) for reductil contains a section on special warnings and precaution for use in which the manufacturers note: "Cases of depression, suicidal (...) ideation and suicide have been reported rarely in patients on sibutramine treatment. Special attention is therefore required in patients with a history of depression. If signs or symptoms of depression occur during the treatment with sibutramine, the discontinuation of sibutramine and commencement of an appropriate treatment should be considered". BNF Issue 46 September 2003 page 200 http://emc.medicines.org.uk/ Answered 6 February 2004 Follow us: © 2019 Trip Database Ltd. company number 04316414. Trip

2004 TRIP Answers

367. Is there any evidence that metformin causes weight loss in non diabetic patients

= 15) were both given for 15 days, and food intake (FI) was recorded at baseline and in the last 4 days of each treatment period.” It concludes: “Our study suggests that metformin administration is useful to inhibit food intake and to lower body weight and body fat in obese non-diabetic patients.” From TRIP we found a review of interventions for obesity in adults (4) which considered metformin and reported: “Evidence for metformin was mixed. 1 RCT showed that sibutramine led to greater weight loss

2006 TRIP Answers

368. Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

>1000 IU) on statin therapy. A history of generalized chronic pain such as fibromyalgia, or generalized arthritis. Any active cardiac problem including chest pain, angina, heart attack, bypass surgery, angioplasty/stent or unstable angina/acute coronary syndrome within the past 6 months. Taking other lipid lowering drugs including: ezetimibe, gemfibrozil, niacin, fibrates or bile acid sequestrants. Triglyceride level more than 400 mg/dl. Taking weight loss medication including orlistat, sibutramine

2008 Clinical Trials

369. The Effectiveness of Commercial Weight Loss Programmes

Taking lipid lowering or anti-hypertensive drugs History of obesity with known cause (i.e. Cushings disease, hypothyroidism) Previous gastric or weight loss surgery Taking any weight loss drug (including Orlistat or Sibutramine) Clinical depression Eating disorders Drug or alcohol abuse Any malabsorptive state (including lactose intolerance) Being treated for a malignancy Being pregnant Breastfeeding Contacts and Locations Go to Information from the National Library of Medicine To learn more about

2006 Clinical Trials

370. A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION

agents Lipid-lowering agents Thyroid replacement therapy Antidepressant agents Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents Exclusion Criteria: Has been previously exposed to exenatide once weekly Has donated blood within 60 days of study start or is planning to donate blood during the study Currently being treated, or is expected to require or undergo treatment

2008 Clinical Trials

371. How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics

, tricyclic antidepressant) that might alter gastric emptying Use prednisone or other systemic glucocorticoid drug in the last 3 months Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months Use of any unproven investigational drug within the last 3 months Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided

2008 Clinical Trials

372. Dopamine and Insulin Resistance

in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body which may interfere with MRI scanning Subjects on medications determined by PI, ex. sibutramine, frequent benzodiazepines or related drugs, which could affect quality of study for last 3 months. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using

2008 Clinical Trials

373. Targeting Inflammation Using Salsalate for Type 2 Diabetes-stage II

continuous oral corticosteroid treatment (more than 2 weeks) Use of weight loss drugs [e.g., Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months Surgery within 30 days prior to screening Serum creatinine >1.4 for women and >1.5 for men or eGFR <60 [possible chronic kidney disease stage 3 or greater calculated using the Modification of Diet in Renal

2008 Clinical Trials

374. PET Imaging and Bariatric Surgery

in the past 12 months Diabetes Mellitis Positive pregnancy test Any condition felt by the PI or co-investigators to interfere with the individual's ability to complete the study Subjects on medications for the last 3 months, such as sibutramine, which could affect the quality of the study, as determined by the PI Inability to travel to Nashville, TN four times Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact

2008 Clinical Trials

375. Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE

this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry) History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder Subjects with a lifetime history of a suicide attempt or history of any suicidal

2008 Clinical Trials

376. Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.

of the studies which look at these weight loss interventions occur in patients who are institutionalized, on restricted diets and may respond to token economy systems while on longer term inpatient unit stays. This token economy approach is not easily translated to usual outpatient or short term inpatient practice settings. In these settings, if lifestyle modification approaches fail, patients may be placed on FDA approved diet medications (sibutramine, orlistat, ionamin…) which carry significant side effect

2008 Clinical Trials

377. MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)

in a clinical study with any DPP-4 inhibitor or incretin mimetic Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks Patient has undergone surgery within the prior 30 days or has major surgery planned during the study Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis Patient has

2008 Clinical Trials

378. Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

medications (e.g. sibutramine, orlistat, rimonabant) within the last 3 months, Participation in another clinical trial within the month prior to visit 1, History of pancreatitis. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751114 Sponsors

2008 Clinical Trials

379. The Effect of Supervised Exercise on Physical Fitness and Energy Expenditure in Post Bariatric Surgery Patients

) hematocrit of less than 30% current alcohol abuse (>7 drinks or 210 g/wk for women and >14 drinks or 420 g/wk for men) recreational drug abuse current use of any drugs capable of inducing weight loss (e.g., orlistat, sibutramine, topiramate, etc.) major neuro-psychiatric illnesses impeding competence or compliance pregnancy and lactation chronic renal insufficiency (serum creatinine > 2 mg/dL) untreated thyroid disorders such as hypothyroidism and hyperthyroidism; and 17) bariatric surgical complications

2008 Clinical Trials

380. Pilot Trial of Naltrexone for Obesity in Women With Schizophrenia

informed consent for participation in this study Ongoing pregnancy Known sensitivity to naltrexone A medical disorder that is known to cause obesity Use of sibutramine, topiramate, amphetamines or over the counter weight remedies Impaired liver functions (greater than 3 times the upper limit of normal) Diagnosed with polycystic ovary syndrome Currently being treated with insulin Current use of Depo-Provera or any natural/synthetic hormone treatment known to cause significant weight gain Contacts

2008 Clinical Trials

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