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Pharmacological and Surgical Treatment of Obesity Residential Pharmacological and surgical treatment of obesity Residential care for severely obese children in Belgium KCE reports vol. 36C Federaal Kenniscentrum voor de gezondheidszorg Centre fédéral dÊexpertise des soins de santé Belgian Health Care Knowledge Centre 2006 Belgian Health Care Knowledge Centre Introduction : The Belgian Health Care Knowledge Centre is a semi-public institution, founded by the program-act of December 24th 2002 (articles 262 to 266) falls under the jurisdiction of the Ministry of Public Health and Social Affaires. The centre is responsible for the realisation of policy- supporting studies within the sector of healthcare and health insurance. Board of Directors Actual members : Gillet Pierre (President), Cuypers Dirk (Vice-President), Avontroodt Yolande, De Cock Jo (Vice-President), De Meyere Frank, De Ridder Henri, Gillet Jean-Bernard, Godin Jean-Noël, Goyens Floris, Kesteloot Katrien, Maes Jef, Mertens Pascal, Mertens Raf, Moens Marc, Perl François Smiets Pierre, Van Massenhove Frank, Vandermeeren Philippe, Verertbruggen Patrick, Vermeyen Karel Substitudes : Annemans Lieven, Boonen Carine, Collin Benoît, Cuypers Rita, Dercq Jean-Paul, Désir Daniel, Lemye Roland, Palsterman Paul, Ponce Annick, Pirlot Viviane, Praet Jean-Claude, Remacle Anne, Schoonjans Chris, Schrooten Renaat, Vanderstappen Anne Government commissioner: Roger Yves Managment General Manager : Dirk Ramaekers Vice-General Manager : Jean-Pierre Closon Contact Belgian Health Care Knowledge Centre (KCE) Résidence Palace (10th floor) Wetstraat 155 Rue de la Loi B-1040 Brussels Belgium Tel: +32 [0]2 287 33 88 Fax: +32 [0]2 287 33 85 Email : [email protected] Web : http://www.kenniscentrum.fgov.be Pharmacological and surgical treatment of obesity Residential care for severely obese children in Belgium KCE reports vol. 36C KCE : MARIE-LAURENCE LAMBERT, LAURENCE KOHN, IMGARD VINCK, IRINA CLEEMPUT, JOAN VLAYEN, MARK LEYS, STEFAAN VAN DE SANDE, DIRK RAMAEKERS UCL : CLAIRE BEGUIN, SOPHIE GERKENS, JEAN-PAUL THISSEN, DELPHINE THIMUS Federaal Kenniscentrum voor de gezondheidszorg Centre fédéral dÊexpertise des soins de santé Belgian Health Care Knowledge Centre 2006 KCE reports vol. 36C Title : Pharmacological and surgical treatment of obesity Residential care for severely obese children in Belgium Authors : KCE : Marie-Laurence Lambert, Laurence Kohn, Imgard Vinck, Irina Cleemput, Joan Vlayen, Mark Leys, Stefaan Van de Sande, Dirk Ramaekers Université Catholique de Louvain (UCL) : Claire Beguin, Sophie Gerkens, Jean-Paul Thissen, Delphine Thimus External experts : Pr Claude Desaive, Centre Hospitalier Universitaire Liege; Pr Dr Luc Van Gaal, Universiteit Antwerpen; Pr Dr Steven Simoens and Pr Dr Stefaan Callens, Koninklijke Universiteit Leuven; Pr Dr Pattyn, Universitair Ziekenhuis Gent External validators : Pr Jaroslaw Kolanowski, Université Catholique de Louvain (émérite); Pr Dr Guy Hubens, Universitair Ziekenhuis Antwerpen; Pr Dr Hugo Robays , Universitair Ziekenhuis Gent Conflict of interest : Non declared Disclaimer : The experts and validators collaborated on the scientific report, but are not responsible for the policy recommendations. These recommendations are under the full responsibility of the Belgian Health Care Knowledge Centre. Layout : Dimitri Bogaerts Brussels, August 2006 (3rd edition, 2nd edition : July 2006, 1st edition : June 2006) Study no. 2005-06 Domain : Health Technology Assessment (HTA) MeSH : Obesity/drug therapy, surgery ; Liability, Legal ; Adult ; Adolescent ; Child NLM classification : WD 210 Language : English Format : Adobe® PDF (A4) Legal depot : D/2006/10.273/30 Any partial reproduction of this document is allowed if the source is indicated. This document is available on the website of the Belgian Health Care Knowledge Centre. How to refer to this document? Lambert M-L, Kohn L, Vinck I, Cleemput I, Vlayen J, Leys M, et al. Pharmacological and surgical treatment of obesity. Residential care for severely obese children in Belgium. Health Technology Assessment (HTA). Bruxelles: Belgian Health Care Knowledge Centre (KCE); 2006. KCE reports 36C (D/2006/10.273/30) KCE reports vol. 36C Obesity i Foreword Obesity is a bigger threat to America than terrorism, said the American surgeon general in March 2006. There is indeed cause for concern as the rise in obesity prevalence has reached epidemic proportions in Western countries, and Belgium is no exception. Is obesity a disease? Severe obesity, as smoKing, is a risk factor for increased morbidity and mortality, but a risK factor is not a disease. Smoking for instance is never called a disease. This is no hair-splitting semantics. Calling obesity a disease gives it a place within the medical paradigm. The role of the medical community is no longer limited to treating the diabetes, hypertension, dyslipedimia, or other associated morbidities. It expands to treating their cause, the cause becomes the disease, and should be treated even in the absence of morbidities. There is therefore no clear limit as to what level of obesity, or overweight constitutes a medical indication, a particular difficulty in this HTA on obesity treatments. Moreover, because of cultural ideals of slimness in Western societies, the development of weight loss interventions designed for medical use (drugs or surgery) exposes the medical community to an increased demand from obese or overweight persons whose motivation does not arise from a medical problem, be it there or not. Medicalising obesity creates a huge marKet. This allows commercial services to advertise in Cosmopolitan UK the merits of undergoing bariatric surgery in Belgium. Prescription-only weight-loss drugs are intensely marKeted to doctors. Solutions to the problem of obesity fall largely outside the medical paradigm. They are to be found in multisectoral approaches to improve diet and encourage physical activity. But - disease or not - obesity is a cause of much suffering, and the medical community is confronted with it. How useful in addressing the problem are weight loss drugs, surgery, or intensive interventions such as residential treatment for obese children? These are the subjects of this report. Jean-Pierre CLOSON DirK RAMAEKERS Adjunct Algemeen Directeur Algemeen Directeur ii Obesity KCE reports vol.36C EXECUTIVE SUMMARY According to the 2004 Health Interview Survey, almost 13% percent of Belgian adults are clinically obese (body mass index - BMI - >=30), and 0.9% are severely obese (BMI >=40); prevalence of obesity is inversely associated with socio-economic status (defined by educational achievement in this survey). Obesity is a risK factor for various health problems such as diabetes and cardio-vascular diseases. The solutions to the problem of obesity at societal level are to be found in multisectoral approaches to improve diet and encourage physical activity, and fall largely outside the medical paradigm. However clinical treatment is also part of the response to the obesity epidemic. Lifestyle modification is and will remain the first treatment of obesity, but pharmacological and surgical approaches are increasingly used. These are the core subjects of this study. We used a standardised health technology assessment methodology to evaluate their effectiveness and cost-effectiveness, and the consequences of our findings for decision maKers in Belgium. This report also includes an analysis of long-term residential care for severely obese children in Belgium. Pharmacological treatment of obesity We considered prescription-only drugs available in Belgium in 2005 (orlistat and sibutramine), as well as rimonabant, which is to be available in a near future. Each of these drugs has been evaluated against placebo as an adjunct to diet in the treatment of clinically obese patients in large randomized placebo-controlled clinical trials of at least one year duration. Virtually all clinical trials are industry-funded, and have a high drop- out rate (40-50%). Given the consensus that sustained weight loss of the order of 10% of initial body weight is a modest but clinically significant objective, we computed the number of patients needed to treat (NNT) with a weight-loss drug, for one of them to achieve and maintain this outcome over 2 years (one year for sibutramine), taKing into account the benefits provided by placebo. Statistical precision of the estimation is given when available (95% confidence interval =95%CI). Only orlistat has been tested in a randomized clinical trial of one year duration in children. Sibutramine (Reductil®): clinicians need to initiate treatment in 3 to 8 obese patients (NNT range: 3-8), for one of them to achieve and/or maintain 10% weight loss after one year, over the benefits provided by placebo. NNT is 10 at 18 months, but the manufacturer recommends limiting the duration of treatment to one year, given concerns about the safety profile of the drug (increases in blood pressure and heart rate). Orlistat (Xenical®): NNT to achieve and/or maintain 10% weight loss in one patient after 2-year treatment is 9 (95% CI: 6-17). Treatment with orlistat for 4 years does not raise serious safety concerns. In children, the mean difference between placebo and treatment groups after one year treatment is one BMI point; the clinical significance of such a difference is open to question. Rimonabant (Acomplia®): NNT to achieve and/or maintain 10% weight loss in one patient after 2-year treatment is 11 (95% CI: 7-25). This is a new drug, number and duration of clinical trials is still limited, and no definite conclusions
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