Bariatric treatments for adult obesity - Institute of Health Economics

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medications that inhibit intestinal fat absorption—the drug orlistat inhibits pancreatic andother lipase; it is the only agent currently available in this class. 20medications that suppress appetite, increase satiety, or increase thermogenesis—drugs in thisclass modify the central nervous system neurotransmission of norepinephrine, dopamine,and serotonin. Sibutramine, a serotonin-norepinephrine reuptake inhibitor, belongs to thisclass. 12 medications that inhibit the endocannabinoid system—rimonabant is the first drug of thisclass and acts by both central and peripheral mechanisms to reduce food intake and bodyweight. 20History and trendAn assessment of US national trends revealed that the use of antiobesity medications drastically rosewith the increased popularity of fenfluramine-phentermine. 6 Fenfluramine was withdrawn from themarket worldwide in 1997 because of reports of aortic valvular regurgitation associated with its use. 6Since then the use of antiobesity medications has declined, but use still remains higher than 1990levels. 14 A brief history of the use of antiobesity medications is summarized in Table T.3.Table T.3: History and mechanisms of antiobesity medicationsMedicationYear ofintroductionThermogenesisMechanism of actionAppetitesuppressionDecreased fatabsorptionStatusThyroid hormone 1893 Widely used until 1980sDinitrophenol 1933 WithdrawnAmphetamines:DexamfetamineMethamphetamineAmphetamine-likeanalogues:1936 Banned, restricted, ordiscouragedPhentermine 1959 US Withdrawn (2000, UK)Amfepramone(diethylpropion)1959 US for short-term use ( 12weeks)Phenylpropanolamine 1939 US Withdrawn (2004)Aminorex 1965 Withdrawn (1968)Ephedrine/caffeine 1970s Denmark Banned (2004)Mazindol 1970s DiscontinuedFenfluramineDexfenfluramineOrlistat1963 Europe1973 US1985 Europe1996 US1998 Europe1999 US Withdrawn (1997) Withdrawn (1997)Available in severalcountriesBariatric treatments for adult obesity 68
Sibutramine1997 US1999 EuropeAvailable in US, Canada;Suspended in Europe(2010)Rimonabant 2006 Europe Suspended (2008)Sources: Ioannides-Demos et al. 2005, 16 Padwal, 2007, 21 European Medicines Agency, 2010, 22 US FDA 2010 23Orlistat is a synthetic gastrointestinal lipase inhibitor which decreases fat absorption by binding topancreatic lipase and increasing fecal fat excretion. 6,16 Orlistat is the most extensively studiedmedication currently available for obesity treatment. 24 Since its introduction in the early 1990s, morethan 150 clinical trials have been published on the use of orlistat alone or in combination with otherantiobesity medications, antidiabetic, antilipidemic, and other related medications for managementof different aspects of the dysmetabolic syndrome. 24Sibutramine, a serotonin and norepinephrine reuptake inhibitor, was originally developed as anantidepressant but was subsequently shown to suppress appetite and possibly increasethermogenesis. 14,25,26Rimonabant is a selective cannabinoid receptor-1 antagonist with resultant central and metabolicperipheral effects; it decreases food intake by blocking the ‘munchie receptor’ that stimulateshunger. 16Criteria for the efficacy of drug therapyThe US FDA recommend a 5% placebo-subtracted weight loss as the criterion for efficacy. 27 TheEuropean Medicines Evaluation Agency suggests a weight loss of greater than 10% from baseline(or of at least 5% placebo-subtracted) as a valid primary efficacy criterion. 28 The National Heart,Lung, and Blood Institute and the North American Association for the Study of Obesityrecommend continuing therapy for responders who have lost 4.4 pounds (or 2 kilograms) in the first4 weeks after initiating therapy, and discontinuing in non-responders. 19 The London Royal Collegeof Physicians recommend stopping drug treatment if a 5% weight loss is not achieved after 12weeks. 29Indications/contraindicationsBecause all medications inherently have more associated risks than do dietary therapy and physicalexercise, antiobesity medications should only be used when the benefit justifies the risk 30 and incombination with lifestyle education and careful monitoring. 13Patients with a BMI of 30 kg/m 2 or greater or a BMI of 27 kg/m 2 or greater with a major obesityrelatedcomorbidity (for example, hypertension, diabetes, obstructive sleep apnea) are currentlyeligible for antiobesity drug treatment. 1,19Orlistat might be useful in patients at high risk for developing type 2 diabetes, with high LDLcholesterol concentrations, or with pre-existing cardiovascular disease. 21 Orlistat should be avoidedfor patients with chronic diarrhea, chronic mal-absorption syndrome and cholestasis. 4,21Because of its satiety-enhancing effects, sibutramine might be beneficial for those patients in whoma lack of satiety or frequent snacking is a major barrier to weight reduction. Sibutramine should beavoided for patients with inadequately controlled hypertension, pre-existing cardiovascular disease,or psychiatric illness. 4Bariatric treatments for adult obesity 69
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Alberta STE ReportBariatric treatme
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Alberta STE ReportBariatric treatme
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EXECUTIVE SUMMARYSocial and System
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Three surgical procedures—adjusta
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Costs of Bariatric Surgery and Pote
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Regulatory status .................
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TABLES AND FIGURESSection One: Soci
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ABBREVIATIONSAll abbreviations that
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LYMmMAMDMUHCNANHLBINHSNICENIHNNHNPH
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Bariatric physician: a licensed Doc
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High-density lipoprotein (HDL): a f
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Very-low-calorie diet (VLCD): a die
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Additional Internet searches were c
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This report addresses obesity in ad
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Many systemic factors have been ide
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Severe obesity is associated with d
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eport their height and under-report
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Also using self-reported data from
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An examination of overall obesity d
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Table S.2 presents the associationa
Page 42 and 43: • have multiple focal points and
Page 45 and 46: The main problem in any weight mana
Page 47: food, and a negative body image. As
Page 50 and 51: directly causes death. 61 To the ex
Page 52 and 53: The addition of a selected pharmaco
Page 54 and 55: lack of formal training in nutritio
Page 56 and 57: slightly more likely to have prescr
Page 58 and 59: selection criteria, have facilities
Page 60 and 61: Barriers to using appropriate baria
Page 62 and 63: Overview of adult obesityOver the p
Page 64 and 65: the need for regular physical activ
Page 66 and 67: phenylpropanolamine/25. Sibutramine
Page 68 and 69: Complianceand AdherenceDemand andut
Page 70 and 71: Aetna Clinical PolicyBulletinswww.a
Page 72 and 73: Overweight 123,821 172,971 157,623
Page 74 and 75: REFERENCES1. 2006 Canadian clinical
Page 76 and 77: 34. Gostin LO. Fast and supersized:
Page 78 and 79: 69. Klarenbach S, Padwal R, Wiebe N
Page 80 and 81: 105. Hill JO, Thompson H, Wyatt H.
Page 82 and 83: 141. Ross R, Bradshaw AJ. The futur
Page 84 and 85: 172. Arkinson J, Ji H, Fallah S, Pe
Page 86 and 87: This section will address a set of
Page 88 and 89: dietary therapy is to reduce total
Page 90 and 91: Additional benefits of exercise ove
Page 94 and 95: Rimonabant may be considered for pa
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Page 98 and 99: Devices used for bariatric surgeryH
Page 100 and 101: Description of the Included Systema
Page 102 and 103: AEs for sibutramineAs compared to a
Page 104 and 105: Evidence on Efficacy/EffectivenessW
Page 106 and 107: Table T.7: Effects of behavioural t
Page 108 and 109: SurgeryDescription of the included
Page 110 and 111: follow-up time was 3 years. Results
Page 112 and 113: group as compared to the VBG group.
Page 114 and 115: The authors identified many methodo
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Page 118 and 119: approximately 3 to 5 kilograms. For
Page 120 and 121: for studies with a mean age of part
Page 122 and 123: Examining whether use of any of the
Page 124 and 125: Evidence from placebo-controlled cl
Page 126 and 127: colorectal or gastroesophageal or f
Page 128 and 129: Web of ScienceISI Interface License
Page 130 and 131: AMA Clinical PracticeGuidelineswww.
Page 132 and 133: critical appraisal of the included
Page 134 and 135: APPENDIX T.B: EXCLUDED STUDIESTable
Page 136 and 137: Padwal R, Li SK, Lau DC. Long-term
Page 138 and 139: Quality subsection 1: At least MEDL
Page 140 and 141: Quality subsection 5a:Study quality
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Partially reported: The study types
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Table T.C.1: Results of quality ass
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Table T.C.1: Results of quality ass
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APPENDIX T.D: CHARACTERISTICS OF SY
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Table T.D.1: Characteristics of the
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APPENDIX T.E: EVIDENCE TABLE ON SAF
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Serious surgical complicationsSurgi
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LSGmMAMDNAnssORQoLRCTRDRRRYGBSBPTGV
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Table T.F.1-2: Weight loss - Behavi
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Table T.F.1-4: Weight loss - Surger
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Table T.F.2: Quality of life (QoL)
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Curioni & Lourenco 2005 58Cholester
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Table T.F.3-3: Risk factors/comorbi
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Table T.F.3-5: Long-term effects of
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Maciejewski et al., 2005 65Avenell
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Table T.G.2: Effects of bariatric s
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Table T.G.4: Effects of bariatric s
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18. Cerulli J, Lomaestro BM, Malone
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50. Health Canada Drug Product Data
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SECTION THREE: ECONOMIC EVALUATIONC
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Definition of bariatric surgical pa
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etween surgical interventions, the
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concluded that adding orlistat to L
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Weight management program (WMP) ver
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groups. Compared with standard care
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Results from Analysis of Provincial
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DiscussionThe objectives of the eco
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surgical suites, and so on. The bud
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APPENDIX E.A: LITERATURE SEARCH SUM
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CRD Databases(DARE, HTA & NHS EED)h
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Web of ScienceISI Interface License
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NEOS Librarywww.library.ualberta.ca
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Table E.A.2: Evidence table of revi
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ResultHealth outcomesCostsMarginal
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CostsMarginal analysisThe cost anal
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Time Horizon/discount rateCurrency/
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Objectivestudy perspective: society
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S4Economic burden of obesityMean co
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15. Lacey LA, Wolf A, O'shea D, Ern
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Author Contribution StatementsPaula
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