Summary
Abstract
Orlistat (Xenical®) is a reversible inhibitor of gastric and pancreatic lipases. In conjunction with a hypocaloric diet and moderate exercise, orlistat is an effective drug for use in the management of obesity in adults with or without comorbidities. Recent data have shown that orlistat is also effective as a component of weight management strategies in obese adolescents. In addition to its well established efficacy in achieving modest weight loss, orlistat has been shown to improve glycaemic parameters in obese adults with type 2 diabetes mellitus as well as some features of the metabolic syndrome. Orlistat is generally well tolerated. Thus, orlistat is an option for the treatment of obese patients with or without type 2 diabetes and also has a role in the management of obese patients with the metabolic syndrome, associated comorbidities or concomitant disorders.
Pharmacological Properties
Orlistat is a reversible inhibitor of gastric and pancreatic lipases; its mechanism of action results in an inhibition of dietary fat absorption of 30% at the approved dosage. It is generally associated with a loss of fat mass in obese adults and adolescents, as well as decreases in levels of the regulatory hormone leptin as patients lose bodyweight. Vitamin levels are not consistently affected with orlistat use, with only β-carotene and vitamin D and E levels shown to be significantly decreased by orlistat administration in at least one study. Mineral levels are also not affected in obese adolescent patients. Orlistat is effective in improving factors involved or implicated in the pathogenesis of cardiovascular disease.
The absorption of orlistat is minimal in both healthy adult volunteers and adult obese patients. Orlistat is not extensively metabolised, with 83% of excreted orlistat found to be intact drug. Accumulation of orlistat is minimal in both short-and long-term studies. Orlistat is excreted primarily via the faeces.
Because orlistat is minimally absorbed, it has a generally favourable drug-interaction profile. Only the pharmacokinetics of ciclosporin (cyclosporin) and amiodarone have been shown to be affected by coadministration with orlistat. The bioavailability of oral contraceptives in women receiving orlistat who experience severe diarrhoea may be reduced.
Therapeutic Efficacy
In numerous randomised, double-blind, placebo-controlled multicentre studies in obese adult patients, orlistat has been shown to be significantly more effective than placebo in reducing weight. Orlistat is also effective in producing modest weight loss in obese adolescent patients and in patients with additional disorders, such as type 2 diabetes and the metabolic syndrome. Several metabolic parameters are consistently improved after orlistat treatment; in patients with type 2 diabetes, mean levels of postprandial glucose and glycosylated haemoglobin are decreased. Orlistat treatment enables some patients with type 2 diabetes to decrease or discontinue their antidiabetic medication, or be reclassified to either impaired or normal glucose tolerance. Orlistat shows efficacy in reducing cardiovascular risk factors irrespective of diabetic status or a confirmed diagnosis of metabolic syndrome.
The benefit of orlistat in reducing the disease burden of obese patients with concomitant disorders has also been shown. Orlistat significantly delayed the progression to type 2 diabetes compared with placebo in obese patients with impaired glucose tolerance at baseline in the 4-year randomised, double-blind, multicentre XENDOS trial.
Orlistat is generally as effective as sibutramine in producing weight loss; when the drugs are used in combination in obese patients with or without type 2 diabetes, weight loss is generally increased compared with orlistat alone. Orlistat and sibutramine are also generally equivalent with regard to improvements in diabetic parameters, but orlistat recipients had significant improvements in blood pressure compared with sibutramine recipients.
Several well designed, fully published pharmacoeconomic studies analysing a range of perspectives, from the healthcare system to the patient, have shown that orlistat is a cost-effective treatment for obese adult patients with or without type 2 diabetes.
Tolerability
Orlistat is generally well tolerated in adults and adolescents. Adverse effects experienced by orlistat recipients were generally mild and transient, with most resolving within a few weeks of treatment. The most common adverse events in recipients of orlistat are associated with the gastrointestinal tract. Tolerability profiles are similar in adults and adolescents, as well as in patients with type 2 diabetes or the metabolic syndrome.
Similar content being viewed by others
Notes
The use of trade names is for product identification purposes only and does not imply endorsement.
References
National Institutes of Health. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary. NIH Publication No. 98-4083, 2001
Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001 May 16; 285(19): 2846–97
Ioannides-Demos LL, Proietto J, Tonkin AM, et al. Safety of drug therapies used for weight loss and treatment of obesity. Drug Saf 2006; 29(4): 277–302
Expert Panel on the Identification, Evaluation and Treatment of Overweight in Adults. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary. Am J Clin Nutr 1998 Oct; 68(4): 899–917
Curran MP, Scott LJ. Orlistat: a review of its use in the management of patients with obesity. Drugs 2004; 64(24): 2845–64
Keating GM, Jarvis B. Orlistat: in the prevention and treatment of type 2 diabetes mellitus. Drugs 2001; 61(14): 2107–19
Hvizdos KM, Markham A. Orlistat: a review of its use in the management of obesity. Drugs 1999 Oct; 58(4): 743–60
Roche Pharmaceuticals. Xenical® (orlistat) capsules: complete product information (US). New Jersey: Roche Laboratories Inc., 2005
Roche Laboratories. Xenical® (orlistat): summary of product characteristics. Hertfordshire: Roche, 2003
Tiikkainen M, Bergholm R, Rissanen A, et al. Effects of equal weight loss with orlistat and placebo on body fat and serum fatty acid composition and insulin resistance in obese women. Am J Clin Nutr 2004 Jan; 79(1): 22–30
Hsieh CJ, Wang PW, Liu RT, et al. Orlistat for obesity: benefits beyond weight loss. Diabetes Res Clin Pract 2005 Jan; 67(1): 78–83
Karhunen L, Franssila-Kallunki A, Rissanen P, et al. Effect of orlistat treatment on body composition and resting energy expenditure during a two-year weight-reduction programme in obese Finns. Int J Obes Relat Metab Disord 2000 Dec; 24(12): 1567–72
Golay A, Laurent-Jaccard A, Habicht F, et al. Effect of orlistat in obese patients with binge eating disorder. Obes Res 2005 Oct; 13(10): 1701–8
Ozcelik O, Dogan H, Kelestimur H. Effects of a weight-reduction program with orlistat on serum leptin levels in obese women: a 12-week, randomized, placebo-controlled study. Curr Ther Res Clin Exp 2004; 65(2): 127–37
Chanoine JP, Hampl S, Jensen C, et al. Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial. JAMA 2005 Jun 15; 293(23): 2873–83
Maahs D, de Serna DG, Kolotkin RL, et al. Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents. Endocr Pract 2006; 12(1): 18–28
Torgerson JS, Hauptman J, Boldrin MN, et al. XENical in the prevention of Diabetes in Obese Subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care 2004 Jan; 27(1): 155–61
McDuffie JR, Calis KA, Booth SL, et al. Effects of orlistat on fat-soluble vitamins in obese adolescents. Pharmacotherapy 2002 Jul; 22(7): 814–22
McDuffie JR, Calis KA, Uwaifo GI, et al. Efficacy of orlistat as an adjunct to behavioral treatment in overweight African American and Caucasian adolescents with obesity-related comorbid conditions. J Pediatr Endocrinol Metab 2004 Mar; 17(3): 307–19
Melia AT, Koss-Twardy SG, Zhi J. The effect of orlistat, an inhibitor of dietary fat absorption, on the absorption of vitamins A and E in heathy volunteers. J Clin Pharmacol 1996; 36: 647–53
Zhi J, Melia AT, Koss-Twardy SG, et al. The effect of orlistat, in inhibitor of dietary fat absorption, on the pharmacokinetics of β-carotene in healthy volunteers. J Clin Pharmacol 1996; 36: 152–9
Zhi J, Moore R, Kanitra L. The effect of short-term (21-day) orlistat treatment on the physiologic balance of six selected macrominerals and microminerals in obese adolescents. J Am Coll Nutr 2003 Oct; 22(5): 357–62
Wauters M, Considine RV, Van Gaal LF. Human leptin: from an adipocyte hormone to an endocrine mediator. Eur J Endocrinol 2000; 143(3): 293–311
Dimitrov D, Bohchelian H, Koeva L. Effect of orlistat on plasma leptin levels and risk factors for the metabolic syndrome. Metabolic Syndrome & Related Disorders 2005; 3(2): 122–9
Suter PM, Marmier G, Veya-Linder C, et al. Effect of orlistat on postprandial lipemia, NMR lipoprotein subclass profiles and particle size. Atherosclerosis 2005 May; 180(1): 127–35
Dayi SU, Kasikcioglu H, Uslu N, et al. Influence of weight loss on myocardial performance index. Heart Vessels 2006 Mar; 21(2): 84–8
Yesilbursa D, Serdar Z, Serdar A, et al. Lipid peroxides in obese patients and effects of weight loss with orlistat on lipid peroxides levels. Int J Obes (London) 2005 Jan; 29(1): 142–5
Diamanti-Kandarakis E, Piperi C, Alexandraki K, et al. Short-term effect of orlistat on dietary glycotoxins in healthy women and women with polycystic ovary syndrome. Metabolism 2006 Apr; 55(4): 494–500
Rissanen P, Vahtera E, Krusius T, et al. Weight change and blood coagulability and fibrinolysis in healthy obese women. Int J Obes Relat Metab Disord 2001 Feb; 25: 212–8
Yesilbursa D, Serdar A, Heper Y, et al. The effect of orlistat-induced weight loss on interleukin-6 and C-reactive protein levels in obese subjects. Acta Cardiol 2005 Jun; 60(3): 265–9
Zhi J, Mulligan TE, Hauptman JB. Long-term systemic exposure of orlistat, a lipase inhibitor, and its metabolites in obese patients. J Clin Pharmacol 1999 Jan; 39(1): 41–6
Zhi J, Melia AT, Funk C, et al. Metabolic profiles of minimally absorbed orlistat in obese/overweight volunteers. J Clin Pharmacol 1996; 36(11): 1006–11
Zhi J, Melia AT, Eggers H, et al. Review of limited systemic absorption of orlistat, a lipase inhibitor, in healthy human volunteers. J Clin Pharmacol 1995; 35: 1103–8
Melia AT, Zhi J, Koss-Twardy SG, et al. The influence of reduced dietary fat absorption induced by orlistat on the pharmacokinetics of digoxin in healthy volunteers. J Clin Pharmacol 1995; 35: 840–3
Zhi J, Moore R, Kanitra L, et al. Pharmacokinetic evaluation of the possible interaction between selected concomitant medications and orlistat at steady state in healthy subjects. J Clin Pharmacol 2002 Sep; 42(9): 1011–9
Zhi J, Moore R, Kanitra L, et al. Effects of orlistat, a lipase inhibitor, on the pharmacokinetics of three highly lipophilic drugs (amiodarone, fluoxetine, and simvastatin) in healthy volunteers. J Clin Pharmacol 2003 Apr; 43(4): 428–35
Melia AT, Mulligan TE, Zhi J. The effect of orlistat on the pharmacokinetics of phenytoin in healthy volunteers. J Clin Pharmacol 1996; 36: 654–8
Zhi J, Melia AT, Koss-Twardy SG, et al. The influence of orlistat on the pharmacokinetics and pharmacodynamics of glyburide in healthy volunteers. J Clin Pharmacol 1995; 35: 521–5
Melia AT, Mulligan TE, Zhi J. Lack of effect of orlistat on the bioavailability of a single dose of nifedipine extended-release tablets (Procardia XL) in healthy volunteers. J Clin Pharmacol 1996; 36: 352–5
Zhi J, Melia AT, Guerciolini R, et al. The effect of orlistat on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers. J Clin Pharmacol 1996 Jul; 36(7): 659–66
Oo CY, Akbari B, Lee S, et al. Effect of orlistat, a novel anti-obesity agent, on the pharmacokinetics and pharmacodynamics of pravastatin in patients with mild hypercholesterolaemia. Clin Drug Invest 1999; 17(3): 217–23
Hartmann D, Guzelhan C, Zuiderwijk PBM, et al. Lack of interaction between orlistat and oral contraceptives. Eur J Clin Pharmacol 1996; 50: 421–4
Melia AT, Zhi J, Zelasko R, et al. The interaction of the lipase inhibitor orlistat with ethanol in healthy volunteers. Eur J Clin Pharmacol 1998; 54: 773–7
Evans S, Michael R, Wells H, et al. Drug interaction in a renal transplant patient: cyclosporin-neoral and orlistat. Am J Kidney Dis 2003 Feb; 41: 493–6
Barbara D, Orsini P, Pallini S, et al. Obesity in transplant patients: case report showing interference of orlistat with absorption of cyclosporine and review of literature. Endocr Pract 2002 Mar–Apr 30; 8(2): 124–6
Errasti P, Garcia I, Lavilla J, et al. Reduction in blood cyclosporine concentration by orlistat in two renal transplant patients. Transplant Proc 2002 Feb; 34(1): 137–9
Broom I, Wilding J, Stott P, et al. Randomised trial of the effect of orlistat on body weight and cardiovascular disease risk profile in obese patients: UK Multimorbidity Study. Int J Clin Pract 2002 Sep; 56(7): 494–9
Lindgarde F. The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: the Swedish Multimorbidity Study. J Intern Med 2000 Sep; 248(3): 245–54
Krempf M, Louvet JP, Allanic H, et al. Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity. Int J Obes Relat Metab Disord 2003 May; 27(5): 591–7
Davidson MH, Hauptman J, DiGirolamo M, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. JAMA 1999; 281(3): 235–42
Hauptman J, Lucas C, Boldrin MN, et al. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med 2000 Feb; 9(2): 160–7
Rössner S, Sjöström L, Noack R, et al. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Obes Res 2000 Jan; 8(1): 49–61
Sjöström L, Rissanen A, Andersen T, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Lancet 1998 Jul 18; 352(9123): 167–72
Swinburn BA, Carey D, Hills AP, et al. Effect of orlistat on cardiovascular disease risk in obese adults. Diabetes Obes Metab 2005 May; 7(3): 254–62
Bakris G, Calhoun D, Egan B, et al. Orlistat improves blood pressure control in obese subjects with treated but inadequately controlled hypertension. J Hypertens 2002 Nov; 20(11): 2257–67
Shi YF, Pan CY, Hill J, et al. Orlistat in the treatment of overweight or obese Chinese patients with newly diagnosed type 2 diabetes. Diabet Med 2005 Dec; 22(12): 1737–43
Berne C, The Orlistat Swedish Type 2 diabetes Study Group. A randomized study of orlistat in combination with a weight management programme in obese patients with type 2 diabetes treated with metformin. Diabet Med 2005 May; 22(5): 612–8
Cocco G, Pandolfi S, Rousson V. Sufficient weight reduction decreases cardiovascular complications in diabetic patients with the metabolic syndrome: a randomized study of orlistat as an adjunct to lifestyle changes (diet and exercise). Heart Drug 2005; 5(2): 68–74
Grilo CM, Masheb RM, Salant SL. Cognitive behavioral therapy guided self-help and orlistat for the treatment of binge eating disorder: a randomized, double-blind, placebo-controlled trial. Biol Psychiatry 2005 May 15; 57(10): 1193–201
Zelber-Sagi S, Kessler A, Brazowsky E, et al. A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol 2006 May; 4(5): 639–44
Derosa G, Cicero AFG, Murdolo G, et al. Efficacy and safety comparative evaluation of orlistat and sibutramine treatment in hypertensive obese patients. Diabetes Obes Metab 2005 Jan; 7(1): 47–55
Kaya A, Aydin N, Topsever P, et al. Efficacy of sibutramine, orlistat and combination therapy on short-term weight management in obese patients. Biomed Pharmacother 2004 Dec; 58(10): 582–7
Filippatos TD, Kiortsis DN, Liberopoulos EN, et al. Effect of orlistat, micronised fenofibrate and their combination on metabolic parameters in overweight and obese patients with the metabolic syndrome: the FenOrli study. Curr Med Res Opin 2005 Dec; 21(12): 1997–2006
Derosa G, Cicero AFG, Murdolo G, et al. Comparison of metabolic effects of orlistat and sibutramine treatment in type 2 diabetic obese patients. Diabetes Nutr Metab 2004 Aug; 17(4): 222–9
Sari R, Balci MK, Cakir M, et al. Comparison of efficacy of sibutramine or orlistat versus their combination in obese women. Endocr Res 2004 May; 30(2): 159–67
Toplak H, Ziegler O, Keller U, et al. X-PERT: weight reduction with orlistat in obese subjects receiving a mildly or moderately reduced-energy diet: early response to treatment predicts weight maintenance. Diabetes Obes Metab 2005 Nov; 7(6): 699–708
Wirth A. Reduction of body weight and co-morbidities by orlistat: The XXL-Primary Health Care Trial. Diabetes Obes Metab 2005 Jan; 7(1): 21–7
Harrison SA, Fincke C, Helinski D, et al. A pilot study of orlistat treatment in obese, non-alcoholic steatohepatitis patients. Aliment Pharmacol Ther 2004 Sep 15; 20(6): 623–8
Rowe R, Cowx M, Poole C, et al. The effects of orlistat in patients with diabetes: improvement in glycaemic control and weight loss. Curr Med Res Opin 2005 Nov; 21(11): 1885–90
McDuffie JR, Calis KA, Uwaifo GI, et al. Three-month tolerability of orlistat in adolescents with obesity-related comorbid conditions. Obes Res 2002 Jul; 10(7): 642–50
Mezquita-Raya P, de Torres A, Fernandez-Garcia D, et al. Orlistat efficacy on weight loss in obese women with depressive symptoms. Obes Rev 2005 Jun; 6 Suppl. 1: 160
Quesada M. Effect of six months treatment with orlistat on weight loss in obese postmenopausal women. Obes Rev 2005 Jun; 6 Suppl. 1: 165
Didangelos TP, Thanopoulou AK, Bousboulas SH, et al. The ORLIstat and CArdiovascular risk profile in patients with metabolic syndrome and type 2 DIAbetes (ORLICARDIA) study. Curr Med Res Opin 2004 Sep; 20(9): 1393–401
Ozkan B, Bereket A, Turan S, et al. Addition of orlistat to conventional treatment in adolescents with severe obesity. Eur J Pediatr 2004 Dec; 163(12): 738–41
Beck-da-Silva L, Higginson L, Fraser M, et al. Effect of orlistat in obese patients with heart failure: a pilot study. Congest Heart Fail 2005 May–Jun 30; 11(3): 118–23
Feigenbaum A, Pasternak S, Zusk E, et al. Influence of intense multidisciplinary follow-up and orlistat on weight reduction in a primary care setting. BMC Fam Pract 2005 Jan 29; 6(1): 5
Guy-Grand B, Drouin P, Eschwege E, et al. Effects of orlistat on obesity-related diseases: a six-month randomized trial. Diabetes Obes Metab 2004 Sep; 6(5): 375–83
Lucas CP, Boldrin MN, Reaven GM. Effect of orlistat added to diet (30% of calories from fat) on plasma lipids, glucose, and insulin in obese patients with hypercholesterolemia. Am J Cardiol 2003 Apr 15; 91(8): 961–4
Broom I, Hughes E, Dodson P, et al. The role of orlistat in the treatment of obese patients with mild to moderate hypercholesterolaemia: consequences for coronary risk. Br J Cardiol 2002; 9(8): 460–8
Kelley DE, Bray GA, Pi-Sunyer FX, et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulintreated type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 2002 Jun; 25(6): 1033–41
Miles JM, Leiter L, Hollander P, et al. Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. Diabetes Care 2002 Jul; 25(7): 1123–8
Mittendorfer B, Ostlund RE Jr, Patterson BW, et al. Orlistat inhibits dietary cholesterol absorption. Obes Res 2001 Oct; 9(10): 599–604
Hollander PA, Elbein SC, Hirsch IB, et al. Role of orlistat in the treatment of obese patients with type 2 diabetes: a 1-year randomized double-blind study. Diabetes Care 1998 Aug; 21(8): 1288–94
Erdmann J, Lippl F, Klose G, et al. Cholesterol lowering effect of dietary weight loss and orlistat treatment: efficacy and limitations. Aliment Pharmacol Ther 2004 Jun 1; 19(11): 1173–9
Muls E, Kolanowski J, Scheen A, et al. The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled, multicentre study. Int J Obes Relat Metab Disord 2001 Nov; 25(11): 1713–21
Sjöström L. Analysis of the XENDOS study (Xenical in the Prevention of Diabetes in Obese Subjects). Endocr Pract 2006 Jan–Feb; 12 Suppl. 1: 31–3
Torgerson JS, Hauptman J, Boldrin M, et al. Efficacy of orlistat plus lifestyle changes in risk reduction of type 2 diabetes in obese patients with metabolic syndrome: a comparative analysis using National Cholesterol Education Program Adult Treatment Panel III vs European group for the study of insulin resistance criteria [abstract no. 690]. Diabetologia 2004; 47 Suppl. 1: A249
DeFronzo R, Sjöström L, Torgerson JS, et al. XENDOS: onset of type 2 diabetes in obese patients with normal glucose tolerance/IGT and metabolic syndrome. [abstract no. 1706-P]. 63rd Scientific Sessions of the American Diabetes Association; 2003 Jun 13–17; New Orleans, LA
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM, Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002; 346(6): 393–403
Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001; 344(18): 1343–50
Rössner S, Sjöström L, Boldrin M, et al. Prevalence of metabolic syndrome in a cohort of Swedish obese patients [abstract no. P4-095]. Plus poster presented at the 12th European Congress on Obesity; 2003 May 29–Jun 1; Helsinki
Bray GA, Torgerson J, Sjöström L, et al. Effect of orlistat in obese patients with the metabolic syndrome as defined by the NCEP (ATPIII) [abstract no. 1703-P]. 63rd Annual Scientific Sessions of the American Diabetes Association; 2003 Jun 13–17; New Orleans, LA
Krempf M, Laville M, Basdevant A, et al. Effect of orlistat on NCEP ATP-III-defined metabolic syndrome in obese or overweight patients: meta-analysis from 20 randomised double-blind studies worldwide [abstract no. P587]. Obese Rev 2005 Jun; 6 Suppl. 1: 166. Plus poster presented at the 14th European Congress on Obesity, Athens, Jun 1–4 2005.
Hanefeld M, Sachse G. The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes Obes Metab 2002 Nov; 4(6): 415–23
Halpern A, Mancini MC, Suplicy H, et al. Latin-American trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients. Diabetes Obes Metab 2003 May; 5(3): 180–8
Hertzman P. The cost effectiveness of orlistat in a 1-year weight-management programme for treating overweight and obese patients in Sweden: a treatment responder approach. Pharmacoeconomics 2005; 23(10): 1007–20
Lacey LA, Wolf A, O'Shea D, et al. Cost-effectiveness of orlistat for the treatment of overweight and obese patients in Ireland. Int J Obes (Lond) 2005 Aug; 29(8): 975–82
Maetzel A, Ruof J, Covington M, et al. Economic evaluation of orlistat in overweight and obese patients with type 2 diabetes mellitus. Pharmacoeconomics 2003; 21(7): 501–12
Ruof J, Golay A, Berne C, et al. Orlistat in responding obese type 2 diabetic patients: meta-analysis findings and cost-effectiveness as rationales for reimbursement in Sweden and Switzerland. Int J Obes (Lond) 2005 May; 29(5): 517–23
Szucs TD, Cathomas G, Muller D. Cost-effectiveness of orlistat in the treatment of overweight and obese patients with type 2 diabetes in Switzerland [in German]. Pharmacoeconomics German Research Articles 2003; 1(1): 49–59
Foxcroft DR. Orlistat for the treatment of obesity: cost utility model. Obes Rev 2005 Nov; 6(4): 323–8
Lamotte M, Annemans L, Lefever A, et al. A health economic model to assess the long-term effects and cost-effectiveness of orlistat in obese type 2 diabetic patients. Diabetes Care 2002 Feb; 25(2): 303–8
Foxcroft DR, Milne R. Orlistat for the treatment of obesity: rapid review and cost-effectiveness model. Obes Rev 2000 Oct; 1(2): 121–6
Clark CM Jr. The burden of chronic hyperglycemia. Diabetes Care 1998; 21 Suppl. 3: C32–4
United Kingdom Prospective Diabetes Study Group. Effect of intensive blood glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352(9131): 854–65
UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352(9131): 837–53
Koskinen P, Manttari M, Manninen V, et al. Coronary heart disease incidence in NIDDM patients in the Helsinki Heart Study. Diabetes Care 1992; 15(7): 820–5
Stratton IM, Adler AI, Neil HAW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. Br Med J 2000; 321(7258): 405–12
Roche. Xenical gains European approval for use in young people [online]. Available from URL: http://www.roche.com/ [Accessed 2006 July].
Roche. US FDA joint advisory committee recommends approval of weight loss drug Orlistat 60mg capsules for over the counter use [online]. Available from URL: http://ww-w.roche.com/[Accessed 2006July].
World Health Organisation. Obesity and overweight [online]. Available from URL: http://www.who.int/ [Accessed 2006 July]
Snow V, Barry P, Fitterman N, et al. Pharmacologic and surgical management of obesity in primary care: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2005 Apr 5; 142(7): 525–31
Sanofi-Aventis. Acomplia (Rimonabant) receives marketing authorisation in the European Union [online]. Available from URL: http://www.sanofi-aventis.com/ [Accessed 2006 July]
Ioannides-Demos LL, Proietto J, McNeil JJ. Pharmacotherapy for obesity. Drugs 2005; 65(10): 1391–418
Halpern A, Mancini MC. Diabesity: are weight loss medications effective? Treat Endocrinol 2005; 4(2): 65–74
Author information
Authors and Affiliations
Corresponding author
Additional information
Various sections of the manuscript reviewed by: I. Broom, School of Life Sciences, The Robert Gordon University, Aberdeen, Scotland; L. Busetto, Clinica Medica 1, Policlinico Universitario, Padova, Italy; J. Erdmann, Department of Internal Medicine II, Technical University of Munich, Munich, Germany; B. Guy-Grand, Service de Medecine et Nutrition, Hopital Hotel-Dieu, Paris, France; A. Inui, Department of Behavioral Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan; J. Kolanowski, Endocrinology and Metabolism Unit, Catholic University of Louvain, Brussels, Belgium; S. O’Meara, Department of Health Sciences, University of York, York, England; V. Schusdziarra, Department of Internal Medicine II, Technical University of Munich, Munich, Germany.
Data Selection
Sources: Medical literature published in any language since 1980 on ‘orlistat’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.
Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘orlistat’. Searches were last updated 21 August 2006.
Selection: Studies in patients with obesity who received orlistat. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.
Index terms: Orlistat, obesity, type 2 diabetes mellitus, metabolic syndrome, pharmacodynamics, pharmacokinetics, therapeutic use.
Rights and permissions
About this article
Cite this article
Henness, S., Perry, C.M. Orlistat. Drugs 66, 1625–1656 (2006). https://doi.org/10.2165/00003495-200666120-00012
Published:
Issue Date:
DOI: https://doi.org/10.2165/00003495-200666120-00012