New progress in research on the efficacy and safety of weight-loss drug orlistat_West China Medical Journal

Authors：

QIN Meng ¹ , TAN Huiwen ¹ ,  YU Yerong ^1,2

1. Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
2. Laboratory of Endocrinolgy and Metabolism, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

YU Yerong, Email: yerongyu@scu.edu.cn

Keywords：

Orlistat; Obesity; Overweight; Effectiveness; Safety

DOI：

10.7507/1002-0179.202011094

Video：

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Abstract Full text Figures/Tables Video References Cited by

Orlistat, which has a new mechanism of action, is currently the only approved weight-loss drug in China. In addition to controlling body weight, orlistat can significantly improve blood glucose, blood pressure, dyslipidemia, adiponectin, insulin concentration and other obesity-related biochemical indicators in patients with overweight/obese. Recently, orlistat was approved for weight management in patients with polycystic ovary syndrome. Although there are clinical trials supporting the good weight loss efficacy of orlistat, its long-term safety and effectiveness in obesity-related diseases still need to be further determined. This article provides a brief review of the new progress in the clinical efficacy and safety of orlistat, aiming to provide a reference for the more rational drug application.

Citation： QIN Meng, TAN Huiwen, YU Yerong. New progress in research on the efficacy and safety of weight-loss drug orlistat. West China Medical Journal, 2021, 36(9): 1297-1302. doi: 10.7507/1002-0179.202011094 Copy

1.	Bray GA, Kim KK, Wilding JPH, et al. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev, 2017, 18(7): 715-723.
2.	NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19.2 million participants. Lancet, 2016, 387(10026): 1377-1396.
3.	Bray GA, Tartaglia LA. Medicinal strategies in the treatment of obesity. Nature, 2000, 404(6778): 672-677.
4.	Dietz WH, Baur LA, Hall K, et al. Management of obesity: improvement of health-care training and systems for prevention and care. Lancet, 2015, 385(9986): 2521-2533.
5.	Son JW, Kim S. Comprehensive review of current and upcoming anti-obesity drugs. Diabetes Metab J, 2020, 44(6): 802-818.
6.	Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA, 2014, 311(1): 74-86.
7.	Hasani-Ranjbar S, Nayebi N, Larijani B, et al. A systematic review of the efficacy and safety of herbal medicines used in the treatment of obesity. World J Gastroenterol, 2009, 15(25): 3073-3085.
8.	蒋亮, 汤旭磊, 关聪会, 等. 肥胖的药物治疗进展. 中国临床药理学杂志, 2021, 37(14): 1923-1927.
9.	Padwal RS, Majumdar SR. Drug treatments for obesity: Orlistat, sibutramine, and rimonabant. Lancet, 2007, 369(9555): 71-77.
10.	Kang JG, Park CY. Anti-obesity drugs: a review about their effects and safety. Diabetes Metab J, 2012, 36(1): 13-25.
11.	Siebenhofer A, Winterholer S, Jeitler K, et al. Long-term effects of weight-reducing drugs in people with hypertension. Cochrane Database Syst Rev, 2021, 1: CD007654.
12.	Singhal V, Sella AC, Malhotra S. Pharmacotherapy in pediatric obesity: current evidence and landscape. Curr Opin Endocrinol Diabetes Obes, 2021, 28(1): 55-63.
13.	Paccosi S, Cresci B, Pala L, et al. Obesity therapy: how and why?. Curr Med Chem, 2020, 27(2): 174-186.
14.	马微, 付丽, 王海波, 等. 新型减肥药奥利司他的研究进展. 华西药学杂志, 2009, 24(4): 431-433.
15.	Khedr NF, Ebeid AM, Khalil RM. New insights into weight management by Orlistat in comparison with cinnamon as a natural lipase inhibitor. Endocrine, 2020, 67(1): 109-116.
16.	Guerciolini R. Mode of action of Orlistat. Int J Obes Relat Metab Disord, 1997, 21(Suppl 3): S12-S23.
17.	Carrière F, Renou C, Ransac S, et al. Inhibition of gastrointestinal lipolysis by Orlistat during digestion of test meals in healthy volunteers. Am J Physiol Gastrointest Liver Physiol, 2001, 281(1): G16-G28.
18.	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(11): 1103-1108.
19.	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): 235-242.
20.	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, 7(6): 699-708.
21.	Singh AK, Singh R. Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs. Expert Rev Clin Pharmacol, 2020, 13(1): 53-64.
22.	Aldekhail NM, Logue J, McLoone P, et al. Effect of Orlistat on glycaemic control in overweight and obese patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. Obes Rev, 2015, 16(12): 1071-1080.
23.	Khera R, Murad MH, Chandar AK, et al. Association of pharmacological treatments for obesity with weight loss and adverse events: a systematic review and meta-analysis. JAMA, 2016, 315(22): 2424-2434.
24.	Sahebkar A, Simental-Mendia LE, Reiner Z, et al. Effect of Orlistat on plasma lipids and body weight: a systematic review and meta-analysis of 33 randomized controlled trials. Pharmacol Res, 2017, 122: 53-65.
25.	中华医学会肝病学分会脂肪肝和酒精性肝病学组, 中国医师协会脂肪性肝病专家委员会. 非酒精性脂肪性肝病防治指南(2018更新版). 现代医药卫生, 2018, 34(5): 641-649.
26.	Suter PM, Marmier G, Veya-Linder C, et al. Effect of Orlistat on postprandial lipemia, NMR lipoprotein subclass profiles and particle size. Atherosclerosis, 2005, 180(1): 127-135.
27.	Sahebkar A, Simental-Mendia LE, Kovanen PT, et al. Effects of Orlistat on blood pressure: a systematic review and meta-analysis of 27 randomized controlled clinical trials. J Am Soc Hypertens, 2018, 12(2): 80-96.
28.	Derosa G, Cicero AF, Murdolo G, et al. Efficacy and safety comparative evaluation of Orlistat and sibutramine treatment in hypertensive obese patients. Diabetes Obes Metab, 2005, 7(1): 47-55.
29.	Madsbad S. Long-term effects of weight-reducing drugs in hypertensive patients-a survey of a Cochrane review. Ugeskr Laeger, 2011, 173(8): 564-567.
30.	Wang H, Wang L, Cheng Y, et al. Efficacy of Orlistat in non-alcoholic fatty liver disease: a systematic review and meta-analysis. Biomed Rep, 2018, 9(1): 90-96.
31.	Shirai K, Tanaka M, Fujita T, et al. Reduction of excessive visceral fat and safety with 52-week administration of lipase inhibitor Orlistat in Japanese: long-term clinical study. Adv Ther, 2019, 36(1): 217-231.
32.	Shirai K, Fujita T, Tanaka M, et al. Efficacy and safety of lipase inhibitor Orlistat in Japanese with excessive visceral fat accumulation: 24-week, double-blind, randomized, placebo-controlled study. Adv Ther, 2019, 36(1): 86-100.
33.	Kwon YJ, Lee H, Nam CM, et al. Effects of Orlistat/Phentermine versus Phentermine on vascular endothelial cell function in obese and overweight adults: a randomized, double-blinded, placebo-controlled trial. Diabetes Metab Syndr Obes, 2021, 14: 941-950.
34.	魏燕, 金剑虹, 王雁秋. 奥利司他降低超重肥胖患者体质量的临床效果及安全性评价. 中国现代医生, 2020, 58(5): 114-117.
35.	Noori S, Mirzababaei A, Amini MR, et al. Effect of Orlistat on serum uric acid level in adults: a systematic review and meta-analysis of randomised controlled trials. Int J Clin Pract, 2021, 29: e14674.
36.	Derosa G, Maffioli P, Sahebkar A. Improvement of plasma adiponectin, leptin and C-reactive protein concentrations by Orlistat: a systematic review and meta-analysis. Br J Clin Pharmacol, 2016, 81(5): 819-834.
37.	Khera R, Pandey A, Chandar AK, et al. Effects of weight-loss medications on cardiometabolic risk profiles: a systematic review and network meta-analysis. Gastroenterology, 2018, 154(5): 1309-1319. e7.
38.	Kadri S, El Ayed M, Kadri A, et al. Protective effect of grape seed extract and Orlistat co-treatment against stroke: effect on oxidative stress and energy failure. Biomed Pharmacother, 2021, 136: 111282.
39.	Saleh A, ElFayoumi HM, Youns M, et al. Rutin and Orlistat produce antitumor effects via antioxidant and apoptotic actions. Naunyn Schmiedebergs Arch Pharmacol, 2019, 392(2): 165-175.
40.	Moini A, Kanani M, Kashani L, et al. Effect of Orlistat on weight loss, hormonal and metabolic profiles in women with polycystic ovarian syndrome: a randomized double-blind placebo-controlled trial. Endocrine, 2015, 49(1): 286-289.
41.	Graff SK, Mario FM, Ziegelmann P, et al. Effects of Orlistat vs. metformin on weight loss-related clinical variables in women with PCOS: systematic review and meta-analysis. Int J Clin Pract, 2016, 70(6): 450-461.
42.	Ruan X, Song J, Gu M, et al. Effect of Diane-35, alone or in combination with Orlistat or metformin in Chinese polycystic ovary syndrome patients. Arch Gynecol Obstet, 2018, 297(6): 1557-1563.
43.	中华医学会妇产科学分会内分泌学组及指南专家组. 多囊卵巢综合征中国诊疗指南. 中华妇产科杂志, 2018, 53(1): 2-6.
44.	闵敏, 阮祥燕, 王虎生, 等. 奥利司他综合干预对超重或肥胖型多囊卵巢综合征患者代谢综合征及其组分的影响. 首都医科大学学报, 2020, 41(4): 514-519.
45.	黄秋菊, 李玉兰. 奥利司他疗效研究及不良反应. 现代医药卫生, 2018, 34(19): 3025-3027.
46.	Sumithran P, Proietto J. Benefit-risk assessment of Orlistat in the treatment of obesity. Drug Saf, 2014, 37(8): 597-608.
47.	Filippatos TD, Derdemezis CS, Gazi IF, et al. Orlistat-associated adverse effects and drug interactions: a critical review. Drug Saf, 2008, 31(1): 53-65.
48.	Pilitsi E, Farr OM, Polyzos SA, et al. Pharmacotherapy of obesity: available medications and drugs under investigation. Metabolism, 2019, 92: 170-192.
49.	Brown SA, Izzy M, Watt KD. Pharmacotherapy for weight loss in cirrhosis and liver transplantation: translating the data and underutilized potential. Hepatology. 2021, 73(5): 2051-2062.
50.	Douglas IJ, Langham J, Bhaskaran K, et al. Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink. BMJ, 2013, 346: f1936.
51.	Cassiman D, Roelants M, Vandenplas G, et al. Orlistat treatment is safe in overweight and obese liver transplant recipients: a prospective, open label trial. Transpl Int, 2006, 19(12): 1000-1005.
52.	Harrison SA, Fecht W, Brunt EM, et al. Orlistat for overweight subjects with nonalcoholic steatohepatitis: a randomized, prospective trial. Hepatology, 2009, 49(1): 80-86.
53.	訾梅, 李祥霞. 奥利司他的不良反应及安全应用. 药物不良反应杂志, 2007, 9(3): 182-185.
54.	Gorgojo-Martínez JJ, Basagoiti-Carreño B, Sanz-Velasco A, et al. Effectiveness and tolerability of Orlistat and liraglutide in patients with obesity in a real-world setting: the XENSOR study. Int J Clin Pract, 2019, 73(11): e13399.
55.	Chao AM, Wadden TA, Berkowitz RI, et al. The risk of cardiovascular complications with current obesity drugs. Expert Opin Drug Saf, 2020, 19(9): 1095-1104.
56.	Avenell A, Robertson C, Skea Z, et al. Bariatric surgery, lifestyle interventions and Orlistat for severe obesity: the REBALANCE mixed-methods systematic review and economic evaluation. Health Technol Assess, 2018, 22(68): 1-246.

1. Bray GA, Kim KK, Wilding JPH, et al. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev, 2017, 18(7): 715-723.
2. NCD Risk Factor Collaboration (NCD-RisC). Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19.2 million participants. Lancet, 2016, 387(10026): 1377-1396.
3. Bray GA, Tartaglia LA. Medicinal strategies in the treatment of obesity. Nature, 2000, 404(6778): 672-677.
4. Dietz WH, Baur LA, Hall K, et al. Management of obesity: improvement of health-care training and systems for prevention and care. Lancet, 2015, 385(9986): 2521-2533.
5. Son JW, Kim S. Comprehensive review of current and upcoming anti-obesity drugs. Diabetes Metab J, 2020, 44(6): 802-818.
6. Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA, 2014, 311(1): 74-86.
7. Hasani-Ranjbar S, Nayebi N, Larijani B, et al. A systematic review of the efficacy and safety of herbal medicines used in the treatment of obesity. World J Gastroenterol, 2009, 15(25): 3073-3085.
8. 蒋亮, 汤旭磊, 关聪会, 等. 肥胖的药物治疗进展. 中国临床药理学杂志, 2021, 37(14): 1923-1927.
9. Padwal RS, Majumdar SR. Drug treatments for obesity: Orlistat, sibutramine, and rimonabant. Lancet, 2007, 369(9555): 71-77.
10. Kang JG, Park CY. Anti-obesity drugs: a review about their effects and safety. Diabetes Metab J, 2012, 36(1): 13-25.
11. Siebenhofer A, Winterholer S, Jeitler K, et al. Long-term effects of weight-reducing drugs in people with hypertension. Cochrane Database Syst Rev, 2021, 1: CD007654.
12. Singhal V, Sella AC, Malhotra S. Pharmacotherapy in pediatric obesity: current evidence and landscape. Curr Opin Endocrinol Diabetes Obes, 2021, 28(1): 55-63.
13. Paccosi S, Cresci B, Pala L, et al. Obesity therapy: how and why?. Curr Med Chem, 2020, 27(2): 174-186.
14. 马微, 付丽, 王海波, 等. 新型减肥药奥利司他的研究进展. 华西药学杂志, 2009, 24(4): 431-433.
15. Khedr NF, Ebeid AM, Khalil RM. New insights into weight management by Orlistat in comparison with cinnamon as a natural lipase inhibitor. Endocrine, 2020, 67(1): 109-116.
16. Guerciolini R. Mode of action of Orlistat. Int J Obes Relat Metab Disord, 1997, 21(Suppl 3): S12-S23.
17. Carrière F, Renou C, Ransac S, et al. Inhibition of gastrointestinal lipolysis by Orlistat during digestion of test meals in healthy volunteers. Am J Physiol Gastrointest Liver Physiol, 2001, 281(1): G16-G28.
18. 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(11): 1103-1108.
19. 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): 235-242.
20. 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, 7(6): 699-708.
21. Singh AK, Singh R. Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs. Expert Rev Clin Pharmacol, 2020, 13(1): 53-64.
22. Aldekhail NM, Logue J, McLoone P, et al. Effect of Orlistat on glycaemic control in overweight and obese patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. Obes Rev, 2015, 16(12): 1071-1080.
23. Khera R, Murad MH, Chandar AK, et al. Association of pharmacological treatments for obesity with weight loss and adverse events: a systematic review and meta-analysis. JAMA, 2016, 315(22): 2424-2434.
24. Sahebkar A, Simental-Mendia LE, Reiner Z, et al. Effect of Orlistat on plasma lipids and body weight: a systematic review and meta-analysis of 33 randomized controlled trials. Pharmacol Res, 2017, 122: 53-65.
25. 中华医学会肝病学分会脂肪肝和酒精性肝病学组, 中国医师协会脂肪性肝病专家委员会. 非酒精性脂肪性肝病防治指南(2018更新版). 现代医药卫生, 2018, 34(5): 641-649.
26. Suter PM, Marmier G, Veya-Linder C, et al. Effect of Orlistat on postprandial lipemia, NMR lipoprotein subclass profiles and particle size. Atherosclerosis, 2005, 180(1): 127-135.
27. Sahebkar A, Simental-Mendia LE, Kovanen PT, et al. Effects of Orlistat on blood pressure: a systematic review and meta-analysis of 27 randomized controlled clinical trials. J Am Soc Hypertens, 2018, 12(2): 80-96.
28. Derosa G, Cicero AF, Murdolo G, et al. Efficacy and safety comparative evaluation of Orlistat and sibutramine treatment in hypertensive obese patients. Diabetes Obes Metab, 2005, 7(1): 47-55.
29. Madsbad S. Long-term effects of weight-reducing drugs in hypertensive patients-a survey of a Cochrane review. Ugeskr Laeger, 2011, 173(8): 564-567.
30. Wang H, Wang L, Cheng Y, et al. Efficacy of Orlistat in non-alcoholic fatty liver disease: a systematic review and meta-analysis. Biomed Rep, 2018, 9(1): 90-96.
31. Shirai K, Tanaka M, Fujita T, et al. Reduction of excessive visceral fat and safety with 52-week administration of lipase inhibitor Orlistat in Japanese: long-term clinical study. Adv Ther, 2019, 36(1): 217-231.
32. Shirai K, Fujita T, Tanaka M, et al. Efficacy and safety of lipase inhibitor Orlistat in Japanese with excessive visceral fat accumulation: 24-week, double-blind, randomized, placebo-controlled study. Adv Ther, 2019, 36(1): 86-100.
33. Kwon YJ, Lee H, Nam CM, et al. Effects of Orlistat/Phentermine versus Phentermine on vascular endothelial cell function in obese and overweight adults: a randomized, double-blinded, placebo-controlled trial. Diabetes Metab Syndr Obes, 2021, 14: 941-950.
34. 魏燕, 金剑虹, 王雁秋. 奥利司他降低超重肥胖患者体质量的临床效果及安全性评价. 中国现代医生, 2020, 58(5): 114-117.
35. Noori S, Mirzababaei A, Amini MR, et al. Effect of Orlistat on serum uric acid level in adults: a systematic review and meta-analysis of randomised controlled trials. Int J Clin Pract, 2021, 29: e14674.
36. Derosa G, Maffioli P, Sahebkar A. Improvement of plasma adiponectin, leptin and C-reactive protein concentrations by Orlistat: a systematic review and meta-analysis. Br J Clin Pharmacol, 2016, 81(5): 819-834.
37. Khera R, Pandey A, Chandar AK, et al. Effects of weight-loss medications on cardiometabolic risk profiles: a systematic review and network meta-analysis. Gastroenterology, 2018, 154(5): 1309-1319. e7.
38. Kadri S, El Ayed M, Kadri A, et al. Protective effect of grape seed extract and Orlistat co-treatment against stroke: effect on oxidative stress and energy failure. Biomed Pharmacother, 2021, 136: 111282.
39. Saleh A, ElFayoumi HM, Youns M, et al. Rutin and Orlistat produce antitumor effects via antioxidant and apoptotic actions. Naunyn Schmiedebergs Arch Pharmacol, 2019, 392(2): 165-175.
40. Moini A, Kanani M, Kashani L, et al. Effect of Orlistat on weight loss, hormonal and metabolic profiles in women with polycystic ovarian syndrome: a randomized double-blind placebo-controlled trial. Endocrine, 2015, 49(1): 286-289.
41. Graff SK, Mario FM, Ziegelmann P, et al. Effects of Orlistat vs. metformin on weight loss-related clinical variables in women with PCOS: systematic review and meta-analysis. Int J Clin Pract, 2016, 70(6): 450-461.
42. Ruan X, Song J, Gu M, et al. Effect of Diane-35, alone or in combination with Orlistat or metformin in Chinese polycystic ovary syndrome patients. Arch Gynecol Obstet, 2018, 297(6): 1557-1563.
43. 中华医学会妇产科学分会内分泌学组及指南专家组. 多囊卵巢综合征中国诊疗指南. 中华妇产科杂志, 2018, 53(1): 2-6.
44. 闵敏, 阮祥燕, 王虎生, 等. 奥利司他综合干预对超重或肥胖型多囊卵巢综合征患者代谢综合征及其组分的影响. 首都医科大学学报, 2020, 41(4): 514-519.
45. 黄秋菊, 李玉兰. 奥利司他疗效研究及不良反应. 现代医药卫生, 2018, 34(19): 3025-3027.
46. Sumithran P, Proietto J. Benefit-risk assessment of Orlistat in the treatment of obesity. Drug Saf, 2014, 37(8): 597-608.
47. Filippatos TD, Derdemezis CS, Gazi IF, et al. Orlistat-associated adverse effects and drug interactions: a critical review. Drug Saf, 2008, 31(1): 53-65.
48. Pilitsi E, Farr OM, Polyzos SA, et al. Pharmacotherapy of obesity: available medications and drugs under investigation. Metabolism, 2019, 92: 170-192.
49. Brown SA, Izzy M, Watt KD. Pharmacotherapy for weight loss in cirrhosis and liver transplantation: translating the data and underutilized potential. Hepatology. 2021, 73(5): 2051-2062.
50. Douglas IJ, Langham J, Bhaskaran K, et al. Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink. BMJ, 2013, 346: f1936.
51. Cassiman D, Roelants M, Vandenplas G, et al. Orlistat treatment is safe in overweight and obese liver transplant recipients: a prospective, open label trial. Transpl Int, 2006, 19(12): 1000-1005.
52. Harrison SA, Fecht W, Brunt EM, et al. Orlistat for overweight subjects with nonalcoholic steatohepatitis: a randomized, prospective trial. Hepatology, 2009, 49(1): 80-86.
53. 訾梅, 李祥霞. 奥利司他的不良反应及安全应用. 药物不良反应杂志, 2007, 9(3): 182-185.
54. Gorgojo-Martínez JJ, Basagoiti-Carreño B, Sanz-Velasco A, et al. Effectiveness and tolerability of Orlistat and liraglutide in patients with obesity in a real-world setting: the XENSOR study. Int J Clin Pract, 2019, 73(11): e13399.
55. Chao AM, Wadden TA, Berkowitz RI, et al. The risk of cardiovascular complications with current obesity drugs. Expert Opin Drug Saf, 2020, 19(9): 1095-1104.
56. Avenell A, Robertson C, Skea Z, et al. Bariatric surgery, lifestyle interventions and Orlistat for severe obesity: the REBALANCE mixed-methods systematic review and economic evaluation. Health Technol Assess, 2018, 22(68): 1-246.

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