Efficacy and safety of orlistat in the treatment of overweight and obese type 2 diabetes mellitus: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

ZHU Jieyun , ZHU Liangfeng , PAN Dongzan , WANG Qiaoyan , HUANG Chunli , LU Zhao ,  SHEN Yin

International Medical Services, the People's Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, P. R. China;

Corresponding author：

SHEN Yin, Email: sy_doctor@163.com

Keywords：

Orlistat; Obese; Type 2 diabetes; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.202201086

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To systematically review the efficacy and safety of orlistat in the treatment of overweight and obese type 2 diabetes mellitus (T2DM). Methods PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of orlistat in the treatment of overweight and obese T2DM patients from inception to June 29^th, 2022. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies; then, meta-analysis was performed by using Stata 16.0 software. Results A total of 24 RCTs involving 3 702 patients were included. The results of meta-analysis showed that compared with control group, orlistat group could significantly decrease the levels of fasting blood glucose (WMD=1.04, 95%CI 0.80 to 1.29, P<0.001), 2h postprandial blood glucose (WMD=1.17, 95%CI 0.78 to 1.56, P<0.001) and hemoglobin A1c (WMD=0.84, 95%CI 0.51 to 1.17, P<0.001), and the levels of total cholesterol, triglyceride, low density lipoprotein, body weight and body mass index also significantly decreased (P<0.001). The incidence of adverse events such as increased defecation and abdominal pain of orlistat was slightly higher than that of control group; however, most could be self-healing.Conclusion Current evidence shows that orlistat can effectively and safely improve blood sugar, lipid index in overweight and obese T2DM patients. Due to limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusion.

Citation： ZHU Jieyun, ZHU Liangfeng, PAN Dongzan, WANG Qiaoyan, HUANG Chunli, LU Zhao, SHEN Yin. Efficacy and safety of orlistat in the treatment of overweight and obese type 2 diabetes mellitus: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2022, 22(9): 1020-1026. doi: 10.7507/1672-2531.202201086 Copy

1.	中国医疗保健国际交流促进会营养与代谢管理分会, 中国营养学会临床营养分会, 中华医学会糖尿病学分会, 等. 中国超重/肥胖医学营养治疗指南(2021). 中国医学前沿杂志(电子版), 2021, 13(11): 1-55.
2.	中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2020年版). 中华糖尿病杂志, 2021, 13(4): 315-409.
3.	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.
4.	张涵, 易敏, 陈容平. 奥利司他的疗效性及安全性研究进展. 海南医学, 2016, 27(18): 3026-3028.
5.	Ballinger A, Peikin SR. Orlistat: its current status as an anti-obesity drug. Eur J Pharmacol, 2002, 440(2-3): 109-117.
6.	菅小红, 徐建宾, 刘洋, 等. 奥利司他胶囊联合二甲双胍片治疗肥胖型2型糖尿病患者的临床研究. 中国临床药理学杂志, 2020, 36(7): 756-759.
7.	闵洁, 谢天. 奥利司他胶囊联合西格列汀二甲双胍片治疗肥胖型2型糖尿病的临床研究. 现代药物与临床, 2018, 33(5): 1130-1134.
8.	熊承云, 周艳红, 李江雁, 等. 奥利司他胶囊联合胰岛素强化治疗初诊肥胖2型糖尿病患者的疗效分析. 中国医学工程, 2021, 29(4): 89-92.
9.	Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions (version 5.1. 0). The Cochrane Collaboration, 2011. Available at:http://www.cochrane-handbook.org.
10.	任品宽. 奥利司他胶囊联合二甲双胍在超重或肥胖2型糖尿病患者治疗中的疗效及安全性. 基层医学论坛, 2020, 24(31): 4462-4464.
11.	刘冬, 黄森湛, 姜惠, 等. 奥利司他对肥胖糖尿病前期患者的血糖和血清CRP, TNF-α的影响及其临床意义. 临床医学工程, 2018, 25(7): 915-916.
12.	高志英. 奥利司他胶囊联合西格列汀二甲双胍片治疗肥胖型2型糖尿病的临床疗效. 中国实用医药, 2021, 16(27): 120-122.
13.	王艳军, 刘聪, 刘英敏. 奥利司他辅助治疗肥胖2型糖尿病32例. 中国新药与临床杂志, 2003, 22(11): 651-653.
14.	俞兰, 陈晓燕, 谢小莉, 等. 奥利司他联合西格列汀二甲双胍对肥胖型2型糖尿病患者稳态模型胰岛素抵抗指数和胰岛β细胞功能指数的影响. 中国临床保健杂志, 2019, 22(6): 790-793.
15.	史轶蘩, 潘长玉, 高妍, 等. 奥利司他在中国超重或肥胖2型糖尿病患者中的疗效分析. 中华内分泌代谢杂志, 2004, 20(5): 403-407.
16.	陆新. 奥利司他对超重或肥胖的初发2型糖尿病患者胰岛素抵抗的影响. 中国实用医药, 2018, 13(16): 131-133.
17.	程林. 奥利司他胶囊联合西格列汀二甲双胍片治疗肥胖型2型糖尿病的疗效观察. 首都食品与医药, 2019, 26(20): 50.
18.	高丹, 王雪琴. 奥利司他对肥胖型2型糖尿病患者糖脂代谢的影响. 现代医学与健康研究(电子版), 2019, 3(12): 37-38.
19.	曹媛, 李娜, 贺苗. 奥利司他对肥胖2型糖尿病患者血糖和血脂的影响. 西南国防医药, 2019, 29(5): 586-588.
20.	卢海德. 肥胖型2型糖尿病患者联用奥利司他与沙格列汀, 二甲双胍治疗的效果. 黑龙江医药, 2021, 34(1): 108-110.
21.	Derosa G, Cicero AF, D'Angelo A, et al. Effects of 1-year orlistat treatment compared to placebo on insulin resistance parameters in patients with type 2 diabetes. J Clin Pharm Ther, 2012, 37(2): 187-195.
22.	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, 20(9): 1393-1401.
23.	Guy-Grand B, Drouin P, Eschwège E, et al. Effects of orlistat on obesity-related diseases - a six-month randomized trial. Diabetes Obes Metab, 2004, 6(5): 375-383.
24.	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, 4(6): 415-423.
25.	Kuo CS, Pei D, Yao CY, et al. Effect of orlistat in overweight poorly controlled Chinese female type 2 diabetic patients: a randomised, double-blind, placebo-controlled study. Int J Clin Pract, 2006, 60(8): 906-910.
26.	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, 5(3): 180-188.
27.	Kelley DE, Bray GA, Pi-Sunyer FX, et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care, 2002, 25(6): 1033-1041.
28.	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, 25(7): 1123-1128.
29.	姜丽娜, 李继红. 奥利司他与二甲双胍联用对肥胖型2型糖尿病患者的疗效及对体重指数, 胰岛β细胞功能指数, 胰岛素抵抗指数水平的影响. 中国药物经济学, 2022, 17(1): 71-74.
30.	汪海才. 奥利司他胶囊联合二甲双胍治疗肥胖2型糖尿病患者的疗效及安全性. 药品评价, 2022, 19(6): 378-381.
31.	GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet, 2017, 390(10100): 1211-1259.
32.	Li Y, Teng D, Shi X, et al. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ, 2020, 369: m997.
33.	《缓解型糖尿病中国专家共识》编写专家委员会. 缓解2型糖尿病中国专家共识. 中国全科医学, 2021, 24(32): 4037-4048.
34.	Lingvay I, Sumithran P, Cohen RV, et al. Obesity management as a primary treatment goal for type 2 diabetes: time to reframe the conversation. Lancet, 2022, 399(10322): 394-405.
35.	WHO. Global report on diabetes, 2018. Available at: http://www.who.int/diabetes/global-report/en/.
36.	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.
37.	Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet, 2018, 391(10120): 541-551.

1. 中国医疗保健国际交流促进会营养与代谢管理分会, 中国营养学会临床营养分会, 中华医学会糖尿病学分会, 等. 中国超重/肥胖医学营养治疗指南(2021). 中国医学前沿杂志(电子版), 2021, 13(11): 1-55.
2. 中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2020年版). 中华糖尿病杂志, 2021, 13(4): 315-409.
3. 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.
4. 张涵, 易敏, 陈容平. 奥利司他的疗效性及安全性研究进展. 海南医学, 2016, 27(18): 3026-3028.
5. Ballinger A, Peikin SR. Orlistat: its current status as an anti-obesity drug. Eur J Pharmacol, 2002, 440(2-3): 109-117.
6. 菅小红, 徐建宾, 刘洋, 等. 奥利司他胶囊联合二甲双胍片治疗肥胖型2型糖尿病患者的临床研究. 中国临床药理学杂志, 2020, 36(7): 756-759.
7. 闵洁, 谢天. 奥利司他胶囊联合西格列汀二甲双胍片治疗肥胖型2型糖尿病的临床研究. 现代药物与临床, 2018, 33(5): 1130-1134.
8. 熊承云, 周艳红, 李江雁, 等. 奥利司他胶囊联合胰岛素强化治疗初诊肥胖2型糖尿病患者的疗效分析. 中国医学工程, 2021, 29(4): 89-92.
9. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions (version 5.1. 0). The Cochrane Collaboration, 2011. Available at:http://www.cochrane-handbook.org.
10. 任品宽. 奥利司他胶囊联合二甲双胍在超重或肥胖2型糖尿病患者治疗中的疗效及安全性. 基层医学论坛, 2020, 24(31): 4462-4464.
11. 刘冬, 黄森湛, 姜惠, 等. 奥利司他对肥胖糖尿病前期患者的血糖和血清CRP, TNF-α的影响及其临床意义. 临床医学工程, 2018, 25(7): 915-916.
12. 高志英. 奥利司他胶囊联合西格列汀二甲双胍片治疗肥胖型2型糖尿病的临床疗效. 中国实用医药, 2021, 16(27): 120-122.
13. 王艳军, 刘聪, 刘英敏. 奥利司他辅助治疗肥胖2型糖尿病32例. 中国新药与临床杂志, 2003, 22(11): 651-653.
14. 俞兰, 陈晓燕, 谢小莉, 等. 奥利司他联合西格列汀二甲双胍对肥胖型2型糖尿病患者稳态模型胰岛素抵抗指数和胰岛β细胞功能指数的影响. 中国临床保健杂志, 2019, 22(6): 790-793.
15. 史轶蘩, 潘长玉, 高妍, 等. 奥利司他在中国超重或肥胖2型糖尿病患者中的疗效分析. 中华内分泌代谢杂志, 2004, 20(5): 403-407.
16. 陆新. 奥利司他对超重或肥胖的初发2型糖尿病患者胰岛素抵抗的影响. 中国实用医药, 2018, 13(16): 131-133.
17. 程林. 奥利司他胶囊联合西格列汀二甲双胍片治疗肥胖型2型糖尿病的疗效观察. 首都食品与医药, 2019, 26(20): 50.
18. 高丹, 王雪琴. 奥利司他对肥胖型2型糖尿病患者糖脂代谢的影响. 现代医学与健康研究(电子版), 2019, 3(12): 37-38.
19. 曹媛, 李娜, 贺苗. 奥利司他对肥胖2型糖尿病患者血糖和血脂的影响. 西南国防医药, 2019, 29(5): 586-588.
20. 卢海德. 肥胖型2型糖尿病患者联用奥利司他与沙格列汀, 二甲双胍治疗的效果. 黑龙江医药, 2021, 34(1): 108-110.
21. Derosa G, Cicero AF, D'Angelo A, et al. Effects of 1-year orlistat treatment compared to placebo on insulin resistance parameters in patients with type 2 diabetes. J Clin Pharm Ther, 2012, 37(2): 187-195.
22. 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, 20(9): 1393-1401.
23. Guy-Grand B, Drouin P, Eschwège E, et al. Effects of orlistat on obesity-related diseases - a six-month randomized trial. Diabetes Obes Metab, 2004, 6(5): 375-383.
24. 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, 4(6): 415-423.
25. Kuo CS, Pei D, Yao CY, et al. Effect of orlistat in overweight poorly controlled Chinese female type 2 diabetic patients: a randomised, double-blind, placebo-controlled study. Int J Clin Pract, 2006, 60(8): 906-910.
26. 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, 5(3): 180-188.
27. Kelley DE, Bray GA, Pi-Sunyer FX, et al. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care, 2002, 25(6): 1033-1041.
28. 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, 25(7): 1123-1128.
29. 姜丽娜, 李继红. 奥利司他与二甲双胍联用对肥胖型2型糖尿病患者的疗效及对体重指数, 胰岛β细胞功能指数, 胰岛素抵抗指数水平的影响. 中国药物经济学, 2022, 17(1): 71-74.
30. 汪海才. 奥利司他胶囊联合二甲双胍治疗肥胖2型糖尿病患者的疗效及安全性. 药品评价, 2022, 19(6): 378-381.
31. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet, 2017, 390(10100): 1211-1259.
32. Li Y, Teng D, Shi X, et al. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ, 2020, 369: m997.
33. 《缓解型糖尿病中国专家共识》编写专家委员会. 缓解2型糖尿病中国专家共识. 中国全科医学, 2021, 24(32): 4037-4048.
34. Lingvay I, Sumithran P, Cohen RV, et al. Obesity management as a primary treatment goal for type 2 diabetes: time to reframe the conversation. Lancet, 2022, 399(10322): 394-405.
35. WHO. Global report on diabetes, 2018. Available at: http://www.who.int/diabetes/global-report/en/.
36. 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.
37. Lean ME, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet, 2018, 391(10120): 541-551.

Previous Article
A pilot study on the ameliorative effect of "Mom’s Good Mood" on antenatal depression
Next Article
Efficacy and safety of the COVID-19 vaccine: a systematic review

Chinese Journal of Evidence-Based Medicine

Efficacy and safety of orlistat in the treatment of overweight and obese type 2 diabetes mellitus: a meta-analysis

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content