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：

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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.	中國醫療保健國際交流促進會營養與代謝管理分會, 中國營養學會臨床營養分會, 中華醫學會糖尿病學分會, 等. 中國超重/肥胖醫學營養治療指南(2021). 中國醫學前沿雜志(電子版), 2021, 13(11): 1-55.
2.	中華醫學會糖尿病學分會. 中國2型糖尿病防治指南(2020年版). 中華糖尿病雜志, 2021, 13(4): 315-409.
3.	蔣亮, 湯旭磊, 關聰會, 等. 肥胖的藥物治療進展. 中國臨床藥理學雜志, 2021, 37(14): 1923-1927.
4.	張涵, 易敏, 陳容平. 奧利司他的療效性及安全性研究進展. 海南醫學, 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.	菅小紅, 徐建賓, 劉洋, 等. 奧利司他膠囊聯合二甲雙胍片治療肥胖型2型糖尿病患者的臨床研究. 中國臨床藥理學雜志, 2020, 36(7): 756-759.
7.	閔潔, 謝天. 奧利司他膠囊聯合西格列汀二甲雙胍片治療肥胖型2型糖尿病的臨床研究. 現代藥物與臨床, 2018, 33(5): 1130-1134.
8.	熊承云, 周艷紅, 李江雁, 等. 奧利司他膠囊聯合胰島素強化治療初診肥胖2型糖尿病患者的療效分析. 中國醫學工程, 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.	任品寬. 奧利司他膠囊聯合二甲雙胍在超重或肥胖2型糖尿病患者治療中的療效及安全性. 基層醫學論壇, 2020, 24(31): 4462-4464.
11.	劉冬, 黃森湛, 姜惠, 等. 奧利司他對肥胖糖尿病前期患者的血糖和血清CRP, TNF-α的影響及其臨床意義. 臨床醫學工程, 2018, 25(7): 915-916.
12.	高志英. 奧利司他膠囊聯合西格列汀二甲雙胍片治療肥胖型2型糖尿病的臨床療效. 中國實用醫藥, 2021, 16(27): 120-122.
13.	王艷軍, 劉聰, 劉英敏. 奧利司他輔助治療肥胖2型糖尿病32例. 中國新藥與臨床雜志, 2003, 22(11): 651-653.
14.	俞蘭, 陳曉燕, 謝小莉, 等. 奧利司他聯合西格列汀二甲雙胍對肥胖型2型糖尿病患者穩態模型胰島素抵抗指數和胰島β細胞功能指數的影響. 中國臨床保健雜志, 2019, 22(6): 790-793.
15.	史軼蘩, 潘長玉, 高妍, 等. 奧利司他在中國超重或肥胖2型糖尿病患者中的療效分析. 中華內分泌代謝雜志, 2004, 20(5): 403-407.
16.	陸新. 奧利司他對超重或肥胖的初發2型糖尿病患者胰島素抵抗的影響. 中國實用醫藥, 2018, 13(16): 131-133.
17.	程林. 奧利司他膠囊聯合西格列汀二甲雙胍片治療肥胖型2型糖尿病的療效觀察. 首都食品與醫藥, 2019, 26(20): 50.
18.	高丹, 王雪琴. 奧利司他對肥胖型2型糖尿病患者糖脂代謝的影響. 現代醫學與健康研究(電子版), 2019, 3(12): 37-38.
19.	曹媛, 李娜, 賀苗. 奧利司他對肥胖2型糖尿病患者血糖和血脂的影響. 西南國防醫藥, 2019, 29(5): 586-588.
20.	盧海德. 肥胖型2型糖尿病患者聯用奧利司他與沙格列汀, 二甲雙胍治療的效果. 黑龍江醫藥, 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.	姜麗娜, 李繼紅. 奧利司他與二甲雙胍聯用對肥胖型2型糖尿病患者的療效及對體重指數, 胰島β細胞功能指數, 胰島素抵抗指數水平的影響. 中國藥物經濟學, 2022, 17(1): 71-74.
30.	汪海才. 奧利司他膠囊聯合二甲雙胍治療肥胖2型糖尿病患者的療效及安全性. 藥品評價, 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.	《緩解型糖尿病中國專家共識》編寫專家委員會. 緩解2型糖尿病中國專家共識. 中國全科醫學, 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. 中國醫療保健國際交流促進會營養與代謝管理分會, 中國營養學會臨床營養分會, 中華醫學會糖尿病學分會, 等. 中國超重/肥胖醫學營養治療指南(2021). 中國醫學前沿雜志(電子版), 2021, 13(11): 1-55.
2. 中華醫學會糖尿病學分會. 中國2型糖尿病防治指南(2020年版). 中華糖尿病雜志, 2021, 13(4): 315-409.
3. 蔣亮, 湯旭磊, 關聰會, 等. 肥胖的藥物治療進展. 中國臨床藥理學雜志, 2021, 37(14): 1923-1927.
4. 張涵, 易敏, 陳容平. 奧利司他的療效性及安全性研究進展. 海南醫學, 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. 菅小紅, 徐建賓, 劉洋, 等. 奧利司他膠囊聯合二甲雙胍片治療肥胖型2型糖尿病患者的臨床研究. 中國臨床藥理學雜志, 2020, 36(7): 756-759.
7. 閔潔, 謝天. 奧利司他膠囊聯合西格列汀二甲雙胍片治療肥胖型2型糖尿病的臨床研究. 現代藥物與臨床, 2018, 33(5): 1130-1134.
8. 熊承云, 周艷紅, 李江雁, 等. 奧利司他膠囊聯合胰島素強化治療初診肥胖2型糖尿病患者的療效分析. 中國醫學工程, 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. 任品寬. 奧利司他膠囊聯合二甲雙胍在超重或肥胖2型糖尿病患者治療中的療效及安全性. 基層醫學論壇, 2020, 24(31): 4462-4464.
11. 劉冬, 黃森湛, 姜惠, 等. 奧利司他對肥胖糖尿病前期患者的血糖和血清CRP, TNF-α的影響及其臨床意義. 臨床醫學工程, 2018, 25(7): 915-916.
12. 高志英. 奧利司他膠囊聯合西格列汀二甲雙胍片治療肥胖型2型糖尿病的臨床療效. 中國實用醫藥, 2021, 16(27): 120-122.
13. 王艷軍, 劉聰, 劉英敏. 奧利司他輔助治療肥胖2型糖尿病32例. 中國新藥與臨床雜志, 2003, 22(11): 651-653.
14. 俞蘭, 陳曉燕, 謝小莉, 等. 奧利司他聯合西格列汀二甲雙胍對肥胖型2型糖尿病患者穩態模型胰島素抵抗指數和胰島β細胞功能指數的影響. 中國臨床保健雜志, 2019, 22(6): 790-793.
15. 史軼蘩, 潘長玉, 高妍, 等. 奧利司他在中國超重或肥胖2型糖尿病患者中的療效分析. 中華內分泌代謝雜志, 2004, 20(5): 403-407.
16. 陸新. 奧利司他對超重或肥胖的初發2型糖尿病患者胰島素抵抗的影響. 中國實用醫藥, 2018, 13(16): 131-133.
17. 程林. 奧利司他膠囊聯合西格列汀二甲雙胍片治療肥胖型2型糖尿病的療效觀察. 首都食品與醫藥, 2019, 26(20): 50.
18. 高丹, 王雪琴. 奧利司他對肥胖型2型糖尿病患者糖脂代謝的影響. 現代醫學與健康研究(電子版), 2019, 3(12): 37-38.
19. 曹媛, 李娜, 賀苗. 奧利司他對肥胖2型糖尿病患者血糖和血脂的影響. 西南國防醫藥, 2019, 29(5): 586-588.
20. 盧海德. 肥胖型2型糖尿病患者聯用奧利司他與沙格列汀, 二甲雙胍治療的效果. 黑龍江醫藥, 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. 姜麗娜, 李繼紅. 奧利司他與二甲雙胍聯用對肥胖型2型糖尿病患者的療效及對體重指數, 胰島β細胞功能指數, 胰島素抵抗指數水平的影響. 中國藥物經濟學, 2022, 17(1): 71-74.
30. 汪海才. 奧利司他膠囊聯合二甲雙胍治療肥胖2型糖尿病患者的療效及安全性. 藥品評價, 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. 《緩解型糖尿病中國專家共識》編寫專家委員會. 緩解2型糖尿病中國專家共識. 中國全科醫學, 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.

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

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