ObjectivesTo systematically review the efficacy and safety of Orlistat for obese patients with cardiovascular risk including hyperlipidemia, hypertension, diabetes and prediabetes.MethodsSinomed, CNKI, WanFang Data, PubMed, EMbase, The Cochrane Library and ClinicalTrails.gov databases were electronically searched to collect randomized controlled trials (RCTs) of Orlistat for obese patients with cardiovascular risk such as hyperlipemia, diabetes, prediabetes and hypertension from inception to Jan 7th, 2017. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using Stata 14.0 software.ResultsA total of 28 RCTs were included. The results of meta-analysis showed that, compared with placebo, Orlistat could significantly reduce the weight (MD=–2.85, 95%CI –3.47 to –2.24, P=0.000), waist (MD=–2.45, 95%CI –3.07 to –1.83, P=0.000) and BMI (MD=–1.29, 95%CI –2.08 to –0.49, P=0.002) of patients. Orlistat could also control the blood pressure, blood glucose and other cardiovascular risk factors well. Compared with the blank control, Orlistat could improve the waist and parts of cardiovascular risk factors (P<0.05). The incidence of adverse events of Orlistat was slightly higher than that of placebo, but most could be self-healing.ConclusionsCurrent evidence shows that compared with placebo and blank control, Orlistat is effective for improving both weight loss and some cardiovascular risk factors. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.