ObjectiveTo systematically review the efficacy of amlodipine versus valsartan in the treatment of diabetes mellitus combined with hypertension and renal impairment. MethodsAll relevant randomized controlled trials (RCTs) were retrieved in WanFang Data, CNKI, VIP, CBM, The Cochrane Library (Issue 10, 2013), PubMed, EMbase and Ovid up to October 2013. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. Then meta-analysis was performed using RevMan 5.2. ResultsNine RCTs were finally included involving 794 cases. The results of meta-analysis showed that amlodipine was better than valsartan in improving 24-hour proteinuria (basic level < 1 000 mg:WMD=-10.24, 95%CI-18.52 to-1.95, P=0.02; basic level > 1 000 mg:WMD=-575.69, 95%CI-781.02 to-370.36, P < 0.000 01). However, there was no significant difference between two groups in lowing urine albumin excretion rates (UAER), serum creatinine (Scr), systolic blood pressure (SBP), diastolic blood pressure (DBP), and incidences of adverse events (UAER:WMD=-11.29, 95%CI-27.93 to 5.36, P=0.18; Scr:WMD=1.05, 95%CI-3.89 to 5.99, P=0.68; SBP:WMD=0.52, 95%CI-0.83 to 1.87, P=0.45; DBP:WMD=-0.40, 95%CI-1.41 to 0.62, P=0.44; ADR:WMD=1.00, 95%CI 0.3 to 3.34, P=1.00). ConclusionCurrent evidence shows that, compared with valsartan, amlodipine has the same efficacy in treatment of diabetes mellitus combined with hypertension and renal impairment, and it is even better in improving 24-hour proteinuria.