RT Journal Article SR Electronic T1 Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e033448 DO 10.1136/bmjopen-2019-033448 VO 10 IS 1 A1 Qiyuan Zhao A1 Jiantong Shen A1 Jingya Lu A1 Fan Li A1 Qi Jiang A1 Yuanyuan Wang YR 2020 UL http://bmjopen.bmj.com/content/10/1/e033448.abstract AB Introduction Aliskiren is a newly developed medicine. As one of the effective renin–angiotensin–aldosterone system inhibitors, its role in lowering blood pressure has been recognised. However, its safety and tolerability still remain controversial. The aim of the paper is to systematically summarise the published studies about the clinical efficacy and side effects of aliskiren monotherapy.Methods and analysis A comprehensive review of PubMed, Embase and Cochrane Library databases published from inception until June 2019 will be conducted. The selected articles are meta-analyses that integrated the randomised controlled studies, which evaluated efficacy, safety and tolerability of aliskiren monotherapy. Two people will select eligible articles and extract data independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the AMSTAR 2 tool. Study selection process will be presented using a flowchart. We will re-analyse each outcome with the random effect methods if necessary. If possible, we will also calculate 95% prediction intervals for each random effect estimate, by using Egger’s test to evaluate if the reporting bias existed.Ethics and dissemination Ethical approval is not required for the study, as we only collected data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion.PROSPERO registration number CRD42019142141.