TY - JOUR T1 - Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2019-033448 VL - 10 IS - 1 SP - e033448 AU - Qiyuan Zhao AU - Jiantong Shen AU - Jingya Lu AU - Fan Li AU - Qi Jiang AU - Yuanyuan Wang Y1 - 2020/01/01 UR - http://bmjopen.bmj.com/content/10/1/e033448.abstract N2 - 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. ER -