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Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review
  1. Qiyuan Zhao1,2,
  2. Jiantong Shen2,
  3. Jingya Lu2,
  4. Fan Li3,
  5. Qi Jiang2,
  6. Yuanyuan Wang1
  1. 1School of Nursing, Huzhou University, Huzhou Central Hospital, Huzhou, China
  2. 2School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, China
  3. 3College of Nursing, University of Missouri System, St. Louis, Missouri, USA
  1. Correspondence to Jiantong Shen; sjiantong{at}


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.

  • monotherapy
  • clinical outcomes
  • cardiology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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  • Contributors JS carried on the conception and construction of this protocol. JL developed the search strategy. QJ and YW compared and found the best tools for assessing possible bias and evaluating quality of included reviews. QZ wrote the protocol. JS reviewed and amended the draft of the protocol. FL added grammar editing and conceptual clarification. All authors read and approved of the final manuscript.

  • Funding This work was supported by the Department of Education of Zhejiang Province, China [Grant numbers Y201635273].

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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