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Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review.

ABSTRACT: 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.

SUBMITTER: Zhao Q

PROVIDER: S-EPMC7045264 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review.

Zhao Qiyuan Q Shen Jiantong J Lu Jingya J Li Fan F Jiang Qi Q Wang Yuanyuan Y

BMJ open 20200121 1

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>A comprehensive review of PubMed, Embase and Cochrane Library database ...[more]

PMID: 31969367

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Project description:The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment with a boosted protease inhibitor (TT).This was a 24-week, open-label, multicentre study in virologically-suppressed HIV-infected participants (N = 225) with a 2:1 randomization: 146 patients who switched to MT were compared with 79 patients who remained on a TT regimen. The primary endpoint was change in patient-reported outcomes in quality of life as measured by the MOS-HIV and EQ-5D questionnaires. Secondary endpoints included treatment adherence, patient satisfaction, incidence of adverse events and differences in plasma HIV-1 RNA viral load (VL) and CD4 cell counts.Baseline quality of life, measured with the MOS-HIV score, was very good (overall score of 83 ± 10.5 in the MT arm and 82.3 ± 11.3 in the TT arm) and suffered no change during the study in any of the arms (at week 24, 83.5 ± 12.2 in MT arm and 81.9 ± 12.7 in TT arm), without statistically significant differences when compared. In regards to adherence to therapy and patient satisfaction, some aspects (number of doses forgotten in the last week and satisfaction of treatment measured with the CESTA score, dimension 1) improved significantly with MT. There were also no differences in the incidence and severity of adverse events, even though 22.8% of those in the MT arm switched their treatment when they were included in the study. Moreover, there was also no significant difference between the immunological and virological evolution of MT and TT. In the MT arm, the VL was always undetectable in 83% of patients (vs 90.7% in the TT arm) and there were only 6.7% of virological failures with VL > 50 copies/mL (vs 2.3% in the TT arm), without resistance mutations and with resuppression of VL after switching back to TT.In a new clinical trial, monotherapy as a treatment simplification strategy in HIV-1 infected patients with sustained viral suppression has demonstrated quality of life, safety and efficacy profiles comparable to those of conventional triple therapy regimens.

Project description:IntroductionEpilepsy causes serious suffering in children and is associated with high morbidity and increased mortality. It impairs children's quality of life and places a heavy burden on healthcare resources. Levetiracetam has been used to prevent and treat paediatric epilepsy for years. To date, a number of systematic reviews have been performed to assess the efficacy and safety of levetiracetam in a variety of clinical settings. Conflicting outcomes have been reported for the same clinical issues. Our objective is to provide a comprehensive overview of the literature for clinicians and policymakers via an umbrella review that assesses the efficacy and safety of levetiracetam in children with epilepsy.Methods and analysisWe will follow the Joanna Briggs Institute's guidelines for umbrella reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The following seven databases will be searched from 1990 to February 2019: PubMed, Embase, Cochrane Database of Systematic Reviews, JBISRIR, EPPI, Epistemonikos and PROSPERO. We will provide evidence from existing systematic reviews and meta-analyses of randomised controlled trials regarding the use of levetiracetam in children with epilepsy. The intervention of interest is levetiracetam monotherapy and add-on therapies for prevention or treatment purposes. Studies will be individually selected and assessed by two reviewers. The primary outcomes of interest are epilepsy control, the efficacy of prophylaxis for provoked seizures and the mortality rate of children with epilepsy who received levetiracetam treatment. The secondary outcomes are adverse events and withdrawal rates due to adverse effects. The methodological quality of all reviews will be individually assessed by two reviewers using the 'A Measurement Tool to Assess Systematic Reviews' instrument. The Grading of Recommendations Assessment, Development and Evaluation assessment will be applied to evaluate the quality of evidence for each outcome of interest. A narrative description of an analysis of the systematic reviews will be tabulated to address objective and specific questions. Information from each review will be detailed in a table including the population, number of studies, total number of participants, year range of the trials, study designs of the primary trials, countries and settings of the trials, heterogeneity of results and assessment tools. Recommendations regarding each outcome of levetiracetam will be categorised based on a protocol.Ethics and disseminationThis umbrella review will inform clinical and policy decisions regarding the efficacy and safety of levetiracetam for preventing and treating paediatric epilepsy. The results will be disseminated through a peer-reviewed publication and conference presentations. Ethical approval is not required for this study.

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Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review.

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Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review.

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