Sulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials

AbstractThrombotic cardiovascular disease (myocardial infarction [MI], stroke, and venous thromboembolism [VTE]) remains a major cause of death and disability. Sulodexide is an oral glycosaminoglycan containing heparan sulfate and dermatan sulfate. We conducted a systematic review and meta-analysis to determine the cardiovascular efficacy, and safety of sulodexide versus control in randomized controlled trials (RCTs). We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for RCTs reporting cardiovascular outcomes in patients receiving sulodexide versus control (placebo or no treatment). Outcomes included all-cause mortality, cardiovascular mortality, MI, stroke, deep vein thrombosis (DVT), pulmonary embolism, and bleeding. We used inverse variance random-effects models with odds ratio (OR) as the effect measure. After screening 360 records, 6 RCTs including 7,596 patients (median follow-up duration: 11.6 months) were included. Patients were enrolled for history of MI, VTE, peripheral arterial disease, or cardiovascular risk factors plus nephropathy. Use of sulodexide compared with control was associated with reduced odds of all-cause mortality (OR 0.67, 95% confidence interval [CI] 0.52–0.85, p = 0.001), cardiovascular mortality (OR 0.44, 95% CI 0.22–0.89, p = 0.02), and MI (OR 0.70, 95% CI 0.51–0.96, p = 0.03), and nonsignificantly reduced odds of stroke (OR 0.78, 95% CI 0.45–1.35, p = 0.38). Sulodexide was associated with significantly reduced odds of VTE (OR 0.44, 95% CI 0.24–0.81, p = 0.008), including DVT (OR 0.41, 95% CI 0.26–0.65, p < 0.001), but not pulmonary embolism (OR 0.92, 95% CI 0.40–2.15, p = 0.86). Bleeding events were not significantly different in the two groups (OR 1.14, 95% CI 0.47–2.74, p = 0.48). In six RCTs across a variety of clinical indications, use of sulodexide compared with placebo or no treatment was associated with reduced odds of all-cause mortality, cardiovascular mortality, MI, and DVT, without a significant increase in bleeding. Additional studies with this agent are warranted.

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Cinacalcet Treatment Significantly Improves All-Cause and Cardiovascular Survival in Dialysis Patients: Results from a Meta-Analysis

Kidney & Blood Pressure Research ◽

10.1159/000504139 ◽

2019 ◽

Vol 44 (6) ◽

pp. 1327-1338 ◽

Cited By ~ 1

Author(s):

Yuan Zu ◽

Xiangxue Lu ◽

Jinghong Song ◽

Ling Yu ◽

Han Li ◽

...

Keyword(s):

Cardiovascular Mortality ◽

Observational Studies ◽

Fixed Effects ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Fixed Effects Model ◽

Long Term Effects ◽

Dialysis Patients ◽

All Cause Mortality

Objective: To assess the long-term effects including all-cause mortality, cardiovascular mortality, and fracture incidence, of cinacalcet on secondary hyperparathyroidism (SHPT) in patients on dialysis. Methods: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from their inception to October 2018. Randomized controlled trials (RCTs) and cohort design prospective observational studies assessing cinacalcet for the treatment of SHPT in dialysis patients were included. Data extraction was independently completed by 2 authors who determined the methodological quality of the studies and extracted data in duplicate. Study-specific risk estimates were tested by using a fixed effects model. Results: A total of 14 articles with 38,219 participants were included, of which 10 RCTs with 7,471 participants and 4 prospective observational studies with 30,748 participants fulfilled the eligibility criteria. Compared with no cinacalcet, cinacalcet administration reduced all-cause mortality (relative risk [RR] 0.91, 95% CI 0.89–0.94, p < 0.001) and cardiovascular mortality (RR 0.92, 95% CI 0.89–0.95, p < 0.001), but it did not significantly reduce the incidence of fractures (RR 0.93, 95% CI 0.87–1.00, p = 0.05). Conclusions: The results of this meta-analysis indicated that the treatment of SHPT with cinacalcet may in fact reduce all-cause mortality and cardiovascular mortality among patients receiving maintenance dialysis.

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Febuxostat use and risks of CVD events, death from cardiac-cause and all-cause mortality: metaanalysis of randomized controlled trials

The Journal of Rheumatology ◽

10.3899/jrheum.200307 ◽

2020 ◽

pp. jrheum.200307

Author(s):

Hao Deng ◽

Bao Long Zhang ◽

Jin Dong Tong ◽

Xiu Hong Yang ◽

Hui Min Jin

Keyword(s):

Web Of Science ◽

Meta Analysis ◽

Relevant Literature ◽

Controlled Trials ◽

Cochrane Central Register ◽

Inclusion Criteria ◽

Randomized Controlled ◽

Central Register ◽

Increased Risk ◽

All Cause Mortality

Objective To assess whether febuxostat use increases the risk of developing cardiovascular events, death from cardiac-cause and all-cause mortalities. Methods The relevant literature was searched in several databases including the MEDLINE (PubMed, 1 Jan. 1966–29 Feb. 2020), Web of science, EMBASE (1 Jan. 1974–29 Feb. 2020), ClinicalTrials.gov and Cochrane Central Register for Controlled Trials. Manual searches for references cited in the original studies and relevant review articles were also performed. All studies included in this metanalysis were published in English. Results In the end, 20 studies that met our inclusion criteria were included in this meta-analysis. Use of febuxostat was found not to be associated with an increased risk of all-cause mortality (RR = 0.87, 95% CI 0.57–1.32, P =0.507). Also, there was no association between febuxostat use and mortalities arising from cardiovascular diseases (CVD) (RR = 0.84, 95% CI 0.49–1.45, P=0.528). The RR also revealed that febuxostat use was not associated with CVD events (RR = 0.98, 95% CI 0.83–1.16, P =0.827). Furthermore, the likelihood of occurrence of CVD events was found not to be dependent on febuxostat dose (RR = 1.04, 95% CI 0.84–1.30, P =0.723). Conclusion Febuxostat use is not associated with increased risks of all-cause mortality, death from CVD or CVD events. Accordingly, it is a safe drug for the treatment of gout. Systematic review registration: PROSPERO CRD42019131872

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Effects of tolvaptan add-on therapy in patients with acute heart failure: meta-analysis on randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2018-025537 ◽

2019 ◽

Vol 9 (4) ◽

pp. e025537 ◽

Cited By ~ 4

Author(s):

Guang Ma ◽

Xixi Ma ◽

Guoliang Wang ◽

Wei Teng ◽

Xuezhi Hui

Keyword(s):

Renal Function ◽

Body Weight ◽

Sodium Level ◽

Meta Analysis ◽

Mean Difference ◽

Controlled Trials ◽

Cochrane Central Register ◽

Short Term ◽

Worsening Renal Function ◽

All Cause Mortality

ObjectivesTreating acute decompensated heartfailure (ADHF) for improving congestion with diuretics may cause worsening renal function (WRF), but the clinical efficacy of tolvaptan add-on therapy on reducing WRF in ADHF patients is inconsistent. This analysis is to evaluate the effects of tolvaptan add-on therapy on reducing WRF in ADHF patients.MethodsMeta-analysis of randomised trials of tolvaptan add-on therapy on reducing WRF in ADHF patients. The MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases were searched for relevant articles from their inception to 31 October, 2017. Two reviewers filtrated the documents on WRF, short-term all-cause mortality, body weight decreased, elevated sodium level for calculating pooled relatives risks, weighted mean difference and associated 95% CIs. We used fixed-effects or random-effects models according to I2statistics.AchievementsSeven random controlled trials with 937 patients were included for analysis. Compared with the control, tolvaptan add-on therapy did not improve incidence of worsening renal function (RR 0.78, 95% CI 0.48 to 1.26, p=0.31, I2=66%) and short-term all-cause mortality (RR 0.85, 95% CI 0.47 to 1.56, p=0.61, I2=0%). On subgroup analyses, there was a suggestion of possible effect modification by dose of tolvaptan, in which benefit was observed in low-dose (≤15 mg/day) group (RR 0.48, 95% CI 0.23 to 1.02, p=0.05, I2=54%), but not with high-dose (30 mg) group (RR 1.33, 95% CI 0.99 to 1.78, p=0.05, I2=0%). However, tolvaptan add-on therapy reduced body weight in 2 days (standardised mean difference −0.49, 95% CI −0.64 to −0.34, p<0.00001, I2=0%), increased sodium level (mean difference 1.56, 95% CI 0.04 to 3.07, p=0.04, I2=0%).ConclusionThe result suggests that comparing with the standard diuretic therapy, tolvaptan add-on therapy did not reduce the incidence of WRF and short-term mortality, however, it can decrease body weight and increase the sodium level in patients who are with ADHF. Further researches are still required for confirmation.

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A Meta-Analysis of Randomized Controlled Trials of Aspirin in Primary Prevention of Cardiovascular Disease.

Blood ◽

10.1182/blood.v114.22.174.174 ◽

2009 ◽

Vol 114 (22) ◽

pp. 174-174

Author(s):

Nina C Raju ◽

Magda Sobieraj-Teague ◽

John W Eikelboom

Keyword(s):

Myocardial Infarction ◽

Cardiovascular Disease ◽

Primary Prevention ◽

Cardiovascular Mortality ◽

Cardiovascular Events ◽

Conflicts Of Interest ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

All Cause Mortality

Abstract Abstract 174 Primary prevention with aspirin reduces the risk of non-fatal cardiovascular events but has not been demonstrated to reduce mortality. We performed an updated meta-analysis of randomised controlled trials of aspirin in primary prevention to obtain best estimates of the benefits and harm of aspirin compared with no aspirin with a focus on mortality. Eligible articles were identified by computerized search of MEDLINE, EMBASE, Cochrane library and CINAHL databases, review of bibliographies of relevant publications and a related article search using PubMed. The outcomes of interest included all cause mortality, cardiovascular mortality, the composite of myocardial infarction, stroke or death, and bleeding. 2 reviewers independently extracted study information and data. Data were pooled from individual trials using the DerSimonian-Laird random-effects model and results are presented as relative risk (RR) and 95% confidence intervals (CI). 8 studies comprising a total of 96,726 subjects were included. Aspirin reduced all-cause mortality (RR 0.94; 95%CI 0.88–1.00), the composite of myocardial infarction, stroke or cardiovascular death (RR 0.87; 95%CI 0.82–0.93), and myocardial infarction (RR 0.8; 95%CI 0.66–0.98) but did not significantly reduce cardiovascular mortality (RR 0.94; 95%CI 0.82–1.08) or stroke (RR 0.93; 95%CI 0.81–1.07). Aspirin increased the risk of major bleeding (RR; 1.69 95%CI 1.38–2.08), gastrointestinal bleeding (RR 1.38; 95%CI 1.16–1.65) and hemorrhagic stroke (RR 1.36; 95%CI 1.01–1.84). There was no interaction between subjects with or without diabetes for the outcomes of all cause mortality, cardiovascular mortality, the composite of myocardial infarction, stroke or death. Aspirin therapy in subjects with no prior history of cardiovascular disease reduces the risk of cardiovascular events, myocardial infarction and overall mortality. These benefits are achieved at the expense of increased bleeding. Disclosures: No relevant conflicts of interest to declare.

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Outcomes of coronavirus 2019 infection in patients with chronic kidney disease: a systematic review and meta-analysis

Therapeutic Advances in Chronic Disease ◽

10.1177/2040622321998860 ◽

2021 ◽

Vol 12 ◽

pp. 204062232199886

Author(s):

Yi-Chih Lin ◽

Tai-Shuan Lai ◽

Shuei-Liong Lin ◽

Yung-Ming Chen ◽

Tzong-Shinn Chu ◽

...

Keyword(s):

Systematic Review ◽

Chronic Kidney Disease ◽

Kidney Disease ◽

Meta Analysis ◽

Statistical Significance ◽

Case Series ◽

Pooled Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

All Cause Mortality

Background: Information on coronavirus disease 2019 (COVID-19) infection in patients with chronic kidney disease (CKD) remains limited. To understand the influence of COVID-19 infection in patients with pre-existing CKD, we conducted a systematic review and meta-analysis to evaluate and compare the risks of all-cause mortality, hospitalization, and critical progression between patients with and without CKD. Methods: We selected randomized controlled trials (RCTs), prospective or retrospective observational, case-control, cross-sectional, and case-series studies analyzing outcomes of COVID-19 infection in patients with pre-existing CKD from the PubMed, Embase, and Cochrane Central Register of Controlled Trials databases published on the Internet before 16 July 2020. Results: A total of 27 studies comprising 77,856 patients with COVID-19 infection was identified; 3922 patients with pre-existing CKD were assigned CKD group, and 73,934 patients were assigned to the non-CKD group. The pooled analysis showed that patients with CKD had a significantly higher risk of all-cause mortality and hospitalization than those without CKD [odds ratio (OR) 2.25, 95% confidence interval (CI) 1.91–2.66, p < 0.001; OR 4.29, 95% CI 2.93–6.28, p < 0.001; respectively]. Patients with CKD had a higher risk of critically ill conditions than those without CKD in the pooled analysis of studies with multivariable adjustment (adjusted OR 2.12, 95% CI 0.95–4.77, p = 0.07) and in the analysis of all included studies (OR 1.27, 95% CI 0.71–2.26, p = 0.41), but both analyses did not attain statistical significance. Conclusion: COVID-19 infected patients with CKD had significantly increased risks of all-cause mortality and hospitalization compared with those without CKD.

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Comparison of Pharmacological Treatment Effects on Long-Time Outcomes in Heart Failure With Preserved Ejection Fraction: A Network Meta-analysis of Randomized Controlled Trials

Frontiers in Pharmacology ◽

10.3389/fphar.2021.707777 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yaowang Lin ◽

Meishan Wu ◽

Bihong Liao ◽

Xinli Pang ◽

Qiuling Chen ◽

...

Keyword(s):

Heart Failure ◽

Ejection Fraction ◽

Cardiovascular Mortality ◽

Meta Analysis ◽

Controlled Trials ◽

Preserved Ejection Fraction ◽

Angiotensin Receptor ◽

Randomized Controlled ◽

Therapeutic Drugs ◽

All Cause Mortality

Beneficial effects of therapeutic drugs are controversial for heart failure with preserved ejection fraction (HFpEF). This meta-analysis aimed to evaluate and compare the interactive effects of different therapeutic drugs and placebo in patients with HFpEF. A comprehensive search was conducted using PubMed, Google Scholar, and Cochrane Central Register to identify related articles published before March 2021. The primary outcome was all-cause mortality. Secondary outcomes were cardiovascular mortality, heart failure (HF) hospitalization, and worsening HF events. A total of 14 randomized controlled trials, comprising 19,573 patients (intervention group, n = 9,954; control group, n = 9,619) were included in this network meta-analysis. All-cause mortality, cardiovascular mortality, and worsening HF events among therapeutic drugs and placebo with follow-up of 0.5–4 years were not found to be significantly correlated. The angiotensin receptor neprilysin inhibitor (ARNI) and angiotensin-converting enzyme inhibitor (ACEI) significantly reduced the HF hospitalizations compared with placebo (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.60–0.87 and HR 0.64, 95% CI 0.43–0.96, respectively), without heterogeneity among studies. The ARNI was superior to angiotensin receptor blocker (ARB) in reducing HF hospitalizations (HR 0.80, 95% CI 0.71–0.91), and vericiguat 10 mg ranked worse than beta-blockers for reducing all-cause mortality in patients with HFpEF (HR 3.76, 95% CI 1.06–13.32). No therapeutic drugs can significantly reduce mortality, but the ARNI or ACEI is associated with the low risk of HF hospitalizations for patients with HFpEF.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/, identifier CRD42021247034

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Effect of Sodium-Glucose Cotransporter Type 2 Inhibitors on Clinical Outcomes in Patients With Cardiovascular Disease: A Meta-Analysis of Randomized Controlled Trials

10.21203/rs.3.rs-154500/v1 ◽

2021 ◽

Author(s):

Caiyun Zheng ◽

Meimei Lin ◽

Yan Chen ◽

Haiting Xu ◽

Lingqun Yan ◽

...

Keyword(s):

Heart Failure ◽

Cardiovascular Disease ◽

Cardiovascular Mortality ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Volume Depletion ◽

Sodium Glucose Cotransporter ◽

All Cause Mortality ◽

Randomised Controlled

Abstract BackgroundControlled studies and observational studies have shown that sodium-glucose cotransporter type 2 inhibitors (SGLT-2s) are beneficial to the mortality of patients with heart failure (HF). However, it is unclear whether SGLT-2s can benefit patients with other cardiovascular diseases. Here, we conducted a systematic review and meta-analysis to determine the clinical benefits of SGLT-2s in cardiovascular patients with or without diabetes.MethodsWe searched PubMed, EMBASE, Cochrane Library, Web of Science databases, and ClinicalTrials.gov databases for randomised controlled trials written in English from inception until November 1, 2020. Two reviewers independently identified randomised controlled trials comparing the effects of SGLT-2s in patients with cardiovascular disease with or without diabetes. Primary outcomes were all-cause mortality, cardiovascular mortality, and hospitalisation for heart failure. Secondary outcomes were major adverse events from cardiovascular, metabolic, renal, and infectious diseases. The effects of SGLT-2s were evaluated using RevMan5.3 software. The Cochrane risk of bias tool was used to assess study quality.ResultsWe identified 10 randomised controlled trials (24500 patients in the SGLT-2 group and 17960 patients in the placebo group). Meta-analysis showed that SGLT-2 treatment significantly reduced all-cause mortality, cardiovascular mortality, and hospitalisation for heart failure (HHF) in patients with cardiovascular disease (all-cause mortality relative risk [RR]: 0.86; 95% confidence interval [CI]: 0.80–0.91; P < 0.00001; I2 = 11%; cardiovascular mortality RR: 0.85; 95% CI: 0.79–0.92; P < 0.0001; I2 = 35%; HHF RR: 0.69; 95% CI: 0.64–0.81; P < 0.00001; I2 = 0%). In patients with heart failure, mortality and HHF after SGLT-2 treatment for heart failure with reduced ejection fraction were significantly reduced, whereas heart failure with preserved ejection fraction did not differ compared with placebo treatment. Moreover, SGLT-2s induced a lower incidence of renal damage and myocardial infarction than the placebo group; however, the risk of infection, amputation, volume depletion, and diabetic ketoacidosis was higher. ConclusionsIn this exploratory analysis, SGLT-2s had significant clinical effects in the treatment of patients with cardiovascular disease and had significant benefits in terms of renal function and myocardial infarction, but were associated with increased risk of infection, ketoacidosis, amputation, and volume depletion.

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The Net Clinical Benefit of Thrombolysis in the Management of Submassive Pulmonary Embolism: Systematic Review and Meta-Analysis

Blood ◽

10.1182/blood-2019-124941 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 2440-2440

Author(s):

Pedro Alcedo ◽

Cristhiam Mauricio Rojas Hernandez ◽

Herney Andres Garcia Perdomo

Keyword(s):

Overall Survival ◽

Pulmonary Embolism ◽

Thrombolytic Therapy ◽

Meta Analysis ◽

Risk Of Bias ◽

Cochrane Central Register ◽

Right Ventricular Strain ◽

Significant Difference ◽

All Cause Mortality ◽

The Impact

Background: Benefit of thrombolytic therapy in patients with massive pulmonary embolism (PE) has been proven. Evidence supporting benefit in clinical outcomes of this approach in the subgroup of patients with submassive PE is lacking. Objective: The primary objective was to determine the impact of thrombolysis on overall survival in patients with submassive PE. Secondary outcomes included bleeding, thrombotic complications, improvement on parameters of right ventricular strain and all cause-mortality. Methods: A search strategy was conducted in MEDLINE (OVID), EMBASE, LILACS and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to nowadays. Search was also conducted in other databases and unpublished literature. Clinical trials were included without language restrictions. The risk of bias was evaluated with the Cochrane Collaboration's tool. We performed a meta-analysis with a fixed effect model according to the heterogeneity. PROSPERO registration number is CRD42019128229. Results: Twelve studies were included in the qualitative and quantitative analysis. 2,564 patients were found among the twelve studies. Risk of bias was assessed mostly as low or unclear risk among the study items. The risk ratio (RR) for all-cause mortality was 1.00 95% CI (0.77 to1.30). The RR of total bleeding and major bleeding were 2.72 95% CI (1.58 to4.69) and 2.17 95% CI (1.03 to4.55), respectively, finding higher risk in thrombolytic therapy. For stroke the RR was 2.22 95% CI (0.17 to28.73), and for recurrent PE the RR was 0.56 95% CI (0.23 to1.37), finding no differences regarding these outcomes. Unfortunately, there were no results reported about overall survival in any of the studies. Conclusion: In patients with submassive PE, the risk of bleeding is higher when thrombolysis is used. There is no significant difference between thrombolysis and anticoagulation in recurrence of PE, stroke, and all-cause mortality Figure Disclosures No relevant conflicts of interest to declare.

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Rivaroxaban for cancer-associated venous thromboembolism

Science Progress ◽

10.1177/00368504211012160 ◽

2021 ◽

Vol 104 (2) ◽

pp. 003685042110121

Author(s):

Bo Liang ◽

Yi Liang ◽

Li-Zhi Zhao ◽

Yu-Xiu Zhao ◽

Ning Gu

Keyword(s):

Venous Thromboembolism ◽

Major Bleeding ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Efficacy And Safety ◽

China National Knowledge Infrastructure ◽

Bleeding Events ◽

Significant Difference ◽

Major Bleeding Events

All cancers can increase the risk of developing venous thromboembolism (VTE), and anticoagulants should be considered as an optimal treatment for patients suffering from cancer-associated VTE. However, there is still a debate about whether the new oral anticoagulant, rivaroxaban, can bring better efficacy and safety outcomes globally. Thus, this systematic review and meta-analysis was conducted to evaluate the efficacy and safety of rivaroxaban. We searched PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and China National Knowledge Infrastructure for relevant published papers before 1 September 2019, with no language restrictions. The primary outcomes are defined as the recurrence of VTE. The secondary outcomes are defined as clinically relevant non-major bleeding, adverse major bleeding events, and all-cause of death. The data were analyzed by Stata with risk ratio (RR) and 95% confidence interval (CI). Four trials encompassing 1996 patients were included. Rivaroxaban reduced recurrent VTE with no significant difference (RR = 0.68, 95% CI = 0.43–1.07). Similarly, there were no significant differences in adverse major bleeding events (RR = 0.86, 95% CI = 0.37–2.00), clinically relevant non-major bleeding (RR = 1.24, 95% CI = 0.73–2.12) and all-cause mortality (RR = 0.76, 95% CI = 0.40–1.44). In a selected study population of cancer patients with VTE, rivaroxaban is as good as other anticoagulants. Further, carefully designed randomized controlled trials should be performed to confirm these results.

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Hydroxychloroquine for Treatment of COVID‐19 Patients: a Systematic Review and Meta-Analysis of Randomized Controlled Trials

10.21203/rs.3.rs-603673/v1 ◽

2021 ◽

Author(s):

Vinícius Y Moraes ◽

Alexandre R Marra ◽

Leandro L Matos ◽

Ary Serpa Neto ◽

Luiz Vicente Rizzo ◽

...

Keyword(s):

Systematic Review ◽

Adverse Effects ◽

Risk Ratio ◽

Meta Analysis ◽

Standard Of Care ◽

Control Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Random Effects Models ◽

Significant Difference

Abstract Background: We performed a systematic review of the literature and meta-analysis on the efficacy and safety of hydroxychloroquine to treat coronavirus disease 2019 (COVID-19) patients. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and LILACS (2019 to March 2021) for patients aged 18 years or older, who had COVID-19 and were treated with hydroxychloroquine versus placebo or standard of care. We also searched the WHO Clinical Trials Registry for ongoing and recently completed studies, and the reference lists of selected articles and reviews for possible relevant studies, with no restrictions regarding language or publication status. Random-effects models were used to obtain pooled mean differences of treatment effect on mortality, and serious adverse effects between hydroxychloroquine (HCQ) and the control group (standard of care or placebo); heterogeneity was assessed using the I2 and the Cochran´s Q statistic. Results: Nine studies met the inclusion criteria and were included in the meta-analysis. There was no significant difference in mortality rate between patients treated with HCQ compared to standard of care or placebo (16.7% vs. 18.5%; pooled risk ratio 1.09; 95%CI: 0.99-1.19). Also, therate of serious adverse effects was similar between both groups, HCQ and control (3.7% vs. 2.9%; pooled risk ratio 1.22; 95%CI: 0.76-1.96). Conclusion: Hydroxychloroquine is not efficacious in reducing mortality of COVID-19 patients.Systematic review registration: Prospero database, registration number: CRD42020197070.

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