scholarly journals Safety of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Twelve Randomized-Controlled Trials

2021 ◽  
Author(s):  
Stefan Strilciuc ◽  
László Vécsei ◽  
Dana Boering ◽  
Aleš Pražnikar ◽  
Oliver Kaut ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ischemic Stroke ◽  
Adverse Events ◽  
Acute Ischemic Stroke ◽  
Systematic Reviews ◽  
Safety Profile ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Safety Information ◽  
High Dose

We performed a systematic search and meta-analysis of available literature to determine the safety profile of Cerebrolysin in acute ischemic stroke, filling existing safety information gaps and inconsistent results. We searched EMBASE, PubMed and Cochrane Databases of Systematic Reviews and Clinical Trials up to the end of February 2021. Data collection and analysis was conducted using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. All safety outcomes were analyzed based on risk ratios (RR) and their 95% confidence intervals. The meta-analysis pooled 2202 patients from twelve randomized clinical trials, registering non-statistically significant (p>0.05) differences between Cerebrolysin and placebo throughout main and subgroup analyses. The lowest rate of Serious Adverse Events (SAE), as compared to placebo, was observed for the highest dose of Cerebrolysin (50 mL), highlighting a moderate reduction (RR = 0.6). We observed a tendency of superiority of Cerebrolysin regarding SAE in high dose treatment courses for moderate-severe ischemic stroke, suggesting some effect of the agent against adverse events. This comprehensive safety meta-analysis confirms the safety profile for patients treated with Cerebrolysin after acute ischemic stroke, as compared to placebo.

scholarly journals Safety of Cerebrolysin for Neurorecovery after Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Twelve Randomized-Controlled Trials

2021 ◽  
Vol 14 (12) ◽  
pp. 1297
Author(s):  
Stefan Strilciuc ◽  
László Vécsei ◽  
Dana Boering ◽  
Aleš Pražnikar ◽  
Oliver Kaut ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ischemic Stroke ◽  
Adverse Events ◽  
Acute Ischemic Stroke ◽  
Systematic Reviews ◽  
Safety Profile ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Safety Information ◽  
High Dose

We perforMed a systematic search and meta-analysis of available literature to determine the safety profile of Cerebrolysin in acute ischemic stroke, filling existing safety information gaps and inconsistent results. We searched EMBASE, PubMed, and Cochrane Databases of Systematic Reviews and Clinical Trials up to the end of February 2021. Data collection and analysis were conducted using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. All safety outcomes were analyzed based on risk ratios (RR) and their 95% confidence intervals. The meta-analysis pooled 2202 patients from twelve randomized clinical trials, registering non-statistically significant (p > 0.05) differences between Cerebrolysin and placebo throughout main and subgroup analyses. The lowest rate of Serious Adverse Events (SAE), as compared to placebo, was observed for the highest dose of Cerebrolysin (50 mL), highlighting a moderate reduction (RR = 0.6). We observed a tendency of superiority of Cerebrolysin regarding SAE in high dose treatment courses for moderate-severe ischemic stroke, suggesting some effect of the agent against adverse events. This comprehensive safety meta-analysis confirms the safety profile for patients treated with Cerebrolysin after acute ischemic stroke, as compared to placebo.

scholarly journals Safety of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Twelve Randomized-Controlled Trials

2021 ◽  
Author(s):  
Stefan Strilciuc ◽  
László Vécsei ◽  
Dana Boering ◽  
Aleš Pražnikar ◽  
Peter Riederer ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Adverse Events ◽  
Acute Ischemic Stroke ◽  
Systematic Reviews ◽  
Safety Profile ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Safety Information ◽  
High Dose ◽  
Serious Adverse Events

We performed a systematic search and meta-analysis of available literature to determine the safety profile of Cerebrolysin in acute ischemic stroke, filling existing safety information gaps and inconsistent results. We searched EMBASE (Excerpta Medica Database, 1947 to March 2021), MEDLINE (1946 to March 2021), CENTRAL (1948 to March 2021) and Cochrane Database of Systematic Reviews (1995 to March 2021). Data collection and analysis was conducted using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. All safety outcomes were analyzed based on risk ratios (RR) and their 95% confidence intervals. The meta-analysis pooled 2202 patients from twelve randomized clinical trials, registering non-statistically significant (p>0.05) differences between Cerebrolysin and placebo throughout main and subgroup analyses. The lowest rate of Serious Adverse Events (SAE), as compared to placebo, was observed for the highest dose of Cerebrolysin (50 mL), highlighting a moderat reduction (RR = 0.6). We observed a tendency of superiority of Cerebrolysin regarding SAE in high dose treatment courses for moderate-severe ischemic stroke, suggesting some effect of the agent against adverse events. This comprehensive safety meta-analysis confirms the safety profile for patients treated with Cerebrolysin after acute ischemic stroke, as compared to placebo.

Tenecteplase versus alteplase for management of acute ischemic stroke: a pairwise and network meta-analysis of randomized clinical trials

2018 ◽  
Vol 46 (4) ◽  
pp. 440-450 ◽  
Author(s):  
Babikir Kheiri ◽  
Mohammed Osman ◽  
Ahmed Abdalla ◽  
Tarek Haykal ◽  
Sahar Ahmed ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Randomized Clinical Trials ◽  
Meta Analysis

Abstract T MP11: Acute Endovascular Reperfusion Therapy Has Inconsistent Results Across Randomized Clinical Trials -A Systematic Review and Meta-Analysis

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Toshiya Osanai ◽  
Vinary Pasupuleti ◽  
Abhishek Deshpande ◽  
Priyaleela Thota ◽  
Yuani Roman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Endovascular Therapy ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Mechanical Thrombectomy ◽  
Meta Analysis ◽  
Good Outcome

Introduction: Endovascular (intra-arterial, IA) therapy for acute ischemic stroke has become part of acute therapy , but limited randomized clinical trials have had inconsistent results. We sought to evaluate efficacy and safety of endovascular therapy in - randomized clinical trials . Methods: We performed a systematic review of literature for randomized clinical trials of endovascular therapy with thrombolytic or mechanical reperfusion compared with comparator groups without IA therapy. Use of systemic thrombolysis was not excluded. Primary outcome was modified Rankin scale of disability of 0-2 at 90 days and secondary outcomes of mortality at 90 days and symptomatic intracranial hemorrhage was noted. Two groups of independent reviewers searched and identified studies and abstracted data. Random-effects meta-analysis was performed. Subgroups were analyzed by study design characteristics. Results: Systematic search identified 10 studies with 1572 subjects, of which 9 studies reported the primary outcome. IA therapy was associated with good outcome at 90 days (Odds ratio (OR) =1.28; 95% CI, 1.01 to 1.62; p=0.04), but there was significant heterogeneity with p of 0.03. Among 3 trials (n=1136) comparing mechanical thrombectomy with control, mechanical thrombectomy was not superior to control with good outcome (OR=0.98; 95 % CI, 0.85 to 1.14; p=0.83). Patients with IA therapy significantly have good outcome in studies without systematic thrombolysis in the comparator (OR=1.55; 95 % CI, 1.05 to 2.29; p=0.03) and required vessel occlusion for randomization (OR=1.54; 95 % CI, 1.10 to 2.14; p=0.01). Mortality was unchanged with IA therapy (OR=0.92; 95 % CI, 0.75 to 1.13; p=0.45) and there was no difference in symptomatic hemorrhage (OR=1.13; 95 % CI, 0.74 to 1.74; p=0.56). Conclusion: IA therapy has a small but significant increase in good outcomes for patients with acute ischemic stroke without increasing mortality and symptomatic hemorrhages.

675 FUNDOPLICATION VERSUS ORAL PROTON PUMP INHIBITORS FOR GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Luca Schiliró Tristão ◽  
Francisco Tustumi ◽  
Guilherme Tavares ◽  
Letícia Nogueira Datrino ◽  
Maria Carolina Andrade Serafim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Adverse Events ◽  
Proton Pump ◽  
Reflux Disease ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Oral Intake

Abstract   Gastroesophageal reflux disease (GERD) is a widely studied and highly prevalent condition. However, few is reported about the exact efficacy and safety of fundoplication (FPT) compared to oral intake proton-pump inhibitors (PPI). This systematic review and meta-analysis of randomized clinical trials (RCT) aims to compare PPI and FPT in relation to the efficacy, as well as the adverse events associated with these therapies. Methods This systematic review was guided by PRISMA statement. Search carried out in June 2020 was conducted on Medline, Cochrane, EMBASE and LILACS. The inclusion criteria were (I) patients with GERD; (II) Randomized clinical trials, comparing oral intake PPI with FPT; (III) relevant outcomes for this review. The exclusion criteria were (I) reviews, case reports, editorials and letters (II) transoral or endoscopic FPT (III) studies with no full text. No restrictions were set for language or period. Certainty of evidence and risk of bias were assessed with GRADE Pro and with Review Manager Version 5.4 bias assessment tool. Results Ten RCT were included. Meta-analysis showed that heartburn (RD = −0.19; 95% CI = −0.29, −0.09) was less frequently reported by patients that underwent FPT. Furthermore, patients undergoing surgery had greater pressure on the lower esophageal sphincter than those who used PPI (MD = 7.81; 95% CI 4.79, 10.83). There was no significant difference between groups in the percentage of time with pH less than 4 in 24 hours, sustained remission and Gastrointestinal Symptom Rating Scale. Finally, FPT did not increase significantly the risk for adverse events such as postoperative dysphagia and impaired belching. Conclusion FPT is a more effective therapy than PPI treatment for GERD, without significantly increasing the risk for adverse events. However, before indicating a possible surgical approach, it is extremely important to correctly assess and select the patients who would benefit from FPT, such as those with severe erosive esophagitis, severe respiratory symptoms, low adherence to continuous drug treatment and patients with non-acid reflux, to ensure better results.

Abstract WMP112: Cilostazol versus Aspirin for Secondary Stroke Prevention: Systematic Review and Meta-Analysis

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Michelle P Lin ◽  
Kevin M Barrett ◽  
James F Meschia ◽  
Benjamin H Eidelman ◽  
Josephine F Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Ischemic Stroke ◽  
Random Effects ◽  
Intracranial Hemorrhage ◽  
Stroke Prevention ◽  
Lower Risk ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Secondary Stroke Prevention

Introduction: Cilostazol has promise as an alternative to aspirin for secondary stroke prevention given its vasodilatory and anti-inflammatory properties in addition to platelet aggregation inhibition. We conducted a systematic review and meta-analysis to estimate the comparative effectiveness and safety of cilostazol compared to aspirin for stroke prevention in patients with previous stroke or TIA. Hypothesis: Cilostazol is more effective than aspirin in preventing recurrent ischemic stroke with lower risk of intracranial hemorrhage and bleeding. Methods: We searched PubMed and the Cochrane Central Register of Controlled Trials from inception to 2019. Randomized clinical trials that compared cilostazol vs aspirin and reported the endpoints of ischemic stroke, intracranial hemorrhage and bleeding were included. A random-effects estimate was computed based on Mantel-Haenszel methods. The pooled estimates with 95% confidence intervals were compared between cilostazol and aspirin and displayed as forest plots (Figure). Results: The search identified 5 randomized clinical trials comparing cilostazol vs aspirin for secondary stroke prevention that enrolled 7,240 patients from primarily Asian countries (3,615 received cilostazol and 3,625 received aspirin). The pooled results from the random-effects model showed that cilostazol was associated with significantly lower risk of recurrent ischemic stroke (Hazard ratio [HR] 0.70; 95%CI, 0.54-0.89), intracranial hemorrhage (HR 0.41; 95%CI, 0.25-0.65) and bleeding (HR 0.71; 95%CI, 0.55-0.91). See forest plots. Conclusion: This meta-analysis suggests cilostazol is more effective than aspirin in the prevention of recurrent ischemic stroke with lower risk of intracranial hemorrhage and bleeding. Confirmatory randomized trials of cilostazol for secondary stroke prevention to be performed in more generalizable populations are needed.

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