Efficacy and safety of erenumab in migraine prevention: evidences from direct and indirect comparisons

2021 ◽  
Author(s):  
Xing Wang ◽  
Qiang He ◽  
Dingke Wen ◽  
Lu Ma ◽  
Chao You
Keyword(s):  
Migraine Prevention ◽  
Efficacy And Safety ◽  
Indirect Comparisons

scholarly journals The impact of inclusion, dose and duration of pyrazinamide (PZA) on efficacy and safety outcomes in tuberculosis: systematic review and meta-analysis protocol

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
James D. Millard ◽  
Elizabeth A. Mackay ◽  
Laura J. Bonnett ◽  
Geraint R. Davies
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Safety Outcomes ◽  
Meta Regression ◽  
Indirect Comparisons

Abstract Background Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. Methods We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. Discussion The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735

scholarly journals Matching-adjusted Indirect Comparisons of the Efficacy and Safety of Acalabrutinib Versus Other Targeted Therapies in Relapsed/Refractory Mantle Cell Lymphoma

2019 ◽  
Vol 41 (11) ◽  
pp. 2357-2379.e1
Author(s):  
Claire Telford ◽  
Shaum M. Kabadi ◽  
Sarang Abhyankar ◽  
Jinlin Song ◽  
James Signorovitch ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Targeted Therapies ◽  
Cell Lymphoma ◽  
Efficacy And Safety ◽  
Mantle Cell ◽  
Indirect Comparisons

Topiramate for Migraine Prevention in Adolescents: A Pooled Analysis of Efficacy and Safety

2006 ◽  
Vol 46 (10) ◽  
pp. 1503-1510 ◽  
Author(s):  
Paul Winner ◽  
Astrid Gendolla ◽  
Catherine Stayer ◽  
Steven Wang ◽  
Eric Yuen ◽  
...  
Keyword(s):  
Pooled Analysis ◽  
Migraine Prevention ◽  
Efficacy And Safety

Indirect Comparisons of the New Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4363-4363 ◽  
Author(s):  
Shabnam Zolfaghari ◽  
Job Harenberg ◽  
Svetlana Marx ◽  
Martin Wehling
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Conflicts Of Interest ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Indirect Comparisons

Abstract Abstract 4363 The efficacy and safety of new oral anticoagulants has been demonstrated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) by dabigatran in the RE-LY trial (150mg and 110mg bid), rivaroxaban in the ROCKET AF trial (20mg od), and apixaban in the ARISTOTLE trial (5mg bid) versus INR-adjusted warfarin. Direct comparisons of the NOACs in this indication are unlikely to be performed. A total of 4 indirect comparisons of these trials on the efficacy and safety of NOACs in patients with NVAF have now been published within only 3 months (Lip et al 2012, Harenberg et al 2012, Mantha et al 2012, Wells et al 2012). Here, we compare the results of these 4 network meta-analysis (NMA). In all 4 NMAs of the 3 new oral anticoagulants dabigatran (150mg bid) showed superior efficacy in preventing ischemic stroke plus systemic embolism to dabigatran (110mg bid, p<0.04) and rivaroxaban (p<0.04). Apixaban had equivalent efficacy with rivaroxaban and dabigatran (either dose). Apixaban was safer (less major bleeding) than dabigatran (150mg bid, p<0.04) or rivaroxaban (p<0.005). Intracerebral haemorrhage occurred with equal frequency for all agents and regimens except for rivaroxaban (higher risk than dabigatran 110mg bid, p<0.005). Myocardial infarction occurred less frequently with rivaroxaban and apixaban compared to either dose of dabigatran (all p<0.05). All-cause mortality was not different for any agent or regimen. Some minor differences between the NMAs may result from the approved doses of dabigatran by the FDA (150mg bid and 75mg bid) and EMA (150mg bid and 110mg bid), as the inclusion of the 110 mg bid dose of dabigatran into the NMA may not be seen relevant in the US. Based on this comparison, doctors and patients have to decide which suggestions of the 4 groups of authors seem more convincing: to change to or to start with one of the NOACs depending on the individual thrombotic or bleeding risk or to wait for the results from a large (and expensive) head-to-head randomised controlled trial which may take years to perform. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Scale for efficacy and safety evidence based on design and methodological quality of treatments and preventive technologies trials

2018 ◽  
Vol 15 (3) ◽  
pp. 25-29
Author(s):  
O Yu Rebrova
Keyword(s):  
Methodological Quality ◽  
Traditional Approach ◽  
Relative Effectiveness ◽  
Assessment Procedure ◽  
Efficacy And Safety ◽  
Modern Approach ◽  
Evidence Quality ◽  
Meta Analyses ◽  
Indirect Comparisons

The quality of the evidence on the efficacy and safety of therapeutic and preventive interventions is analyzed in health technology assessment procedure (including the development of reimbursement lists such as the List of Vital and Essential Drugs in Russian Federation) and during development of clinical guidelines. The traditional approach to assess the evidence quality is based on the well-known pyramid of research designs (from meta-analyses to case descriptions), and now it is obsolete. The modern approach is to take into account also the methodological quality of studies. The methodological quality depends on risks of biases and the risk of incorrect data analysis. The article proposes a scale based on combinations of designs and three levels of methodological quality (high, medium, poor) for each of them. The scale differentiates meta-analyses based on randomized controlled trials and comparative studies of other designs. In the scale, the new design of indirect comparisons is envisaged, its’ evidence is lower than for RCT that are used for indirect comparisons. The scale can be used for assessing the absolute and relative effectiveness and safety of medical and preventive medical technologies. At present, the scale is included in the guidelines for the complex assessment of pharmaceuticals.

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