scholarly journals Effect of tofacitinib on cardiovascular events and all-cause mortality in patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis of randomized controlled trials

2019 ◽  
Vol 11 ◽  
pp. 1759720X1989549 ◽  
Author(s):  
Wenhui Xie ◽  
Shiyu Xiao ◽  
Yanrong Huang ◽  
Xiaoying Sun ◽  
Zhuoli Zhang
Keyword(s):  
Randomized Controlled Trials ◽  
Cardiovascular Events ◽  
Inflammatory Diseases ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Immune Mediated ◽  
Increased Risk ◽  
All Cause Mortality

Background: We aimed to systematically assess a possible association of tofacitinib therapy with cardiovascular events (CVEs) and all-cause mortality. Methods: Systematic searches of PubMed, Embase, and Cochrane Library were conducted from inception through March 2019. Randomized controlled trials in patients with immune-mediated inflammatory diseases (IMIDs) reporting safety data were included. Included studies compared tofacitinib with placebo or 5 mg tofacitinib with 10 mg tofacitinib. The primary and secondary outcome measures were all CVEs [major adverse cardiovascular events (MACEs)/venous thromboembolism events (VTEs)] and all-cause mortality. Results: 29 studies randomizing 13,611 patients were included. Compared with placebo, there was no significant increased risk of all CVEs (OR = 1.07, 95% CI 0.49–2.34), MACEs (OR 1.54, 95% CI 0.42–5.59), or all-cause mortality (OR = 1.13, 95% CI 0.26–4.95), but a decreased rate of VTEs (OR 0.03, 95% CI 0.00–0.21) in patients with IMIDs initiating tofacitinib. Meanwhile, paired comparison showed 10 mg tofacitinib twice daily was associated with a significantly lower incidence of all CVEs (OR = 0.56, 95% CI 0.33–0.96), MACEs (OR = 0.48, 95% CI 0.22–1.05), or all-cause mortality (OR = 0.47, 95% CI 0.19–1.17), but a trend toward an increase in VTEs risk (OR = 1.47, 95% CI 0.25–8.50), compared with the 5 mg regimen. Conclusion: Compared with placebo, there was no augmented risk of CVEs and all-cause mortality in patients with IMIDs following tofacitinib treatment in a short-term perspective, whereas 10 mg twice daily tofacitinib appeared to be associated with reduction in cardiovascular and all-cause mortality risks, except VTEs, relative to the 5 mg twice daily dose. Long-term studies and postmarketing risk monitoring are increasingly needed to develop a better understanding.

scholarly journals Poly(ADP-Ribose) Polymerase Inhibitors (PARPi) for Patients With Advanced Breast Cancer: a Meta-analysis of Randomized Controlled Trials

2020 ◽  
Author(s):  
YongCheng Su ◽  
XiaoGang Zheng
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trials ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Parp Inhibitors ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Grade 3

Abstract BACKGROUND: Poly(ADP–ribose) polymerase (PARP) inhibitors are new class of drugs that are currently being studied in several malignancies. However, datas about the efficacy and safety of the PARP inhibitors are limited. Therefore, we conducted a meta-analysis of randomized controlled trials (RCT) in patients with breast cancer.METHODS: Pubmed/Medline, Embase, Cochrane Library, and abstracts presented at the annual meeting of the American Society of Clinical Oncology (ASCO) were searched for articles published from 2000 to June 2018.Summary incidences and the RR, HR with 95% confidence intervals, were calculated by using a random-effects or fixed-effects model.RESULTS: The summary HR indicated PARPi was not associated with OS (HR=0.83, 95%CI 0.66–1.06, Z=1.49, P=0.14), while it could significantly improve PFS ande time to deterioration (TTD) of global health status/quality of life(GHS/QoL) as compared with traditional standard therapy, the HR was 0.60(95%CI 0.50-0.72; Z=5.52, P＜0.00001) and 0.4 (95%CI 0.29–0.54,z=5.80 ,p=0.000),respectively.The RR of grade 3 or more anemia ,fatigue and headache was 3.02 (95% CI, 0.69–13.17;p = 0.14,,I2=90%),0.77 (95%CI, 0.34–1.73;p=0.52,I2=7%) and 1.13 (95% CI,0.30–4.18;p=0.86,I2=0%),respectively.CONCLUSION: The findings of this meta-analysis showed that PARPi has no significant effect on OS, while it could significantly improve in PFS and TTD of GHS/QoL for patients with advanced or metastatic breast cancer.Furthermore,our findings also demonstrated that the PARPi treatment is connected with an increased risk of grade 3 or more anemia adverse events.

scholarly journals Is there value in prescribing colchicine in coronary artery disease for secondary prevention: a meta-analysis of over 5,000 patients

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A.F Sunjaya ◽  
A.P Sunjaya
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Randomized Controlled Trials ◽  
Cardiovascular Events ◽  
Low Dose ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Artery Disease

Abstract Introduction Coronary Artery Disease (CAD) is the single greatest cause of mortality and loss of disability adjusted life years (DALYs) worldwide. Inflammation plays a central role in the pathogenesis of atherosclerosis, with numerous evidence from prospective studies indicating that increasing C-reactive protein levels (hs-CRP) are independently associated with increasing risk of cardiovascular events. Colchicine, is an inexpensive, potent anti-inflammatory drug considered as a staple therapy for gout. Recent studies have shown that colchicine use may prove to be useful in the prevention of cardiovascular events. Purpose In patients with coronary artery disease (CAD) does administration of low dose colchicine lead to reduced all-cause mortality, cardiovascular risk and morbidity. Methods A meta-analysis was performed based on randomized controlled trials obtained from Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Medline and Medline ahead of print published between 2000 and 2020. Main outcome measures include all-cause mortality, cardiovascular events, CRP levels and prevalence of CRP levels less than 2.0 mg/L. Data synthesis and analysis was done using RevMan 5.3 using a random effects model. Results A total of 5 randomized controlled trials, representing 5,430 patients were included in this meta-analysis. Three trials administered colchicine 1 mg/day while the rest were assigned colchicine. 5 mg/day. Administration of colchicine in CAD patients was found to reduce all-cause mortality (RR=0.66, 95% CI: 0.30 to 1.46, p=0.31) and major adverse cardiovascular events (MACE) (RR=0.61, 95% CI: 0.25 to 1.47, p=0.27), although results were non-significant. Reduced CRP levels (Mean difference = −0.88, 95% CI: −1.76 to 0.01, p=0.05) compared to control group as well as a higher prevalence of patients with CRP levels <2.0 mg/L were found (RR=2.27, 95% CI: 0.45 to 11.33, p=0.32), although results were non-significant. Discussion Few studies are available evaluating the benefits of low dose colchicine in CAD patients. The beneficial effects of colchicine has been proposed due to its ability to inhibit neutrophil chemotaxis which may reduce the risk of plaque instability. The use of colchicine for secondary prevention of CAD will require long-term use, which will require the need for preparations that address its intolerance (mostly gastrointestinal) to prevent early discontinuation of the medication. Conclusion There's limited evidence on the benefit of low dose colchicine in CAD patients. Further large scale randomized-controlled trials are needed, and its dose-response relationship ascertained before consideration of its use could be given in CAD patients. Funding Acknowledgement Type of funding source: None

Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
pp. 152660282110235
Author(s):  
Krystal Dinh ◽  
Alexandra M. Limmer ◽  
Andy Z. L. Chen ◽  
Shannon D. Thomas ◽  
Andrew Holden ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Occlusive Disease ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
All Cause Mortality

Purpose: A late increased mortality risk has been reported in a summary level meta-analysis of patients with femoropopliteal artery occlusive disease treated with paclitaxel-coated angioplasty balloons and stents. However, at the longer follow up timepoints that analysis was limited by small trial numbers and few participants. The aim of this study was to report an updated summary level risk of all-cause mortality after treatment with paclitaxel-coated devices in that same patient group. Materials and Methods: We performed a systematic review and meta-analysis of randomized controlled trials to investigate the mortality outcomes associated with paclitaxel-coated devices used to treat patients with occlusive disease of femoropopliteal arteries (last search date December 10, 2020). The single primary endpoint was all-cause mortality. Results: We identified 34 randomized controlled trials (7654 patients; 84% intermittent claudication). There were 622 deaths among 4147 (15.0%) subjects in the paclitaxel device group and 475 deaths among 3507 (13.5%) subjects in the noncoated control group [relative risk ratio (RR) 1.07, 95% confidence interval (CI) 0.96 to 1.20, p=0.20, I2=0%). All-cause mortality was similar between groups at 12 months (34 studies, 7654 patients; RR 0.99, 95% CI 0.81 to 1.22, p=0.94, I2=0%), 24 months (20 studies, 3799 patients; RR 1.16, 95% CI 0.87 to 1.55, p=0.31, I2=0%), and 60 months (9 studies, 2288 patients; RR 1.19, 95% CI 0.98 to 1.45, p=0.08, I2=0%). Conclusion: This updated meta-analysis with included additional trials and larger patient numbers shows no evidence of increased risk of all-cause mortality in patients treated with paclitaxel-coated devices, compared with uncoated devices for femoropopliteal disease at all time points to 60 months. There is therefore no justification to limit their use, or alter regulatory body follow-up recommendations in this patient population. Systematic Review Registration: CRD42020216140.

Abstract 325: Prasugrel vs Ticagrelor for Dapt Therapy in Patients With Acs Undergoing Pci; A Systematic Review and Meta-analysis of Randomized Controlled Trials

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Ahmad Al-Abdouh ◽  
Mahmoud Amr ◽  
Nazir Savji ◽  
Di Zhao ◽  
Rani K Hasan ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Stent Thrombosis ◽  
Major Bleeding ◽  
Cardiovascular Mortality ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Coronary Syndrome ◽  
Randomized Controlled ◽  
Significant Difference ◽  
All Cause Mortality

Introduction: Dual antiplatelet therapy (DAPT) with a P2Y12 inhibitor added to aspirin is considered the standard of care for patients with acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI). Prasugrel and ticagrelor are commonly used P2Y12 inhibitors. However, few head-to-head randomized controlled trials have been performed to directly compare the efficacy and safety of these two agents when used in patients with ACS undergoing PCI. Methods: We searched PubMed/MEDLINE and Cochrane library. The primary endpoint was major adverse cardiovascular events (MACE). Secondary outcomes were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stent thrombosis, major bleeding, and all bleeding event. Estimates were calculated as random effects risk ratios (RRs) with 95% confidence intervals (CI). Results: Six trials with 6807 patients were included [ FIGURE ]. There were no significant differences in MACE (RR 0.93; 95% CI [0.72-1.20]; p = 0.59; I 2 = 26%), all-cause mortality (RR 0.92; 95% CI [0.73-1.17]; p = 0.51; I 2 = 0%),cardiovascular mortality (RR 0.99; 95% CI [0.75-1.31]; p = 0.96; I 2 = 0%), MI (RR 0.87; 95% CI [0.60-1.27]; p = 0.48; I 2 = 27%), stent thrombosis (RR 0.64; 95% CI [0.39-1.04]; p = 0.07; I 2 = 0%), major bleeding (RR 0.94; 95% CI [0.70-1.26]; p = 0.68; I 2 = 6%), and all bleeding events (RR 0.92; 95% CI [0.77-1.09]; p = 0.32; I 2 = 0%) when ticagrelor was compared to prasugrel. Conclusion: There are no significant difference of MACE, all-cause mortality, cardiovascular mortality, MI, stent thrombosis, and bleeding between prasugrel and ticagrelor for DAPT in PCI for ACS based current clinical trial data. However, the most recently published and largest of these trials suggests a reduction in MACE. More such comparisons are warranted to inform clinical practice.

scholarly journals Selenium, antioxidants, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 112 (6) ◽  
pp. 1642-1652
Author(s):  
David J A Jenkins ◽  
David Kitts ◽  
Edward L Giovannucci ◽  
Sandhya Sahye-Pudaruth ◽  
Melanie Paquette ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cardiovascular Disease ◽  
Randomized Controlled Trials ◽  
Risk Reduction ◽  
Meta Analysis ◽  
Selenium Supplementation ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
All Cause Mortality

ABSTRACT Background Antioxidants have been promoted for cardiovascular disease (CVD) risk reduction and for the prevention of cancer. Our preliminary analysis suggested that only when selenium was present were antioxidant mixtures associated with reduced all-cause mortality. Objective We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to determine the effect of selenium supplementation alone and of antioxidant mixtures with or without selenium on the risk of CVD, cancer, and mortality. Methods We identified studies using the Cochrane Library, Medline, and Embase for potential CVD outcomes, cancer, and all-cause mortality following selenium supplementation alone or after antioxidant supplement mixtures with and without selenium up to June 5, 2020. RCTs of ≥24 wk were included and data were analyzed using random-effects models and classified by the Grading of Recommendations, Assessment, Development, and Evaluation approach. Results The meta-analysis identified 9423 studies, of which 43 were used in the final analysis. Overall, no association of selenium alone or antioxidants was seen with CVD and all-cause mortality. However, a decreased risk with antioxidant mixtures was seen for CVD mortality when selenium was part of the mix (RR: 0.77; 95% CI: 0.62, 0.97; P = 0.02), with no association when selenium was absent. Similarly, when selenium was part of the antioxidant mixture, a decreased risk was seen for all-cause mortality (RR: 0.90; 95% CI: 0.82, 0.98; P = 0.02) as opposed to an increased risk when selenium was absent (RR: 1.09; 95% CI: 1.04, 1.13; P = 0.0002). Conclusion The addition of selenium should be considered for supplements containing antioxidant mixtures if they are to be associated with CVD and all-cause mortality risk reduction. This trial was registered at https://www.crd.york.ac.uk/PROSPERO/ as CRD42019138268.

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