scholarly journals Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information

2013 ◽  
Vol 168 (4) ◽  
pp. 3572-3579 ◽  
Author(s):  
Anthony J. Barron ◽  
Nabeela Zaman ◽  
Graham D. Cole ◽  
Roland Wensel ◽  
Darlington O. Okonko ◽  
...  
2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Antonio Cerciello ◽  
Norman Lamaida

Abstract Aims The PARADIGM-HF study has shown, as is well known, that the association of sacubitril/valsartan (SV) was superior in terms of efficacy compared to enalapril in patients suffering from heart failure chronic cardiac (SC) and reduced systolic function (HFrEF). We have analysed the use of SV in patients with symptomatic HF and HFrEF, andits effect on humoural and functional parameters of easy evaluation. Methods and results From March 2018 to December 2019 we have introduced the SV in 158 patients 135 M and 23 F mean age 40–80 years with fraction of ejection <35% with idiopathic dilated cardiomyopathy (six patients) or post-ischaemic (150 patients), in NYHA III class. Patients were declared eligible according to the ESC 2016 criteria (EF 40%, NT-proBNP> 400 ng/l, target dose of ACE inhibitors/receptor antagonists angiotensin, GFR> 30 ml/min/1.73 m2, serum S-potassium <5.2 mmol/l, treatment with beta-blockers and antialdosteronics). Initially the administration of SV was a cp of 49/51 mg bid up to maximum tolerated dose (one tablet of 97/103 mg bid). All the patients had stopped taking ACE-I or sartans 48 h before and were evaluated at 4-week intervals for two years. In all patients we evaluated: ejection fraction (FE), filtered glomerular, systolic blood pressure, body weight, side effects, hospitalization and mortality. Of the 156 patients, 17 achieved the optimal dose of SV (97/103 mg), 113 achieved SV 49/51 mg bid. In all patients did not experience side effects or alterations of the electrolyte picture and renal function. The SV has determined an improvement NYHA class of at least 1; the echocardiogram showed a significant increase in FE: at follow-up 89 patients reached FE 45%, 44 patients FE 40–44%, and 6 patients about 50%; besides it is an improvement in indexed end-diastolic volume in moles was noted above patients (from 118.4 ± 38.4 to 110.9 ± 30 ml/m2). No case of re-hospitalization. Conclusions Our experience shows that the use of SV is well tolerated, improves functional capacity and ventricular remodelling and that does not modify the parameters of renal function and electrolytic of the patients.


2021 ◽  
Author(s):  
Nischit Baral ◽  
Nabin Raj Karki ◽  
Imran Akram ◽  
Ashiya Khan ◽  
Govinda Adhikari ◽  
...  

Introduction: The role of intravenous (IV) iron in chronic heart failure has been well studied, however, its role in acute heart failure (AHF) is less well-known. Including the recent AFFIRM-HF trial, we performed a systematic review and meta-analysis to highlight the role of IV iron in AHF with iron deficiency. Hypothesis: We hypothesized that IV iron does not change mortality or heart failure re-hospitalization rates in patients with AHF with iron deficiency. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and cohort studies published from inception till June 30, 2021. We searched PubMed, MEDLINE, EMBASE (embase.com), and Cochrane database including only RCTs and Cohort studies. We also included one prospective and one retrospective Cohort studies and two RCTs in our meta-analysis. Eligible studies included adults with AHF, left ventricular ejection fraction less than 40%-50%, and able to receive IV iron therapy. Outcomes included re-hospitalization rates and overall mortality from 30 days to 52 weeks post randomization (in one RCT). We used random-effects model calculating Risk Ratio (RR) with 95% confidence interval (95% CI) using Review Manger 5.4 software. I2statistics was used to assess heterogeneity. Results: There were total 1561 participants in both groups (IV iron and placebo/control) of four studies. The controls were comparable in both cohort studies and both the RCTs were well matched. Our results showed re-hospitalization in 278 of 833 (33.37%) patients in the IV iron/exposure group and 337 of 728 (0.46%) patients in the placebo/control group. The pooled result showed that the risk of re-hospitalization was comparable across both groups (RR 0.85, 95%CI 0.62-1.17; I2=45%, P=0.14). However, subgroup analysis, including RCTs only showed that IV iron decreases re-hospitalization rate by 28% compared to placebo (RR 0.72, 95% CI: 0.64, 0.82, I2=0%, P<0.00001) but did not improve mortality when compared to placebo (RR 0.97, 95% CI: 0.73, 1.30, I2 =0%). Conclusions: IV iron showed significant improvement in re-hospitalization rate for AHF hospitalizations in iron deficient patients but did not improve overall mortality. We need larger RCTs to further validate its effect on mortality.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3465-3465
Author(s):  
Muhammad Zain Farooq ◽  
Prasanth Lingamaneni ◽  
Saira Farid ◽  
Muhammad Saad Farooq ◽  
Ishaan Vohra ◽  
...  

Introduction: Spleen tyrosine kinase (Syk), a cytoplasmic tyrosine kinase, is a member of the non-receptor type protein kinase family. Apart from the hematopoietic cells, it is also expressed in the epithelial and endothelial cells. Fostamatinib, a Syk inhibitor, has been proven beneficial in autoimmune disease like rheumatoid arthritis (RA) and immune thrombocytopenia (ITP). Murine models have shown a direct correlation between hypertension and level of R406, the active metabolite of fostamatinib. In this study, we sought to examine the cardiovascular profile of fostamatinib in published and unpublished randomized controlled trials. Methods: A systematic search of Pubmed, Medline and Scopus databases were done from inception till date to identify all phase 2 and 3 clinical trials of fostamatinib in patients with ITP and RA by two independent reviewers. Trials were included if they reported side effects including but not limited to cerebral ischemia or infarction, myocardial ischemia and myocardial infarction, hypertension and cardiac rhythm disorders. 35 trials were retrieved in the initial search which were excluded according to PRISMA (Preferred Reporting Items for Systematic review and Meta-Analyses) guidelines. 11 trials met the eligibility criteria and were included in the final analysis. All statistical analysis was carried out using OpenMetaAnalyst software. Categorical variables from each study are presented as proportions. The proportions from each study were subjected to arcsine transformation and pooled using a random-effects model. This yielded the pooled estimate with 95% confidence intervals. The I2 statistic was used to assess heterogeneity and a value of I2 = 25%-50% was considered mild, 50%-75% as moderate, and &gt; 75% as severe. A P value of &lt;0.05 was considered significant in all cases. Results: 11 trials included in final study had 3941 patients. Cardio-vascular side effects were reported by all trials which ranged from 0.7% to 19.2%. The pooled estimate was 11.7% (8.6%-15.3%, P&lt;0.001 (I2=89.97%)). The most common adverse event reported was hypertension by 10 trials with pooled estimate of 11.1% (8.3%-14.2%, p&lt;0.001(I2=87.27%). The FIT-3 trial reported hypertension as the sole cardiovascular adverse event in 16.7% (n=21) of patients. Other adverse events reported were arrhythmias by 3 trials with incidence of 0.4% (n=11), angina was reported by 5 trials with incidence of 0.8% (n=19). Malignant hypertension was reported in 3 trials with incidence of 0.2%(n=4). 3 trials report heart failure with incidence of 0.3% (n=7). Carotid artery stenosis was observed in only one patient in Oskira 2 trial. Only 2 patients were found to have stroke from all trials, no incidence of aortic stenosis/aneurysm reported. Ventricular fibrillation and peripheral ischemia were observed in one patient respectively and circulatory shock was seen in two patients. Left bundle branch block and pericarditis were also rare side effects observed in only one patient. Conclusion: Our study shows that the use of fostamatinib is significantly associated with cardiovascular side effects, of which hypertension is most significant adverse event. We also recorded a few serious adverse events like hypertensive crises, myocardial infarction, coronary artery disease and congestive heart failure in few patients, but at a very low rate. Larger longitudinal studies are needed to determine the side effect profile of fostamatinib. Disclosures No relevant conflicts of interest to declare.


2021 ◽  
Vol 27 ◽  
Author(s):  
Goran Koraćević ◽  
Milovan Stojanović ◽  
Tomislav Kostić ◽  
Dragan Lović ◽  
Marija Zdravković ◽  
...  

: Beta-blockers (BBs) have significant side effects that contribute to low adherence and persistence. Therefore, the optimal choice of BB is a vital mode to prevent BB's side effects, leading to an increase in compliance, which can improve the outcomes in BBs' evidence-based indications such as acute myocardial infarction, heart failure, etc. The paper aims to suggest an improved method of reporting contraindications for BBs. We used a search of the following indexing databases: SCOPUS and PubMed, and web search engine Google Scholar to identify guidelines on arterial hypertension (HTN). HTN guidelines published during the last two decades were analyzed (from 2000 to 2020). Some of the contraindications (e.g., bradycardia, acute heart failure) are true for every BB. However, some contraindications do not belong to the whole BB class. For example, propranolol and carvedilol are contraindicated in chronic obstructive lung disease, but nebivolol and bisoprolol are not. To our knowledge, there is a lack of guidelines citing contraindications for individual BBs because they vary a lot within the class of BBs. We suggest that contraindications specific for some BBs (i.e., not for the whole class) ought to be listed with the exact name(s) of the individual BBs. In this way, we may decrease the number of wrong choices among BBs and consequently increase drug adherence (which is currently worse for the class of BBs than for most of the other antihypertensive drugs). It is an approach to improve both primary medical education and guidelines.


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