scholarly journals Serious adverse events experienced by patients with chronic heart failure taking spironolactone

Heart ◽  
2001 ◽  
Vol 85 (4) ◽  
pp. 8e-8 ◽  
Author(s):  
C Berry
2020 ◽  
Vol 24 (2) ◽  
pp. 125-134
Author(s):  
Z. D. Kobalava ◽  
S. A. Galochkin ◽  
V. V. Tolkacheva ◽  
N. Kh. Bagmanova

Aim : to evaluate effects and clinical outcomes of early initiation of sacubitril/valsartan in patients with chronic heart failure with a low ejection fraction. Methods : 30 patients admitted to the clinic for an episode of acute heart failure (AHF) II-IV class NYHA and decreased ejection fraction 40% (83.3% of men, mean age 66.0 [58.0-76.0] years) were included into the open study. Patients received the first dose of the study drug no later than 6 hours before discharge from the hospital. The period of active treatment was 26 weeks. At week 12 and 26, the number of patients receiving the target dose of 400 mg/day, as well as the dynamics of symptoms and severity of heart failure (HF) were evaluated. During the entire period of the study, safety parameters were investigated in all patients. Results . 70% of patients (n=21) received the target dose by week 2 77,8% (n=21) received the target dose of 200 mg 2 times a day at week 26. The positive effect in the dynamics of symptoms, as well as the severity of HF in the vast majority of patients were observed, a significant reduction in the severity of the main symptoms of HF was achieved, patients moved to a lower class of HF. 3 patients dropped out due to adverse events (1) and serious adverse events (2). 27 (90%) patients completed the program in accordance with the Protocol. Conclusion . Sacubitril/valsartanis is well tolerated, effective and safety drug in patients with CHF and a low ejection fraction.


2020 ◽  
Author(s):  
Yuan Lu ◽  
Yu Yang ◽  
Yong Fan ◽  
Chenzong Li ◽  
Min Zhang ◽  
...  

Abstract Background Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) are significantly effective in reducing cardiovascular events in patients with type 2 diabetes mellitus (T2DM). However, the magnitude of the effect of SGLT-2i on cardiovascular outcomes in established heart failure (HF) patients with T2DM remains undefined. Methods We systematically searched the PubMed, Embase, Cochrane Central and Web of Science databases for articles published prior to 09 April 2020 to identify randomized controlled trials that compared SGLT-2i with placebo in patients with heart failure concomitant with T2DM. Efficacy outcomes included the composite of cardiovascular death (CVD) or hospitalization for heart failure (HHF), individual CVD, individual HHF, and all-cause mortality (ACM). Hazard ratios (HRs) with 95% confidence intervals (95% CIs) were pooled across trials by using the generic inverse variance method. Sensitivity analyses were conducted by excluding specific studies or using risk ratios (RRs) with 95% CIs as measures of the effect size. Serious adverse events served as safety outcomes. Results A total of 5 large trials comprising 6945 patients with HF and T2DM were enrolled. Pooled data demonstrated that SGLT-2i significantly reduced the risk for the primary composite outcome of CVD or HHF by 13% (HR: 0.87, 95% CI: 0.83–0.91, I2: 0%, P < 0.00001) in patients with HF concomitant with T2DM. Similarly, the use of SGLT-2i was associated with a statistically significant 14% reduction in HHF (pooled HR: 0.86, 95% CI: 0.81–0.91, I2: 0%, P < 0.00001) and a 10% reduction in ACM (pooled HR: 0.90, 95% CI: 0.86–0.96, I2: 16%, P < 0.0005) but was not significantly associated with a reduction in CVD (HR: 0.91, 95% CI: 0.81–1.02, I2: 60%, P = 0.11). Sensitivity analyses indicted consistent results. Compared with placebo plus standard care, the SGLT-2i group had a lower proportion of serious adverse events (weighted proportions: 44.3% vs 50.3%; RR 0.88, 95% CI 0.82–0.95, I2: 22%, p = 0∙006). Conclusions SGLT-2i significantly reduced the risk of HHF and ACM in a broad range of HF patients concomitant with T2DM. Compared with standard care, SGLT-2i plus standard therapy was associated with a reduction in serious adverse events.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Mayron F Oliveira ◽  
Rita L Santos ◽  
Vanessa M Mendez ◽  
Priscila A Sperandio ◽  
Iracema I Umeda ◽  
...  

Background: Exercise training (ET) is well established to improve functional capacity and quality of life in patients (pts) with chronic heart failure. However, the ET benefits in acute heart failure (AHF) are unknown. Purpose: We aimed to study the safety and efficacy of ET alone or combined with non-invasive ventilation (NIV) compared to standard medical treatment in hospitalized pts with AHF. Methods: Twenty-nine pts with AHF (68% ischemic), 56±7 years, left ventricle ejection fraction of 25±5%, NTproBNP of 2456±730, 6-minute walk test distance (6MWD = 225±39meters) were randomized into 3 groups: ET + NIV with sub therapeutic positive airway pressure (PAP) (ET,n=9), ET + NIV set to 14 of inspiratory and 8 cmH2O of expiratory PAP, respectively (EV,n=11) and standard treatment (CO,n=9). The ET and EV groups performed a daily session of unloaded exercise on cycle ergometer for 20 min or tolerance limit, for 8 consecutives days. In EV and ET, oxygen pulse saturation (SpO2), heart rate (HR), respiratory rate (RR), blood pressure (BP), blood lactate were measured at baseline (D1), during exercise, and at day 10 (D10). Serious adverse events (death or worsening heart failure) were also assessed on D10. Results: Length of hospital stay was shorter in EV group (17±10 days) compared to ET (23±8 days) and CO (39±15 days) (p<0,05). There were more serious adverse events in CO (66,6%) compared to both EV and ET (15%). Dobutamine use at D10 was less frequent in EV (18,2%) and ET (22,2%) groups than in CO (33,3%) (p<0.05). There was a marked improvement in Δ6MWD between D1 and D10 in EV (Δ127±72 meters), though increase in Δ6MWD was also seen in ET (Δ72±26 meters) and CO (Δ41±19meters), p<0,05. The EV group also showed higher endurance and lower peak HR at end-exercise than ET at D10 (128±10 vs. 92±8 min and 73±12 vs. 104±25 bpm, respectively; p<0,05). There was a similar reduction in NTproBNP levels but no differences were found in BP, SpO2, RR and blood lactate. Conclusion: Aerobic exercise in AHF was safe, reduced length of hospital stay and need for inotropics at D10. NIV + ET increased exercise endurance with lower cardiovascular stress.


ESC CardioMed ◽  
2018 ◽  
pp. 2663-2665
Author(s):  
Rodrigo Modolo ◽  
Ana Paula de Faria

Hypertension and chronic heart failure are clinical conditions that greatly impact perioperative adverse outcomes of patients undergoing non-cardiac surgery. Although the first does not have a major impact on morbidity and mortality, it is the most frequent condition present in these patients. The second—chronic heart failure—is increasing in prevalence, with the ageing of the population and with the identification of incipient structural cardiac abnormalities, and has a major impact on the perioperative morbidity and mortality. For those reasons, the proper identification of these conditions in the perioperative setting is imperative in order to diminish perioperative adverse events. This chapter summarizes the current indications for identification, assessment of heart function and of cardiac markers, and the therapeutic management of these patients.


2020 ◽  
pp. postgradmedj-2019-137342
Author(s):  
Junyi Zhang ◽  
Shengda Hu ◽  
Yufeng Jiang ◽  
Yafeng Zhou

Trials studying iron administration in patients with chronic heart failure (CHF) and iron deficiency (ID) have sprung up these years but the results remain inconsistent. The aim of this meta-analysis was to comprehensively evaluate the efficacy and safety of iron therapy in patients with CHF and ID. A literature search was conducted across PubMed, Embase, Cochrane Library, OVID and Web of Science up to 31 July 2019 to search for randomised controlled trials (RCT) comparing iron therapy with placebo in CHF with ID, regardless of presence of anaemia. Published studies reporting data of any of the following outcomes were included: all-cause death, cardiovascular hospitalisation, adverse events, New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF), N-terminal pro b-type natriuretic peptide, peak oxygen consumption, 6 min walking test (6MWT) distance and quality of life (QoL) parameters. 15 RCTs with a total of 1627 patients (911 in iron therapy and 716 in control) were included. Iron therapy was demonstrated to reduce the risk of cardiovascular hospitalisation (OR 0.35, 95% CI 0.12 to 0.99, p=0.049), but was ineffective in reducing all-cause death (OR 0.59, 95% CI 0.33 to 1.06, p=0.078) or cardiovascular death (OR 0.80, 95% CI 0.39 to 1.63, p=0.540). Iron therapy resulted in a reduction in NYHA class (mean difference (MD) −0.73, 95% CI −0.99 to −0.47, p<0.001), an increase in LVEF (MD +4.35, 95% CI 0.69 to 8.00, p=0.020), 6MWT distance (MD +35.44, 95% CI 11.55 to 59.33, p=0.004) and an improvement in QoL: EQ-5D score (MD +4.07, 95% CI 0.84 to 7.31, p=0.014); Minnesota Living With Heart Failure Questionnaire score (MD −19.47, 95% CI −23.36 to −15.59, p<0.001) and Patients Global Assessment (PGA) scale (MD 0.71, 95% CI 0.32 to 1.10, p<0.001). There was no significant difference in adverse events or serious adverse events between iron treatment group and control group. Iron therapy reduces cardiovascular hospitalisation in patients with CHF with ID, and additionally improves cardiac function, exercise capacity and QoL in patients with CHF with ID and anaemia, without an increase of adverse events.


2020 ◽  
Vol 54 (5) ◽  
pp. 294-299 ◽  
Author(s):  
Rasmus Stilling Tougaard ◽  
Anders Jorsal ◽  
Lise Tarnow ◽  
Nils Henrik Hansson ◽  
Caroline Kistorp ◽  
...  

Angiology ◽  
1989 ◽  
Vol 40 (4_part_2) ◽  
pp. 405-415 ◽  
Author(s):  
G.J. Frank ◽  
L.E. Knapp ◽  
R.W. McLain ◽  
Graham J. Frank

A comprehensive analysis of the reporting of adverse events, with drawals due to adverse events, and serious adverse events has been con ducted on 2,010 patients treated with quinapril hydrochloride. An analysis of all events (from both double-blind and open label studies combined) showed no increase in the incidence of events reported in congestive heart failure (CHF) patients compared to hypertensive patients. When the data for all studies were combined, an age analysis showed no increase in the total reporting of ad verse events in the 379 elderly pa tients studied. The incidence of events was lower in those patients who did not take concomitant di uretic therapy. A comparison of the double-blind phases showed quinapril to have a lower incidence of adverse events than captopril, enalapril, or chlor thalidone. An analysis of the onset of events, or withrawals, did not show an increase with time on quinapril therapy, and no dose-relationship. A review of serious adverse events did not reveal an unexpected occurrence or a high incidence of serious events considered to be related to quinapril therapy. The proportion of patients who experienced "first-dose" hypo tension, or symptomatic hypotension was similar to captopril or enalapril. Quinapril, a nonsulfhydryl ACE inhibitor, has been extensively stud ied and is equally well tolerated in the young and elderly for the treatment of hypertension and CHF.


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