5.4 out of 10 from a total of More randomized clinical trials assessing the clinical effects of digoxin are needed, especially considering that our results indicate that digoxin might increase the risk of serious adverse events. Women's health is once again the center of a political ping-pong match with evidence-based science on one side and anti-choice advocates on the other. Oral quinidine (Quinaglute) also may be used for the acute termination of atrial fibrillation. When we deal with harms, it should be considered if we need the same statistical backing as if we were dealing with benefits [107]. Calcium channel blockers . It works very well, and it's used all over the world. Forest plot of the comparison of trials with participants with heart failure to trials without participants with heart failure for serious adverse events. S22 Fig. In the last two decades, several studies have correlated therapeutic use of digoxin with increased mortality. They are used to slow the heart rate in patients with AFib and to reduce the strength of the muscle cell's contraction. See also: digoxin side effects in more detail. S4 Table. 23 trials reported length of follow-up. Increasing the force of heart contractions: Digoxin inhibits certain pumps in the cardiac cell membranes, reducing the movement of sodium from the inside of cells to the outside of cells. What can we learn from the study by Whitbeck et al.12 and whatif anyis the place of digoxin in AF patients with or without HF? S17 Fig. Bias risk assessment of each included trial. To treat this, you'll need to. Beta blockers and calcium antagonists might reduce the heart rate more effectively than digoxin, but the clinical benefit of this is not known. Examples are: Diltiazem (Cardizem, Dilacor) Verapamil (Calan, Calan SR, Covera . Digoxin may increase the risk of a serious adverse event, but no firm evidence was available. Meta-analysis on serious adverse events suggested that digoxin might have a harmful effect. 17 ratings on Drugs.com. Forest plot of digoxin versus beta blockers on conversion to sinus rhythm within 6 hours of treatment onset. Meta-analysis on acute conversion to sinus rhythm showed that digoxin compared with amiodarone reduced the probability of converting atrial fibrillation to sinus rhythm, but TSA showed that we lacked information (RR, 0.54; TSA-adjusted CI, 0.13 to 2.21; I2 = 0%). Digoxin has two major mechanisms of action that can help in the treatment of heart failure or atrial fibrillation: 1. Meta-analyses on acute heart rate control showed that digoxin was inferior compared with both calcium antagonists (MD, 21.0 bpm; TSA-adjusted CI, -30.3 to 72.3) and with amiodarone (MD, 14.7 bpm; TSA-adjusted CI, -0.58 to 30.0; I2 = 42%), but in both comparisons TSAs showed that we lacked information. Although observational data suggest that its use is associated with an increased mortality in AF patients with or without HF, its effect becomes neutral when differences in baseline characteristics are taken into account.11. Our analyses showed that digoxin was more effective in controlling the heart rate 6 to 24 hours after treatment onset than within 6 hours of treatment onset. Risk prediction in patients with diabetes: is SCORE 2D the perfect solution? Forest plot of worst-best case scenario for stroke. Generally, first-line therapy for the management of Therefore, digoxin in patients with HF may still have a place, not as an inotropic drug, because for these drugs paradise is lost,20 but as a neurohormonal modulator, when given in low doses. Forest plot of worst-best case scenario of digoxin versus beta blockers on heart rate control 6 to 24 hours after treatment onset. S3 Text. Trial Sequential Analysis (TSA) of digoxin versus placebo on heart rate control within 6 hours of treatment onset showed that the Z-curve (the blue line) crossed the upper trial sequential monitoring boundary for benefit (the upper red line). The investigators used three different ways to examine the effect of digoxin on mortality, but all have significant limitations, as acknowledged by the authors, and, thus, conclusions are subject to significant uncertainty.15 The second, and probably even more important issue is that patients in AFFIRM were receiving high doses of digoxin, since they were encouraged to have an SDC 1.0 ng/mL. Furthermore, we have not identified any previous systematic review of randomized clinical trials comparing digoxin versus placebo, no intervention, or other medical interventions in patients with atrial fibrillation and atrial flutter. The search strategy can be found in the supplementary material (S3 Text). In the past, it was assumed that the beneficial effect of digoxin in HF was due to its (positive) inotropic properties, which were more pronounced at higher doses of the drug.1,5 However, a large number of studies in patients with HF has shown that positive inotropic drugs lead to an unfavourable effect on outcome, and these drugs are now contraindicated in patients with (chronic) HF. Goals of therapy with the use of these drugs include a reduction in the frequency and duration of episodes of arrhythmia as well an emerging goal of reducing mortality and hospitalizations associated with AF. According to the protocol, we would use the trial results reported within 48 hours after treatment onset. Atrial fibrillation : metoprolol tartrate . Whitbeck et al. S33 Fig. Two different salts are available, metoprolol tartrate and metoprolol We performed TSAs on all meta-analysis results. more Prescription only Search for other works by this author on: University of Alabama, at Birmingham, VA Medical Center, Birmingham, AL, USA, Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA, Contemporary use of digoxin in the management of cardiovascular disorders, on behalf of the ESC Committee for Practice Guidelines, ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Our review also has several limitations. Copyright: 2018 Sethi et al. The long-term effect of digoxin is unclear, as no trials reported long-term follow-up. Given the availability of other alternatives to digoxin for achieving heart rate control, and the limited and conflicting evidence about digoxin and risk of death in atrial fibrillation, we evaluated the independent association between newly initiated digoxin and the risks of death and hospitalization in a large, diverse, community-based cohort . Digoxin has an average rating of View more, Xarelto limits the ability of the blood to clot and is effective at treating or preventing conditions where the risk of blood clotting is high (such as atrial fibrillation, DVT, PE); however, it may In atrial fibrillation, there is still much debate Hypokalaemia, hypomagnesaemia, hypercalcaemia, and hypoxia . More trials at low risk of bias and low risk of random errors assessing the clinical effects of digoxin are needed. In another analysis, in which other cut-off levels were used, a serum SDC of 1.2 was associated with a crude mortality of 48.0%! The increased risk of death found in observational studies might be caused by selection, prescription biases, or due to a longer follow-up [21, 22]. Digoxin is one of the oldest drugs in cardiovascular medicine, and it was traditionally used in patients with atrial fibrillation (AF) and heart failure (HF).1 In the last 20 years, the use of this drug has markedly declined, and in the most recent 2012 European Society of Cardiology (ESC) HF Guidelines,2 it is stated that for patients with HF and a left ventricular ejection fraction (LVEF) 40%, who are in sinus rhythm digoxin may be used. For HF patients with AF, other drugs (in particular beta-blockers) should be preferred,2 since they provide better rate control. We used Trial Sequential Analysis (TSA) to control for random errors by estimating the diversity-adjusted required information size (DARIS) (that is the number of participants needed in a meta-analysis to detect or reject a certain intervention effect) [24, 25, 36, 3948]. Moreover, the amount of heart rate reduction needed to sufficiently limit symptoms and reduce the risk of morbidity and mortality has also not been established. Forest plot of the meta-analysis of digoxin versus beta blockers on heart rate control within 6 hours of treatment onset. Firm evidence for lack of the postulated intervention effect can also be assessed with TSA. PLOS ONE promises fair, rigorous peer review, Three authors (NJS, JF, EEN) independently selected relevant trials, and four authors (NJS, SS, JF, EEN) independently extracted data in pairs using a standardized data extraction sheet and assessed the risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions and Lundh et al. S56 Fig. In heart failure, it is usually only used alongside standard medications. Our results confirm with firm evidence that beta blockers versus digoxin more effectively reduced the heart rate acutely. Our present review is the first systematic review of randomized clinical trials showing that digoxin is superior compared with placebo, but inferior compared with beta blockers in controlling the heart rate acutely. Furthermore, achieving an SDC 1.0 ng/mL should no longer be recommended. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The potential relevance of heart rate control as a surrogate outcome is questionable. Although the findings of Whitbeck et al.12 are important and intriguing, there are two major issues that need to be discussed, which may cause serious concern. Our literature search identified a total of 17 003 references. We screened 17 003 records and included 32 publications of 28 trials in this systematic review. We used the trial results reported at maximal follow-up for all outcomes, except for heart rate control and conversion to sinus rhythm. Characteristics of each included, excluded, and ongoing study. We conducted this systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA) (S1 Text) [23], and the updated Cochrane methodology used in this systematic review is described in detail in our protocol (S2 Text) [2426], which was registered prior to the systematic literature search. There was no incomplete outcome data. Digoxin is one of the oldest drugs in cardiovascular medicine, and it was traditionally used in patients with atrial fibrillation (AF) and heart failure (HF). S43 Fig. For the latter outcomes, we used the trial results reported at two different time ranges (within 6 hours of treatment onset, and 6 to 24 hours after treatment onset). However, none of these effects of digoxin have been confirmed in placebo controlled studies. The premium product BATCH gummies is full-spectrum, vegan-friendly, and made with solely natural components. Our analyses on acute heart rate control (within 6 hours of treatment onset) showed firm evidence of digoxin being superior compared with placebo (mean difference (MD), -12.0 beats per minute (bpm); TSA-adjusted CI, -17.2 to -6.76; I2 = 0%) and inferior compared with beta blockers (MD, 20.7 bpm; TSA-adjusted CI, 14.2 to 27.2; I2 = 0%). Trial sequential analysis of digoxin versus beta blockers on heart rate control 6 to 24 hours after treatment onset. (digoxin) Ventricular rate control in atrial fibrillation or atrial flutter: 0.125 to 0.25 mg once daily: Digitek coupons: Digox (digoxin) Ventricular rate control in atrial fibrillation or atrial flutter: 0.125 to 0.25 mg once . Meta-analysis 6 to 24 hours after treatment onset showed evidence of a difference, but TSA showed that there was not enough information to confirm or reject a MD of 7.73 bpm (MD, 11.7 bpm; TSA-adjusted CI, -9.86 to 33.3; P = 0.006; I2 = 0%; 52 participants; 2 trials; very low quality of evidence; S39 and S40 Figs). We have reported the baseline characteristics of the participants in Table 1. The planned subgroup analyses of all-cause mortality (S17S20 Figs) and serious adverse events (S21S24 Figs) showed no significant differences. Forest plot of digoxin versus amiodarone on conversion to sinus rhythm 6 to 24 hours after treatment onset. Forest plot of worst-best case scenario of digoxin versus amiodarone on heart rate control 6 to 24 hours after treatment onset. These are another type of blood pressure medicine. However, such studies have po Forest plot of worst-best case scenario of digoxin versus beta blockers on heart rate control within 6 hours of treatment onset. Alternative drugs used to treat atrial fibrillation include beta-blockers, calcium-channel blockers and anti-arrhythmic medications. See also: Xarelto side effects in more detail. Hence, we have enough information to confirm that digoxin is superior compared with placebo in controlling the heart rate within 6 hours of treatment onset. Trial sequential analysis of digoxin versus calcium antagonists on conversion to sinus rhythm within 6 hours of treatment onset. S72 Fig. S12 Fig. 5.8 out of 10 from a total of Forest plot of best-worst case scenario of digoxin versus amiodarone on conversion to sinus rhythm 6 to 24 hours after treatment onset. We performed both random-effects (DerSimonian-Laird model) and fixed-effect meta-analyses with the Mantel-Haenszel method and chose the most conservative result as our primary result [36]. Data Availability: All relevant data are within the paper and its Supporting Information files. Our analyses showed no evidence of a difference between the digoxin versus the control group on AF-SFS (MD, 0.98 points; TSA-adjusted CI, -1.45 to 3.41; P = 0.43; I2 = 0%; 166 participants; 2 trials; very low quality of evidence; S25 and S26 Figs), AF-SSS (MD, -0.24 points; TSA-adjusted CI, -7.95 to 7.47; P = 0.88, I2 = 60%; 166 participants; 2 trials; very low quality of evidence; S27 and S28 Figs), SF-36 PCS (MD, 0.00 points; TSA-adjusted CI, -84.7 to 84.7; P = 1.00; 16 participants; 1 trial; very low quality of evidence; S29 and S30 Figs), and SF-36 MCS (MD, -5.00 points; TSA-adjusted CI, -94.8 to 84.8; P = 0.66; 16 participants; 1 trial; very low quality of evidence; S31 and S32 Figs). Sick sinus syndrome. The clinical effects of digoxin on all-cause mortality, serious adverse events, quality of life, heart failure, and stroke are unclear based on current evidence. S32 Fig. Meta-analysis on heart rate control in all patients regardless of type of rhythm supported these findings (S4 Table). Another limitation of our present review is the use of a composite outcome such as serious adverse events. The tour begins on Aug. 3 in Sterling . Introduction. Atrial fibrillation (AF) is the most common arrhythmia worldwide, affecting an estimated 33.5 million adults. All trials included participants with atrial fibrillation and two trials included both participants with atrial fibrillation and atrial flutter [72, 85]. Digitalis has been widely used in the treatment of cardiac disease for more than 200 years. These data together therefore question the influence of the effect of lowering heart rate on outcome in patients with AF (with or without HF). Digoxin was also associated with cardiovascular mortality and arrhythmic mortality. Search strategy for MEDLINE (OVIDSP; 1946 to October 2016). Our analyses showed no evidence of a difference on heart rate control 6 to 24 hours after treatment onset (MD, 17.0 bpm; TSA-adjusted CI, -63.6 to 97.6; P = 0.09; 23 participants; 1 trial; very low quality of evidence; S55 and S56 Figs), conversion to sinus rhythm within 6 hours of treatment onset (RR, 0.82; TSA-adjusted CI, 0.01 to 59.3; P = 0.72; I2 = 46%; 122 participants; 4 trials; very low quality of evidence; S57 and S58 Figs), and conversion to sinus rhythm 6 to 24 hours after treatment onset (RR, 0.82; TSA-adjusted CI, 0.16 to 4.07; P = 0.32; I2 = 40%; 156 participants; 3 trials; very low quality of evidence; S59 and S60 Figs). It is used to improve the strength and efficiency of the heart, or to control the rate and rhythm of the heartbeat. S65 Fig. Forest plot of digoxin versus amiodarone on conversion to sinus rhythm within 6 hours of treatment onset. When digoxin was compared with all control interventions in one analysis, our analyses on all-cause mortality (RR, 0.82; TSA-adjusted CI, 0.02 to 31.2; P = 0.67; I2 = 0%; 522 participants; 6 trials; very low quality of evidence; S2 and S3 Figs), heart failure (RR, 1.05; TSA-adjusted CI, 0.00 to 1141.8; P = 0.96; I2 = 51%; 462 participants; 4 trials; very low quality of evidence; S4 and S5 Figs), and stroke (RR, 2.27; TSA-adjusted CI, 0.00 to 7887.3; P = 0.42; I2 = 17%; 325 participants; 3 trials; very low quality of evidence; S6 and S7 Figs) showed no evidence of a difference between the digoxin versus the control group. Our primary outcomes were all-cause mortality, serious adverse events (as defined by the ICH guidelines) [34], and quality of life. Propranolol. Forest plot of best-worst case scenario of digoxin versus amiodarone on conversion to sinus rhythm within 6 hours of treatment onset. Forest plot of digoxin versus calcium antagonists on heart rate control within 6 hours of treatment onset. Forest plot of best-worst case scenario of digoxin versus calcium antagonists on conversion to sinus rhythm within 6 hours of treatment onset. Sanam Safi, Digoxin: a neurohormonal modulator in heart failure? Baseline characteristics of the participants. Specific types of serious adverse events in each trial comparison. Interestingly, a randomized clinical trial, RACE II, compared lenient rate control (<110 bpm at rest) with strict rate control (<80 bpm at rest) and showed that lenient rate control was as effective as strict rate control, easier to achieve, and required fewer outpatient visits and examinations [110]. Meta-analysis on heart rate control in all patients regardless of type of rhythm supported these findings (S4 Table). Our review has several strengths. Emil E. Nielsen, This is contrary to our results, as we showed no evidence of a difference between digoxin and the control group based on current randomized evidence, which generally is more dependable [22]. We were able to include 28 randomized clinical trials reported in 32 publications with 37 comparisons including a total of 2223 participants (Fig 1) [5485]. Current guidelines recommend that beta blockers and calcium antagonists should be preferred over digoxin for acute rate control in patients with normal ejection fraction [12, 112, 113]. Try searching the Price Guide directly. Furthermore, the trials that were included in our review generally randomized a small number of participants and had short follow-up periods which limits the usefulness of the results (see S2 Table). Low-dose digoxin in patients with heart failure: less toxic and at least as effective? Trial sequential analysis of SF-36 MCS. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. S40 Fig. Department of Cardiology, Holbk Hospital, Holbk, Denmark. Forest plot of the comparison of trials with different age of participants for serious adverse events. S50 Fig. With regard to the place of digoxin in AF, it is likely that this will further diminish in the future, because of its inefficacy to reduce heart rate during exercise on the one hand, and the outcome of studies such as the study of Whitbeck et al.,12 albeit that it was a post hoc study and non-randomized, on the other hand. S68 Fig. The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, Affiliations: Forest plot of the comparison of different types of control interventions for serious adverse events. Effect of Digoxin vs Bisoprolol for Heart Rate Control in Atrial Fibrillation on Patient-Reported Quality of Life: The RATE-AF Randomized Clinical Trial | Atrial Fibrillation | JAMA | JAMA Network Developed in collaboration with the Heart Failure Association (HFA) of the ESC, The effect of digoxin on mortality and morbidity in patients with heart failure, on behalf of the ESC Guidelines for the management of atrial fibrillation of the European Society of Cardiology (ESC), Guidelines for the management of atrial fibrillation. Verapamil ( Calan, Calan SR, Covera arrhythmic mortality subgroup analyses of all-cause mortality S17S20. Harmful effect include beta-blockers, calcium-channel blockers and calcium antagonists on conversion to sinus rhythm within 6 of! 003 references than digoxin, but the clinical effects of digoxin versus beta blockers conversion! ( S4 Table ) follow-up for all outcomes, except for heart rate control 6 24! 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