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BMJ Clinical Evidence May 2015Atrial fibrillation is a supraventricular tachyarrhythmia characterised by the presence of fast and uncoordinated atrial activation leading to reduced atrial mechanical... (Review)
Review
INTRODUCTION
Atrial fibrillation is a supraventricular tachyarrhythmia characterised by the presence of fast and uncoordinated atrial activation leading to reduced atrial mechanical function. Risk factors for atrial fibrillation include increasing age, male sex, co-existing cardiac and thyroid disease, pyrexial illness, electrolyte imbalance, cancer, and co-existing infection.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of oral medical treatments to control heart rate in people with chronic (defined as longer than 1 week for this review) non-valvular atrial fibrillation? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found four studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: beta-blockers (rate-limiting, with or without digoxin), calcium-channel blockers (with or without digoxin), and digoxin.
Topics: Adrenergic beta-Antagonists; Atrial Fibrillation; Digoxin; Drug Therapy, Combination; Humans; Treatment Outcome
PubMed: 25994013
DOI: No ID Found -
European Heart Journal Jul 2015There are conflicting data regarding the effect of digoxin use on mortality in patients with atrial fibrillation (AF) or with congestive heart failure (CHF). The aim of... (Meta-Analysis)
Meta-Analysis Review
There are conflicting data regarding the effect of digoxin use on mortality in patients with atrial fibrillation (AF) or with congestive heart failure (CHF). The aim of this meta-analysis was to provide detailed analysis of the currently available study reports. We performed a MEDLINE and a COCHRANE search (1993-2014) of the English literature dealing with the effects of digoxin on all-cause-mortality in subjects with AF or CHF. Only full-sized articles published in peer-reviewed journals were considered for this meta-analysis. A total of 19 reports were identified. Nine reports dealt with AF patients, seven with patients suffering from CHF, and three with both clinical conditions. Based on the analysis of adjusted mortality results of all 19 studies comprising 326 426 patients, digoxin use was associated with an increased relative risk of all-cause mortality [Hazard ratio (HR) 1.21, 95% confidence interval (CI), 1.07 to 1.38, P < 0.01]. Compared with subjects not receiving glycosides, digoxin was associated with a 29% increased mortality risk (HR 1.29; 95% CI, 1.21 to 1.39) in the subgroup of publications comprising 235 047 AF patients. Among 91.379 heart failure patients, digoxin-associated mortality risk increased by 14% (HR 1.14, 95% CI, 1.06 to 1.22). The present systematic review and meta-analysis of all available data sources suggest that digoxin use is associated with an increased mortality risk, particularly among patients suffering from AF.
Topics: Anti-Arrhythmia Agents; Atrial Fibrillation; Digoxin; Epidemiologic Methods; Heart Failure; Humans
PubMed: 25939649
DOI: 10.1093/eurheartj/ehv143 -
BMJ Clinical Evidence Nov 2014Acute atrial fibrillation is rapid, irregular, and chaotic atrial activity of recent onset. Various definitions of acute atrial fibrillation have been used in the... (Review)
Review
INTRODUCTION
Acute atrial fibrillation is rapid, irregular, and chaotic atrial activity of recent onset. Various definitions of acute atrial fibrillation have been used in the literature, but for the purposes of this review we have included studies where atrial fibrillation may have occurred up to 7 days previously. Risk factors for acute atrial fibrillation include increasing age, cardiovascular disease, alcohol, diabetes, and lung disease. Acute atrial fibrillation increases the risk of stroke and heart failure. The condition resolves spontaneously within 24 to 48 hours in more than 50% of people; however, many people will require interventions to control heart rate or restore sinus rhythm.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent embolism, for conversion to sinus rhythm, and to control heart rate in people with recent-onset atrial fibrillation (within 7 days) who are haemodynamically stable? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 26 studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: amiodarone, antithrombotic treatment before cardioversion, atenolol, bisoprolol, carvedilol, digoxin, diltiazem, direct current cardioversion, flecainide, metoprolol, nebivolol, propafenone, sotalol, timolol, and verapamil.
Topics: Acute Disease; Anti-Arrhythmia Agents; Atrial Fibrillation; Electric Countershock; Humans; Safety
PubMed: 25430048
DOI: No ID Found -
Clinical Toxicology (Philadelphia, Pa.) Nov 2014Calcium channel blocker poisoning is a common and sometimes life-threatening ingestion. (Review)
Review
CONTEXT
Calcium channel blocker poisoning is a common and sometimes life-threatening ingestion.
OBJECTIVE
To evaluate the reported effects of treatments for calcium channel blocker poisoning. The primary outcomes of interest were mortality and hemodynamic parameters. The secondary outcomes included length of stay in hospital, length of stay in intensive care unit, duration of vasopressor use, functional outcomes, and serum calcium channel blocker concentrations.
METHODS
Medline/Ovid, PubMed, EMBASE, Cochrane Library, TOXLINE, International pharmaceutical abstracts, Google Scholar, and the gray literature up to December 31, 2013 were searched without time restriction to identify all types of studies that examined effects of various treatments for calcium channel blocker poisoning for the outcomes of interest. The search strategy included the following Keywords: [calcium channel blockers OR calcium channel antagonist OR calcium channel blocking agent OR (amlodipine or bencyclane or bepridil or cinnarizine or felodipine or fendiline or flunarizine or gallopamil or isradipine or lidoflazine or mibefradil or nicardipine or nifedipine or nimodipine or nisoldipine or nitrendipine or prenylamine or verapamil or diltiazem)] AND [overdose OR medication errors OR poisoning OR intoxication OR toxicity OR adverse effect]. Two reviewers independently selected studies and a group of reviewers abstracted all relevant data using a pilot-tested form. A second group analyzed the risk of bias and overall quality using the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) checklist and the Thomas tool for observational studies, the Institute of Health Economics tool for Quality of Case Series, the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines, and the modified NRCNA (National Research Council for the National Academies) list for animal studies. Qualitative synthesis was used to summarize the evidence. Of 15,577 citations identified in the initial search, 216 were selected for analysis, including 117 case reports. The kappa on the quality analysis tools was greater than 0.80 for all study types.
RESULTS
The only observational study in humans examined high-dose insulin and extracorporeal life support. The risk of bias across studies was high for all interventions and moderate to high for extracorporeal life support. High-dose insulin. High-dose insulin (bolus of 1 unit/kg followed by an infusion of 0.5-2.0 units/kg/h) was associated with improved hemodynamic parameters and lower mortality, at the risks of hypoglycemia and hypokalemia (low quality of evidence). Extracorporeal life support. Extracorporeal life support was associated with improved survival in patients with severe shock or cardiac arrest at the cost of limb ischemia, thrombosis, and bleeding (low quality of evidence). Calcium, dopamine, and norepinephrine. These agents improved hemodynamic parameters and survival without documented severe side effects (very low quality of evidence). 4-Aminopyridine. Use of 4-aminopyridine was associated with improved hemodynamic parameters and survival in animal studies, at the risk of seizures. Lipid emulsion therapy. Lipid emulsion was associated with improved hemodynamic parameters and survival in animal models of intravenous verapamil poisoning, but not in models of oral verapamil poisoning. Other studies. Studies on decontamination, atropine, glucagon, pacemakers, levosimendan, and plasma exchange reported variable results, and the methodologies used limit their interpretation. No trial was documented in humans poisoned with calcium channel blockers for Bay K8644, CGP 28932, digoxin, cyclodextrin, liposomes, bicarbonate, carnitine, fructose 1,6-diphosphate, PK 11195, or triiodothyronine. Case reports were only found for charcoal hemoperfusion, dialysis, intra-aortic balloon pump, Impella device and methylene blue.
CONCLUSIONS
The treatment for calcium channel blocker poisoning is supported by low-quality evidence drawn from a heterogeneous and heavily biased literature. High-dose insulin and extracorporeal life support were the interventions supported by the strongest evidence, although the evidence is of low quality.
Topics: Animals; Calcium Channel Blockers; Disease Models, Animal; Dose-Response Relationship, Drug; Drug Overdose; Guidelines as Topic; Hospitalization; Humans; Insulin; Length of Stay; Observational Studies as Topic; Treatment Outcome; Vasoconstrictor Agents
PubMed: 25283255
DOI: 10.3109/15563650.2014.965827 -
Journal of Cardiac Failure Jul 2014Heart failure (HF) therapy involves use of multiple medications. There is little guidance on the safety and impact on clinical outcomes of stopping HF medications. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Heart failure (HF) therapy involves use of multiple medications. There is little guidance on the safety and impact on clinical outcomes of stopping HF medications.
METHODS AND RESULTS
A comprehensive systematic search for studies of drug therapy withdrawal in HF was performed. Meta-analysis of the risk ratio (RR) was performed with the use of the Mantel-Haenszel random effects model for all-cause mortality and cardiovascular outcomes. Twenty-six studies met the inclusion criteria. Studies on withdrawal of renin-angiotensin-aldosterone system (RAAS) inhibitors and beta-blockers in HF are scarce and small, yet show relatively convincingly that such withdrawals have untoward effects on cardiac structure, symptoms, and major outcomes. Meta-analysis of 7 studies of digoxin withdrawal (2,987 participants) without background beta-blocker showed increased HF hospitalizations (RR 1.30, 95% confidence interval [CI] 1.16-1.46; P < .0001), but no impact on all-cause mortality (RR 1.00, 95% CI 0.90-1.12; P = .06) nor reduction in all-cause hospitalization (RR 1.03, 95% CI 0.98-1.09; P = .27). Diuretic withdrawal trials demonstrated an ongoing need for these agents in chronic HF. Studies in peripartum cardiomyopathy showed that medications could be successfully withdrawn after recovery.
CONCLUSION
Current evidence discourages any attempt to discontinue RAAS inhibitors or beta-blockers in patients with stable HF, regardless of clinical and/or echocardiographic status. Formal withdrawal trials of other classes are needed.
Topics: Cardiovascular Agents; Chronic Disease; Heart Failure; Humans; Randomized Controlled Trials as Topic; Substance Withdrawal Syndrome
PubMed: 24747201
DOI: 10.1016/j.cardfail.2014.04.013 -
European Journal of Clinical... Jun 2014A medication error (ME) is an error that causes damage or poses a threat of harm to a patient. Several studies have shown that only a minority of MEs actually causes... (Review)
Review
PURPOSE
A medication error (ME) is an error that causes damage or poses a threat of harm to a patient. Several studies have shown that only a minority of MEs actually causes harm, and this might explain why medication reviews at hospital admission reduce the number of MEs without showing an effect on length of hospital stay, readmissions, or death. The purpose of this study was to define drugs that actually cause serious MEs. We conducted a literature search of medication reviews and other preventive efforts.
METHODS
A systematic search in PubMed, Embase, Cochrane Reviews, Psycinfo, and SweMed+ was performed. Danish databases containing published patient complaints, patient compensation, and reported medication errors were also searched. Articles and case reports were included if they contained information of an ME causing a serious adverse reaction (AR) in a patient. Information concerning AR seriousness, causality, and preventability was required for inclusion.
RESULTS
This systematic literature review revealed that 47 % of all serious MEs were caused by seven drugs or drug classes: methotrexate, warfarin, nonsteroidal anti-inflammatory drugs (NSAIDS), digoxin, opioids, acetylic salicylic acid, and beta-blockers; 30 drugs or drug classes caused 82 % of all serious MEs. The top ten drugs involved in fatal events accounted for 73 % of all drugs identified.
CONCLUSION
Increasing focus on seven drugs/drug classes can potentially reduce hospitalizations, extended hospitalizations, disability, life-threatening conditions, and death by almost 50 %.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Hospitalization; Humans; Medication Errors; Pharmaceutical Preparations
PubMed: 24671697
DOI: 10.1007/s00228-014-1668-z -
Journal of the Saudi Heart Association Oct 2012Atrial fibrillation (AF) is a major global public health problem. Observational studies are necessary to understand patient characteristics, management, and outcomes of... (Review)
Review
BACKGROUND
Atrial fibrillation (AF) is a major global public health problem. Observational studies are necessary to understand patient characteristics, management, and outcomes of this common arrhythmia. Accordingly, our objective was to describe the current status of published prospective observational studies of AF.
METHODS AND RESULTS
MEDLINE and EMBASE (to June 2012) and reference lists of eligible studies were searched for English-language prospective observational registries of AF (n ⩾ 100 and follow-up ⩾6 months). Two reviewers independently extracted data. Disagreements were resolved by consensus. Eight prospective studies enrolled a total of 17,924 patients with AF (total 41,306 patient-years of exposure; follow-up 11 months to 9.9 years). The majority of subjects were enrolled in Europe (74%) or North America (21%), and 0.3% had rheumatic AF. The most consistently reported comorbidities were diabetes mellitus (range 5-18%), hypertension (39-68%), heart failure (5-58%), and prior stroke (4-17%). Three studies did not report all the variables necessary to calculate the currently recommended stroke risk assessment score, and no study reported all the variables required to calculate a recently validated bleeding risk score. The most consistently reported management features were oral anticoagulation (32-64%) and aspirin (28-61%) use. Calcium channel blockers were less frequently used than other rate controlling agents, and digoxin was most common in the single study from Africa (63%). Total mortality was reported in all studies, while data on stroke/systemic embolism, hospitalizations, and major hemorrhage rates were not always reported.
CONCLUSIONS
Current literature on real-world management of AF is relatively limited with inadequate data to allow detailed comparisons among reports. Data on rheumatic AF and from Africa and the developing world in general are sparse.
PubMed: 24174832
DOI: 10.1016/j.jsha.2012.08.001 -
The Cochrane Database of Systematic... Jan 2013Atrial fibrillation is a common post-operative complication of cardiac surgery and is associated with an increased risk of post-operative stroke, increased length of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Atrial fibrillation is a common post-operative complication of cardiac surgery and is associated with an increased risk of post-operative stroke, increased length of intensive care unit and hospital stays, healthcare costs and mortality. Numerous trials have evaluated various pharmacological and non-pharmacological prophylactic interventions for their efficacy in preventing post-operative atrial fibrillation. We conducted an update to a 2004 Cochrane systematic review and meta-analysis of the literature to gain a better understanding of the effectiveness of these interventions.
OBJECTIVES
The primary objective was to assess the effects of pharmacological and non-pharmacological interventions for preventing post-operative atrial fibrillation or supraventricular tachycardia after cardiac surgery. Secondary objectives were to determine the effects on post-operative stroke or cerebrovascular accident, mortality, cardiovascular mortality, length of hospital stay and cost of treatment during the hospital stay.
SEARCH METHODS
We searched the Cochrane Central Register of ControlLed Trials (CENTRAL) (Issue 8, 2011), MEDLINE (from 1946 to July 2011), EMBASE (from 1974 to July 2011) and CINAHL (from 1981 to July 2011).
SELECTION CRITERIA
We selected randomized controlled trials (RCTs) that included adult patients undergoing cardiac surgery who were allocated to pharmacological or non-pharmacological interventions for the prevention of post-operative atrial fibrillation or supraventricular tachycardia, except digoxin, potassium (K(+)), or steroids.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted study data and assessed trial quality.
MAIN RESULTS
One hundred and eighteen studies with 138 treatment groups and 17,364 participants were included in this review. Fifty-seven of these studies were included in the original version of this review while 61 were added, including 27 on interventions that were not considered in the original version. Interventions included amiodarone, beta-blockers, sotalol, magnesium, atrial pacing and posterior pericardiotomy. Each of the studied interventions significantly reduced the rate of post-operative atrial fibrillation after cardiac surgery compared with a control. Beta-blockers (odds ratio (OR) 0.33; 95% confidence interval) CI 0.26 to 0.43; I(2) = 55%) and sotalol (OR 0.34; 95% CI 0.26 to 0.43; I(2) = 3%) appear to have similar efficacy while magnesium's efficacy (OR 0.55; 95% CI 0.41 to 0.73; I(2) = 51%) may be slightly less. Amiodarone (OR 0.43; 95% CI 0.34 to 0.54; I(2) = 63%), atrial pacing (OR 0.47; 95% CI 0.36 to 0.61; I(2) = 50%) and posterior pericardiotomy (OR 0.35; 95% CI 0.18 to 0.67; I(2) = 66%) were all found to be effective. Prophylactic intervention decreased the hospital length of stay by approximately two-thirds of a day and decreased the cost of hospital treatment by roughly $1250 US. Intervention was also found to reduce the odds of post-operative stroke, though this reduction did not reach statistical significance (OR 0.69; 95% CI 0.47 to 1.01; I(2) = 0%). No significant effect on all-cause or cardiovascular mortality was demonstrated.
AUTHORS' CONCLUSIONS
Prophylaxis to prevent atrial fibrillation after cardiac surgery with any of the studied pharmacological or non-pharmacological interventions may be favored because of its reduction in the rate of atrial fibrillation, decrease in the length of stay and cost of hospital treatment and a possible decrease in the rate of stroke. However, this review is limited by the quality of the available data and heterogeneity between the included studies. Selection of appropriate interventions may depend on the individual patient situation and should take into consideration adverse effects and the cost associated with each approach.
Topics: Adrenergic beta-Antagonists; Adult; Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Cardiac Pacing, Artificial; Cardiac Surgical Procedures; Humans; Magnesium Compounds; Pericardiectomy; Randomized Controlled Trials as Topic; Sotalol; Tachycardia, Supraventricular
PubMed: 23440790
DOI: 10.1002/14651858.CD003611.pub3 -
International Journal of Clinical... Nov 2012The use of herbs and dietary supplements (HDS) alone or concomitantly with medications can potentially increase the risk of adverse events experienced by the patients.... (Review)
Review
BACKGROUND AND AIMS
The use of herbs and dietary supplements (HDS) alone or concomitantly with medications can potentially increase the risk of adverse events experienced by the patients. This review aims to evaluate the documented HDS-drug interactions and contraindications.
METHODS
A structured literature review was conducted on PubMed, EMBASE, Cochrane Library, tertiary literature and Internet.
RESULTS
While 85 primary literatures, six books and two web sites were reviewed for a total of 1,491 unique pairs of HDS-drug interactions, 213 HDS entities and 509 medications were involved. HDS products containing St. John's Wort, magnesium, calcium, iron, ginkgo had the greatest number of documented interactions with medications. Warfarin, insulin, aspirin, digoxin, and ticlopidine had the greatest number of reported interactions with HDS. Medications affecting the central nervous system or cardiovascular system had more documented interactions with HDS. Of the 882 HDS-drug interactions being described its mechanism and severity, 42.3% were due to altered pharmacokinetics and 240 were described as major interactions. Of the 152 identified HDS contraindications, the most frequent involved gastrointestinal (16.4%), neurological (14.5%), and renal/genitourinary diseases (12.5%). Flaxseed, echinacea, and yohimbe had the largest number of documented contraindications.
CONCLUSIONS
Although HDS-drug interactions and contraindications primarily concerned a relatively small subset of commonly used medications and HDS entities, this review provides the summary to identify patients, HDS products, and medications that are more susceptible to HDS-drug interactions and contraindications. The findings would facilitate the health-care professionals to communicate these documented interactions and contraindications to their patients and/or caregivers thereby preventing serious adverse events and improving desired therapeutic outcomes.
Topics: Animals; Clinical Trials as Topic; Contraindications; Dietary Supplements; Disease Models, Animal; Herb-Drug Interactions; Humans; Plant Preparations; Rats; Research Design
PubMed: 23067030
DOI: 10.1111/j.1742-1241.2012.03008.x -
Archives of Cardiovascular Diseases Oct 2012Digoxin is highly potent and efficacious for treatment of heart failure (HF) and/or atrial fibrillation (AF) yet compliance is often poor. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Digoxin is highly potent and efficacious for treatment of heart failure (HF) and/or atrial fibrillation (AF) yet compliance is often poor.
AIMS
To examine prevalence rates of non-compliance with digoxin; variations between clinical settings, types of non-compliance and methods of detection; and potential factors influencing non-compliance with digoxin.
METHODS
This was a systematic review and meta-analysis of prospective observational studies of non-compliance with digoxin in patients with HF and/or AF, published in English. The studies were identified through these bibliographic databases: MEDLINE, EMBASE, CINAHL, IPA and Cochrane CENTRAL. Subgroup analysis examined the influence of clinical settings, types of non-compliance and methods of detection.
RESULTS
Ten studies met the inclusion criteria, comprising 1841 patients with HF and/or AF. The corresponding prevalence rates of non-compliance for outpatients, after hospital discharge and inpatients were 43.1% (interquartile range [IQR] 29-48%), 25% (95% confidence interval [CI] 12-37%) and 4.5%, respectively. In patients with HF and AF co-morbidities, the prevalence rate of non-compliance with digoxin was 38.7% (IQR 27-46%); the corresponding prevalence rates of overdosing and underdosing were 33.04% (IQR 22-49%) and 33.8% (95% CI 25-42%), respectively. Rates varied depending on the methods of detecting non-compliance. Regularity of prescribed dose, diuretic use, coronary artery bypass, implantable cardioverter-defibrillator, number of office visits and pill boxes demonstrated strong associations with non-compliance with digoxin.
CONCLUSIONS
Non-compliance with digoxin is prevalent among patients with HF and/or AF. A better understanding of the factors influencing compliance and improved intervention strategies are necessary to increase digoxin compliance.
Topics: Ambulatory Care; Anti-Arrhythmia Agents; Atrial Fibrillation; Cardiotonic Agents; Chi-Square Distribution; Comorbidity; Digoxin; Drug Monitoring; Female; Heart Failure; Humans; Inpatients; Male; Medication Adherence; Risk Factors; Treatment Outcome
PubMed: 23062482
DOI: 10.1016/j.acvd.2012.06.004