0
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Flecainide is well-tolerated and effective in patient with atrial fibrillation at 12 months: a retrospective study

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Introduction:

          Current atrial fibrillation (AF) guidelines recommend flecainide as a first-line rhythm control option in patients without structural heart disease. While there is proven efficacy in clinical trials and guideline support, it is hypothesized that flecainide may be underutilized due to negative outcomes in the CAST trial and that adverse effects are less common than previously perceived.

          Methods:

          This retrospective chart review evaluated patients ⩾18 years initiated on flecainide for AF from August 2011 to October 2016 by a cardiology provider at the study site. Exclusion criteria included: <5 days of flecainide therapy, AF due to a reversible cause, and inadequate documentation. The primary outcome was efficacy of flecainide at maintaining symptomatic control at 6 and 12 months. Secondary outcomes included characterization of alterations in rhythm control strategies and documented normal sinus rhythm per electrocardiogram at 6 and 12 months.

          Results:

          Of the 326 patients identified, 144 patients were included. After 6 and 12 months, 102 patients (70.8%) and 89 patients (61.8%) of the 144 were symptomatically controlled. Atenolol use ( p = 0.024), female sex ( p = 0.006), hypertension ( p = 0.040), and dronedarone failure ( p = 0.012) were associated with flecainide discontinuation at 6 months. At 12 months, only previous propafenone failure ( p = 0.032) was significant. Of the 144 patients, 16 (11.1%) reported adverse effects with dizziness, hot flashes, bradycardia, and headache (1.4% each) being the most common.

          Conclusion:

          Flecainide is a well-tolerated medication, even at 12 months, with very minor adverse effects. These results support the utility of flecainide in guideline recommended patient populations.

          Related collections

          Most cited references9

          • Record: found
          • Abstract: found
          • Article: not found

          Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide

          Purpose The therapeutic index (TI) is the range of doses at which a medication is effective without unacceptable adverse events. Drugs with a narrow TI (NTIDs) have a narrow window between their effective doses and those at which they produce adverse toxic effects. Generic drugs may be substituted for brand-name drugs provided that they meet the recommended bioequivalence (BE) limits. However, an appropriate range of BE for NTIDs is essential to define due to the potential for ineffectiveness or adverse events. Flecainide is an antiarrhythmic agent that has the potential to be considered an NTID. This review aims to evaluate the literature surrounding guidelines on generic substitution for NTIDs and to evaluate the evidence for flecainide to be considered an NTID. Methods A review of recommendations from various regulatory authorities regarding BE and NTIDs, and publications regarding the NTID characteristics of flecainide, was carried out. Results Regulatory authorities generally recommend reduced BE limits for NTIDs. Some, but not all, regulatory authorities specify flecainide as an NTID. The literature review demonstrated that flecainide displays NTID characteristics including a steep drug dose–response relationship for safety and efficacy, a need for therapeutic drug monitoring of pharmacokinetic (PK) or pharmacodynamics measures and intra-subject variability in its PK properties. Conclusions There is much evidence for flecainide to be considered an NTID based on both preclinical and clinical data. A clear understanding of the potential of proarrhythmic effects or lack of efficacy, careful patient selection and regular monitoring are essential for the safe and rational administration of flecainide. Electronic supplementary material The online version of this article (doi:10.1007/s00228-015-1832-0) contains supplementary material, which is available to authorized users.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Atenolol in hypertension: is it a wise choice?

            Atenolol is one of the most widely used beta blockers clinically, and has often been used as a reference drug in randomised controlled trials of hypertension. However, questions have been raised about atenolol as the best reference drug for comparisons with other antihypertensives. Thus, our aim was to systematically review the effect of atenolol on cardiovascular morbidity and mortality in hypertensive patients. Reports were identified through searches of The Cochrane Library, MEDLINE, relevant textbooks, and by personal communication with established researchers in hypertension. Randomised controlled trials that assessed the effect of atenolol on cardiovascular morbidity or mortality in patients with primary hypertension were included. We identified four studies that compared atenolol with placebo or no treatment, and five that compared atenolol with other antihypertensive drugs. Despite major differences in blood pressure lowering, there were no outcome differences between atenolol and placebo in the four studies, comprising 6825 patients, who were followed up for a mean of 4.6 years on all-cause mortality (relative risk 1.01 [95% CI 0.89-1.15]), cardiovascular mortality (0.99 [0.83-1.18]), or myocardial infarction (0.99 [0.83-1.19]). The risk of stroke, however, tended to be lower in the atenolol than in the placebo group (0.85 [0.72-1.01]). When atenolol was compared with other antihypertensives, there were no major differences in blood pressure lowering between the treatment arms. Our meta-analysis showed a significantly higher mortality (1.13 [1.02-1.25]) with atenolol treatment than with other active treatment, in the five studies comprising 17671 patients who were followed up for a mean of 4.6 years. Moreover, cardiovascular mortality also tended to be higher with atenolol treatment than with other antihypertensive treatment. Stroke was also more frequent with atenolol treatment. Our results cast doubts on atenolol as a suitable drug for hypertensive patients. Moreover, they challenge the use of atenolol as a reference drug in outcome trials in hypertension.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              Twenty-five years in the making: flecainide is safe and effective for the management of atrial fibrillation

              Atrial fibrillation (AF) is the most common arrhythmia in clinical practise and its prevalence is increasing. Over the last 25 years, flecainide has been used extensively worldwide, and its capacity to reduce AF symptoms and provide long-term restoration of sinus rhythm (SR) has been well documented. The increased mortality seen in patients treated with flecainide in the Cardiac Arrhythmia Suppression Trial (CAST) study, published in 1991, still deters many clinicians from using flecainide, denying many new AF patients a valuable treatment option. There is now a body of evidence that clearly demonstrates that flecainide has a favourable safety profile in AF patients without significant left ventricular disease or coronary heart disease. As a result of this evidence, flecainide is now recommended as one of the first-line treatment options for restoring and maintaining SR in patients with AF under current treatment guidelines. The objective of this article is to review the literature pertaining to the pharmacological characteristics, safety and efficacy of flecainide, and to place this drug in the context of current therapeutic management strategies for AF.
                Bookmark

                Author and article information

                Contributors
                Journal
                Ther Adv Cardiovasc Dis
                Ther Adv Cardiovasc Dis
                TAK
                sptak
                Therapeutic Advances in Cardiovascular Disease
                SAGE Publications (Sage UK: London, England )
                1753-9447
                1753-9455
                7 July 2020
                2020
                : 14
                : 1753944720926824
                Affiliations
                [1-1753944720926824]North Kansas City Hospital, Kansas City, MO, USA
                [2-1753944720926824]St. Louis College of Pharmacy, St. Louis, MO, USA
                [3-1753944720926824]Electrophysiology Laboratory, The Arrhythmia Center at Missouri Baptist Medical Center (study institution), St. Louis, MO, USA
                [4-1753944720926824]Cardiology, BJC Medical Group Cardiology (study institution), St. Louis, MO, USA
                [5-1753944720926824]St. Louis College of Pharmacy, 4588 Parkview Place, St. Louis, MO 63110 USA
                Author notes
                Author information
                https://orcid.org/0000-0003-0980-9888
                https://orcid.org/0000-0002-1516-4118
                Article
                10.1177_1753944720926824
                10.1177/1753944720926824
                7343357
                32633682
                41da1041-701b-4c63-b1cf-0beb64036c66
                © The Author(s), 2020

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 26 March 2019
                : 24 April 2020
                Categories
                Original Research
                Custom metadata
                January-December 2020
                ts1

                Cardiovascular Medicine
                antiarrhythmics,atrial fibrillation,flecainide,symptomatic control
                Cardiovascular Medicine
                antiarrhythmics, atrial fibrillation, flecainide, symptomatic control

                Comments

                Comment on this article