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Cardiovascular Drugs during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
No studies are published of human pregnancies exposed to dronedarone. At doses similar to the usual human dose, the drug was associated with an increased rate of birth defects. In rabbits, doses about 50 percent of the usual human therapeutic dose were associated with an increased frequency of birth defects (Manufacturer’s package insert). It is an old FDA pregnancy risk category X drug. The Swedish Birth Defects Registry included only three infants exposed to dronedarone during the first trimester (Kallen, 2019).
Supraventricular tachyarrhythmias in the elderly
Published in Wilbert S. Aronow, Jerome L. Fleg, Michael W. Rich, Tresch and Aronow’s Cardiovascular Disease in the Elderly, 2019
Jason T. Jacobson, Sei Iwai, Ali Ahmed, Wilbert S. Aronow
Dronedarone was found to be effective in treating patients with intermittent AF (69). However, in 3236 patients with permanent AF at risk for major vascular events dronedarone was found to significantly increase rates of CHF (81%), stroke (232%), and cardiovascular death (211%), and should not be used in patients with permanent AF, class IV CHF or unstable class II or III CHF (70,71).
Atrial fibrillation and flutter
Published in Ian Mann, Christopher Critoph, Caroline Coats, Peter Collins, The Junior Doctor’s Guide to Cardiology, 2017
Ian Mann, Christopher Critoph, Caroline Coats, Peter Collins
Drugs that are used to restore sinus rhythm include the following. Amiodarone. This can be an effective drug, but it has several potentially severe side-effects, including photosensitivity reactions, corneal microdeposits, hepatic and thyroid toxicity, and pulmonary fibrosis. These tend to be cumulative and problematic with long-term use. Amiodarone can also cause severe reactions if extravasated, so should be administered with extreme caution if given peripherally. Amiodarone has a very long half-life (> 1 month), so even when it has been discontinued the effects will persist for some time.Dronedarone. This new drug is structurally related to amiodarone, but has a much smaller volume of distribution and a shorter elimination half-life (13-19 hours), has NYHA class I, II, III and IV actions, is a safer alternative than amiodarone for atrial fibrillation/atrial flutter, and is contraindicated in severe or recently decompensated symptomatic heart failure. It is currently being appraised by NICE for use in the UK. Dronedarone should be used as a second-line agent, after beta-blockers.Flecainide. This is a class Ic agent that affects sodium channels. It can be used both intravenously and orally, in acute and chronic AF. However, it should only be used in people with structurally normal hearts, as it can cause life-threatening ventricular arrhythmias. In practice, any patient with a history of any cardiac condition should not receive flecainide without expert advice.Sotalol. This has both class II and III effects. It is used less frequently in current practice.
Pharmacokinetic interaction between dronedarone and ticagrelor following oral administration in rats
Published in Xenobiotica, 2021
Dong Kyun Kim, Soo Yong Chung, Jae-Hwan Kwak, Min-Soo Kim, Christine E. Staatz, Hye Suk Lee, In-Hwan Baek
Dronedarone (N-[2-butyl-3-[4-(3-dibutyl-aminopropoxy) benzoyl] methanesulfonamide) is an antiarrhythmic drug used for rate and rhythm control in atrial fibrillation patients; it was approved by the US Food & Drug Administration (US FDA) and the European Union (EU) in 2009 (Hohnloser et al., 2009; Laughlin & Kowey, 2008). It is a non-iodinated benzofuran derivative of amiodarone; therefore, it retains the pharmacological efficacy of amiodarone and is better tolerated than amiodarone, for which iodine-related adverse reactions have been reported (Kathofer et al., 2005). The American College of Cardiology/American Heart Association and the European Society of Cardiology recommend dronedarone as a Class IA drug for the maintenance of sinus rhythm in atrial fibrillation patients (Camm et al., 2010; January et al., 2014). Dronedarone is particularly useful for paroxysmal or persistent atrial fibrillation (Vamos & Hohnloser, 2016).
Current pharmacotherapeutic strategies for cardiac arrhythmias in heart failure
Published in Expert Opinion on Pharmacotherapy, 2020
Ashish Correa, Yogita Rochlani, Wilbert S. Aronow
Dronedarone is an antiarrhythmic drug, similar to amiodarone, that is frequently used for the rhythm control in AF. However, its use in patients with concomitant HF and AF has proven to be less favorable as shown by the Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease Study (ANDROMEDA) [59]. This trial randomized patients with severe HFrEF and New York Heart Association (NYHA) functional class III or IV to either dronedarone or placebo. The trial had to be stopped early by its data and safety monitoring board due to significantly increased deaths and worsening HF in the dronedarone arm. As such, dronedarone must be used with extreme caution, if at all, in patients with HF, and definitely not in patients with severe HFrEF in whom it is contraindicated.
Emerging pharmacotherapies for the treatment of atrial fibrillation
Published in Expert Opinion on Emerging Drugs, 2018
Alessandro Capucci, Laura Cipolletta, Federico Guerra, Irene Giannini
The efficacy of dronedarone in heart rate control in permanent AF, as an addition to standard therapy, was assessed in the ERATO trial [23]. Mean ventricular rate was reduced by 11.7 bpm at rest and by 24.5 bpm during maximal exercise with dronedarone, without any negative effect on exercise capacity. After these results, investigators hypothesized that dronedarone would show similar beneficial effects in permanent AF patients with additional risk factors [24]. Nevertheless, after the enrolment of 3236 patients, the PALLAS study was prematurely stopped for safety reasons. Dronedarone increased nearly twofold the risk of any primary outcome (stroke, myocardial infarction, systemic embolism, or cardiovascular death) and secondary outcome (unplanned hospitalization for cardiovascular causes or death). Twenty-five deaths were verified in the dronedarone group and 13 in the placebo group (HR 1.94), with the majority of arrhythmic deaths in the dronedarone group (13 vs. 4). Eleven out of 13 patients, treated with dronedarone, who died of arrhythmia, were assuming concomitant digoxin therapy, while none of the patients who experimented arrhythmic death on placebo group used digoxin. Also, dronedarone could induce digoxin toxicity, probably related to the increased mortality. Moreover, despite the results of ATHENA, [22] dronedarone increased the risk of stroke (HR: 2.32) and hospitalization for worsening HF (HR: 1.81). The rate of events could be explained by the higher risk of the included population, related to age, comorbidities, and rate to conversion to sinus rhythm (SR).