A review on dronedarone: Pharmacological, pharmacodynamic and pharmacokinetic profile

Iram, Farah; Ali, Sadaf; Ahmad, Aftab; Khan, Shah Alam; Husain, Asif

doi:10.1016/j.joad.2015.10.002

Cited by 26 publications

(18 citation statements)

References 44 publications

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“…13 The greater C trough_avg concentrations observed in the female population are consistent with the known PK properties of dronedarone and are likely linked to BMI, as patients with a body weight of 60 kg have a 1.4-fold greater plasma exposure than in those with a body weight of 60-100 kg. 14 The distribution of CHAD 2 S 2 -VASc scores was consistent with that of age and sex, with higher scores observed in a greater proportion of patients in the above-median versus below-median C trough_avg groups.…”

Section: Trough_avg Values Of Dronedarone and Safetysupporting

confidence: 67%

Predictors of dronedarone plasma drug concentrations and effect on atrial fibrillation/atrial flutter recurrence: Analyses from the EURIDIS and ADONIS studies

Thind

McKindley

Reiffel

et al. 2022

Clinical Cardiology

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Background: In this post hoc analysis, we assessed patient characteristics as predictors of dronedarone trough concentrations and characterized the relationship of trough concentrations of dronedarone with its efficacy and safety.Hypothesis: Dronedarone is recommended as a 400 mg twice daily dose taken orally with meals. We hypothesize that drug concentration/bioavailability of dronedarone, measured as above-and below-median trough concentrations, does not impact the efficacy outcomes. Methods: Average trough concentrations (C trough_avg ) across multiple timepoints were calculated for each patient, and patient C trough_avg values were categorized as below-median or above-median concentrations. The effect of patient baseline characteristics on dronedarone C trough_avg was assessed in the below-median versus above-median groups. The effect of dronedarone in each C trough_avg group versus placebo on risk of first atrial fibrillation/atrial flutter (AF/AFL) recurrence and safety was also evaluated.Results: Overall, 1795 plasma samples were available from 507 dronedarone-treated patients. An above-median C trough_avg was associated with age ≥75 years, female sex, lower weight, higher pacemaker use, and higher oral anticoagulant use. The risk of adjudicated first AF/AFL recurrence was significantly lower with dronedarone versus placebo in the below-median (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.56-0.91; p = .0054) and above-median groups (HR: 0.63; 95% CI: 0.50-0.81; p = .0002). No difference in risk of AF/AFL recurrence was observed between the above-and below-median groups. Safety and tolerability of dronedarone were similar between groups. Conclusion:Significant reduction in AF/AFL recurrence was observed in patients treated with dronedarone versus placebo, regardless of dronedarone concentrations above or below the median value.

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Section: Trough_avg Values Of Dronedarone and Safetysupporting

confidence: 67%

Predictors of dronedarone plasma drug concentrations and effect on atrial fibrillation/atrial flutter recurrence: Analyses from the EURIDIS and ADONIS studies

Thind

McKindley

Reiffel

et al. 2022

Clinical Cardiology

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“…Due to reduced lipophilicity, it has lower toxicity and superior pharmacokinetic characteristics than the amiodarone belonging to the same Class III antiarrhythmic drug [4]. DRO is crystalline in nature with a melting point of 149-153°C [5], with white to practically white, non-hygroscopic fine powder. It is a new active substance, and there is no official pharmacopoeial procedure available [6].…”

Section: Preparation Of Nickel Standard Stock Solution (Solution A)mentioning

confidence: 99%

Atomic Absorption Spectrophotometer – A Versatile Tool for the Estimation of Nickel Content in Dronedarone

Dasari¹,

Dugasani²,

Gopireddy

2019

Asian J Pharm Clin Res

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Objective: The present investigation is to develop a validated analytical method for the determination of nickel content in dronedarone hydrochloride bulk drug by atomic absorption spectrophotometer (AAS). Methods: Samples were analyzed after a preparation of sample solution by dissolving in suitable diluents of nitric acid and perchloric acid. In the present method, AAS with 0.2 nm slit width, nickel hollow cathode lamp with a wavelength of 232 nm has been employed. Results: The system suitability parameters were performed to assess the system performance. The limit of detection and limit of quantification (LOQ) were found to be 0.051 ppm and 0.15 ppm, respectively. The percentage recovery at LOQ, 50%, 100%, and 150% levels of nickel in dronedarone was found to be 95.55, 109.33, 96, and 97.55, respectively. Conclusion: With the developed method, the nickel content in dronedarone bulk sample was found to be 3.0 ppm.

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“…Dronedarone has a molecular formula C31H44N2O5S with molecular mass of 556.758 g/mol. The chemical name of dronedarone is N-(2-Butyl-3-(p-(3(dibutylamino)propoxy)benzoyl)-5 benzofuranyl) methanesulfonamide ( Figure 3) [10]. The similarity of Amiodarone with triiodothyronine (Figure 4) is the basis for hypo-and hyperthyroid disorders associated with its use [6].…”

Section: Structure-activity Relationshipmentioning

confidence: 99%

A Review of Structure Activity Relationship of Amiodarone and Its Derivatives

Siddiqui¹,

Khan²,

Zaka³

2016

OJMC

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Structure Activity Relationship forms the basis of Rational Drug Design in the circles of pharmaceutical and medicinal chemistry. Appropriate knowledge of functional outcomes of structural modifications is crucial in conferring desired pharmacological properties to a chemical compound. Amiodarone is a classical antiarrythmic agent with a long list of adverse effects. This article attempts to review the structure activity relationship of some of the homologues of amiodarone in order to determine the most clinically desirable molecule.

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A review on dronedarone: Pharmacological, pharmacodynamic and pharmacokinetic profile

Cited by 26 publications

References 44 publications

Predictors of dronedarone plasma drug concentrations and effect on atrial fibrillation/atrial flutter recurrence: Analyses from the EURIDIS and ADONIS studies

Predictors of dronedarone plasma drug concentrations and effect on atrial fibrillation/atrial flutter recurrence: Analyses from the EURIDIS and ADONIS studies

Atomic Absorption Spectrophotometer – A Versatile Tool for the Estimation of Nickel Content in Dronedarone

A Review of Structure Activity Relationship of Amiodarone and Its Derivatives

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