Arrhythmia Watch » Dronederone

Dronedarone approved for use in England and Wales

admin — Mon, 20 Sep 2010 11:49:26 +0000

The final guidance confirms the earlier decision in the Final Appraisal Determination, published by NICE on 15thJuly, and represents confirmation of that decision, that dronedarone is approved for the treatment of non-permanent AF in people with a cardio-vascular risk factors whose condition is not controlled by standard rate controlling therapies, such as beta blockers. For these patients, Multaq® is recommended as a therapeutic option.

Dr Derick Todd, Consultant Electrophysiologist at The Liverpool Heart and Chest Hospital, says: “The treatment of AF is about making patients feel better and protecting them from the negative health outcomes associated with AF. I am excited that dronedarone (Multaq®) is now available, which is a valuable additional choice for the treatment of AF. For the first time I will feel that a drug I use to treat AF will also reduce the morbidity associated with AF such as hospitalisation, stroke and cardiovascular mortality.”

Indicated in adult clinically stable patients with a history of, or current non permanent atrial fibrillation (AF) to prevent recurrence of AF or lower ventricular rate dronedarone is the first heart rhythm drug shown in clinical studies not only to maintain normal heart rhythm and reduce ventricular rate, but also to help keep patients out of hospital and to reduce the risk of death due to cardiova scular-related causes, compared to placebo, in addition to standard therapy.

Trudie Lobban, Founder and Chief Executive Officer of the Atrial Fibrillation Association said “The availability of a new treatment for AF is very welcome news for patients with this potentially life-limiting condition. AF affects the quality of life of both patients and their families and it has been a long time since we’ve seen new therapies in this area, giving hope to thousands who are struggling with this debilitating condition.”

Pallas study of 10,000 patients with dronedarone in permanent AF announced

admin — Fri, 25 Jun 2010 09:15:22 +0000

Permanent AF afflicts 50% of patients suffering from AF and these patients are at high risk of major adverse cardiovascular events. The trial rationale was based on post-hoc findings from the landmark ATHENA trial, in which a trend towards reduction of CV hospitalization and death was seen in patients classified as “permanent” (i.e. with AF/AFL at each ECG recording).

“This is a trial of major significance since no anti-arrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large-scale clinical trial,” said Dr Stuart Connolly, Division of Cardiology, McMaster University, Hamilton, Canada, one of the trial’s principal investigators. “We designed the PALLAS trial to further assess the role of Multaq^® to reduce cardiovascular outcomes in patients with AF.”

The primary objective of the PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) trial is to demonstrate a reduction in either or both of two composite outcomes which are 1. major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or 2. cardiovascular hospitalization or death from any cause among patients with permanent atrial fibrillation and additional risk factors. The secondary objectives are to evaluate the efficacy of Multaq^® in preventing cardiovascular death and whether the drug is well-tolerated in this patient population.

About PALLAS

PALLAS* is a multinational, randomized, double-blind, parallel-group, placebo-controlled, multicenter Phase IIIb trial comparing the efficacy of Multaq^® 400mg twice-daily with placebo in permanent AF patients. All patients will receive standard treatment to control heart rate and prevent blood clots (antithrombotic therapy); patients will be randomized to receive additional treatment with either Multaq^® 400mg BID or placebo.

Required risk factors include age above 65 years with at least one of the following major risk factors: systemic arterial embolism, myocardial infarction, documented coronary artery disease, prior stroke, symptomatic heart failure, or the combination of age above 75 years, hypertension and diabetes mellitus. Exclusion criteria include patients with New York Heart Association (NYHA) Class IV heart failure or unstable NYHA Class III heart failure.

The trial has two composite co-primary endpoints: 1. Major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death). 2. Cardiovascular hospitalization or death from any cause.

There will be 10,800 patients enrolled in 43 countries at 700 sites. The trial is event-driven with a fixed Common Study End Date, meaning that the study duration will depend upon the occurrence of a statistically required number of outcome events.

Read our full report from HRS by Dr Ben Glover here

Robust response to NICE decision on dronedarone

admin — Wed, 03 Mar 2010 09:52:03 +0000

Last December’s appraisal consultation document (ACD) (which can be accessed here), is not NICEs final guidance on this technology, and following the initial consultation period, there will be another publicly held Appraisal Committee meeting in Manchester on 24^th February 2010. This meeting will consider comments from the consultees, which includes dronedarone manufacturers, sanofi-aventis, as well as professional /specialist and patient/carer groups, such as Heart Rhythm UK (HRUK) and the Arrhythmia Alliance, Atrial Fibrillation Association, and others. The Committee will also consider comments made by non-consultees and will then prepare the final appraisal determination (FAD), which subject to appeal by consultees, may be used as the basis for NICEs guidance on using dronedarone in England and Wales.

In its initial consideration the Appraisal Committee also assessed the submission by the Evidence Review Group (ERG) which was prepared by the Centre for Reviews and Dissemination (CRD) and the Centre for Health Economics (CHE), University of York. They decided that they could not give the drug a positive recommendation based on their assessments of cost effectiveness.

Critics of the ruling argue that dronedarone, while costing more (about £2/day) than other agents, such as amiodarone, offers patients a better short-term side effect profile. The protests were spearheaded by the Daily Express (27 January) who voiced concerns from a number of Members of Parliament, notably Mark Hunter, Liberal Democrat MP for Cheadle who was quoted saying, “At the end of the day, dronedarone, represents a huge step forward for heart patients. It’s a breakthrough drug and if it can benefit all these people, then it’s got to be worthy of reassessment by NICE”.

A group of over 170 doctors are also reported to have written in protest to NICE calling on it to reverse its verdict, claiming that the expense (of dronedarone) is neglible compared with the burden of the effects of atrial fibrillation to the NHS.