Multaq, which is already approved for temporary irregular heartbeat, was being tested on patients with permanent atrial fibrillation. The trial was stopped because it was causing increased cardiovascular problems.
Multaq makers and marketers, Sanofi, announced yesterday that the PALLAS Phase IIIb trial in patients with permanent Atrial Fibrillation was halted after the Operations Committee and the Data Monitoring Committee detected a considerable increase in cardiovascular events among the participants taking Multaq.
Sanofi's Chief Medical Officer Jean-Pierre Lehner, said:
"We are notifying regulatory authorities in all countries where the product is approved or under review on this matter. We remain committed to Multaq as an essential treatment option for non-permanent atrial fibrillation patients."
No liver problems were reported in this trial, unlike the one in January, the company added.
Sanofi says that regulatory authorities have been informed of its decision to halt the trial. PALLAS clinical investigators are urged to tell trial participants to stop taking the study drug and to check with their clinical trial center - this applies to the PALLAS study patients only.
The company adds that patients with non-permanent atrial fibrillation who are currently taking Multaq should not stop taking their medication. If they have any concerns they should contact their doctor.
Atrial fibrillation (AF) is an irregular heart rate, often a fast one. Patients generally have poor blood flow to the body. The atria (two upper chambers in the heart) beat irregularly and chaotically, and not in coordination with the ventricles (two lower chambers). The patient may experience palpitations, weakness and shortness of breath. Atrial fibrillation is a serious disease which is linked to a higher risk of premature death.
There are two types of AF:
Non-permanent AF - Multaq is approved for this type of AF. Sanofi says that approximately 400,000 patients have taken Multaq worldwide.
Permanent AF - the atrial fibrillation persists for over six months. There is a higher risk of major adverse cardiovascular events, compared to non-permanent AF. The halted trial was testing patients with this type of AF.
Stuart Connolly, M.D., Division of Cardiology, McMaster University, Hamilton, Canada, and the PALLAS trial's co- principal investigator, said:
"Patients with permanent AF and vascular risk factors are at high risk of major vascular events and no previous study has investigated whether any intervention can reduce major morbidity or mortality in these patients. PALLAS is the first trial to investigate whether an anti-arrhythmic drug can decrease outcomes in this important population of patients. The PALLAS Operations Committee is very disappointed to discover that the hypothesis that dronedarone would improve major outcomes for this high risk patient population has been refuted."
Sanofi needs new products to replace expected lost income when some of its top selling medications have to face competition from generic versions. It was hoped Multaq could offset some of these losses. Approximately one-third of Sanofi's 2008 sales base will have lost patent protection by 2013.
View drug information on Multaq.