Navigation Links
FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atrial Flutter
Date:7/2/2009

nnovations in patients with atrial fibrillation in the last twenty years.

The efficacy and safety of Multaq(R) 400 mg twice daily was evaluated in five controlled studies, ATHENA, ANDROMEDA, EURIDIS, ADONIS, and DAFNE, involving nearly 6,300 patients including more than 3200 patients who received Multaq(R).

The ATHENA trial, which involved 4,628 patients with AF or AFL and more than 2,300 patients receiving Multaq(R) on top of standard therapy, demonstrated a 24% reduction in time to first CV hospitalization or all-cause mortality (P<0.001) compared with placebo meeting the primary endpoint.

The ANDROMEDA study, was terminated prematurely after enrolment of 627 of 1000 planned patients with congestive heart failure, in relation to excess mortality due to worsening heart failure in the dronedarone group [n=25 versus 12 (placebo), p=0.027].

The patient population enrolled in the ANDROMEDA and ATHENA studies was significantly different. The patients enrolled in ANDROMEDA had relatively severe heart failure and had been hospitalized, or referred to a specialty heart failure clinic for worsening symptoms. Patients were predominantly NYHA II and III (New York Heart Association classification) and only 25% had a history of AF/AFL at randomization. In contrast, in ATHENA, all patients had a history of AF/AFL, and 71% of patients had no heart failure, 25% were NYHA class I or II, and only 4% were class III.

The ANDROMEDA and ATHENA trials were published in the New England Journal of Medicine (NEJM) respectively in 2008 and 2009.

Important Safety Information

Multaq(R) is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent
'/>"/>

SOURCE sanofi-aventis
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine news :

1. FDA Approves Lamictal(R)XR(TM); An Extended-Release Once-Daily, New Generation Treatment for Epilepsy
2. FDA Approves Reclast(R) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing
3. FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
4. ClearWay Minnesota(SM) Board Approves Four Regional Grants
5. Department of Defense Approves ISSA as Fitness Education Provider to Military Spouses
6. FDA Approves ACTOplus met(R) XR (pioglitazone HCl and metformin HCl extended-release) Tablets for the Treatment of Type 2 Diabetes
7. Treating Untreatable Brain Tumors: FDA Approves New Laser Surgery
8. FDA Approves Lamictal(R) ODT(TM) Orally Disintegrating Tablets
9. Video: FDA approves Exforge HCT(R) - the Only High Blood Pressure Treatment to Combine Three Medications in a Single Pill
10. Kaiser Permanente Approves $13 Million in Community Benefit Grants in First Quarter of 2009
11. FDA Approves Plan B Pill for 17-Year-Olds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... (PRWEB) January 22, 2015 The federal court ... the U.S. District Court, Southern District of West Virginia has ... in that proceeding’s first bellwether trial. In an Order dated ... new trial after finding that C.R. Bard had not proven ...
(Date:1/22/2015)... 2015 Autocarinsurancebest.com has released a new blog ... auto insurance policy . , Auto insurance quotes help ... is no longer necessary to call an agent or visit ... online on a single website: http://autocarinsurancebest.com/ . , Every ...
(Date:1/22/2015)... NY (PRWEB) January 22, 2015 ... of Sports Medicine flagship journal Medicine & Science ... L-Citrulline before exercise may help reduce gastrointestinal (GI) ... 1 , Participants in the double-blind, placebo-controlled ...
(Date:1/22/2015)... Four years since the release of their debut ... the marriage of Avasa & Matthew Love – the duo are ... for release through White Swan Records on February 24, 2015. , ... sacred path available to all of us to walk out of ...
(Date:1/22/2015)... 2015 JJsHouse.com is a famous dress online ... business announces its latest collection of wedding dresses , ... important issue is the wedding dress on your big day; ... woman’s life. Every bride wants to find the most suitable ...
Breaking Medicine News(10 mins):Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 2Health News:Study Shows Kyowa Hakko’s L-Citrulline May Help Reduce Gastrointestinal Injury During Strenuous Exercise 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2
... Canada are raising a hue and cry over inadequate facilities in ... ill-equipped and many a times patients have to be treated in ... the B.C. Nurses' Union president Deb McPherson said that the status ... have no privacy and no direct access to a washroom, or ...
... reporting that the traditional method of assessing the heart ... danger //of missing one-third of women who are predisposed ... ,Roger Blumenthal, M.D., an associate professor and director ... Hopkins University School of Medicine and its Heart Institute ...
... The health services in Australia’s Townsville will be revolutionized after ... the James Cook University (JCU).// A rural medical school has ... JCU. The University’s new clinic will cost A$ 3 million, ... This will serve to give them experience with regard medicine ...
... to Food science and consumer acceptance in Norway the ... do experts to cheese.// ,The food compared was ... expert dairy assessors. The rating was based on reaction ... was difference of opinion in both factions. As a ...
... Researchers from the Pennsylvania State University are trying to determine ... the zebra fish. The team led by Mark Shriver studied ... change in their key gene plays a major role in ... of Science, may not only help explain why people of ...
... against cancer focusing at the molecular and genetic levels, ... coming under increasing scrutiny.// Now scientists at the University ... these supporting cells are indeed key players in the ... ,These findings were arrived at after studying a ...
Cached Medicine News:Health News:Calcium Levels Could Indicate Future Heart Disease Risk 2Health News:Cancer Cells Trigger Supporting Cells to Turn Cancerous 2
(Date:1/23/2015)... VEGAS , Jan. 23, 2015 Cord Blood America, ... ) ("CBAI" or the "Company")  filed a Preliminary Proxy Statement, ... www.sec.gov ) today, and provides an update for shareholders detailing ... shares is requested. Dear Shareholders, As ...
(Date:1/23/2015)... Gem Pharmaceuticals announced today that the initial soft ... Company,s Phase 2 clinical trial.  This open-label study will ... GPX-150 (an investigational medication), in approximately 30 adults as ... Logo - http://photos.prnewswire.com/prnh/20150123/170966LOGO GPX-150 ...
(Date:1/22/2015)... BOULDER, Colo. , Jan. 22, 2015  BiOptix is ... Klakamp as Vice President of Chemistry and Biochemistry. Scott ... Takeda Pharmaceuticals, AstraZeneca Pharmaceuticals, and Amgen throughout the course ... and development. "Scott is a nationally recognized ...
Breaking Medicine Technology:Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 3Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 4Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2BiOptix Expands Leadership Team with the Appointment of Dr. Scott Klakamp as Vice President of Chemistry and Biochemistry 2
... J. Fox Foundation for Parkinson,s Research awarded about $2.9 ... drugs already approved in other disease indications for potential ... are already known to be safe for humans, they ... use in Parkinson,s patients if they prove effective in ...
... 12 Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ... development of drugs for the treatment of human viral ... initiated a proof-of-concept study of IDX184, a liver-targeted nucleotide ... Investigational New Drug application (IND) with the U.S. Food ...
Cached Medicine Technology:Michael J. Fox Foundation Awards $2.9 Million for Two New Parkinson's Disease Clinical Trials 2Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV) 2Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV) 3Idenix Pharmaceuticals Initiates Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV) 4
... High Speed Performance of Daily Routine ... Requirements and Information. VISUPAC has been ... Important for routine operation is the ... sequences. Extensive default settings reduce the ...
... Microscope with excellent maneuverability. Konan ... weight maintaining high quality. Easy ... by simply changing the adapter. ... has resulted in a sharp ...
... use with patients who have cataract and ... is a semicircular elastic PMMA ring for ... It is supplied in sterile packing for ... pupil during phacoemulsification for patients who have ...
To maintain the conjunctival cul-de-sacs after enucleation or evisceration without hindering lid closure....
Medicine Products: