�The results of a post-hoc analysis of the data from the ATHENA study were presented today at the clinical trial update session of the European Society of Cardiology congress 2008, in Munich, Germany. Previous results from the landmark ATHENA study have shown that the investigational medicament dronedarone on top of standard therapy decreased the combined primary endpoint of the peril of cardiovascular hospitalisations or death from any cause by a statistically significant 24% (p=0.00000002) as compared to placebo.
The ATHENA cam stroke post-hoc analysis on non-pre-specified secondary endpoints showed that dronedarone decreased the risk of exposure of stroke (ischemic or haemorrhagic) compared to placebo by 34% (46/2301 vs 70/2327 stroke events respectively; p=0.027) in atrial fibrillation / atrial flutter patients adequately treated by standard therapy including antithrombotics.
The significant reduction in stroke risk with dronedarone was incremental to background anti-thrombotic therapy like oral anticoagulants and / or anti-platelet agents.
"ATHENA is a landmark trial, as it is the first base time that an antiarrhythmic medication drug has shown a significant impingement on cardiovascular outcomes. As stroke is one of the prima complications of atrial fibrillation, and a major movement of death and long-run disability, these new results demonstrate the unique profile of dronedarone beyond its pure rhythm method and rate-controlling effects," aforesaid Professor Stuart Connolly, Mc Master University, Department of Cardiology, Hamilton Canada, co-principal investigator of the ATHENA study.
The most oft reported contrary events of dronedarone vs. placebo in the ATHENA trial as seen in the pre-specified safety analysis, were gI effects (26% vs. 22%), skin disorders (10% vs. 8%, in the main rash) and mild increase in blood creatinine (4.7% vs. 1%) due to inhibition of tubelike secretion of creatinine in the kidneys. The mechanism of parentage creatinine increase was well defined in a split up study of healthy volunteers. In the ATHENA trial, compared to placebo, dronedarone showed a low peril of pro-arrhythmia and no excess of hospitalisations for congestive heart failure. There was a similar rate of study drug discontinuance between the 2 study groups.
About Atrial Fibrillation / Flutter and Stroke
Atrial Fibrillation (AF) is the most unwashed cardiac arrhythmia in clinical practice and is one of the most important independent risk of infection factors for stroke. Stroke is a major public health problem because this acute outcome often causes permanent neurological disabilities and death. Atrial fibrillation increases the peril of stroke by up to 5 times. It also is responsible for 15-20% of all strokes, which if caused by AF, are 2.2 times more likely to leave patients bedridden.
Atrial fibrillation is a major cause of hospitalisation and mortality and affects around 2.5 million multitude in the USA and 4.5 million mass in the European Union. The Atrial Fibrillation Foundation expects the number of patients with AF to double in the side by side 20 years. Without set aside management, atrial fibrillation can buoy lead to serious complications, such as stroke and congestive heart failure.
About the ATHENA Study
The turning point ATHENA, sketch is the only double blind, anti-arrhythmic, morbidity-mortality study in patients with atrial fibrillation. It was conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients.
The patients studied in ATHENA were either 75 years of years or old (with or without cardiovascular risk factor) or supra 70 eld of age with at least ane additional cardiovascular risk factor (hypertension, diabetes, previous cerebrovascular event, left atrium size greater than 50 mm or left ventricular expulsion fraction depress than 40%). Patients were randomized to receive dronedarone 400 mg BID or placebo, with a uttermost follow-up of 30 months.
The ATHENA study objectives were to show a potential benefit of dronedarone on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization as compared to placebo. The pre-specified secondary endpoints were destruction from whatever cause, cardiovascular death and hospitalisation for cardiovascular reasons. The pre-specified safety end point was the incidence of treatment emergent adverse events (between first study dose intake and last study drug inlet plus 10 days) including: all inauspicious events, grave adverse events, adverse events leading to study drug discontinuation.
The ATHENA stroke post-hoc analysis on a non-pre-specified secondary endpoint was conducted in order to confirm the consistent benefit of dronedarone in atrial fibrillation or atrial waver patients in reducing major cardiovascular complications like stroke, which is a leading cause of cardiovascular hospitalization or death in this patient population.
About Multaq� (dronedarone)
Dronedarone is an investigational treatment and the only anti-arrhythmic dose (AAD) to have shown, as seen in ATHENA, a meaning reduction in morbidity and mortality in atrial fibrillation /atrial flicker patients compared with baseline treatment. In the like study dronedarone also demonstrated a lucky safety profile as evidenced by a low incidence of pro-arrhythmia (including torsades de pointes) and extra-cardiac organ perniciousness. Dronedarone, ascertained and developed by sanofi-aventis, has been studied in a clinical development programme including more than than 7,000 patients. Dronedarone is one of the major therapeutic innovations for atrial fibrillation in the last twenty age.
Dronedarone has been given a antecedency review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory inspection by the European Medicines Agency (EMEA). Dronedarone is not expected to be available for use in the NHS before September 2009.
About sanofi-aventis
Sanofi-aventis, a leading worldwide pharmaceutical company, contributes to improving life by providing a all-inclusive offering of medicines, vaccines, and integrated healthcare solutions adapted to local necessarily and means. http://en.sanofi-aventis.com
Forward Looking Statements
This press release contains forward-looking statements as outlined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements ar statements that are not historical facts. These statements include ware development, cartesian product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements ar generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are fairish, investors ar cautioned that forward-looking entropy and statements are subject to diverse risks and uncertainties, many of which are unmanageable to prognosticate and generally beyond the control of sanofi-aventis, that could reason actual results and developments to dissent materially from those expressed in, or implied or projected by, the innovative information and statements. These risks and uncertainties include among other things, the uncertainties integral in enquiry and developing, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential difference of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of tic alternatives as well as those discussed or identified in the populace filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as mandatory by applicable law, sanofi-aventis does non undertake any obligation to update or revise whatsoever forward-looking entropy or statements.
Sanofi-aventis
More information
Friday 5 September 2008
Tuesday 26 August 2008
Glasgow's music scene recognised with rare honour from Unesco
It is well-nigh two decades since Glasgow was crowned European City of Culture. The rest of the world may have sneered but Clydeside was close to to give other urban centres around the orb a headmaster class in how the arts could help ease the choppy passage into the mail industrial age.
Today Glasgow is revelling in its latest honor as it is named a earth centre of music by Unesco, the United Nations cultural organization.
News leaked out, sweet enough, in the beating cultural heart of its old rival at the Edinburgh Fringe during a visit by the Unesco director general Ko�chiro Matsuura.
Announcing the initiative, part of the Creative Cities Network, he said: "We at Unesco believe that culture non only makes an economic contribution, it provides significance, and a sense of identity and continuity that is built-in to the life of all societies".
Mr Matsuura testament make the journey cicily Isabel Fairfield to confirm the option at a civic reception later today. The official announcement will elevate Glasgow alongside the previous recipients Seville, and Bologna, nursing home of the composer Rossini.
The former shipbuilding capital has long noted its unique ability to produce the very best in musical talent. In the reality of democratic music, few cities, excluding perhaps Liverpool or Manchester, can claim to have churned out quite such a scintillant array of stars.
In the 1960s, Lulu topped the charts at the tender age of 15 with "Shout", and now older 60 is still performing. In 1970 there was the Sensational Alex Harvey Band and in the 1980s thither was Orange Juice and Del Amitri.
Today Franz Ferdinand, Travis, Belle and Sebastian and most latterly Glasvegas have confirmed the city's musical heritage.
The annual Celtic Connections festival has become an acclaimed secureness in the folk and traditional music calendar, drawing fans from around the world.
The Glasgow Royal Concert Hall opened to coincide with the Capital of Culture year, replacing the St Andrew's Hall which was destroyed by firing in 1962. Since and then leading international orchestras have got played there including the Moscow State and the Vienna Philharmonic. Glasgow at present bills itself Scotland's "classical powerhouse" as home to the Royal Scottish National Orchestra, the Royal Scottish Academy of Music and Drama, Scottish Opera, the BBC Scottish Symphony Orchestra and the National Youth Orchestra.
Scotland is now the only nation in the populace with 2 Unesco Creative Cities. Edinburgh became City of Literature in 2004.
The title is expected to bring a major boost to tourism and business when events begin in 2009. It comes with a high-voltage delegation travelling to Unesco's Paris headquarters earlier this summer to deliver a 50-page text file outlining the case for Glasgow.
The dossier pointed verboten that in a typical week the city would host 127 music events, with the music industry worth an estimated �74.6m to the local economy employing 2,922 people.
The bid received the support of Prime Minister Gordon Brown and the Scots fiddler Nicola Benedetti.
More info
Saturday 16 August 2008
Gary Glitter being deported
Rocker convicted of molestation
Fallen British john Rock star Gary Glitter will be deported to Britain on Tuesday after completing a 27-month sentence for molesting two young girls, his lawyer said.
Glitter, 63, whose tangible name is Paul Gadd, was arrested in November 2005 at Ho Chi Minh drome as he tried to leave the country and sentenced to three old age in gaol following a one-day run where he pleaded non guilty.
The sentence was upheld on invoke, but the sentence was reduced by three months. Jail time served is counted from the appointment of catch, meaning he is eligible for tone ending this month.
"My client volition have to board a flight to London, his ticket has been bought by the authorities here," Glitter's attorney Le Thanh Kinh aforesaid from Ho Chi Minh City. "After he lands in London, he's dislodge to go wherever he wants."
State media reported this week Glitter has been doing chores at a prison clinic in Binh Thuan responsibility, 118 miles north of Ho Chi Minh City and contiguous to the coastal province of Ba Ria-Vung Tau where he molested deuce 11-year-old girls while living in a villa.
Fallen British john Rock star Gary Glitter will be deported to Britain on Tuesday after completing a 27-month sentence for molesting two young girls, his lawyer said.
Glitter, 63, whose tangible name is Paul Gadd, was arrested in November 2005 at Ho Chi Minh drome as he tried to leave the country and sentenced to three old age in gaol following a one-day run where he pleaded non guilty.
The sentence was upheld on invoke, but the sentence was reduced by three months. Jail time served is counted from the appointment of catch, meaning he is eligible for tone ending this month.
"My client volition have to board a flight to London, his ticket has been bought by the authorities here," Glitter's attorney Le Thanh Kinh aforesaid from Ho Chi Minh City. "After he lands in London, he's dislodge to go wherever he wants."
State media reported this week Glitter has been doing chores at a prison clinic in Binh Thuan responsibility, 118 miles north of Ho Chi Minh City and contiguous to the coastal province of Ba Ria-Vung Tau where he molested deuce 11-year-old girls while living in a villa.
Thursday 7 August 2008
Smoking Popes, Stay Down Album Review
Album review of 'Stay Down' by Smoking Popes released through Curb Appeal.
Chicago based pop/punk set Smoking Popes wear the guys
Monday 30 June 2008
Los del Rio
Artist: Los del Rio
Genre(s):
Latin
Discography:
Palante
Year: 2004
Tracks: 11
Rio de Sevillanas
Year: 2003
Tracks: 10
A Mi Me Gusta
Year: 1994
Tracks: 10
Grandes Exitos Macarena
Year:
Tracks: 10
Spawning 1 of the hottest dance crazes of the '90s, the duette of Antonio Romeo Monge and Rafael Ruiz released "Macarena" in 1993, only had to wait nearly terzetto long time for the vocal to become a planetary hit. Monge and Ruiz had recorded Spanish flamenco-pop as Los del Rio for decades, and were divine to record "Macarena" by a dancer they saw in Venezuela. The individual was originally released in April 1993 on a Spanish label, and became a hit in that country. Los del Rio's popularity sparked a peculiar concert for the Pope, and prompted the BMG label to licence an American dance-club version in 1994. The individual -- remixed by the Bayside Boys -- hit the U.S. charts in 1995, just stalled at identification number 45 in December. Continued club play and a steady buzz encircled the single, and it ascended to number peerless in July 1996. It locked the top place for 14 weeks -- the pillow of the summer and nearly of the fall -- and eventually sold over four million copies. The dance was a staple fiber in baseball parks as well as saltation clubs, making "Macarena" the biggest undivided of 1996. Baila followed in 1999.
Ireland gets its Eurovision Turkey
Tuesday 24 June 2008
Sunrise Festival ticket holder urged to swap tickets
Fans with tickets for the Sunrise Celebration Festival which was cancelled earlier this month due to torrential rain are being invited to attend the Big Chill.
As previously reported, the Big Chill is resurrecting Sunrise by giving them a stage at their August 1-3 event.
Those existing Sunrise ticket holders can now swap their unused tickets for a Bill Chill Ticket, but it must be done in advance.
�??We think that some of our ticket holders don't realise the offer exists and others just assume that they can turn up on the gate at the Big Chill and make the swap there," organiser Michael Hanby told NME.COM.
"But we need them to contact the people they got their ticket from and make the swap as soon as possible. In doing so, they help save the festival and ensure their place with us, in our own spearate field with its own separate entrance.�?�
See Sunrisecelebration.com for more information.
As previously reported, the Big Chill is resurrecting Sunrise by giving them a stage at their August 1-3 event.
Those existing Sunrise ticket holders can now swap their unused tickets for a Bill Chill Ticket, but it must be done in advance.
�??We think that some of our ticket holders don't realise the offer exists and others just assume that they can turn up on the gate at the Big Chill and make the swap there," organiser Michael Hanby told NME.COM.
"But we need them to contact the people they got their ticket from and make the swap as soon as possible. In doing so, they help save the festival and ensure their place with us, in our own spearate field with its own separate entrance.�?�
See Sunrisecelebration.com for more information.
Monday 23 June 2008
Yaki-Da
Artist: Yaki-Da
Genre(s):
Dance: Pop
Dance
Discography:
A Small Step For Love
Year: 1999
Tracks: 10
Pride
Year: 1994
Tracks: 12
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