This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

ELIQUIS®(apixaban) Approved In Europe For Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

Stocks in this article: BMY PFE

AVERROES

As described in the SmPC, the AVERROES (Apixaban Versus Acetylsalicylic Acid to Prevent Strokes) trial was designed to demonstrate the efficacy and safety of ELIQUIS versus aspirin for the prevention of stroke or systemic embolism in patients who were unsuitable for VKA therapy.

AVERROES was stopped early based on the recommendation of the trial’s independent Data Monitoring Committee due to clear evidence of reduction of stroke and systemic embolism with an acceptable safety profile. In AVERROES, ELIQUIS was statistically superior to acetyl salicylic acid (ASA) in the primary endpoint of prevention of stroke (hemorrhagic or ischemic) and systemic embolism compared to ASA (1.62% vs. 3.63%, HR=0.45; CI=0.32, 0.62, P<0.0001), as well as in the key secondary composite endpoint of stroke, systemic embolism, MI or vascular death (4.21% vs. 6.35%, HR=0.66; CI=0.53, 0.83, P = 0.003). While not significant, there was an increase in the incidence of major bleeding with ELIQUIS compared to aspirin (1.41%/year vs. 0.92%/year). The incidence of fatal bleeding (0.16%/year vs. 0.16%/year) and intracranial bleeding (0.34%/year vs. 0.35%/year) bleeding were similar in the ELIQUIS and ASA treatment groups.

The safety of ELIQUIS has been investigated in 11,886 patients in NVAF studies treated for an average total exposure of 1.7 years. In ARISTOTLE and AVERROES, 24.4% (ELIQUIS vs. warfarin) and 9.6% (ELIQUIS vs. aspirin) of the patients treated with ELIQUIS (5 mg or 2.5 mg) twice daily experienced adverse reactions. Common adverse reactions were epistaxis, contusion, haematuria, haematoma, eye haemorrhage, and gastrointestinal haemorrhage. The overall incidence of adverse reactions related to bleeding with ELIQUIS was 24.3% in the ELIQUIS vs. warfarin study and was 9.6% in the ELIQUIS vs. aspirin study. In ARISTOTLE study, the incidence of ISTH major gastrointestinal bleeds (including upper GI, lower GI, and rectal bleeding) with ELIQUIS was .76%/year. The incidence of ISTH major intraocular bleeding with ELIQUIS was 0.18%/year.

3 of 6

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs