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
TheStreet Open House

Santarus And VeroScience Announce Publication Of New Analysis Of CYCLOSET (bromocriptine Mesylate) Cardiovascular Data In The Journal Of The American Heart Association

Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today announced that new analyses of cardiovascular endpoint data from a previously disclosed 52-week, randomized safety study with CYCLOSET ® (bromocriptine mesylate) tablets were published in the Journal of the American Heart Association (JAHA), an online publication. CYCLOSET is a unique, quick release form of bromocriptine, a dopamine D2 receptor agonist, and is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In this safety study, a total of 3,070 patients on stable doses of up to two antidiabetes medications (including insulin) with HbA1c ≤ 10.0 (average baseline HbA1c=7.0) were randomized 2:1 to CYCLOSET (1.6 to 4.8 mg/day) or placebo for a 52-week treatment period. Patients with heart failure (New York Heart Classes I and II) and precedent myocardial infarction or revascularization surgery were allowed to participate in the trial.

The original prospective analysis of a prespecified cardiovascular endpoint (composite of myocardial infarction, stroke, hospitalization for unstable angina, congestive heart failure, or revascularization surgery) from this study indicated a significant 40% relative risk reduction in this cardiovascular endpoint ( Diabetes Care 33:1503-1508, 2010).

The new analyses published in JAHA investigated 1) the impact of CYCLOSET on the ischemic cardiovascular composite endpoint of myocardial infarction, stroke, and cardiovascular death (major adverse cardiovascular events; MACE) and 2) cardiovascular death as a component of a new composite cardiovascular endpoint (myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for congestive heart failure, coronary revascularization and cardiovascular death) to more critically evaluate the impact of CYCLOSET on cardiovascular outcomes in the study population.

Regarding the MACE endpoint, there were 14 events (0.7%) among 2,054 CYCLOSET-treated subjects and 15 events (1.5%) among 1,106 placebo-treated subjects, yielding a significant, 52% reduction in relative risk in cumulative percent of cardiovascular events over time of this MACE endpoint (p<0.05; log-rank test). With respect to the cardiovascular death-inclusive cardiovascular endpoint, there were 39 events (1.9%) among 2,054 CYCLOSET-treated subjects versus 33 events (3.2%) among 1,016 placebo subjects, yielding a significant, 39% reduction in relative risk in the cumulative percent over time of this composite cardiovascular endpoint (p=0.0346; log-rank test).

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
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!
SYM TRADE IT LAST %CHG

Markets

DOW 17,712.66 +34.43 0.19%
S&P 500 2,061.02 +4.87 0.24%
NASDAQ 4,891.2190 +27.8570 0.57%

Partners Compare Online Brokers

Free Reports

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