New Drug Update 2010-2011 Faculty Disclaimer - CME Conferences

2 nd Annual Essentials in Primary Care
Fall Conference
Friday, November 11, 2011
ROCKET-AF Trial
• The ROCKET AF study was a multicenter, doubleblind,
randomized trial of once-daily oral rivaroxaban
20 mg or 15 mg daily in patients with a creatinine
clearance of 30 to 49 ml per minute) compared with
dose-adjusted warfarin (INR 2-3) in moderate-tohigh-risk
patients with nonvalvular AF. The authors
hypothesized that rivaroxaban is noninferior to
warfarin at preventing the composite of stroke
(ischemic and hemorrhagic) and systemic embolism.
The 14,264 enrolled patients (median age, 73; 40%
women) had a mean CHADS2 score of 3.5; about half
had a CHADS2 score of 4.
– N Engl J Med 2011;365:883-91.
ROCKET-AF Trial
• Median follow-up was 707 days.
• In the warfarin group, the overall mean proportion of
time in therapeutic international normalized ratio
range was 55%.
– N Engl J Med 2011;365:883-91.
• On Sept 9, 2011 the FDA Cardiovascular and Renal
Drugs Advisory Committee recommended approval
of rivaroxaban for the prevention of stroke and
systemic embolism in patients with non-valvular
atrial fibrillation (AF) by a 9-2 vote.
– The FDA had expressed concern over the low rate of
desired INR’s)
Wayne Weart
New Drug Update Part I