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).