7:03AM Santarus announced publication of new analysis of CYCLOSET; CYCLOSET demonstrated a significant 52% relative risk reduction in cardiovascular events (SNTS) 9.03 : Co disclosed 52-week, randomized safety study with CYCLOSET tablets were published in the Journal of the American Heart Association, 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 with HbA1c = 10.0 (average baseline HbA1c=7.0) were randomized 2:1 to CYCLOSET 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.
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. 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.
"Our analysis indicated that bromocriptine-QR, or CYCLOSET, significantly reduced the cardiovascular death-inclusive composite cardiovascular endpoint by 39% in type 2 diabetes patients after one year of treatment. Importantly, this observed relative risk reduction was consistent regardless of age, race, sex, duration of disease or preexisting macrovascular disease...Furthermore, among patients in the study, CYCLOSET significantly reduced the relative risk for the composite cardiovascular endpoint of myocardial infarction, stroke and cardiovascular death by 52%."
