An objective morbid condition or cause of death linked to cardiovascular disease, used as an indicator in a clinical trial or reportable event Examples Cardiovascular death, nonfatal myocardial infarction, hospitalization for heart failure, increase in blood pressure, etc.
After the primary composite cardiovascular endpoint was assessed, the trial continued as an observational study, with all patients given the intensified, multifactorial treatment that consisted of lifestyle measures and medications targeting hyperglycemia, hypertension, hypercholesterolemia, and hypercoagulation.
But large, well-designed, randomized controlled trials of intensive blood pressure lowering in people with diabetes, such as ACCORD-BP, did not demonstrate that intensive blood pressure lowering targeting a systolic less than 120 mm Hg had a significant benefit on the composite primary cardiovascular endpoint.
Two DAD Study analyses, (2,20) a EuroSIDA review, (1) the SMART cardiovascular endpoint dissection, (3) and a combined analysis of the ESPRIT and SILCAAT interleukin 2 (IL-2) trials (37) discerned no link between CD4 count (measured various ways) and risk of cardiovascular disease (also measured various ways) (Table 1).
The independent safety monitoring board for the RECORD trial--a large, long-term clinical trial, which has been designed to look at cardiovascular outcomes in people with diabetes--reviewed an interim analysis of cardiovascular endpoint in all study participants, and determined that the study should be allowed to continue.
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([R]) (bromocriptine mesylate) tablets were published in the Journal of the American Heart Association (JAHA), an online publication.
During the 76-week treatment phase, the pre-specified adjudicated cardiovascular endpoint (defined as cardiovascular death, myocardial infarction, unstable angina or stroke) occurred in 16 anacetrapib-treated patients (2.
Major finding: Sitagliptin was found noninferior to placebo for a combined cardiovascular endpoint comprising first time to CV death, nonfatal myocardial infarction, or stroke; and hospitalization for unstable angina (HR, 0.
The primary safety assessment will be determined by the analysis of non-inferiority to comparator drugs using a composite cardiovascular endpoint from a safety database pooled from the four Phase 3 trials.