At 1 year, intracoronary infusion of BMC was associated with a reduction in the prespecified combined
clinical end point of death, recurrence of myocardial infarction, and any revascularization procedure (P=0.
Critical elements of signatures that correlate most strongly with the
clinical end point of interest must be identified and confirmed.
The
clinical end point trial - REDUCE-IT (Reduction of Cardiovascular Events With EPA--Intervention Trial)--that Amarin plans for AMR101 will enroll about 8,000 patients with elevated triglycerides and will last for 6 years.
These approvals can be based on a surrogate end point that is considered "reasonably likely" to predict clinical benefit, or on an effect on a
clinical end point "other than survival or irreversible morbidity.
The Food and Drug Administration has changed the
clinical end point of a large study designed to assess the effectiveness of a patent foramen ovale closure device in patients with migraines.
But her main focus was on the drug's impact on quality of life, increasingly seen as a major
clinical end point in the management of chronic incurable diseases such as Crohn's disease, heart failure, and arthritis.
At first you'll see results of studies with carotid IMT or intravascular ultrasound because we still don't understand the mechanisms of action or dosing of some of these drugs well enough to do the large, classic,
clinical end point trials," he explained.
Even more impressive was the impact on major coronary events in this high-risk post-MI population: a 41% reduction in risk of recurrent nonfatal MI in the carvedilol arm, a 26% relative risk reduction in sudden death, and a 29% decrease in the combined end point of all-cause mortality or nonfatal MI, the most widely employed
clinical end point today in studies looking at acute coronary events, said Dr.
Compared with those assigned to a "prudent" diet akin to the AHA step 1 diet, those on the intervention diet had a 70% reduction in the combined
clinical end point of death, repeat MI, unstable angina, stroke, congestive heart failure, or embolic events (Circulation 99[6]:779-85, 1999).
Among placebo-treated patients who had blood pressure lowering comparable to that in the ramipril group, the reduction in the HOPE primary
clinical end point -- a composite of stroke, MI, or death from cardiovascular causes--was a mere 3%, compared with 22% in the ramipril group.
