Events included cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, coronary revascularization, hospitalization for angina pectoris, hospitalization for congestive heart failure, fatal or nonfatal stroke or transient ischemic attack, and new diagnosis of peripheral vascular disease. Other outcomes included comparisons of amlodipine vs enalapril and enalapril vs placebo. The primary efficacy parameter was incidence of cardiovascular events for amlodipine vs placebo.
IVUS was performed at baseline and study completion. Patients were randomized to receive amlodipine, 10 mg enalapril, 20 mg or placebo. A substudy of 274 patients measured atherosclerosis progression by intravascular ultrasound (IVUS).
Trojka w lotto trial#
To compare the effects of amlodipine or enalapril vs placebo on cardiovascular events in patients with CAD.ĭouble-blind, randomized, multicenter, 24-month trial (enrollment April 1999-April 2002) comparing amlodipine or enalapril with placebo in 1991 patients with angiographically documented CAD (>20% stenosis by coronary angiography) and diastolic blood pressure <100 mm Hg. The effect of antihypertensive drugs on cardiovascular events in patients with coronary artery disease (CAD) and normal blood pressure remains uncertain. (Funded by the National Health and Medical Research Council of Australia and others ADVANCE-ON number, NCT00949286.) There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events. The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure–lowering therapy were attenuated but still evident at the end of follow-up. No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and 1.00 (95% CI, 0.92 to 1.08), respectively. The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure–lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up the hazard ratios were 0.91 (95% confidence interval, 0.84 to 0.99 P=0.03) and 0.88 (95% CI, 0.77 to 0.99 P=0.04), respectively.
Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit.
The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure–lowering comparison) or 5.4 years (glucose-control comparison). The primary end points were death from any cause and major macrovascular events.
We invited surviving participants, who had previously been assigned to perindopril–indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. We now report results of the 6-year post-trial follow-up. In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not.
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