吡格列酮研究进展.pptVIP

* Several secondary IVUS endpoints were pre-specified in the study protocol. These included the mean maximum atheroma thickness, the total atheroma volume, and the atheroma volume in the most diseased 10 mm sub-segment. For these three endpoints, the most significant difference was observed for the maximum atheroma thickness, p=0.006. There were no statistical differences in the 10 mm most diseased sub-segment. * * This graphic shows the results for the primary endpoint, PAV, in pre-specified subgroups. There was no statistical heterogeneity based upon age, gender, BMI, systolic blood pressure, statin use, duration of diabetes or baseline hemoglobin A1c. * * In these non-pre-specified, exploratory subgroups, there was no heterogeneity dicotomized by baseline levels of HDL, LDL, triglycerides, presence or absence of the metabolic syndrome, baseline levels of CRP, or percent atheroma volume. * * Although the study was not powered to assess major cardiovascular events, we did adjudicate these events during the trial. The composite of cardiovascular death, non-fatal MI or non-fatal stroke occurred in 2.2% of glimepiride-treated and 1.9% of pioglitazone-treated patients. Due to the small size of the trial, none of these differences approached statistical significance. ? * * Both regimens were well tolerated, but revealed a different pattern of adverse effects. Hypoglycemia was more common with glimepiride, 37% versus 15%, p.001. Peripheral edema was more common with pioglitazone, 17.8% compared with 11% for glimepiride, p=0.02. Angina was more common in the glimepiride group. Bone fractures occurred exclusively in the pioglitazone group, affecting 3% of patients. There was approximately a 2 kg greater weight gain in the pioglitazone group. * * This graph compares these to other recent IVUS regression-progression trials. Notably, the glimepiride treatment group (shown in blue) progressed at a rate close to what would be expected for the achieved level of LDL.