非他汀降脂药物临床应用评价.ppt

* NIASPAN? Efficacy: Combined Data From Pivotal Studies NIASPAN? was dosed at 1000, 1500, or 2000 mg daily at bedtime with a low-fat snack for 16 weeks (including 4 weeks of dose escalation). The differences from placebo were statistically significant (P < 0.05) for all doses for all lipid parameters shown. As shown in this table of results from two randomized, double-blind, parallel, multicenter placebo-controlled studies in patients with hypercholesterolemia, NIASPAN? produced dose-related improvements in all lipid variables from baseline to week 16 of treatment. Reference NIASPAN? [package insert]. Miami, Fla: Kos Pharmaceuticals, Inc.; 2003. * Dose-Escalation Study Results This figure shows the mean percent changes in HDL-C from baseline to study end point in a double-blind, multicenter, forced-dose-escalation study, with monthly 500-mg increases in NIASPAN? dose. Number of patients enrolled: placebo = 44; NIASPAN? = 87. Placebo data shown are after 24 weeks of placebo treatment. For all NIASPAN? doses except 500 mg, the mean percent changes in HDL-C levels from baseline were significantly greater for the NIASPAN? compared with the placebo group (P < 0.05). Reference NIASPAN? [package insert]. Miami, Fla: Kos Pharmaceuticals, Inc.; 2003. * Substantial differences between the groups were noted on the primary end point of change in coronary stenosis as demonstrated on arteriography. After 3 years of treatment with placebo, the mean percent stenosis in the proximal arteries increased by an average of 3.9%. After treatment with antioxidants alone, the mean percent arterial stenosis increased by 1.8% (Bonferroni-adjusted P=.16 for comparison with the placebo group). [p 1588] The only group in which stenosis actually regressed was the simvastatin/niacin group; these patients had an average decrease in stenosis of 0.4% (P<.001); this finding surprised the investigators, who had expected only slowed progression rather than actual regression. [pp 1588, 1590] Once again,