单剂量缓释烟酸和缓释烟酸/拉罗匹仑组合的降压效果:一项针对血脂异常患者的24周安慰剂对照试验的事后分析。
Blood pressure-lowering effects of extended-release niacin alone and extended-release niacin/laropiprant combination: a post hoc analysis of a 24-week, placebo-controlled trial in dyslipidemic patients.
作者信息
Bays Harold E, Maccubbin Darbie, Meehan Alan G, Kuznetsova Olga, Mitchel Yale B, Paolini John F
机构信息
Louisville Metabolic and Atherosclerosis Research Center Inc., Louisville, Kentucky, USA.
出版信息
Clin Ther. 2009 Jan;31(1):115-22. doi: 10.1016/j.clinthera.2009.01.010.
BACKGROUND
Dyslipidemia and high blood pressure are both major cardiovascular disease risk factors. Niacin is an effective lipid-altering agent that has been reported to reduce the risk of cardiovascular disease. However, the more widespread use of niacin is limited, mainly due to the occurrence of flushing. Laropiprant (LRPT) is a selective antagonist of prostaglandin D(2) receptor subtype 1 that reduces extended-release niacin (ERN)-induced flushing without affecting its beneficial lipid effects. While the lipid effects of ERN are well known, the blood pressure effects are unclear.
OBJECTIVE
The aim of this analysis was to examine the blood pressure effects of ERN and ERN/LRPT.
METHODS
This was a post hoc analysis of a 24-week, worldwide, multicenter, double-blind, randomized, placebo-controlled, parallel, Phase III, previously published study of dyslipidemic patients, which examined the effect of ERN and ERN/LRPT on systolic blood pressure (SBP) and diastolic blood pressure (DBP).
RESULTS
A total of 1613 men and women, aged 21 to 85 years, with primary hypercholesterolemia or mixed dyslipidemia (66% on statins), were included in the original analysis. ERN alone, or in combination with LRPT, was associated with significant reductions in SBP and DBP at 24 weeks from baseline. The placebo-adjusted mean changes from baseline at week 24 in SBP were -2.2 and -3.1 mm Hg for the ERN and ERN/LRPT groups, respectively (P < 0.05 and P < 0.001). Similar changes in DBP were observed; -2.7 and -2.5 mm Hg in the ERN and ERN/ LRPT groups, respectively (both, P < 0.001).
CONCLUSION
This post hoc analysis of a 24-week trial found that ERN alone, or in combination with LRPT, was associated with significant placebo-adjusted reductions from baseline in blood pressure in these hyperlipidemic hypertensive or normotensive subjects.
背景
血脂异常和高血压均为主要的心血管疾病危险因素。烟酸是一种有效的血脂调节药物,据报道可降低心血管疾病风险。然而,烟酸的更广泛应用受到限制,主要是因为会出现潮红。拉罗匹坦(LRPT)是前列腺素D2受体亚型1的选择性拮抗剂,可减少缓释烟酸(ERN)引起的潮红,而不影响其有益的血脂作用。虽然ERN的血脂作用已为人所知,但其对血压的影响尚不清楚。
目的
本分析旨在研究ERN和ERN/LRPT对血压的影响。
方法
这是一项对之前发表的一项为期24周、全球多中心、双盲、随机、安慰剂对照、平行的III期血脂异常患者研究的事后分析,该研究考察了ERN和ERN/LRPT对收缩压(SBP)和舒张压(DBP)的影响。
结果
最初的分析纳入了1613名年龄在21至85岁之间、患有原发性高胆固醇血症或混合性血脂异常(66%服用他汀类药物)的男性和女性。单独使用ERN或与LRPT联合使用,在24周时与基线相比SBP和DBP均显著降低。ERN组和ERN/LRPT组在第24周时,安慰剂调整后的SBP较基线的平均变化分别为-2.2和-3.1 mmHg(P<0.05和P<0.001)。DBP也观察到类似变化;ERN组和ERN/LRPT组分别为-2.7和-2.5 mmHg(均P<0.001)。
结论
这项对为期周试验的事后分析发现,在这些高脂血症高血压或血压正常的受试者中,单独使用ERN或与LRPT联合使用,与安慰剂调整后的血压较基线显著降低有关。