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首页> 外文期刊>Pediatric drugs >Colesevelam: in pediatric patients with heterozygous familial hypercholesterolemia.
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Colesevelam: in pediatric patients with heterozygous familial hypercholesterolemia.

机译：Colesevelam：在杂合性家族性高胆固醇血症的儿科患者中。

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Colesevelam hydrochloride (colesevelam), a non-absorbed, synthetic, lipid-lowering polymer, is a bile acid sequestrant. Colesevelam binds with high affinity to bile acids within the gastrointestinal tract, thereby inhibiting the reabsorption of bile acids, resulting in decreases in serum low-density lipoprotein cholesterol (LDL-C) levels. Colesevelam is available as tablets and as powder for oral suspension. At dosages of 3.75 g once daily or 1.875 g twice daily, colesevelam is approved in the US for the treatment of pediatric patients aged 10-17 years with heterozygous familial hypercholesterolemia. Colesevelam may be administered as monotherapy or in combination with an HMG-CoA reductase inhibitor (statin). A 32-week trial was conducted and consisted of a stablilization period ( approximately 4 weeks), a randomized period (8 weeks), an open-label period (18 weeks), and a 2-week follow-up period. In the 8-week, randomized, double-blind, placebo-controlled period of the trial, colesevelam (tablets), as monotherapy or with a statin, was an effective treatment for pediatric patients with heterozygous familial hypercholesterolemia. At week 8, recipients of colesevelam 3.75 g/day had significant percentage reductions from baseline in mean LDL-C levels (primary endpoint) compared with placebo recipients. Significant beneficial treatment effects for colesevelam 3.75 g/day versus placebo were also reported for several other lipid/lipoprotein parameters at week 8 of the study. The reported treatment effects on lipid/lipoprotein parameters were maintained over a subsequent 18-week, open-label, noncomparative period, when all patients received colesevelam 3.75 g/day. Colesevelam 3.75 g/day was generally well tolerated for up to 26 weeks by pediatric patients with heterozygous familial hypercholesterolemia.
机译：盐酸考来维仑（colesevelam）是一种不吸收的，合成的，降低脂质的聚合物，是一种胆汁酸螯合剂。 Colesevelam以高亲和力与胃肠道内的胆汁酸结合，从而抑制了胆汁酸的重吸收，从而导致血清低密度脂蛋白胆固醇（LDL-C）水平降低。 Colesevelam可作为片剂和口服混悬液的粉剂使用。每天一次3.75克或每天两次1.875克的剂量，在美国已批准了可列塞仑用于治疗10-17岁患有杂合性家族性高胆固醇血症的小儿患者。 Colesevelam可作为单一疗法或与HMG-CoA还原酶抑制剂（他汀类）联合使用。进行了为期32周的试验，包括稳定期（约4周），随机期（8周），开放期（18周）和2周的随访期。在为期8周，随机，双盲，安慰剂对照的试验期内，作为单一疗法或与他汀类药物联合使用的ceesevelam（片剂）对于杂合性家族性高胆固醇血症的小儿患者是一种有效的治疗方法。在第8周时，与安慰剂接受者相比，三苯乙酰胺3.75 g /天的接受者的平均LDL-C水平（主要终点）较基线显着降低。在研究的第8周，对于其他几种脂质/脂蛋白参数，也报告了相对于安慰剂而言，colesevelam 3.75 g / day的显着有益治疗效果。当所有患者均接受3.75 g /天的colesevelam治疗后，在随后的18周开放标签非比较期内，维持了对脂质/脂蛋白参数的报道治疗效果。杂合性家族性高胆固醇血症的小儿患者一般耐受Colesevelam 3.75 g / day达26周。

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