ST LOUIS (MD Consult) - On October 7, 2009, Daiichi Sankyo announced that the US Food and Drug Administration has approved a supplemental new drug application for the cholesterol-lowering product Welchol (colesevelam). This new approval allows for Wechol to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, aged 10 to 17 years, with heterozygous familial hypercholesterolemia (heFH). In this population, Welchol may be used alone or in combination with a statin after a patient's condition fails to respond to an adequate trial of diet therapy.
The FDA also approved Welchol in an oral suspension formulation, providing an alternative to the current tablet formulation. The oral suspension is indicated as an adjunct to diet and exercise to improve both glycemic control in adults with type 2 diabetes mellitus, and to reduce elevated LDL-C in adults with primary hyperlipidemia as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A reductase inhibitor (a statin). The oral suspension is also indicated for use as an adjunct to diet and exercise for the reduction of elevated LDL-C in boys and postmenarchal girls with heFH, aged 10 to 17 years, either alone or in combination with a statin after diet therapy has been deemed ineffective. The recommended dose of Welchol for oral suspension is one 3.75-g packet once daily.
The approval of Welchol for pediatric patients with heFH was granted on the basis of data from an 8-week, multicenter, randomized, placebo-controlled clinical study. The purpose of the study was to evaluate the efficacy of treatment with Welchol (1.875 or 3.75 g/d [tablets]) as monotherapy or in combination with a statin. Boys and postmenarchal girls aged 10 to 17 years, who were either treatment naive or who had been receiving stable doses of statins, were included in the study.
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圣路易斯(MD Consult)——2009年10月7日，日本第一制药三共公司宣布，美国食品药物管理局(FDA)已批准增加降胆固醇药考来维仑(Welchol)的一个新适应证。这项新批准令使得考来维仑可作为10~17岁、患杂合子家族性高胆固醇血症(heFH)男孩及月经初潮后女孩饮食和运动疗法外的辅助治疗药，以降低其升高的低密度脂蛋白胆固醇(LDL-C)水平。可在这类患者对充分的饮食疗法试验无效后单独应用考来维仑，亦可联用一种他汀类药物。
FDA同时还批准了考来维仑口服混悬液，这使得现有片剂有了替代剂型。口服混悬液可作为成人2型糖尿病患者饮食和运动疗法外的辅助治疗药以改善血糖控制，还可作为成人原发性高脂血症患者饮食和运动疗法外的辅助治疗药以降低其升高的LDL-C水平，以上两种情况均可单独应用考来维仑口服混悬液或联用羟甲基戊二酰辅酶A还原酶抑制剂(他汀类药物)。口服混悬液亦适用于10~17岁、患heFH男孩及月经初潮后女孩饮食控制和运动疗法外的辅助治疗，以降低其升高的LDL-C水平，在认为其对饮食疗法无效后应用，既可单独用药，亦可与他汀类药物联合应用。考来维仑口服混悬液的推荐剂量为1日1包(规格：3.75 g/包)。
批准考来维仑用于治疗儿科heFH患者是基于一项历时8周、多中心、随机、安慰剂对照临床研究的数据。该研究旨在评价考来维仑单药(1.875 g/d 或3.75 g/d，片剂)或与他汀类药物联用的疗效。研究所纳入的男孩及月经初潮后女孩的年龄介于10~17岁，他们先前未接受过治疗或一直接受稳定剂量的他汀类药物治疗。
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