Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).
Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).
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DOI：
10.1007/s10557-011-6304-x
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发表时间：
2011-12-01
影响因子：
3.4
通讯作者：
Fukunami, Masatake
中科院分区：
文献类型：
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作者：
Matsuzaki, Masunori;Hori, Masatsugu;Fukunami, Masatake
目得：利尿剂被推荐用于治疗容量超负荷伴心力衰竭（HF），然而，它们可能导致血清电解质失衡，限制了它们的使用。此外，晚期HF患者对这些利尿剂的反应较差。在这项研究中，我们评估的有效性和安全性托伐普坦，一个竞争性的血管加压素V2受体拮抗剂开发的新药，以治疗容量超负荷的HF patients.METHODS：一个III期，多中心，随机，双盲，安慰剂对照平行研究进行，以评估托伐普坦治疗容量超负荷的HF患者的有效性和安全性，尽管使用传统的利尿剂。110例患者被随机分配到接受安慰剂或15 mg/天托伐普坦连续7 day.Results：与安慰剂相比，托伐普坦管理7天显着降低体重和改善症状与容量超负荷。托伐普坦的安全性被认为是可以接受的临床使用最小的不良反应.CONCLUSION：托伐普坦减少容量超负荷和改善充血性症状与HF由一个强大的水利尿（aquaresis）。
PURPOSE: Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients.METHODS: A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days.RESULTS: Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects.CONCLUSION: Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).