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).

Matsuzaki M; Hori M; Izumi T; Fukunami M

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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).

机译：尽管使用常规利尿剂进行了标准治疗，但是托伐普坦在体力超负荷的心力衰竭患者中的疗效和安全性：III期，随机，双盲，安慰剂对照研究（QUEST研究）。

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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).

机译：目的：建议使用利尿剂治疗心力衰竭（HF）引起的容量超负荷，但是它们可能会导致血清电解质失衡，从而限制了其使用范围。而且，晚期HF患者对这些利尿剂的反应较差。在这项研究中，我们评估了竞争性血管加压素V2受体拮抗剂Tolvaptan的疗效和安全性，该药物被开发为治疗HF患者的容量超负荷的新药。方法：进行了一项III期，多中心，随机，双盲，安慰剂对照的平行研究，以评估托伐普坦在治疗容量超负荷的HF患者中的有效性和安全性，尽管使用了常规利尿剂。 110名患者被随机分配连续7天接受安慰剂或15 mg /天的托伐普坦治疗。结果：与安慰剂相比，托伐普坦治疗7天可显着减轻体重并改善与容量超负荷有关的症状。托伐普坦的安全性被认为是临床可接受的，副作用最小。结论：托伐普坦通过有效的水利尿作用（aquaresis）减少了容量负荷并改善了与HF相关的充血症状。

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《Cardiovascular drugs and therapy》 |2011年第1期|共13页
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Matsuzaki M; Hori M; Izumi T; Fukunami M;
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1. 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). [J] . Matsuzaki M, Hori M, Izumi T, Cardiovascular drugs and therapy . 2011,第Suppla1期

机译：尽管使用常规利尿剂进行了标准治疗，但是托伐普坦在体力超负荷的心力衰竭患者中的疗效和安全性：III期，随机，双盲，安慰剂对照研究（QUEST研究）。
2. Efficacy and safety of tolvaptan in heart failure patients with sustained volume overload despite the use of conventional diuretics: a phase III open-label study. [J] . Fukunami M, Matsuzaki M, Hori M, Cardiovascular drugs and therapy . 2011,第Suppla1期

机译：尽管使用常规利尿剂，托伐普坦在持续容量超负荷的心力衰竭患者中的疗效和安全性：一项III期开放标签研究。
3. Efficacy and Safety of Tolvaptan in Heart Failure Patients with Sustained Volume Overload despite the Use of Conventional Diuretics: A Phase III Open-Label Study [J] . Masatake Fukunami, Masunori Matsuzaki, Masatsugu Hori, Cardiovascular Drugs and Therapy . 2011,第s1期

机译：托伐普坦在尽管使用常规利尿剂的情况下持续容量超负荷的心力衰竭患者的疗效和安全性：III期开放标签研究
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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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