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Use of KW-3902 for achieving diuresis in patients with congestive heart failure and acute fluid overload

A technology of use, body fluid, applied in the use field of KW-3902 to achieve diuretic effect in patients with congestive heart failure and acute body fluid overload, which can solve problems such as not allowing sufficient diuresis

Inactive Publication Date: 2009-06-24
NOVACARDIA INC (US)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the shorter hospital stay may not allow adequate diuretic

Method used

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  • Use of KW-3902 for achieving diuresis in patients with congestive heart failure and acute fluid overload
  • Use of KW-3902 for achieving diuresis in patients with congestive heart failure and acute fluid overload
  • Use of KW-3902 for achieving diuresis in patients with congestive heart failure and acute fluid overload

Examples

Experimental program
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example 1

[0130] A double-blind, randomized multicenter placebo-controlled study was conducted as follows: approximately 157 individuals were randomized to yield 144 evaluable individuals in an intention-to-treat analysis performed at approximately 50 sites. The study population included males and females at least 18 years of age with New York Heart Association grades II-IV CHF. All subjects had an estimated creatinine clearance between 20 mL / min and 80 mL / min. The mean serum creatinine for all enrolled subjects was 1.75 mg / dL. All subjects were taking oral loop diuretics. The population data for the study are presented in Table 1 below.

[0131] Table 1: Study Population Data

[0132]

[0133] Study visits included pre-treatment days -2 to -1, treatment period days 1 to 3, day 4 / early termination, and day 30 follow-up contact. Procedures and observations include history, physical examination, CHF grade, vital signs, weight, CHF sign and symptom score, Holter monitor recording, c...

example 2

[0141] Over 300 individuals hospitalized due to acute CHF requiring intravenous diuretic therapy for fluid overload and exhibiting creatinine clearance values ​​between 20 mL / min and 80 mL / min were identified. Subjects were randomized to receive placebo or 10 mg, 20 mg or 30 mg intravenous KW-3902 daily.

[0142] On day 1, co-administer KW-3902 (or placebo) with intravenous furosemide (LASIX TM ). Specific doses of KW-3902 (or placebo) were infused over a 4-hour period. Individuals receive therapy for up to 3 days. Patients were assessed daily during the initial hospitalization and on Days 7 and 14 for signs and symptoms of heart failure. Patients who achieved adequate diuresis were discharged early ("early termination") and did not receive treatment on Day 2 or 3. As shown in Table 2 below, a higher percentage of subjects in the KW-3902 treated group were discharged early from the hospital compared to subjects in the placebo treated group. These data demonstrate that KW-...

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Abstract

Methods of treating patients with acute fluid overload comprising administering diuretic therapy and an amount of KW-3902, a pharmaceutically acceptable salt, ester, amide, metabolite, or prodrug thereof, effective to accelerate removal of excess fluid from the patient in comparison to diuretic therapy alone. Methods of improving the treatment time to achieve adequate diuresis in an individual experiencing acute fluid overload comprising administering to said individual a diuretic and a therapeutically effective amount of KW-3902 or a pharmaceutically acceptable salt, ester, amide, metabolite, or prodrug thereof.

Description

[0001] Related applications [0002] The present application claims U.S. Provisional Application No. 60 / 814,109, filed June 16, 2006, by Dittrich et al. Priority, said provisional application is expressly incorporated herein by reference in its entirety. technical field [0003] The present invention relates to xanthine derivatives and their use in the treatment of patients suffering from acute humoral overload. Background technique [0004] Fluid overload is a condition in which there is excess body fluid in circulation. The main cause of fluid overload is congestive heart failure (CHF). In the United States (U.S.), advanced CHF accounts for more than one million hospital admissions each year and a 5-year mortality rate of 40%-50%. (American Heart Association 2001 Heart and Stroke Statistical Update, Dallas, Tex.; American Heart Association, 2000; Massie, B.M. and Shah, N.B., Am. Heart J. 133:703-712 (1997)). Currently, most HF patients presenting with acute fluid over...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P7/10A61K31/635A61K31/4985A61K45/06
CPCA61K45/06A61K31/635A61K31/4985A61P7/10A61P9/04A61P13/12
Inventor 霍华德·迪特里奇布莱恩·法默兰迪·伍兹
Owner NOVACARDIA INC (US)