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Treatment of ascites

A technique for ascites and patients, which is applied in medical preparations containing active ingredients, peptide/protein ingredients, drug combinations, etc.

Pending Publication Date: 2017-08-01
BIOVIE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, to date there have been no published studies using continuous low-dose infusions of terlipressin to control ascites in ambulatory patients with cirrhosis

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0023] Example 1 : Treatment of ascites with continuous infusion pump terlipressin

[0024] Fifteen subjects with documented ascites due to cirrhosis, but not type 1 or 2 HRS, will be administered continuous low doses (2.0 to 3.0 mg escalating every 24 hours) via a portable infusion pump terlipressin. These patients are expected to experience a reduction in ascites severity and ascites fluid accumulation over the course of 1 to 28 days of treatment. This approach is also expected to reduce the number of puncture procedures required to remove ascitic fluid over a 28-day period compared to a 28-day cycle prior to treatment initiation, and some patients should avoid punctures altogether. In addition, the mean volume of fluid withdrawn after initiation of continuous infusion pump terlipressin therapy should be significantly less than before initiation of therapy. Furthermore, improvements in the patient's health status can be safely achieved without serious side effects. Ther...

Embodiment 2

[0025] Example 2 : Treatment of ascites with continuous infusion pump terlipressin

[0026] Ascites improvement was assessed in six HRS patients treated with continuous infusion terlipressin. All 6 patients had diuretic-refractory or refractory ascites (5 of 6 with hyponatremia). Patients were evaluated before, during and after treatment with the following parameters: number of puncture procedures per month, volume of ascites removed, body weight, serum sodium, urinary sodium excretion, serum creatinine, serum urea, and whether diuretics were included in the course of treatment middle. None of the six patients had a complete dataset for all parameters. The effect of continuous infusion of terlipressin on each parameter is shown in Tables 1-7.

[0027] Reduced puncture frequency and fluid volume during treatment

[0028] The average number of monthly paracentesis procedures decreased from three before starting continuous infusion therapy to two during treatment, and the a...

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Abstract

A method for treating ascites patients by administering the peptide drug terlipressin by continuous infusion. The patients include those whose ascites condition has not progressed to hepatorenal syndrome (HRS). Administration may be accomplished with a continuous infusion pump.

Description

[0001] related application [0002] This application claims U.S. Provisional Patent Application No. 62 / 321,558, filed April 12, 2016, U.S. Provisional Patent Application No. 62 / 267,510, filed December 15, 2015, filed June 30, 2015 The benefit of U.S. Provisional Patent Application No. 62 / 186,638, the entire contents of each of which are incorporated herein by reference. technical field [0003] The present disclosure relates to methods of treating patients with ascites by administering the polypeptide drug terlipressin. Background technique [0004] Ascites is a common and life-threatening complication of advanced cirrhosis with an expected mortality rate of 40% within two years of diagnosis. To date, the US FDA has not approved any treatment specifically for the treatment of ascites, although some drugs (eg, diuretics) are used off-label with limited and temporary efficacy. Intravenous (IV) injections of terlipressin every 4 to 6 hours in hospitalized patients with type 1...

Claims

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Application Information

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IPC IPC(8): A61K38/11C07K7/16A61K38/095
CPCA61P1/16A61P1/00A61K38/095
Inventor P.昂厄利P.马卡姆J.阿达姆斯
Owner BIOVIE INC
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