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Method for treating a pulmonary hypertension condition

a pulmonary hypertension and pulmonary arterial pressure technology, applied in the direction of biocide, cardiovascular disorder, drug composition, etc., can solve the problems of difficult heart pumping blood through the lungs to be oxygenated, extreme shortness of breath of patients with pulmonary arterial hypertension, and high pulmonary arterial pressure, so as to prolong the life of the subject, improve the prognosis, and reduce the effect of baselin

Inactive Publication Date: 2010-06-17
GILEAD SCI INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0026]There is still further provided a method for prolonging life of a subject having a pulmonary hypertension condition, comprising administering to the subject ambrisentan at a dose and frequency and for a treatment period effective to increase life expectancy, from a time of initiation of treatment, by at least about 30 days; wherein, at baseline, time from first diagnosis of the condition in the subject is not greater than about 2 years.
[0027]There is still further provided a method for extending time to clinical worsening in a subject having PAH, comprising administering to the subject ambrisentan at a dose and frequency and for a treatment period effective to decrease the probability of a clinical worsening event by at least about 25%; wherein, at baseline, time from first diagnosis of the condition in the subject is not greater than about 2 years.
[0028]There is still further provided a method for treating a pulmonary hypertension condition in a reproductively active male subject, the method comprising administering a therapeutically effective amount of ambrisentan to the subject, wherein fertility of the subject is not substantially compromised.

Problems solved by technology

Severe constriction of the blood vessels in the lungs leads to very high pulmonary arterial pressures.
These high pressures make it difficult for the heart to pump blood through the lungs to be oxygenated.
Patients with PAH suffer from extreme shortness of breath as the heart struggles to pump against these high pressures.
Patients with PAH typically develop significant increases in pulmonary vascular resistance (PVR) and sustained elevations in pulmonary artery pressure (PAP), which ultimately lead to right ventricular failure and death.
Patients diagnosed with PAH have a poor prognosis and equally compromised quality of life, with a mean life expectancy of 2 to 5 years from the time of diagnosis if untreated.

Method used

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  • Method for treating a pulmonary hypertension condition
  • Method for treating a pulmonary hypertension condition
  • Method for treating a pulmonary hypertension condition

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0418]The ambrisentan treatment benefit observed by the primary and secondary endpoints of this study was robust, internally consistent, and clinically relevant.

[0419]Both doses demonstrated a statistically significant and clinically relevant improvement in 6MWD that was associated with a significant decrease in BDI. The improvement in 6MWD was nearly twice as large in the 5 mg dose group compared to the 2.5 mg dose group, and improvements in 6MWD were consistently dose-responsive for most subgroups evaluated. Furthermore, plasma BNP, a molecular marker that has been shown to decrease in patients with PAH who demonstrate improvements in 6MWD or hemodynamics, was substantially reduced with ambrisentan treatment. Ultimately, these symptomatic improvements resulted in a patient's self-assessment of an overall better quality of life, as measured by statistically significant improvements in several scales of the SF-36® health survey.

[0420]In addition to the symptomatic improvements obser...

example 2

[0509]This study demonstrated that both the 5 mg and 10 mg dose of ambrisentan administered once daily provided statistically significant and clinically relevant improvements in exercise capacity and symptoms in subjects with PAH. The improvements in 6MWD were evident within 4 weeks and appeared dose-dependent by Week 8. At Week 12, the increase in 6MWD was nearly twice as large in the 10 mg dose group compared to the 5 mg dose group. Improvements in 6MWD were observed in most subgroups and, in general, appeared to be dose-dependent. Clinically relevant improvements in 6MWD were observed in subjects with WHO functional class I / II and class III / IV symptoms. Both doses also demonstrated clinically relevant treatment benefits for several secondary endpoints, including WHO functional class and BDI, as well as a notable reduction in plasma BNP.

[0510]Ambrisentan was well tolerated as indicated by the lack of dose reduction and AEs leading to premature discontinuation as well as more subje...

example 3

[0512]The trials described in Examples 1 and 2 enrolled subjects from a population having PAH including idiopathic PAH and PAH associated with CTD, anorexigen use or HIV infection. Patients with pulmonary hypertension due to other etiologies were generally excluded. However, the efficacy and safety of ambrisentan observed in this classic PAH population, and the need for effective therapy in pulmonary hypertension associated with other conditions, merits evaluation in these non-traditional groups. Therefore, a further study is conducted to evaluate safety and efficacy of ambrisentan in both classic PAH patients (WHO Group 1) and in an expanded pulmonary hypertension patient population (WHO Groups 3 and 4).

[0513]This expanded population includes subjects having idiopathic and familial PAH; PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts, HIV infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease and splenectomy;...

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Abstract

A method for treating a pulmonary hypertension condition such as pulmonary arterial hypertension (PAH) in a subject comprises administering to the subject a therapeutically effective amount of ambrisentan, wherein, at baseline, time from first diagnosis of the condition in the subject is not greater than about 2 years.

Description

[0001]This application claims the benefit of U.S. provisional application Ser. No. 60 / 869,667, filed Dec. 12, 2006, incorporated in its entirety herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to methods useful for treating a subject having a pulmonary hypertension condition, and for improving clinical outcome in such a subject.BACKGROUND OF THE INVENTION[0003]Pulmonary hypertension (PH) has been previously classified as primary (idiopathic) or secondary. Recently, the World Health Organization (WHO) has classified pulmonary hypertension into five groups:[0004]Group 1: pulmonary arterial hypertension (PAH);[0005]Group 2: PH with left heart disease;[0006]Group 3: PH with lung disease and / or hypoxemia;[0007]Group 4: PH due to chronic thrombotic and / or embolic disease; and[0008]Group 5: miscellaneous conditions (e.g., sarcoidosis, histiocytosis X, lymphangiomatosis and compression of pulmonary vessels).See, for example, Rubin (2004) Chest 126:7-10.[0009]Pu...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/513
CPCA61K31/505A61K31/53A61K31/519A61K31/4985A61P9/00A61P9/12A61P11/00
Inventor GERBER, MICHAEL J.DUFTON, CHRISTOPHER
Owner GILEAD SCI INC
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