mbrisentan during the 12-week primary endpoint
period. Of the 36 patients evaluated, two patients discontinued due
to adverse events not related to liver toxicity. As of October 2006
(mean exposure = 1.1 years, maximum duration 1.4 years), one
patient had developed a transient liver function abnormality that
was greater than three times the upper limit of normal and this
patient continued receiving treatment with ambrisentan. The
long-term adverse event profile appeared similar to results from
previous ambrisentan clinical studies and included peripheral
edema, headache, dyspnea and flushing.
"Endothelin receptor antagonism has well-established clinical
benefits in patients with PAH, but liver toxicity, which frequently
leads to discontinuation of treatment, has limited the usefulness
of these drugs in some patients," said Dr. McGoon. "The results of
this study support the potential of ambrisentan in newly diagnosed
patients with PAH, as well as patients who have failed other ERA
therapies due to liver function abnormalities."
"PAH is a chronic disease and, as such, we recognize the
importance of evaluating the long-term efficacy and safety profile
of ambrisentan," said Michael J. Gerber, MD, Senior Vice President,
Clinical Research at Gilead. "We will continue to work with the
clinical investigators and follow patients from each of these
studies so we can better understand the benefits and risks of
ambrisentan with long-term treatment."
In addition to these long-term ambrisentan data presentations,
two posters describing an integrated analysis of 12-week ARIES-1
and ARIES-2 data are also being presented at ATS. The first poster
(Abstract #3192) titled "Ambrisentan Therapy for Pulmonary Arterial
Hypertension: An Integrated Analysis of the ARIES-1 and ARIES-2
Studies" was presented today by Nazzareno Galie, MD, Professor of
Cardiology at the University of Bologna in Bologna, Italy. The
second poster (Abstract #2873) titled "Ambrisentan Improves
E
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Page: 1 2 3 4 5 6 Related medicine technology :1.
Second Phase III Study Evaluating Gileads Viread for the Treatment
of Chronic Hepatitis B Virus Meets Primary Endpoint2.
Second Phase III Study Evaluating Gileads Viread for the Treatment
of Chronic Hepatitis B Virus Meets Primary Endpoint3.
Phase III Study Evaluating Gileads Viread for the Treatment of
Chronic Hepatitis B Virus Meets Primary Endpoint4.
Gilead Announces Achievement of Primary Efficacy Endpoint in Second
Phase III Study of Aztreonam Lysine for Inhalation in Patients With
Cystic Fibrosis5.
Gilead Announces Presentation of Positive Phase III Data on
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis6.
Data from Preclinical Studies of Gilead Nucleotide Compound GS 9219
to be Presented at AACR7.
Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial8.
Neose Announces Presentation of Positive Preclinical Data on
GlycoPEGylated Factor VIIa at the XXI Congress of the International
Society on Thrombosis and Haemostasis9.
Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy
of BF-200 ALA In Actinic Keratosis10.
YM BioSciences Announces Secondary Efficacy and Safety Findings in
Randomized Phase IIB Aerolef Trial11.
BioSante Pharmaceuticals Announces New Findings for Potential Bird
Flu Vaccine