Another rehash of ARIES-2 being presented tomorrow morning at the World Congress of Cardiology 2006 in Barcelona. Here they add the BNP biomarker data (yawn):
>>Abstract: 4875
Ambrisentan improves 6-minute walk distance and decreases brain natriuretic peptide in patients with pulmonary arterial hypertension
Authors:
N. Galie1, H. Olschewsky2, H.A. Ghofrani3, M.R. Kramer4, B.L. Wiens5, C. Dufton4, L.J. Rubin6, 1Bologna - Italy, 2Graz - Austria, 3Giessen - Germany, 4Tel Aviv - Israel, 5Westminster-Co - United States of America, 6San Diego-Ca - United States of America,
On behalf: ARIES-2 Study Group
Topic(s):
Chronic Pulmonary Hypertension
Purpose: Plasma brain natriuretic peptide (BNP), a hormone secreted primarily from the cardiac ventricles, has been proposed as a prognostic indicator of mortality in patients with pulmonary arterial hypertension (PAH). Furthermore, reductions in BNP have been shown to parallel improvements in hemodynamics and 6-minute walk distance (6MWD) in patients with PAH. Ambrisentan is a propanoic acid-class, ETA-selective endothelin receptor antagonist that was shown to significantly improve 6MWD and delay clinical worsening in a Phase 3 placebo-controlled PAH study (ARIES-2).
Methods: In the ARIES-2 study, 192 patients with idiopathic PAH or PAH associated with connective tissue disease, anorexigen use or HIV were randomized to received placebo, 2.5 mg or 5 mg ambrisentan for 12 weeks. Post-hoc analyses are presented for all subjects with BNP data prior to first dose and after 12 weeks of ambrisentan therapy.
Results: As previously reported, the placebo-corrected change from baseline in 6WMD at week 12 improved by 59.4 m (95% CI: 29.6-89.3; p<0.001) in patients receiving 5 mg ambrisentan and 32.3 m (95% CI: 1.5-63.1; p = 0.022) in patients receiving 2.5 mg ambrisentan. 153 of these patients had BNP data pre-dose and at week 12: placebo (n = 46); 2.5 mg group (n = 55); or 5 mg group (n = 52). At baseline, mean plasma BNP was similar for the placebo group (252.4 ± 33.5 pg/mL), 2.5 mg group (267.7 ± 37.1 pg/mL) and the 5 mg group (267.7 ± 65.2 pg/mL). At week 12, mean plasma BNP decreased from baseline in the 2.5 mg (-98.6 ± 26.4 pg/mL; p<0.001) and 5 mg groups (-121.4 ± 58.0 pg/mL; p = 0.041), but increased in the placebo group (47.6 ± 30.9 pg/mL; p = 0.130). The change in BNP from baseline to week 12 was greater for both the 2.5 mg (p<0.001) and 5 mg groups (p = 0.015), compared to placebo, but was similar in both ambrisentan dose groups (p = 0.717). Regression analysis of all groups combined (n = 153) suggested that decreased BNP was associated with increased 6MWD at week 12 (p = 0.050).
Conclusions: During the 12-week study, ambrisentan significantly improved 6MWD and decreased plasma BNP concentrations, compared to placebo. Decreased plasma BNP appeared to be associated with improvement in 6MWD and may reflect underlying improvements in cardiopulmonary hemodynamics.<<
MYOG ran hard today ahead of this 4PM release. Except for the not very important BNP data, there isn't anything new here. Will MYOG shares give up some ground? It's given up half today's gains after hours . . .
Cheers, Tuck |
