Navigation Links
Tracleer(R) Shows Clinical Benefit as Combination Therapy with Sildenafil for Pulmonary Arterial Hypertension
Date:10/23/2007

- Studies Show Improvement in Hemodynamics and Delay Disease Progression -

CHICAGO, Oct. 23 /PRNewswire/ -- Actelion Pharmaceuticals US, Inc. today announced positive results from two trials demonstrating that Tracleer(R) (bosentan) may be safe and effective as a combination therapy for the treatment of pulmonary arterial hypertension (PAH). Data from both studies suggest that Tracleer, when given in combination with sildenafil, is well-tolerated and improves hemodynamics in PAH patients. The data were presented at CHEST 2007, the annual meeting of the American College of Chest Physicians, taking place in Chicago.

COMPASS-1 (Effects of Combination Of bosentan and sildenafil versus sildenafil Monotherapy on morbidity and mortality in symptomatic PAtientS with pulmonary arterial hypertenSion) was the first clinical trial to provide detailed hemodynamic information on the combination of Tracleer and sildenafil, and showed that the combination of acute oral sildenafil together with long-term Tracleer therapy significantly reduced pulmonary vascular resistance (PVR).

Data from the sildenafil cohort of the Phase 3 EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) study showed that Tracleer improved hemodynamics and suggested a delay in disease progression in sildenafil-treated mildly symptomatic PAH patients. The EARLY trial was the first study of its kind to evaluate the benefit of Tracleer and sildenafil combination therapy.

"Despite the availability of effective PAH therapies, we are not meeting key treatment goals for long-term stabilization in the majority of patients," said Nazzareno Galie from the University of Bologna, Italy, also the lead author of the COMPASS-1 study. "Given the progressive and destructive nature of this disease, combining therapies with different modes of action has become an important focus for research, and these results support our belief that adding bosentan to sildenafil could potentially slow disease progression."

"The results of the COMPASS-1 and EARLY studies demonstrate that Tracleer, when used alone or in combination with other therapies, appears to be well-tolerated and an effective treatment option for patients with PAH," said Craig Hopkinson, vice president of U.S. medical at Actelion. "Actelion is committed to conducting studies with Tracleer in combination with other approved therapies in order to evaluate the drug's effect in a combination therapy setting on delaying disease progression and improving patient care."

COMPASS-1 Study Details and Results

The COMPASS-1 trial assessed the acute hemodynamic effects of sildenafil in combination therapy with Tracleer. The open-label, uncontrolled, prospective, multicenter study evaluated 45 patients receiving Tracleer and measured PVR with the addition of inhaled nitric oxide (iNO) and a single 25mg dose of sildenafil.

The % change in PVR induced by iNO and sildenafil was similar. Sildenafil lowered mean PVR by 15.1% from 828+/-724 to 721+/-651 dyne.s.cm-5 60 minutes after intake (p<0.0001). iNO was shown to reduce mean PVR by 14.9% from 807+/-635 to 745+/-740 dyne.s.cm-5 after inhalation (p<0.0001).

EARLY Study Details and Results

The EARLY trial evaluated the safety and efficacy of Tracleer in mildly symptomatic (WHO Functional Class II) PAH patients. This randomized, double-blind, placebo-controlled trial (n=185) assessed the efficacy of Tracleer as a monotherapy and as a combination therapy in patients receiving background sildenafil treatment (n=29).

Mean baseline PVR was higher in patients receiving sildenafil than in patients not taking sildenafil; and six-minute walk distances were similar at baseline. At six months, patients treated with Tracleer (in sildenafil and non-sildenafil subgroups) both saw a reduction in PVR (-20%, P=0.0478 sildenafil; -23%, P<0.0001 no sildenafil).

Data from the trial also suggest that Tracleer is effective in early stage PAH patients as a monotherapy.

About Tracleer(R) in Pulmonary Arterial Hypertension (PAH)

Tracleer(R) (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion Ltd. subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide.

Tracleer requires attention to two significant safety concerns: potential for serious liver injury (including rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring) and high potential for major birth defects. Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. Pregnancy must be excluded and prevented by two forms of birth control; monthly pregnancy tests should be obtained. Because of these risks, Tracleer is only supplied through a controlled distribution system.

About Actelion Pharmaceuticals

Actelion Pharmaceuticals has pioneered research and development in the pulmonary arterial hypertension (PAH) disease area. More than 40,000 PAH patients have been prescribed Actelion's product Tracleer(R) (bosentan), an orally available dual endothelin receptor antagonist for patients with World Health Organization (WHO) Class III or IV PAH in the U.S., and Class III PAH in Europe. Tracleer was approved in 2001 as the first oral treatment for PAH, and is currently approved in the U.S., the European Union, and other markets worldwide. In January 2007, Actelion acquired CoTherix, Inc., whose product Ventavis(R) (iloprost) Inhalation Solution is approved and marketed in the United States for the treatment of patients with WHO Class III or IV PAH.


'/>"/>
SOURCE Actelion Pharmaceuticals US, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
2. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
3. New Study Shows That Extending Prophylaxis With Clexane / Lovenox (enoxaparin Sodium Injection) to 5 Weeks is More Effective Than 10 Days for Reducing the Risk of Venous Thromboembolism (VTE) in Acutely ill Medical Patients With Reduced Mobility
4. MediGene Announces Cancer-Fighting Virus Shows Promise in Early Clinical Trial
5. Study Shows Ixabepilone Demonstrated Clear Activity in Patients with Metastatic Breast Cancer Resistant to Anthracycline, Taxane, and Capecitabine
6. Ceragenix Compound Shows Promise for Treating Lethal Cystic Fibrosis Infections
7. Largest Cervical Cancer Vaccine Efficacy Trial Shows Cervarix Provides Excellent Protection Against Lesions Caused by Most Common Cancer-Causing Virus Types
8. CombinatoRx Product Candidate CRx-150 Shows Activity on DAS28 and Pain, but Not CRP
9. New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir
10. First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes
11. New Poll Shows Men, Women Incorrectly Blame Symptoms of Low Testosterone on Normal Aging
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... Los innovadores de COMBO[TM], ... introduce catéteres para la intervención de extremidades inferiores ... global especializada en el suministro de soluciones vasculares ... incluyendo productos para tratar la enfermedad arterial periférica. ... los dispositivos de primera entrada de la compañía ...
(Date:5/24/2016)... AMSTERDAM , May 24, 2016 Dutch ... their best practices around the world and treat patients on a ... Africa , Asia and the ... streaming with instant messaging and networking in a totally secure environment. ... Frontieres in a war zone working together with a surgeon at ...
(Date:5/23/2016)... , May 23, 2016 ... across 163 pages, profiles 12 companies and the Paclitaxel ... and figures on the industry and its players. ... is comprehensive in nature, details the current state of ... industry including definitions, classifications, applications and industry chain structure. ...
Breaking Medicine Technology:
(Date:5/24/2016)... ... May 24, 2016 , ... Loma Linda University Health (LLUH) ... hospital and expanded Children’s Hospital. Over 3,000 people looked on as the shovels hit ... the event photo slidehsow. , During the program, Richard H. Hart, MD, DrPH, ...
(Date:5/24/2016)... ... 2016 , ... Boyd Industries, a leading supplier of dental chairs and ... for pediatric dentistry , at AAPD 2016, the annual conference and trade show ... Concealed Delivery Unit keeps dental hand pieces and other anxiety-provoking pieces of the dental ...
(Date:5/24/2016)... ... 24, 2016 , ... A newly released report reveals that improving life outcomes ... resources, both in face-to-face interactions and online. In “Heard, Not Judged – Insights into ... creative use of mobile digital devices can be an effective tool to help boys ...
(Date:5/24/2016)... ... May 24, 2016 , ... Growing in popularity, more and more people continue ... available and easily accessible. Whether someone chooses to cut gluten out of their life ... King Kullen Grocery stocks their shelves with many different gluten-free products all year round. ...
(Date:5/24/2016)... ... 24, 2016 , ... American Gene Technologies International, Inc ... its board of directors. Otterstatter is co-founder, president and CEO of Preventice, ... that lead to broad-based healthcare solutions. , “Jon knows how to create disruptive ...
Breaking Medicine News(10 mins):