Unique Surveillance Programme Confirms The Clinical Safety Of Bosentan In Pulmonary Arterial Hypertension

Main Category: Respiratory / Asthma
Also Included In: Cardiovascular / Cardiology;  Blood / Hematology
Article Date: 26 Jul 2007 - 15:00 PDT

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The safety profile of bosentan (Tracleer®), an endothelin receptor antagonist approved for the treatment of pulmonary arterial hypertension (PAH), has been confirmed in a unique large-scale pan-European surveillance programme, according to a study undertaken by Marc Humbert (Antoine Beclere Hospital, Clamart, France) and his colleagues.

PAH, an orphan disease, is a serious and life-limiting condition characterised by vascular remodelling and a progressive increase in pulmonary vascular resistance, which can ultimately lead to right ventricular failure and premature death. Endothelin, a pathogenic mediator of PAH, contributes to these cardiopulmonary vascular and structural changes. Bosentan blocks the harmful effects of endothelin.

The unique two and a half year web-based surveillance programme generated real-world data from almost 5,000 bosentan-treated patients from 17 countries across Europe. This represents almost 80% of all people treated with the drug between May 2002 and November 2004.

These results suggest that a post-marketing surveillance programme is a useful tool to confirm the safety profile of drugs approved for the treatment of orphan diseases.

The surveillance programme had three aims:

- Educate doctors on the appropriate use of bosentan and encourage reporting of adverse drug reactions
- Analyse frequency of potential adverse events outside a controlled clinical trial setting
- Assess the practicality and appropriate use of the protocol for managing increased liver enzyme levels.

Compared with clinical trial data, no new safety issues arose. The increase in liver enzyme levels observed in this programme, covering 3,416 patient-years of treatment, matches that originally seen in the clinical trial setting with 59 patient-years of treatment.

After more than two years of monitoring nearly 5,000 patients, the bosentan surveillance programme is now successfully completed.

European Respiratory Journal