Long-term follow-up confirms safety profile of bosentan
Long-term follow-up of almost 5,000 patients with pulmonary arterial hypertension (PAH) treated with the endothelin receptor antagonist bosentan revealed a good safety profile with a low risk of liver function abnormalities.
Data from 3,416 patient-years of treatment collected between May 2002
and November 2004, with an average treatment duration of 30.6 weeks (20
per cent >= 1 year), showed that the safety profile of bosentan in
routine clinical practice was consistent with that reported previously
in clinical trials.
Results, presented this week at the American
Thoracic Society’s
meeting in San Diego, showed no safety signal in 69 per cent of patients.
Liver enzyme monitoring showed elevated alanine aminotransferase or aspartate
aminotransferase or both in 7.7 per cent of patients compared with 11
per cent as seen in clinical trials. The likelihood of developing a first
aminotransferase elevation also decreased over time.
Most patients were able to continue bosentan when it was retried after
being stopped because of raised liver enzymes. No case of permanent liver
damage was linked to bosentan.
David Kiely, director of the Sheffield Pulmonary Vascular Disease Unit
based at the Royal Hallamshire Hospital, and co-ordinator of the bosentan
monitoring programme in the UK, said: “The data confirm the safety
profile of bosentan in patients with PAH in routine clinical practice,
in addition to the proven efficacy of this drug in the treatment of this
life-threatening disease.” |
The
Pharmaceutical Journal
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