Treatment of nonarteritic anterior ischemic optic neuropathy with an endothelin antagonist: ENDOTHELION (ENDOTHELin antagonist receptor in Ischemic Optic Neuropathy)—a multicentre randomised controlled trial protocol

Table 6 Adverse events and their frequency for bosentan

Organ class	Frequency	Adverse event
Haematologic and lymphatic system disorders	Frequent	Anaemia, decreased haemoglobin level
	Infrequent	Thrombocytopaenia^a neutropenia, leucopenia^a
	Undetermined frequency^a	Anaemia or decreased haemoglobin level requiring blood transfusion^a
Immune system disorders	Frequent	Hypersensitivity reactions (including dermatitis, pruritis and skin rash)^b
Immune system disorders	Rare	Anaphylaxis and/or angioedema^a.
Nervous system disorders	Very frequent	Headaches^c
Nervous system disorders	Frequent	Syncope^a,d
Ocular disorders	Undetermined frequency	Blurred vision
Cardiac disorders	Frequent	Palpitations^a,d
Vascular disorders	Frequent	Vasomotor symptoms, hypotension^a,d
Respiratory, thoracic and mediastinal disorders	Frequent	Nasal congestion^a
Gastro-intestinal disorders	Frequent	Gastro-oesophageal reflux, diarrhoea
Hepatobiliary disorders	Very frequent	Liver enzymes abnormality
	Infrequent	High liver aminotransferases associated with hepatitis (including possible aggravation of underlying hepatitis) and/or jaundice^a
	Rare	Liver cirrhosis, liver failure^a
Skin and subcutaneous tissue disorders	Frequent	Erythema
General disorders and abnormalities at administration site	Very frequent	Oedema, sodium and water retention^e

^aData from post-marketing authorisation of bosentan, frequencies are based on the statistical model of the clinical trial with controls versus placebo
^bHypersensitivity reactions have been reported in 9.9% of patients taking bosentan and 9.1% of patients on placebo
^cHeadaches have been reported in 11.5% of patients on bosentan and 9.8% of patients on placebo
^dThese types of reactions can also be caused by the underlying disease
^eEdemas or water/sodium retention have been reported in 13.2% of patients on bosentan and 10.9% of patients on placebo
Since market authorisation, rare cases of liver cirrhosis have been reported after prolonged bosentan treatment in multi-medicated patients presenting multiple co-morbidity factors. Rare cases of liver failure have also been reported. These cases underscore the importance of monthly monitoring of liver function throughout the bosentan treatment and the need to follow the above recommendations

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