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LETTER TO EDITOR Table of Contents   
Year : 2008  |  Volume : 11  |  Issue : 2  |  Page : 138
Hidden hazards of Bosentan therapy in pulmonary hypertension


Department of Anaesthesiology & Intensive Care, GB Pant Hospital, Delhi, India and Intensive Care Unit, Lyell Mcewin Hospital, South Australia 5082, Australia

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How to cite this article:
Sethi S, Sethi R, Wareham C. Hidden hazards of Bosentan therapy in pulmonary hypertension. Ann Card Anaesth 2008;11:138

How to cite this URL:
Sethi S, Sethi R, Wareham C. Hidden hazards of Bosentan therapy in pulmonary hypertension. Ann Card Anaesth [serial online] 2008 [cited 2020 Aug 3];11:138. Available from: http://www.annals.in/text.asp?2008/11/2/138/41593


The Editor,

We read with interest the review article on the "Current status of Bosentan for the treatment of pulmonary hypertension (PAH)", [1] published in the January 2008 issue of your journal. While we appreciate all the benefits of bosentan, the potential demerits associated with its use must not be overlooked.

Bosentan has hepatotoxic potential [2] and may cause up to eight-fold elevation in hepatic enzyme levels. [3] Mortality has also been reported with bosentan therapy, [3] the cause being attributed either to cardiac failure or respiratory complications. Patients with PAH may have subclinical hepatic dysfunction secondary to congestive hepatopathy. [4] Given the potential hepatotoxicity of the drug, the use of bosentan may be questionable in such sub-group of patients.

Perinatal use of bosentan has been associated with the occurrence of major birth defects. [2] Moreover, bosentan decreases the efficacy of hormonal contraceptive agents, necessitating the use of supplemental protection.

Trials conducted on bosentan also have certain limitations, as patients with PAH secondary to portal hypertension or human immunodeficiency virus infections have not been studied adequately. Although there is only one reported clinical experience of bosentan therapy for porto-pulmonary hypertension with a sample size of 11, [5] the validity of the drug in larger number of patients with advanced liver disease is debatable. Also, there is no study evaluating the long-term safety and efficacy of the drug or demonstrating the improved survival.

The references quoted in your review refer to randomised placebo-controlled studies. It would be a good idea to conduct randomised prospective trials with other well-established treatment options to evaluate the risk-benefit ratio before drawing any firm conclusions. Alternatively, bearing in mind the chronic course of PAH, cross-over studies may produce clearer evidence of benefit.

 
   References Top

1.Raja SG, Dreyfus GD. Current status of bosentan for treatment of pulmonary hypertension. Ann Card Anaesth 2008;11:6-14.  Back to cited text no. 1  [PUBMED]  [FULLTEXT]
2.Kenyon KW, Nappi JM. Bosentan for the treatment of pulmonary arterial hypertension. Ann Pharmacother 2003;37:1055-62.  Back to cited text no. 2  [PUBMED]  [FULLTEXT]
3.Rubin LJ, Badesch DB, Barst RG, Nazzareno G, Black CM, Keogh A, et al . Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002;346:896- 903  Back to cited text no. 3    
4.Krowka MJ. Hepatopulmonary syndrome and portopulmonary hypertension: Distinctions and dilemmas. Hepatology 1997;25:1282-4.  Back to cited text no. 4  [PUBMED]  [FULLTEXT]
5.Hoeper MM, Halank M, Marx C, Hoeffken G, Seyfarth HJ, Schauer J et al . Bosentan therapy for portopulmonary hypertension. Eur Respir J 2005;25:502-8.  Back to cited text no. 5    

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Correspondence Address:
Swati Sethi
30, Rose Street, Prospect, South Australia 5082
Australia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0971-9784.41593

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