Safety experience with bosentan in 146 children 2-11 years old with pulmonary arterial hypertension: Results from the european postmarketing surveillance program

Pediatric Research

Volumn 64, Issue 2, 2008, Pages 200-204

  Beghetti, Maurice ^a,h   Hoeper, Marius M ^b   Kiely, David G ^c   Carlsen, Joern ^d   Schwierin, Barbara ^e   Segal, Eleanor S ^f   Humbert, Marc ^g  

^a GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^b HANNOVER MEDICAL SCHOOL   (Germany)

^c ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^d Rigshospitalet   (Denmark)

^e Global Medical Science and Communication   (Switzerland)

^f ACTELION PHARMACEUTICALS LTD   (Switzerland)

^g HÔPITAL ANTOINE BÉCLÈRE   (France)

^h Hopital des Enfants Hopitaux universitaires de Geneve   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOTRANSFERASE; ANTICOAGULANT AGENT; BOSENTAN; CALCIUM CHANNEL BLOCKING AGENT; DIGOXIN; DIURETIC AGENT; PROSTANOID; SILDENAFIL; ANTIHYPERTENSIVE AGENT; SULFONAMIDE;

ADOLESCENT; ADULT; ARTICLE; CARDIOMYOPATHY; CHILD; CONGENITAL HEART DISEASE; CONTROLLED STUDY; DATA BASE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEART FAILURE; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; POSTMARKETING SURVEILLANCE; PRESCHOOL CHILD; PRIORITY JOURNAL; PULMONARY HYPERTENSION; SCHOOL CHILD; SIDE EFFECT; THROMBUS; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; ENZYMOLOGY; EUROPE; LIVER; LONGITUDINAL STUDY; METABOLISM;

ANTIHYPERTENSIVE AGENTS; CHILD; CHILD, PRESCHOOL; EUROPE; FEMALE; HUMANS; HYPERTENSION, PULMONARY; LIVER; LONGITUDINAL STUDIES; MALE; PRODUCT SURVEILLANCE, POSTMARKETING; SULFONAMIDES; TRANSAMINASES;

EID: 52649178334     PISSN: 00313998     EISSN: 15300447     Source Type: Journal    
DOI: 10.1203/PDR.0b013e318179954c     Document Type: Article

References (19)

1. Rubin LJ 1997 Primary pulmonary hypertension. N Engl J Med 336:111-117
2. Humbert M, Morrell NW, Archer SL, Stenmark KR, MacLean MR, Lang IM, Christman BW, Weir EK, Eickelberg O, Voelkel NF, Rabinovitch M 2004 Cellular and molecular pathobiology of pulmonary arterial hypertension. J Am Coll Cardiol 43:13S-24S
3. Widlitz A, Barst RJ 2003 Pulmonary arterial hypertension in children. Eur Respir J 21:155-176
4. Yung D, Widlitz AC, Rosenzweig EB, Kerstein D, Maislin G, Barst RJ 2004 Outcomes in children with idiopathic pulmonary arterial hypertension. Circulation 110:660-665
5. Lammers AE, Hislop AA, Flynn Y, Haworth SG 2007 Epoprostenol treatment in children with severe pulmonary hypertension. Heart 93:739 -743
6. Barst RJ, Maislin G, Fishman AP 1999 Vasodilator therapy for primary pulmonary hypertension in children. Circulation 99:1197-1208
7. Barst RJ, Galie N, Naeije R, Simonneau G, Jeffs R, Arneson C, Rubin LJ 2006 Long-term outcome in pulmonary arterial hypertension patients treated with subcutaneous treprostinil. Eur Respir J 28:1195-1203
8. Channick RN, Simonneau G, Sitbon O, Robbins IM, Frost A, Tapson VF, Badesch DB, Roux S, Rainisio M, Bodin F, Rubin LJ 2001 Effects of the dual endothelin- receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet 358:1119 -1123
9. Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G 2002 Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 346:896 -903
10. Sitbon O, Badesch DB, Channick RN, Frost A, Robbins IM, Simonneau G, Tapson VF, Rubin LJ 2003 Effects of the dual endothelin receptor antagonist bosentan in patients with pulmonary arterial hypertension: a 1-year follow-up study. Chest 124:247-254
11. McLaughlin VV, Sitbon O, Badesch DB, Barst RJ, Black C, Galie N, Rainisio M, Simonneau G, Rubin LJ 2005 Survival with first-line bosentan in patients with primary pulmonary hypertension. Eur Respir J 25:244-249
12. Barst RJ, Ivy D, Dingemanse J, Widlitz A, Schmitt K, Doran A, Bingaman D, Nguyen N, Gaitonde M, van Giersbergen PL 2003 Pharmacokinetics, safety, and efficacy of bosentan in pediatric patients with pulmonary arterial hypertension. Clin Pharmacol Ther 73:372-382
13. Rosenzweig EB, Ivy DD, Widlitz A, Doran A, Claussen LR, Yung D, Abman SH, Morganti A, Nguyen N, Barst RJ 2005 Effects of long-term bosentan in children with pulmonary arterial hypertension. J Am Coll Cardiol 46:697-704
14. Maiya S, Hislop AA, Flynn Y, Haworth SG 2006 Response to bosentan in children with pulmonary hypertension. Heart 92:664-670
15. Segal ES, Valette C, Oster L, Bouley L, Edfjall C, Herrmann P, Raineri M, Kempff M, Beacham S, van Lierop C 2005 Risk management strategies in the postmarketing period: safety experience with the US and European bosentan surveillance programmes. Drug Saf 28:971-980
16. Humbert M, Segal ES, Kiely DG, Carlsen J, Schwierin B, Hoeper MM 2007 Results of European post-marketing surveillance of bosentan in pulmonary hypertension. Eur Respir J 30:338 -344
17. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 2000 ICH Tripartite Harmonised Guideline: Clinical Investigation of Medicinal Products in the Pediatric Population. E11. Federal Register 65:19777-19781
18. Haworth SG 1998 Primary pulmonary hypertension in children. Arch Dis Child 79:452-455
19. Strom BL, Tugwell P 1990 Pharmacoepidemiology: current status, prospects, and problems. Ann Intern Med 113:179 -181