Pharmacokinetic and clinical profile of a novel formulation of bosentan in children with pulmonary arterial hypertension: The FUTURE-1 study

British Journal of Clinical Pharmacology

Volumn 68, Issue 6, 2009, Pages 948-955

  Beghetti, Maurice ^a   Haworth, Sheila G ^b   Bonnet, Damien ^c   Barst, Robyn J ^d   Acar, Philippe ^e   Fraisse, Alain ^f   Ivy, Dunbar D ^g   Jais, Xavier ^h   Schulze Neick, Ingram ⁱ   Galiè, Nazzareno ^j   Morganti, Adele ^k   Dingemanse, Jasper ^k   Kusic Pajic, Andjela ^k   Berger, Rolf M F ^l  

^a UNIVERSITY OF GENEVA   (Switzerland)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c HÔPITAL NECKER ENFANTS MALADES   (France)

^d HÔPITAL DES ENFANTS   (France)

^e TIMONE HOSPITAL   (France)

^f HÔPITAL ANTOINE BÉCLÈRE   (France)

^g Och Spine at New York Presbyterian Hospitals   (United States)

^h Children's Hospital   (United States)

ⁱ DEUTSCHES HERZZENTRUM BERLIN   (Germany)

^j UNIVERSITY OF BOLOGNA   (Italy)

^k ACTELION PHARMACEUTICALS LTD   (Switzerland)

^l UNIVERSITY OF GRONINGEN   (Netherlands)

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Author keywords

Bosentan; Children; Paediatric formulation; Pharmacokinetics; Pulmonary arterial hypertension

Indexed keywords

BOSENTAN; CALCIUM CHANNEL BLOCKING AGENT; DRUG METABOLITE; ILOPROST; PROSTACYCLIN; RO 48 5033; RO 64 1056; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; AGGRESSION; ANEMIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BACTERIAL INFECTION; BRONCHITIS; CHILD; CLINICAL ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DRUG ABSORPTION; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EAR INFECTION; FATIGUE; FEMALE; FLUSHING; HEADACHE; HUMAN; HYPERTENSION; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NOSE CONGESTION; PAIN; PLASMA CONCENTRATION-TIME CURVE; PRESCHOOL CHILD; PRIORITY JOURNAL; PULMONARY HYPERTENSION; SCHOOL CHILD; SIDE EFFECT; THORAX PAIN; TIME TO MAXIMUM PLASMA CONCENTRATION; TONSILLITIS; TREATMENT RESPONSE; VIRUS INFECTION; WORLD HEALTH ORGANIZATION;

ADULT; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; HYPERTENSION, PULMONARY; MALE; SULFONAMIDES;

EID: 70849089564     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2009.03532.x     Document Type: Article

References (22)

1. Rubin LJ. Primary pulmonary hypertension. N Engl J Med 1997 336 : 111 7.
2. Farber HW, Loscalzo J. Pulmonary arterial hypertension. N Engl J Med 2004 351 : 1655 65.
3. Haworth SG. The management of pulmonary hypertension in children. Arch Dis Child 2008 93 : 620 5.
4. Rosenzweig EB, Barst RJ. Pulmonary arterial hypertension in children: a medical update. Curr Opin Pediatr 2008 20 : 288 93.
5. Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, Levy PS, Pietra GG, Reid LM, Reeves JT, Rich S, Vreim CE, Williams GW, Wu M. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med 1991 115 : 343 9.
6. Beghetti M, Hoeper MM, Kiely DG, Carlsen J, Schwierin B, Segal ES, Humbert M. Safety experience with bosentan in 146 children 2-11 years with pulmonary arterial hypertension: Results from the European post-marketing surveillance program. Pediatr Res 2008 64 : 200 4.
7. Rich S, Dantzker DR, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Koerner SK, Levy PC, Reid LM, Vreim CE, Williams GW. Primary pulmonary hypertension. A national prospective study. Ann Intern Med 1987 107 : 216 23. (Pubitemid 17137857)
8. Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary hypertension. N Engl J Med 2004 351 : 1425 36.
9. Rosenzweig EB, Ivy DD, Widlitz A, Doran A, Claussen LR, Yung D, Abman SH, Morganti A, Nguyen N, Barst RJ. Effects of long-term bosentan in children with pulmonary arterial hypertension. J Am Coll Cardiol 2005 46 : 697 704.
10. Lammers A, Hislop A, Flynn Y, Haworth SG. Epoprostenol treatment in children with severe pulmonary hypertension. Heart 2007 93 : 739 43.
11. Dingemanse J, van Giersbergen PLM. Clinical pharmacology of bosentan, a dual endothelin receptor antagonist. Clin Pharmacokinet 2004 43 : 1089 115.
12. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Tripartite Harmonised Guideline. Clinical Investigation of Medicinal Products in the Pediatric Population, E11. Fed Regist 2000 65 : 19777 81.
13. Barst RJ, Ivy D, Dingemanse J, Widlitz A, Schmitt K, Doran A, Bingaman D, Nguyen N, Gaitonde M, van Giersbergen PLM. Pharmacokinetics, safety, and efficacy of bosentan in pediatric patients with pulmonary arterial hypertension. Clin Pharmacol Ther 2003 73 : 372 82.
14. Dell D, Lausecker B, Hopfgartner G, van Giersbergen PLM, Dingemanse J. Evolving bioanalytical methods for the cardiovascular drug bosentan. Chromatographia 2002 55 (Suppl. S115 9.
15. Turner-Bowker DM, Bayliss MS, Kosinski M, Zhao J, Saris-Baglama RN. SF-10 for Children™: A User's Guide. Lincoln, RI : QualityMetric Incorporated, 2003.
16. Guy W, ed. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD : US Department of Health, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, 1976.
17. Weber C, Schmitt R, Birnboeck H, Hopfgartner G, Eggers H, Meyer J, van Marle S, Viischer HW, Jonkman JH. Multiple-dose pharmacokinetics, safety, and tolerability of bosentan, an endothelin receptor antagonist, in healthy male volunteers. J Clin Pharmacol 1999 39 : 703 14.
18. Dingemanse J, Bodin F, Weidekamm E, Kutz K, van Giersbergen P. Influence of food intake and formulation on the pharmacokinetics and metabolism of bosentan, a dual endothelin receptor antagonist. J Clin Pharmacol 2002 42 : 283 9. (Pubitemid 34163474)
19. Channick RN, Simonneau G, Sitbon O, Robbins IM, Frost A, Tapson VF, Badesch DB, Roux S, Rainisio M, Bodin F, Rubin LJ. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet 2001 358 : 1119 23. (Pubitemid 32971843)
20. Maiya S, Hislop AA, Flynn Y, Haworth SG. Response to bosentan in children with pulmonary hypertension. Heart 2006 92 : 664 70.
21. Summary of Product Characteristics Tracleer®. Actelion Pharmaceuticals Ltd., 15 May 2007.
22. Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 2002 346 : 896 903. (Pubitemid 34984638)