Document Detail


Tadalafil monotherapy and as add-on to background bosentan in patients with pulmonary arterial hypertension.
MedLine Citation:
PMID:  21256048     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Tadalafil 40 mg orally once daily, was shown to be well-tolerated and efficacious for pulmonary arterial hypertension in a 16-week, double-blind, placebo (PBO)-controlled trial. Inclusion criteria included the option for background bosentan. Analyses of tadalafil in treatment-naive patients and as add-on to bosentan were pre-specified. Objectives were to provide safety and efficacy data for both groups.
METHODS: Groups analyzed included: treatment-naive + PBO; treatment-naive + tadalafil; background bosentan + PBO; and background bosentan + tadalafil. Patients randomized to tadalafil or PBO (N = 405) were analyzed by bosentan use (yes = 216, no = 189). Treatment differences in 6-minute walk distance (6MWD, PBO-adjusted), functional class (FC), clinical worsening (CW) and adverse events were assessed. Hazard ratios (HRs) with 95% confidence intervals (CIs) are presented for FC and CW.
RESULTS: At Week 16, PBO-adjusted 6MWD increases were 44 m (CI: 20 to 69 m; n = 37) for tadalafil 40 mg in treatment-naive patients and 23 m (CI: -2 to 48 m; n = 42) for tadalafil 40 mg add-on to bosentan. The 6MWD for treatment-naive and background bosentan PBO patients decreased by 3 m and increased by 19 m, respectively, at Week 16 compared with baseline. Two (5%) treatment-naive patients had CW with tadalafil 40 mg vs 8 (22%) with PBO (HR = 3.3, CI: 1.1 to 10.0). Two (5%) background bosentan patients had CW with tadalafil 40 mg add-on vs 5 (11%) for PBO add-on (HR = 1.9, CI: 0.4 to 10.2). Adverse events for tadalafil monotherapy and as add-on were similar.
CONCLUSION: Tadalafil 40 mg was well-tolerated and provided clinical benefit in patients as monotherapy. It was also well-tolerated when added to background bosentan, but data are insufficient to conclude additional benefit.
Authors:
Robyn J Barst; Ronald J Oudiz; Anthony Beardsworth; Bruce H Brundage; Gerald Simonneau; Hossein A Ghofrani; David P Sundin; Nazzareno Galiè;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2011-01-21
Journal Detail:
Title:  The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation     Volume:  30     ISSN:  1557-3117     ISO Abbreviation:  J. Heart Lung Transplant.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-10     Completed Date:  2011-08-26     Revised Date:  2013-06-18    
Medline Journal Info:
Nlm Unique ID:  9102703     Medline TA:  J Heart Lung Transplant     Country:  United States    
Other Details:
Languages:  eng     Pagination:  632-43     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Pediatrics and Medicine, Columbia University, New York, New York, USA. robyn.barst@gmail.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antihypertensive Agents / adverse effects,  therapeutic use*
Carbolines / adverse effects,  therapeutic use*
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Hypertension, Pulmonary / drug therapy*
Male
Middle Aged
Sulfonamides / adverse effects,  therapeutic use*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antihypertensive Agents; 0/Carbolines; 0/Sulfonamides; 0/tadalafil; Q326023R30/bosentan
Investigator
Investigator/Affiliation:
N Galie / ; Z Safdar / ; S Shapiro / ; R J White / ; R J Barst / ; E Rosenzweig / ; R Girgis / ; F Grimminger / ; A Ghofrani / ; W Seeger / ; J Feldman / ; G Simonneau / ; J Klinger / ; V Cottin / ; J Granton / ; N Nakanishi / ; G Staehler / ; S Mehta / ; G Coghlan / ; D Ostrow / ; D Badesch / ; J Behr / ; L Bruch / ; H Farber / ; T Mubarak / ; C Lawrence / ; C Markin / ; O Minai / ; G Saydain / ; M Widmer / ; B Degano / ; S Fazio / ; M Gomberg-Maitland / ; D Langleben / ; J Meyer / ; J Michaelson / ; E Michelakis / ; R Naeije / ; A Peacock / ; B Rayburn / ; M Chakinala / ; St Louis / ; T DeMarco / ; F Fedele / ; R Frantz / ; M A Gomez-Sanchez / ; D Helmersen / ; P Hernandez / ; A Hurewitz / ; A Waxman / ; D Baratz / ; C Campana / ; E Hachulla / ; N Hill / ; S Knoper / ; K Kusano / ; M Mathier / ; S Murali / ; S Ogawa / ; J Pepke-Zaba / ; J Barbera / ; R Oudiz / ; J Beckman / ; D Camanga / ; Z Bshouty / ; M Delcroix / ; R Ewert / ; J Gossage / ; F Grimminger / ; H Matsubara / ; O Miera / ; M Mizoguchi / ; M Pfeifer / ; M Reynaud-Gaubert / ; H Watanabe / ; D Zwicke / ; P Corris / ; G Elliott / ; H Endo / ; P Fairman / ; S Gaine / ; D Kiely / ; Y Kihara / ; H Kuraishi / ; P Morales-Martin / ; J Suzuki / ; Y Takeda / ; T Ziedalski /

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