Document Detail


Hospitalization for pain in patients with sickle cell disease treated with sildenafil for elevated TRV and low exercise capacity.
MedLine Citation:
PMID:  21527519     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In adults with sickle cell disease (SCD), an increased tricuspid regurgitation velocity (TRV) by Doppler echocardiography is associated with increased morbidity and mortality. Although sildenafil has been shown to improve exercise capacity in patients with pulmonary arterial hypertension, it has not been evaluated in SCD. We therefore sought to determine whether sildenafil could improve exercise capacity in SCD patients with increased TRV and a low exercise capacity. A TRV ≥ 2.7 m/s and a 6-minute walk distance (6MWD) between 150 and 500 m were required for enrollment in this 16-week, double-blind, placebo-controlled sildenafil trial. After 74 of the screened subjects were randomized, the study was stopped early due to a higher percentage of subjects experiencing serious adverse events in the sildenafil arm (45% of sildenafil, 22% of placebo, P = .022). Subject hospitalization for pain was the predominant cause for this difference: 35% with sildenafil compared with 14% with placebo (P = .029). There was no evidence of a treatment effect on 6MWD (placebo-corrected effect -9 m; 95% confidence interval [95% CI] -56-38; P = .703), TRV (P = .503), or N-terminal pro-brain natriuretic peptide (P = .410). Sildenafil appeared to increase hospitalization rates for pain in patients with SCD. This study is registered at www.clinicaltrials.gov as NCT00492531.
Authors:
Roberto F Machado; Robyn J Barst; Nancy A Yovetich; Kathryn L Hassell; Gregory J Kato; Victor R Gordeuk; J Simon R Gibbs; Jane A Little; Dean E Schraufnagel; Lakshmanan Krishnamurti; Reda E Girgis; Claudia R Morris; Erika B Rosenzweig; David B Badesch; Sophie Lanzkron; Onyinye Onyekwere; Oswaldo L Castro; Vandana Sachdev; Myron A Waclawiw; Rob Woolson; Jonathan C Goldsmith; Mark T Gladwin;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.     Date:  2011-04-28
Journal Detail:
Title:  Blood     Volume:  118     ISSN:  1528-0020     ISO Abbreviation:  Blood     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-07-29     Completed Date:  2011-10-14     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  7603509     Medline TA:  Blood     Country:  United States    
Other Details:
Languages:  eng     Pagination:  855-64     Citation Subset:  AIM; IM    
Affiliation:
University of Illinois, Chicago, IL, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00492531
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MeSH Terms
Descriptor/Qualifier:
Anemia, Sickle Cell / complications,  drug therapy*
Double-Blind Method
Exercise Tolerance / drug effects*
Female
Hemodynamics / drug effects
Hospitalization
Humans
Male
Middle Aged
Pain / chemically induced*
Piperazines / adverse effects*
Purines / adverse effects
Sulfones / adverse effects*
Tricuspid Valve Insufficiency / drug therapy,  etiology
Vasodilator Agents / adverse effects*
Grant Support
ID/Acronym/Agency:
K23HL083089-03/HL/NHLBI NIH HHS; UL1 RR024131/RR/NCRR NIH HHS; ZIA HL005116-03/HL/NHLBI NIH HHS; ZIA HL005116-04/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Piperazines; 0/Purines; 0/Sulfones; 0/Vasodilator Agents; 3M7OB98Y7H/sildenafil
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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