PMID- 21527519
OWN - NLM
STAT- MEDLINE
DCOM- 20111014
LR  - 20220408
IS  - 1528-0020 (Electronic)
IS  - 0006-4971 (Print)
IS  - 0006-4971 (Linking)
VI  - 118
IP  - 4
DP  - 2011 Jul 28
TI  - Hospitalization for pain in patients with sickle cell disease treated with 
      sildenafil for elevated TRV and low exercise capacity.
PG  - 855-64
LID - 10.1182/blood-2010-09-306167 [doi]
AB  - 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.
FAU - Machado, Roberto F
AU  - Machado RF
AD  - University of Illinois, Chicago, IL, USA.
FAU - Barst, Robyn J
AU  - Barst RJ
FAU - Yovetich, Nancy A
AU  - Yovetich NA
FAU - Hassell, Kathryn L
AU  - Hassell KL
FAU - Kato, Gregory J
AU  - Kato GJ
FAU - Gordeuk, Victor R
AU  - Gordeuk VR
FAU - Gibbs, J Simon R
AU  - Gibbs JS
FAU - Little, Jane A
AU  - Little JA
FAU - Schraufnagel, Dean E
AU  - Schraufnagel DE
FAU - Krishnamurti, Lakshmanan
AU  - Krishnamurti L
FAU - Girgis, Reda E
AU  - Girgis RE
FAU - Morris, Claudia R
AU  - Morris CR
FAU - Rosenzweig, Erika B
AU  - Rosenzweig EB
FAU - Badesch, David B
AU  - Badesch DB
FAU - Lanzkron, Sophie
AU  - Lanzkron S
FAU - Onyekwere, Onyinye
AU  - Onyekwere O
FAU - Castro, Oswaldo L
AU  - Castro OL
FAU - Sachdev, Vandana
AU  - Sachdev V
FAU - Waclawiw, Myron A
AU  - Waclawiw MA
FAU - Woolson, Rob
AU  - Woolson R
FAU - Goldsmith, Jonathan C
AU  - Goldsmith JC
FAU - Gladwin, Mark T
AU  - Gladwin MT
CN  - walk-PHaSST Investigators and Patients
LA  - eng
SI  - ClinicalTrials.gov/NCT00492531
GR  - UL1 RR024131/RR/NCRR NIH HHS/United States
GR  - ZIA HL005116-03/ImNIH/Intramural NIH HHS/United States
GR  - ZIA HL005116-04/ImNIH/Intramural NIH HHS/United States
GR  - K23HL083089-03/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20110428
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 0 (Piperazines)
RN  - 0 (Purines)
RN  - 0 (Sulfones)
RN  - 0 (Vasodilator Agents)
RN  - BW9B0ZE037 (Sildenafil Citrate)
SB  - IM
MH  - Anemia, Sickle Cell/complications/*drug therapy
MH  - Double-Blind Method
MH  - Exercise Tolerance/*drug effects
MH  - Female
MH  - Hemodynamics/drug effects
MH  - Hospitalization
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain/*chemically induced
MH  - Piperazines/*adverse effects
MH  - Purines/adverse effects
MH  - Sildenafil Citrate
MH  - Sulfones/*adverse effects
MH  - Tricuspid Valve Insufficiency/drug therapy/etiology
MH  - Vasodilator Agents/*adverse effects
PMC - PMC3148167
EDAT- 2011/04/30 06:00
MHDA- 2011/10/15 06:00
PMCR- 2012/07/28
CRDT- 2011/04/30 06:00
PHST- 2011/04/30 06:00 [entrez]
PHST- 2011/04/30 06:00 [pubmed]
PHST- 2011/10/15 06:00 [medline]
PHST- 2012/07/28 00:00 [pmc-release]
AID - S0006-4971(20)44674-9 [pii]
AID - 2010/306167 [pii]
AID - 10.1182/blood-2010-09-306167 [doi]
PST - ppublish
SO  - Blood. 2011 Jul 28;118(4):855-64. doi: 10.1182/blood-2010-09-306167. Epub 2011 
      Apr 28.