PMID- 16569546
OWN - NLM
STAT- MEDLINE
DCOM- 20060421
LR  - 20151119
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 151
IP  - 4
DP  - 2006 Apr
TI  - A randomized, placebo-controlled, double-blind, crossover study to evaluate the 
      efficacy of oral sildenafil therapy in severe pulmonary artery hypertension.
PG  - 851.e1-5
AB  - BACKGROUND: Severe pulmonary artery hypertension (PAH) is a disorder with limited 
      treatment options. Recently, several newer drugs have recently been introduced to 
      treat PAH. Sildenafil is one which has shown promise in several uncontrolled 
      studies, but controlled trials have been few. In this randomized 
      placebo-controlled study, we evaluated the efficacy of oral sildenafil in 
      idiopathic PAH and PAH caused by Eisenmenger syndrome. METHODS: This was a 
      randomized, double-blind, placebo-controlled crossover study. Twenty patients, 10 
      of each of idiopathic PAH and Eisenmenger syndrome, were randomized to receive 
      placebo or sildenafil in a double-blind manner for 6 weeks and, after a washout 
      period of 2 weeks, were crossed over. The primary end point of efficacy was the 
      improvement in distance covered in 6-minute walk test. Secondary end points were 
      reduction in pulmonary artery pressure as measured by Doppler echocardiography 
      after 6 weeks of treatment, improvement in clinical condition, New York Heart 
      Association (NYHA) class, and exercise duration and metabolic equivalents (Mets) 
      achieved on modified Bruce exercise protocol. RESULTS: There was significant 
      improvement in primary and secondary end points. The primary end point of 
      distance covered in 6-minute walk test improved from 262 +/- 99 to 358.9 +/- 96.5 
      m (P < .0001) after treatment with sildenafil. Pulmonary artery pressure, the 
      secondary end point, improved from the baseline of 98.8 +/- 20.5 to 78.3 +/- 15.3 
      mm Hg (P < .0001), NYHA class improved from 2.65 +/- 0.59 to 1.55 +/- 0.51 (P < 
      .0001), exercise duration from 6.4 +/- 3.1 to 10.2 +/- 2.05 minutes (P < .0001), 
      and Mets achieved from 3.32 +/- 1.57 to 6.04 +/- 1.87 (P < .0001) after treatment 
      with sildenafil. There was no significant fall in blood pressure with placebo and 
      sildenafil, and no serious side effects of drug were observed in the study. 
      CONCLUSIONS: Sildenafil significantly improved the symptomatic status, exercise 
      capacity, NYHA class, and hemodynamic parameters of patients with severe PAH and 
      can be safely used as a primary or adjunctive treatment of the same.
FAU - Singh, Tarvinder P
AU  - Singh TP
AD  - Department of Cardiology, Post Graduate Institute of Medical Education and 
      Research, Chandigarh, India. tpsinghtp@yahoo.co.in
FAU - Rohit, Manojkumar
AU  - Rohit M
FAU - Grover, Anil
AU  - Grover A
FAU - Malhotra, Samir
AU  - Malhotra S
FAU - Vijayvergiya, Rajesh
AU  - Vijayvergiya R
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Piperazines)
RN  - 0 (Purines)
RN  - 0 (Sulfones)
RN  - 0 (Vasodilator Agents)
RN  - BW9B0ZE037 (Sildenafil Citrate)
RN  - EC 3.1.4.35 (3',5'-Cyclic-GMP Phosphodiesterases)
SB  - IM
MH  - 3',5'-Cyclic-GMP Phosphodiesterases/antagonists & inhibitors
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Eisenmenger Complex/complications
MH  - Exercise Tolerance/drug effects
MH  - Female
MH  - Humans
MH  - Hypertension, Pulmonary/*drug therapy/etiology
MH  - Male
MH  - Middle Aged
MH  - Piperazines/*therapeutic use
MH  - Purines
MH  - Sildenafil Citrate
MH  - Sulfones
MH  - Vasodilator Agents/*therapeutic use
EDAT- 2006/03/30 09:00
MHDA- 2006/04/25 09:00
CRDT- 2006/03/30 09:00
PHST- 2005/04/07 00:00 [received]
PHST- 2005/09/09 00:00 [accepted]
PHST- 2006/03/30 09:00 [pubmed]
PHST- 2006/04/25 09:00 [medline]
PHST- 2006/03/30 09:00 [entrez]
AID - S0002-8703(05)00851-3 [pii]
AID - 10.1016/j.ahj.2005.09.006 [doi]
PST - ppublish
SO  - Am Heart J. 2006 Apr;151(4):851.e1-5. doi: 10.1016/j.ahj.2005.09.006.