Document Detail

The efficacy and tolerability of sildenafil in patients with moderate-to-severe pulmonary hypertension.
MedLine Citation:
PMID:  12760589     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous infusion of prostacyclin has proved effective. However, it carries the risk of serious complications arising from the complex delivery system. Prostacyclin analogs, endothelin antagonists, and the phosphodiesterase-5 inhibitor sildenafil are emerging promising therapies. This study was aimed at evaluating the utility of oral sildenafil in patients with pulmonary hypertension of varied etiology, poorly controlled on conventional treatment. METHODS AND RESULTS: Ten consecutive patients with pulmonary hypertension, either primary or related to previous left-to-right shunts, thromboembolism, or interstitial lung disease, poorly controlled on conventional therapy such as warfarin, calcium antagonists, digitalis, and diuretics, were included. A thorough clinical, laboratory, and comprehensive echo Doppler evaluation was performed before enrollment in the trial to establish the diagnosis and obtain baseline data. Subjects received sildenafil 25 mg 8 hourly, or a matching placebo for two weeks each, in a randomized, double-blind, crossover design. A run-in period of two weeks was permitted between the two therapies during which patients continued to receive the conventional therapy without any vasodilator. At the end of each therapy period, the patients were evaluated for symptoms, New York Heart Association class, distance covered during the 6 min walk test, rating of modified Borg dyspnea score, and systolic pulmonary artery pressure using echo Doppler. The differences in the above variables at the end of sildenafil and placebo therapies were compared. Nine patients completed the study protocol. Sildenafil, compared to placebo, was associated with improved exercise tolerance as determined by the 6 min walk test (266.67+/-131.45 m v. 170+/-105 m; p<0.005), decrease in modified Borg dyspnea score (3.56+/-1.01 v. 5.11+/-1.45; p<0.01), decrease in Doppler-estimated pulmonary artery systolic pressures (55.33+/-16.52 mmHg v. 75.33+/-19.75 mmHg; p<0.005), improvement in New York Heart Association class (2 patients), and improvement in symptoms. Sildenafil was well tolerated with no untoward effects; further, no significant changes in heart rate or blood pressure occurred during the study period. CONCLUSIONS: Sildenafil improves exercise capacity and symptoms, and decreases pulmonary artery pressures in patients with primary or secondary pulmonary hypertension of varied etiology.
Anil Bharani; Vivek Mathew; Ashutosh Sahu; Basant Lunia
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Indian heart journal     Volume:  55     ISSN:  0019-4832     ISO Abbreviation:  Indian Heart J     Publication Date:    2003 Jan-Feb
Date Detail:
Created Date:  2003-05-22     Completed Date:  2003-09-03     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0374675     Medline TA:  Indian Heart J     Country:  India    
Other Details:
Languages:  eng     Pagination:  55-9     Citation Subset:  IM    
Division of Cardiology, Department of Medicine, M.G.M. Medical College and M.Y. Hospital, Indore.
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MeSH Terms
3',5'-Cyclic-GMP Phosphodiesterases / antagonists & inhibitors*
Cross-Over Studies
Double-Blind Method
Hypertension, Pulmonary / drug therapy*
Middle Aged
Phosphodiesterase Inhibitors / therapeutic use*
Piperazines / therapeutic use*
Prospective Studies
Reg. No./Substance:
0/Phosphodiesterase Inhibitors; 0/Piperazines; 0/Purines; 0/Sulfones; 139755-83-2/sildenafil; EC',5'-Cyclic-GMP Phosphodiesterases
Comment In:
Indian Heart J. 2003 May-Jun;55(3):285; author reply 285   [PMID:  14560947 ]

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