Long-term use of sildenafil in inoperable chronic thromboembolic pulmonary hypertension.
Chest
; 134(2): 229-236, 2008 Aug.
Article
em En
| MEDLINE
| ID: mdl-18263674
ABSTRACT
BACKGROUND:
There are currently no licensed medical therapies for inoperable chronic thromboembolic pulmonary hypertension (CTEPH).METHODS:
In this double-blind, placebo-controlled pilot study, 19 subjects with inoperable CTEPH were randomly assigned to sildenafil or placebo for 12 weeks. The primary end point was change in 6-min walking distance (6MWD). Secondary end points included changes in World Health Organization (WHO) class, cardiopulmonary hemodynamics, quality of life (QOL) scores, and N-terminal pro brain natriuretic peptide (NT-proBNP). All subjects were transferred to open-label sildenafil at the end of the study and offered repeat assessment at 12 months.RESULTS:
There were no significant differences between the two groups with respect to change in exercise capacity. However significant improvements were seen in WHO class and pulmonary vascular resistance (PVR). Seventeen subjects were eligible for reassessment at 12 months and demonstrated significant improvements in 6MWD, activity and symptom components of QOL, cardiac index, PVR, and NT-proBNP.CONCLUSIONS:
Although this pilot study was insufficiently powered to test the primary end point, it did suggest beneficial effects in favor of sildenafil in several secondary end points at both 3 months and 12 months. Further larger-scale trials of sildenafil in inoperable CTEPH are required to confirm these findings and potentially increase the treatment options available for this devastating disease. TRIAL REGISTRATION The study protocol was registered with the UK National Research Register database (publication ID N0542136603).
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piperazinas
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Embolia Pulmonar
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Sulfonas
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Vasodilatadores
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Hipertensão Pulmonar
Tipo de estudo:
Clinical_trials
/
Etiology_studies
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Guideline
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2008
Tipo de documento:
Article